%0 Journal Article %@ 1438-8871 %I JMIR Publications %V 27 %N %P e66815 %T Integrating a Mobile App to Enhance Atrial Fibrillation Care: Key Insights From an Implementation Study Guided by the Consolidated Framework for Implementation Research %A Hewage,Sumudu %A Kularatna,Sanjeewa %A Parsonage,William %A Walters,Tomos %A McPhail,Steven %A Brain,David %A Allen,Michelle J %+ Australian Centre for Health Services Innovation, Queensland University of Technology, 88, Musk Avenue, Kelvin Grove, 4059, Australia, 61 073388 ext 6670, sumuduavanthi@gmail.com %K mobile health apps %K digital health integration %K health care innovation %K technology adoption %K cardiac rehabilitation %K lifestyle modification %K implementation science %K consolidated framework for implementation framework %K mHealth %K mobile health %K app %K digital health %K smartphone %K eHealth %K telehealth %K telemedicine %K digital %K technology %K CFIR %K implementation research %K cardiac %K rehabilitation %K cardiology %K atrial fibrillation %K Australia %K interview %D 2025 %7 30.4.2025 %9 Original Paper %J J Med Internet Res %G English %X Background: Despite the growing use of mobile health apps in managing chronic heart disease, their integration into routine care remains challenging due to dynamic, context-specific barriers. Objective: This study aimed to identify the key enablers and challenges of implementing a mobile app for cardiac rehabilitation and healthy lifestyles in patients with atrial fibrillation at an Australian cardiology clinic. Methods: We interviewed both clinicians and patients to understand their perspectives about the mobile app and what factors affected the implementation. The two semistructured interview guides used, one for clinicians and one for patients, were developed based on the Consolidated Framework for Implementation Research (CFIR) and nonadoption abandonment, scale-up, spread, and sustainability complexity assessment tool. All interviews were recorded and transcribed, and the transcripts were analyzed inductively to generate codes using a constructionist perspective. These codes were subsequently mapped onto the constructs within the CFIR across its five domains. This framework analysis was followed by examining the interconnections among the constructs to understand their collective impact on the implementation process, thereby identifying key enablers and challenges for the integration efforts. Results: We interviewed 24 participants including 18 patients, whose mean age was 69 (SD 9.2) years, and 6 clinicians, comprising 4 specialist cardiac electrophysiologists and 2 nurses. Patient engagement with the app varied: 3 participants completed the cardiac rehabilitation plan, 1 participant was still actively engaged, 2 participants had partial use, 10 participants downloaded but never used the app, and 2 participants did not download the app. We identified a complex interplay between key determinants across all five CFIR domains, collectively impacting two main elements in the implementation process: (1) acceptability and user engagement with the app and (2) the clinic’s implementation readiness. The app was more likely to be accepted and used by patients who needed to establish healthy lifestyle habits. Those with established healthy lifestyle habits did not indicate that the app provided sufficient added value to justify adoption. Interoperability with other devices and design issues, for example, limited customization options, also negatively impacted the uptake. The clinic’s implementation readiness was limited by various challenges including limited staff availability, insufficient internal communication processes, the absence of an implementation evaluation plan, and lack of clarity around who is funding the app’s use beyond the initial trial. Despite the clinician’s overall inclination toward technology use, diverse opinions on the evidence for short-term cardiac rehabilitation programs in atrial fibrillation critically reduced their commitment to app integration. Conclusions: Mobile health apps have seen rapid expansion and offer clear benefits, yet their integration into complex health systems remains challenging. Whilst our findings are from a single app implementation, they highlight the importance of embedding contextual analysis and proactive strategic planning in the integration process. %M 40306646 %R 10.2196/66815 %U https://www.jmir.org/2025/1/e66815 %U https://doi.org/10.2196/66815 %U http://www.ncbi.nlm.nih.gov/pubmed/40306646 %0 Journal Article %@ 2369-1999 %I JMIR Publications %V 11 %N %P e64208 %T The Efficacy of Digital Interventions on Adherence to Oral Systemic Anticancer Therapy Among Patients With Cancer: Systematic Review and Meta-Analysis %A Liao,Wan-Chuen %A Angus,Fiona %A Conley,Jane %A Chen,Li-Chia %K efficacy %K digital interventions %K oral systemic anticancer therapy %K medication adherence %K cancer %K oral %K patients with cancer %K therapy %K systematic review %K meta-analysis %K care plans %K medication %K treatments %K mobile app %K mobile applications %K mHealth %K multimedia platforms %K digital technology %K self-reported %K mobile phone %D 2025 %7 16.4.2025 %9 %J JMIR Cancer %G English %X Background: Digital interventions have been increasingly applied in multidisciplinary care plans to improve medication adherence to oral systemic anticancer therapy (SACT), the crucial lifesaving treatments for many cancers. However, there is still a lack of consensus on the efficacy of those digital interventions. Objectives: This systematic review and meta-analysis aimed to investigate the efficacy of digital interventions in improving adherence to oral SACTs in patients with cancer. Methods: This systematic review and meta-analysis followed the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) statement guidelines. The protocol has been registered at PROSPERO (no. CRD42024550203). Fully published, randomized controlled trials (RCTs) in English on adults with cancer assessing digital interventions for improving adherence to oral SACTs were retrieved from MEDLINE, Embase, APA PsycINFO, and CINAHL Plus up to May 31, 2024. Adherence measures compared between digital intervention users and nonusers were extracted. The proportions of poor adherence were synthesized using a random-effects model. The pooled results were reported as the odds ratio and 95% CI. The heterogeneity was assessed with the I2 test (%). The mean difference and 95% CI were calculated from the mean adherence score and SD. A risk of bias assessment was conducted using version 2 of the Cochrane Risk of Bias Assessment Tool (RoB 2) for RCTs, which ensured that a quality assessment of all included studies was conducted as recommended by the Cochrane Collaboration. Results: This study included 13 RCTs on digital interventions for improving adherence to oral SACTs in patients with cancer. The 13 RCTs, published between 2016 and 2024, were conducted in the United States, South Korea, France, Egypt, Finland, Australia, Colombia, Singapore, and Turkey. The technologies used were mobile apps (n=4), reminder systems (n=4), telephone follow-ups (n=3), and interactive multimedia platforms (n=2). Adherence was measured by surveys (n=8), relative dose intensity (n=2), pill count (n=1), self-reported missed doses (n=1), a smart pill bottle (n=1), and urine aromatase inhibitor metabolite assays (n=1). Concerns regarding risk of bias primarily involved randomization, missing outcome data, and outcome measurement, including nonblinded randomization, subjective patient-reported data, and difficulties in distinguishing between missed appointments and actual medication nonadherence. Pooled results from 11 trials showed that digital technology users had significantly lower risk of poor adherence (odds ratio 0.60, 95% CI 0.47‐0.77). Two studies reported positive mean differences in adherence scores comparing digital intervention users and nonusers. However, due to considerable heterogeneity (I²=73.1%), it is difficult to make a definitive conclusion from the pooled results about the effect of digital interventions upon adherence to oral anticancer therapy. Conclusions: Digital intervention users exhibited significantly lower risk of poor oral SACTs adherence than nonusers. Acknowledging individual variation and tailoring digital technologies to prioritize patient needs is essential. Trial Registration: PROSPERO CRD42024550203; https://www.crd.york.ac.uk/PROSPERO/view/CRD42024550203 %R 10.2196/64208 %U https://cancer.jmir.org/2025/1/e64208 %U https://doi.org/10.2196/64208 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 27 %N %P e53144 %T Effectiveness of Mobile Apps in Improving Medication Adherence Among Chronic Kidney Disease Patients: Systematic Review %A Paneerselvam,Ganesh Sritheran %A Lua,Pei Lin %A Chooi,Wen Han %A Rehman,Inayat Ur %A Goh,Khang Wen %A Ming,Long Chiau %+ School of Pharmacy, Taylor's University, 1, Jln Taylors, Subang Jaya, 47500, Malaysia, 60 5629 5000, ganeshsritheran.Paneerselvam@taylors.edu.my %K mobile applications %K medication adherence %K chronic kidney disease %K health outcomes %K mobile health %K mhealth %K digital health %K kidney disease %K patient education %K medication monitoring %K e-medication %K electronic medication %D 2025 %7 16.4.2025 %9 Review %J J Med Internet Res %G English %X Background: Chronic kidney disease (CKD) is a serious condition affecting millions of individuals worldwide. Adherence to medication regimens among patients with CKD is often suboptimal, leading to poor health outcomes. In recent years, mobile apps have gained popularity as a promising tool to improve medication adherence and self-management in various chronic diseases. Objective: This study aimed to evaluate the effectiveness of mobile apps to improve medication adherence among patients with CKD (including end-stage and renal replacement therapy). Methods: A systematic search was conducted using Scopus, Cochrane, PubMed, and EBSCOhost to include eligible articles that studied mobile apps to improve medication adherence among patients with CKD. The quality of the selected studies was evaluated using the Newcastle‒Ottawa Scale and the Cochrane risk-of-bias tool. Results: Out of 231 relevant articles, only 9 studies were selected for this systematic review. Based on Newcastle‒Ottawa Scale, 7 were deemed to be of high quality, while others were of fair quality. The Cochrane risk-of-bias tool indicated a low to moderate risk of bias across the included studies. Most of the included studies had a randomized controlled design. Of the 9 selected studies, 3 papers represented medication adherence by a coefficient of 10 variability of tacrolimus, 3 papers used adherence measurement scales to calculate the score for assessing medication adherence, 2 papers represented medication adherence by self-reporting, 2 papers represented medication adherence using electronic monitoring, and 1 represented medication adherence by pill count. The mobile apps were identified as Transplant Hero (Transplant Hero LLC), Perx (Perx Health), Smartphone Medication Adherence Saves Kidneys (developed by John McGillicuddy), Adhere4U (developed by Ahram Han), My Dialysis (developed by Benyamin Saadatifar), Kidney Love (developed by National Kidney foundation), and iCKD (developed by Dr Vivek Kumar). Of these apps, 3 focused on evaluating Transplant Hero, while the remaining investigated each of the other mentioned apps individually. The apps use various strategies to promote medication adherence, including reminders, gamification, patient education, and medication monitoring. A majority, 5 out of 9 mobile apps, had a statistically significant (P<.05) effect on medication adherence. There was strong evidence for a positive effect of interventions focusing on games and reminders combined with electronic medication tray monitoring and patient education. Conclusions: Mobile apps effectively improved medication adherence in patients with CKD, but low evidence and short intervention duration warrant caution. Future research should identify ideal features, provider costs, and user-friendly, secure apps. %M 40239197 %R 10.2196/53144 %U https://www.jmir.org/2025/1/e53144 %U https://doi.org/10.2196/53144 %U http://www.ncbi.nlm.nih.gov/pubmed/40239197 %0 Journal Article %@ 2561-1011 %I JMIR Publications %V 9 %N %P e55846 %T MARIA (Medical Assistance and Rehabilitation Intelligent Agent) for Medication Adherence in Patients With Heart Failure: Empirical Results From a Wizard of Oz Systematic Conversational Agent Design Clinical Protocol %A Abdullah,Nik Nailah %A Tang,Jia %A Fetrati,Hemad %A Kaukiah,Nor Fadhilah Binti %A Saharudin,Sahrin Bin %A Yong,Vee Sim %A Yen,Chia How %+ School of Information Technology, Monash University Malaysia, Jalan Lagoon Selatan, Bandar Sunway, Subang Jaya, Selangor, Petaling Jaya, 47500, Malaysia, 60 03 55146000, nik.nailah@monash.edu %K heart failure %K medication adherence %K self-monitoring %K chatbot %K conversational agent %K Wizard of Oz %K digital health %D 2025 %7 10.4.2025 %9 Original Paper %J JMIR Cardio %G English %X Background: Nonadherence to medication is a key factor contributing to high heart failure (HF) rehospitalization rates. A conversational agent (CA) or chatbot is a technology that can enhance medication adherence by helping patients self-manage their medication routines at home. Objective: This study outlines the conception of a design method for developing a CA to support patients in medication adherence, utilizing design thinking as the primary process for gathering requirements, prototyping, and testing. We apply this design method to the ongoing development of Medical Assistance and Rehabilitation Intelligent Agent (MARIA), a rule-based CA. Methods: Following the design thinking process, at the ideation stage, we engaged a multidisciplinary group of stakeholders (patients and pharmacists) to elicit requirements for the early conception of MARIA. In collaboration with pharmacists, we structured MARIA’s dialogue into a workflow based on Adlerian therapy, a psychoeducational theory. At the testing stage, we conducted an observational study using the Wizard of Oz (WoZ) research method to simulate the MARIA prototype with 20 patient participants. This approach validated and refined our application of Adlerian therapy in the CA’s dialogue. We incorporated human-likeness and trust scoring into user satisfaction assessments after each WoZ session to evaluate MARIA’s feasibility and acceptance of medication adherence. Dialogue data collected through WoZ simulations were analyzed using a coding analysis technique. Results: Our design method for the CA revealed gaps in MARIA’s conception, including (1) handling negative responses, (2) appropriate use of emoticons to enhance human-likeness, (3) system feedback mechanisms during turn-taking delays, and (4) defining the extent to which a CA can communicate on behalf of a health care provider regarding medication adherence. Conclusions: The design thinking process provided interactive steps to involve users early in the development of a CA. Notably, the use of WoZ in an observational clinical protocol highlighted the following: (1) coding analysis offered guidelines for modeling CA dialogue with patient safety in mind; (2) incorporating human-likeness and trust in user satisfaction assessments provided insights into attributes that foster patient trust in a CA; and (3) the application of Adlerian therapy demonstrated its effectiveness in motivating patients with HF to adhere to medication within a CA framework. In conclusion, our method is valuable for modeling and validating CA interactions with patients, assessing system reliability, user expectations, and constraints. It can guide designers in leveraging existing CA technologies, such as ChatGPT or AWS Lex, for adaptation in health care settings. %M 40209206 %R 10.2196/55846 %U https://cardio.jmir.org/2025/1/e55846 %U https://doi.org/10.2196/55846 %U http://www.ncbi.nlm.nih.gov/pubmed/40209206 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 27 %N %P e60758 %T Efficacy of a Digital Educational Intervention for Patients With Type 2 Diabetes Mellitus: Multicenter, Randomized, Prospective, 6-Month Follow-Up Study %A Caballero Mateos,Irene %A Morales Portillo,Cristóbal %A Lainez López,María %A Vilches-Arenas,Ángel %+ , Endocrinology and Nutrition Department, Vithas Hospital, Avda Plácido Fernández Viagas s/n. 3ª floor, Castilleja de la Cuesta, Sevilla, 41009, Spain, 34 955 00 80 00, irenecaballerom@hotmail.com %K body composition %K type 2 diabetes mellitus %K digital %K metabolic control %K social networks %K satisfaction %K telemedicine %D 2025 %7 10.4.2025 %9 Original Paper %J J Med Internet Res %G English %X Background: Adherence to therapies and metabolic control among patients with type 2 diabetes mellitus (T2DM) remain challenging. The use of new technologies, such as telemedicine, digitalized systems, and social networks, could improve self-management and disease control. Objective: We evaluated the efficacy of a digital educational intervention for patients with T2DM, expressed as changes in glycated hemoglobin (HbA1c) and body composition and evaluation of the response using validated questionnaires of satisfaction with health care professionals (Instrument for Evaluation of the Experience of Chronic Patients), Diabetes Knowledge Scale (ECODI), and adherence to treatment over 6 months of follow-up (Morisky, Green, Levine Medication Assessment Questionnaire). Methods: This multicenter, randomized, prospective study included adults with T2DM with poor metabolic control who started treatment with glucagon-like peptide-1 receptor agonists. Patients were randomized to digital intervention or usual care. The intervention group received education through social networks and digital tools in a structured program of healthy lifestyle changes. This was provided by a “Digital Coach” for weekly and on-demand advice and individualized support. Baseline and follow-up demographic, clinical parameter, adherence, and quality of life data were collected. Results: We included 85 patients (control: n=41; intervention: n=44). Both groups were matched regarding demographics, physical examination, insulin, and biochemical parameters. We observed a reduction in body weight (intervention: –8.7, SD 6.1 kg vs control: –4.9, SD 5.0 kg; t83=–3.13; P=.002), BMI (intervention: –3.0, SD 2.1 kg/m2 vs control: –1.8, SD 1.8 kg/m2; t83=–2.82; P=.006), and fast mass in both groups but greater in the intervention group. There were greater reductions in fasting plasma glucose (intervention: 122.6, SD 81.5 mg/dL vs control: 70.5, SD 72.9 mg/dL; t83=3.10; P=.004) and HbA1c (intervention: 3.7%, SD 1.9% vs control: 2.6%, SD 2.1%; t83=2.54; P=.006) in the intervention group. Although there was no significant change in the Spanish version of the Diabetes Quality of Life Questionnaire (EsDQOL) satisfaction score in the control group after 6 months of follow-up (0.7, SD 19.8), there was a marked reduction in EsDQOL satisfaction score in the intervention group (–13.7, SD 23.1; t83=–3.08; P=.02). According to the ECODI scale, knowledge about diabetes increased more in the intervention group (intervention: 0.3, SD 1.8 vs control: 1.5, SD 1.5; t83=–3.33; P=.001). Although the medication adherence score worsened in the control group after 6 months, it significantly improved with the intervention (control: –8% vs intervention: 13.8%; χ21=0.35; P=.01). Patients’ health care experiences improved with the intervention but not with the control. Conclusions: The digital educational intervention was effective at improving glycemic control, body composition, adherence, and patient satisfaction compared with usual care in patients with T2DM. The implementation of digital tools and social media could highly improve the multidisciplinary approach to the management of this population. Trial Registration: ClinicalTrials.gov NCT06850129; https://clinicaltrials.gov/study/NCT06850129 %M 40209213 %R 10.2196/60758 %U https://www.jmir.org/2025/1/e60758 %U https://doi.org/10.2196/60758 %U http://www.ncbi.nlm.nih.gov/pubmed/40209213 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 13 %N %P e65668 %T Participant Adherence in Repeated-Dose Clinical Studies Using Video-Based Observation: Retrospective Data Analysis %A Han,Seunghoon %A Song,Jihong %A Han,Sungpil %A Choi,Suein %A Lim,Jonghyuk %A Oh,Byeong Yeob %A Shin,Dongoh %+ Department of Clinical Pharmacology and Therapeutics, Seoul St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, 222 Banpo-daero, Seocho-gu, Seoul, 06591, Republic of Korea, 82 10 9484 2415, waystolove@catholic.ac.kr %K adherence %K mobile health %K self-administration %K repeated-dose clinical trials %K video-based monitoring %K mobile phone %D 2025 %7 7.4.2025 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Maintaining accurate medication records in clinical trials is essential to ensure data validity. Traditional methods such as direct observation, self-reporting, and pill counts have shown limitations that make them inaccurate or impractical. Video-based monitoring systems, available as commercial or proprietary mobile applications for smartphones and tablets, offer a promising solution to these traditional limitations. In Korea, a system applicable to the clinical trial context has been developed and used. Objective: This study aimed to evaluate the usefulness of an asynchronous video-based self-administration of the investigational medicinal product (SAI) monitoring system (VSMS) in ensuring accurate dosing and validating participant adherence to planned dosing times in repeated-dose clinical trials. Methods: A retrospective analysis was conducted using data from 17,619 SAI events in repeated-dose clinical trials using the VSMS between February 2020 and March 2023. The SAI events were classified into four categories: (1) Verified on-time dosing, (2) Verified deviated dosing, (3) Unverified dosing, and (4) Missed dosing. Analysis methods included calculating the success rate for verified SAI events and analyzing trends in difference between planned and actual dosing times (PADEV) over the dosing period and by push notification type. The mean PADEV for each subsequent dosing period was compared with the initial period using either a paired t test or a Wilcoxon signed-rank test to assess any differences. Results: A comprehensive analysis of 17,619 scheduled SAI events across 14 cohorts demonstrated a high success rate of 97% (17,151/17,619), with only 3% (468/17,619) unsuccessful due to issues like unclear video recordings or technical difficulties. Of the successful events, 99% (16,975/17,151) were verified as on-time dosing, confirming that the dosing occurred within the designated SAI time window with appropriate recorded behavior. In addition, over 90% (367/407) of participants consistently reported dosing videos on all analyzed SAI days, with most days showing over 90% objective dosing data, underscoring the system’s effectiveness in supporting accurate SAI. There were cohort differences in the tendency to dose earlier or later, but no associated cohort characteristics were identified. The initial SAI behaviors were generally sustained during the whole period of participation, with only 16% (13/79) of study days showing significant shifts in actual dosing times. Earlier deviations in SAI times were observed when only dosing notifications were used, compared with using reminders together or no notifications. Conclusions: VSMS has proven to be an effective tool for obtaining dosing information with accuracy comparable to direct observation, even in remote settings. The use of various alarm features and appropriate intervention by the investigator or observer was identified as a way to minimize adherence deterioration. It is expected that the usage and usefulness of VSMS will be continuously improved through the accumulation of experience in various medical fields. %M 40194283 %R 10.2196/65668 %U https://mhealth.jmir.org/2025/1/e65668 %U https://doi.org/10.2196/65668 %U http://www.ncbi.nlm.nih.gov/pubmed/40194283 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 27 %N %P e65268 %T Effect of a WeChat-Based Hybrid Intervention on the Adaptation Outcomes of People Living With HIV/AIDS: Pilot Randomized Controlled Trial %A Wang,Honghong %A Qin,Ziqi %A Li,Yixuan %A Duan,Yuqiong %A Lu,Qiaoyue %A Xiao,Xueling %+ Xiangya School of Nursing, Central South University, No. 172 Tongzipo Road, Changsha, 410083, China, 86 15286826132, xuelingxiao93@hotmail.com %K HIV/AIDS %K quality of life %K acceptance of illness %K mental health %K randomized controlled trial %K mobile phone %D 2025 %7 3.4.2025 %9 Original Paper %J J Med Internet Res %G English %X Background: People living with HIV/AIDS face multiple challenges that collectively impede their adaptation outcomes. These outcomes include quality of life (QoL), acceptance of illness, mental health (including symptoms of anxiety and depression), and antiretroviral therapy (ART) adherence. While existing evidence addresses specific challenges, it often overlooks the interactions among the various problems people living with HIV/AIDS encounter. The comprehensive-task disease management framework and positive self-management framework provide a theoretical basis for understanding the adaptation process. A culturally tailored, theory-based intervention may be necessary and effective in facilitating better adaptation outcomes for people living with HIV/AIDS. Objective: This study aimed to evaluate the effect of a hybrid intervention called AiCare (Adaptation intervention with Comprehensive-task disease management framework to achieve renormal life) on improving QoL, acceptance of illness, mental health (anxiety and depression), and ART adherence among people living with HIV/AIDS in China. Methods: We conducted a 2-arm randomized controlled trial, recruiting 92 people living with HIV/AIDS from an HIV clinic in Hunan, China. Participants were randomly assigned in a 1:1 ratio to either the control group (receiving standard care) or the intervention group (receiving AiCare in addition to standard care). All analyses were performed from an intention-to-treat perspective. Sociodemographic and HIV-specific clinical characteristics, along with key adaptation outcomes—including QoL, acceptance of illness, mental health (anxiety and depression), and ART adherence—were assessed at baseline (T0), post intervention (T1), and 3 months post intervention (T2). We used generalized estimating equation models and difference-in-difference analysis to evaluate the interventions’ effects. Results: The difference-in-difference model showed that at T1, the intervention group experienced significant improvements compared to the control group. QoL increased by 6.35 (95% CI 2.62-10.93, P=.001), acceptance of illness improved by 4.49 (95% CI 2.29-6.68, P<.001), and anxiety decreased by 2.15 (95% CI 1.19-3.11; P=.01). At T2, the intervention group’s improvement in QoL was not statistically significant (β 3.62, 95% CI –1.53 to 8.77; P=.17). However, acceptance of illness remained significantly improved by 3.65 (95% CI 1.22-6.08; P=.003), and anxiety decreased by 1.58 (95% CI 0.42-2.74; P=.007). No significant changes were observed in depression or ART adherence between the intervention and control groups. Feedback regarding the AiCare program indicated its acceptability and feasibility. Conclusions: The AiCare program demonstrated promising effects in improving disease adaptation outcomes among people living with HIV/AIDS, notably in enhancing QoL, fostering acceptance of illness, and mitigating anxiety symptoms. These findings underscore the hybrid program’s potential clinical utility to facilitate the adaptation of people living with HIV/AIDS. Trial Registration: Chinese Clinical Trial Registry ChiCTR2400087255; https://www.chictr.org.cn/showproj.html?proj=220729 %M 39988931 %R 10.2196/65268 %U https://www.jmir.org/2025/1/e65268 %U https://doi.org/10.2196/65268 %U http://www.ncbi.nlm.nih.gov/pubmed/39988931 %0 Journal Article %@ 2561-1011 %I JMIR Publications %V 9 %N %P e58837 %T Pharmacist-Initiated Team-Based Intervention for Optimizing Guideline-Directed Lipid Therapy of Hospitalized Patients With Acute Coronary Syndrome: Pilot Study Using a Stepped-Wedge Cluster Design %A Flo,Gayle L %A Alzate Aguirre,Mateo %A Gochanour,Benjamin R %A Hynes,Kristin J %A Scott,Christopher G %A Fink,Angela L %A M Arruda-Olson,Adelaide %K coronary disease %K follow-up studies %K lipids %K myocardial infarction %K statins %D 2025 %7 28.3.2025 %9 %J JMIR Cardio %G English %X Background: Clinical guidelines recommend high-intensity statin therapy for patients with acute coronary syndrome (ACS). However, high-intensity statins have been underused in this population. Objective: The objective of this study was to evaluate the feasibility of a pharmacist-initiated, team-based intervention for the delivery of individualized, guideline-directed, lipid-lowering therapy for patients with ACS. Methods: Patients admitted with ACS to cardiology hospital services at Mayo Clinic from August 1, 2021, to June 19, 2022, were assigned to a pharmacist-initiated, team-based intervention group or control group using a stepped wedge cluster study design. For the intervention group, pharmacists reviewed electronic health records and provided recommendations for lipid lowering therapy in hospital and at follow-up. In the control group, patients received usual care. Neither care team, nor study team were blinded to study assignments. The primary outcome was the proportion of patients with ACS discharged on high-intensity statins in the intervention group compared to controls. Secondary outcomes were (1) proportion of patients in the intervention group with a specific templated pharmacist intervention note in their electronic health records, (2) frequency of low-density lipoprotein (LDL) measurements in hospital, (3) proportion of patients with information related to lipid follow-up in their discharge summary, and (4) proportion of patients that received LDL monitoring at the outpatient follow-up 4 to 12 weeks post discharge. Results: There were 410 patients included in this study (median age 68, IQR 60-78 years) of whom 285 (69.5%) were male. Of the 402 patients alive at discharge, 355 (88.3%) were discharged taking a high-intensity statin, with no significant difference (P=.89) observed between groups. Lipid levels were measured in the hospital for 176/210 (83.8%) patients in the intervention group and 155/200 (77.5%) patients in the control group (P=.14). Fifty-four of 205 (26.3%) intervention patients alive at discharge had lipid-related recommendations in their discharge summary compared to 27/197 (13.7%) controls (P=.002). Forty-seven of 81 (58%) patients with lipid management recommendations provided in the discharge summary had LDL measured in the follow-up period compared with only 119/321 (37.1%) patients without these recommendations (P=.001). Of the 402 patients who survived to discharge, 166 (41.3%) had LDL measured at follow-up; the median LDL level was 63.5 (IQR 49-79) mg/dL, and distributions were similar by group (P=.95). Only 101/166 (60.8%) patients had follow-up LDL values below the target of 70 mg/dL. Conclusions: During hospitalization, there was no group difference in the primary outcome of high-intensity statin therapy. Feasibility of an effective pharmacist-initiated intervention for improvement of lipid management was demonstrated by entry of recommendations in the discharge summary and related adjustment in outpatient statin therapy. The main opportunity for future improvement in lipid management of patients with ACS is in longitudinal patient follow-up. %R 10.2196/58837 %U https://cardio.jmir.org/2025/1/e58837 %U https://doi.org/10.2196/58837 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 9 %N %P e59953 %T Mobile Health Tool to Capture Social Determinants of Health and Their Impact on HIV Treatment Outcomes Among People Who Use Drugs: Pilot Feasibility Study %A Gicquelais,Rachel E %A Conway,Caitlin %A Vjorn,Olivia %A Genz,Andrew %A Kirk,Gregory %A Westergaard,Ryan %K HIV %K drug use %K social determinants of health %K mobile health %K mHealth %K smartphone %D 2025 %7 26.3.2025 %9 %J JMIR Form Res %G English %X Background: Active substance use, food or housing insecurity, and criminal legal system involvement can disrupt HIV care for people living with HIV and opioid use disorder (OUD). These social determinants of health are not routinely captured in clinical settings. Objective: We evaluated whether real-time reports of social and behavioral factors using a smartphone app could predict viral nonsuppression and missed care visits to inform future mobile health interventions. Methods: We enrolled 59 participants from the AIDS Linked to the Intravenous Experience (ALIVE) Study in Baltimore, Maryland, into a 12-month substudy between February 2017 and October 2018. Participants were eligible if they had OUD and had either a measured HIV RNA ≥1000 copies/mL or a ≥1-month lapse in antiretroviral therapy in the preceding 2 years. Participants received a smartphone and reported HIV medication adherence, drug use or injection, and several disruptive life events, including not having a place to sleep at night, skipping a meal due to lack of income, being stopped by police, being arrested, or experiencing violence on a weekly basis, through a survey on a mobile health app. We described weekly survey completion and investigated which factors were associated with viral nonsuppression (HIV RNA ≥200 copies/mL) or a missed care visit using logistic regression with generalized estimating equations adjusted for age, gender, smartphone comfort, and drug use. Results: Participants were predominantly male (36/59, 61%), Black (53/59, 90%), and had a median of 53 years old. At baseline, 16% (6/38) were virally unsuppressed. Participants completed an average of 23.3 (SD 16.3) total surveys and reported missing a dose of antiretroviral therapy, using or injecting drugs, or experiencing any disruptive life events on an average of 13.1 (SD 9.8) weekly surveys over 1 year. Reporting use of any drugs (adjusted odds ratio [aOR] 2.3, 95% CI 1.4‐3.7), injecting drugs (aOR 2.3, 95% CI 1.3‐3.9), and noncompletion of all surveys (aOR 1.6, 95% CI 1.1‐2.2) were associated with missing a scheduled care visit over the subsequent 30 days. Missing ≥2 antiretroviral medication doses within 1 week was associated with HIV viral nonsuppression (aOR 3.7, 95% CI: 1.2‐11.1) in the subsequent 30 days. Conclusions: Mobile health apps can capture risk factors that predict viral nonsuppression and missed care visits among people living with HIV who have OUD. Using mobile health tools to detect sociobehavioral factors that occur prior to treatment disengagement may facilitate early intervention by health care teams. %R 10.2196/59953 %U https://formative.jmir.org/2025/1/e59953 %U https://doi.org/10.2196/59953 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 27 %N %P e67246 %T Efficacy of eHealth Interventions for Hemodialysis Patients: Systematic Review and Meta-Analysis %A Zhou,Xu-Hua %A Chen,Hui %A Yang,Weiwei %A Wang,Li %A Chen,Lin %A Zhu,Ying %A Zhang,Yingjun %A Shi,Mei %A Zhang,Qin %+ Hemodialysis Center, Department of Nephrology, West China Hospital, Sichuan University, 37 Guo-xue-xiang Lane, Wuhou district, Chengdu, Sichuan, PR China, Chengdu, 610041, China, 86 18980601205, clhxxuetou@163.com %K hemodialysis %K eHealth interventions %K quality of life %K treatment adherence %K anxiety %K depression %K meta-analysis %K kidney %K systematic review %K kidney diseases %K kidney function %K chronic diseases %D 2025 %7 26.3.2025 %9 Review %J J Med Internet Res %G English %X Background: Within hemodialysis patient populations, eHealth interventions have been considered as an alternative and complementary option to routine care services. However, the efficacy of eHealth interventions for hemodialysis patients remains poorly understood owing to a lack of rigorous quantitative evidence synthesis. Objective: This meta-analysis aimed to evaluate the efficacy of eHealth interventions in improving quality of life, treatment adherence, and psychological outcomes (anxiety and depression) among hemodialysis patients. In addition, the study sought to identify specific intervention components and methodological quality associated with enhanced quality of life and health outcomes in this population. Methods: A comprehensive search was performed across PubMed, Web of Science, Embase, CINAHL, Cochrane Library, PsycINFO, China National Knowledge Infrastructure, WanFang, China Science and Technology Journal Database, and China BioMedical Literature Database databases from their inception to September 7, 2024. Randomized controlled trials on eHealth interventions for hemodialysis patients published in English or Chinese were included. Critical appraisal was carried out independently by 2 reviewers to assess the bias risk of the studies included. Quantitative synthesis of the outcomes of interest was conducted using a random-effects model. The quality of evidence for the outcomes was evaluated following the Grading of Recommendations, Assessment, Development, and Evaluation approach. Results: A total of 17 randomized controlled trials involving 1728 participants were included in this meta-analysis out of 5741 articles identified in the initial database search and additional search references. In the 17 studies, 8 kinds of eHealth intervention delivery formats were used, including text messages, telephone sessions, video, network platforms, social media, computers, websites, and mobile apps. The majority of research studies used a single form of eHealth intervention, and 7 studies adopted a combined approach of 2 or more eHealth technologies. The duration of eHealth interventions demonstrated substantial variability across studies, spanning from 4 weeks to 12 months, of which 3 months was the most common. A total of 14 (82%) studies were considered to have “some concern” about selection bias. In addition, 15 (88%) trials were classified as having a “high risk” of performance and detection bias, and all trials were judged to be at “low risk” of attrition and reporting bias. The pooled results revealed a significant difference between the eHealth interventions and control groups on quality of life (standardized mean difference [SMD]=0.87, 95 % CI 0.38 to 1.37, low certainty evidence), treatment adherence (SMD=1.11, 95 % CI 0.30 to 1.91, moderate certainty evidence), anxiety (SMD=–2.11, 95 % CI –3.25 to –0.97, moderate certainty evidence), and depression (SMD=–2.46, 95 % CI –3.68 to –1.25, moderate certainty evidence). Conclusions: eHealth interventions could be a beneficial approach for improving quality of life and treatment adherence and reducing anxiety and depression among hemodialysis patients. However, future high-quality randomized controlled trials are essential to draw more reliable conclusions. Trial Registration: PROSPERO CRD42024589799; https://www.crd.york.ac.uk/PROSPERO/view/CRD42024589799 %R 10.2196/67246 %U https://www.jmir.org/2025/1/e67246 %U https://doi.org/10.2196/67246 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 27 %N %P e69204 %T Enhancing Digital Health Interventions for Medication Adherence: Considerations for Broader Applicability and Long-Term Impact %A Du,ShanShan %A Zhao,Yining %+ Renhe Rehabilitation Hospital, Renhe Street, Hubei, China, 86 15767853433, 1547838432@qq.com %K mobile apps %K digital health %K atrial fibrillation %K anticoagulants %K medication adherence %K mobile phone %D 2025 %7 14.3.2025 %9 Letter to the Editor %J J Med Internet Res %G English %X %R 10.2196/69204 %U https://www.jmir.org/2025/1/e69204 %U https://doi.org/10.2196/69204 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 12 %N %P e59780 %T The mChoice App, an mHealth Tool for the Monitoring of Preexposure Prophylaxis Adherence and Sexual Behaviors in Young Men Who Have Sex With Men: Usability Evaluation %A Dos Santos,Fabiana Cristina %A Brin,Maeve %A Tanner,Mary R %A Galindo,Carla A %A Schnall,Rebecca %K HIV prevention %K data visualization %K patient-reported health information %K mHealth %K digital health %K usability %K human immunodeficiency virus %K preexposure prophylaxis %K men who have sex with men %K apps %K HIV %K PrEP %D 2025 %7 28.2.2025 %9 %J JMIR Hum Factors %G English %X Background: Mobile health (mHealth) apps provide easy and quick access for end users to monitor their health-related activities. Features such as medication reminders help end users adhere to their medication schedules and automatically record these actions, thereby helping manage their overall health. Due to insufficient mHealth tools tailored for HIV preventive care in young men who have sex with men (MSM), our study evaluated the usability of the mChoice app, a tool designed to enhance preexposure prophylaxis (PrEP) adherence and promote sexual health (eg, encouraging the use of condoms and being aware of the partner’s HIV status and PrEP use). Objective: This study aimed to apply systematic usability evaluations to test the mChoice app and to refine the visualizations to better capture and display patient-reported health information. Methods: Usability testing involved heuristic evaluations conducted with 5 experts in informatics and user testing with 20 young MSM who were taking or were eligible to take PrEP. Results: End users demonstrated satisfaction with the appearance of the mChoice app, reporting that the app has an intuitive interface to track PrEP adherence. However, participants highlighted areas needing improvement, including chart titles and the inclusion of “undo” and “edit” buttons to improve user control when recording PrEP use. Conclusions: Usability evaluations involving heuristic experts and end users provided valuable insights into the mChoice app’s design. Areas for improvement were identified, such as enhancing chart readability and providing additional user controls. These findings will guide iterative refinements, ensuring that future versions of the app better address the needs of its target audience and effectively support HIV prevention. %R 10.2196/59780 %U https://humanfactors.jmir.org/2025/1/e59780 %U https://doi.org/10.2196/59780 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 27 %N %P e58341 %T Web-Based Application for Reducing Methamphetamine Use Among Aboriginal and Torres Strait Islander People: Randomized Waitlist Controlled Trial %A Reilly,Rachel %A McKetin,Rebecca %A Barzi,Federica %A Degan,Tayla %A Ezard,Nadine %A Conigrave,Katherine %A Butt,Julia %A Roe,Yvette %A Wand,Handan %A Quinn,Brendan %A Longbottom,Wade %A Treloar,Carla %A Dunlop,Adrian %A Ward,James %+ School of Psychology, University of Adelaide, North Terrace, Adelaide, 5005, Australia, 61 881284216, rachel.reilly@sahmri.com %K methamphetamine %K Aboriginal and Torres Strait Islander Health %K web-based intervention %K randomised controlled trial %K therapeutic program %K methamphetamine use %K substance use %K digital interventions %K treatment %K psychosocial wellbeing %K effectiveness %K app %K psychosocial distress %K mobile phone %D 2025 %7 28.2.2025 %9 Original Paper %J J Med Internet Res %G English %X Background: Digital interventions can help to overcome barriers to care, including stigma, geographical distance, and a lack of culturally appropriate treatment options. “We Can Do This” is a web-based app that was designed with input from cultural advisors and end users to support Aboriginal and Torres Strait Islander people seeking to stop or reduce their use of methamphetamine and increase psychosocial well-being. Objective: This study aimed to evaluate the effectiveness of the “We Can Do This” web-based app as a psychosocial treatment for Aboriginal and Torres Strait Islander people who use methamphetamine. Methods: The web app was evaluated using a randomized waitlist controlled parallel group trial. Participants were Aboriginal and Torres Strait Islander people aged 16 years or older who self-identified as having used methamphetamine at least weekly for the past 3 months. Participants were randomized on a 1:1 ratio to receive either access to the web-based app for 6 weeks or a waitlist control group. Both groups received access to a website with harm minimization information. The primary outcome was days of methamphetamine use in the past 4 weeks assessed at 1, 2, and 3 months post randomization. Secondary outcomes included severity of methamphetamine dependence (Severity of Dependence Scale [SDS]), psychological distress (Kessler 10 [K10]), help-seeking behavior, and days spent out of role due to methamphetamine use. Results: Participants (N=210) were randomized to receive either access to the web-based app (n=115) or the waitlist control condition (n=95). Follow-up was 63% at 1 month, 57% at 2 months, and 54% at 3 months. There were no significant group differences in days of methamphetamine use in the past 4 weeks at 1 the month (mean difference 0.2 days, 95% CI –1.5 to –2), 2 months (mean difference 0.6 days, 95% CI –1 to 2.4 days) or 3 months (mean difference 1.4 days, 95% CI –0.3 to 3.3 days) follow-up. There were no significant group differences in K10 scores, SDS scores, days out of role, or help-seeking at any of the 3 follow-up timepoints. There was poor adherence to the web-based app, only 20% of participants in the intervention group returned to the web-based app after their initial log-in. Participants cited personal issues and forgetting about the web-based app as the most common reasons for nonadherence. Conclusions: We found poor engagement with this web-based app. The web-based app had no significant effects on methamphetamine use or psychosocial well-being. Poor adherence and low follow-up hindered our ability to accurately evaluate the effectiveness of the web-based app. Future web-based apps for this population need to consider methods to increase participant engagement. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12619000134123p; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=376088 International Registered Report Identifier (IRRID): RR2-10.2196/14084 %M 40053754 %R 10.2196/58341 %U https://www.jmir.org/2025/1/e58341 %U https://doi.org/10.2196/58341 %U http://www.ncbi.nlm.nih.gov/pubmed/40053754 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 9 %N %P e65302 %T Digital Solution to Support Medication Adherence and Self-Management in Patients with Cancer (SAMSON): Pilot Randomized Controlled Trial %A Dang,Thu Ha %A Wickramasinghe,Nilmini %A Jayaraman,Prem Prakash %A Burbury,Kate %A Alexander,Marliese %A Whitechurch,Ashley %A Dyer,Mitchell %A Quinn,Stephen %A Forkan,Abdur Rahim Mohammad %A Schofield,Penelope %+ Department of Psychological Sciences, School of Health Sciences, Swinburne University of Technology, John Street, Hawthorn, Melbourne, 3122, Australia, 61 422703347, thuhadang@swin.edu.au %K home-based cancer treatment %K smartphone app %K oral chemotherapy %K patient safety %K SAMSON %K mobile phone %K digital solution %K medication adherence %K self-management %K cancer %K randomized controlled trial %K RCT %K pilot study %K oncology %K mobile health %K mHealth %K quality of life %K eHealth %D 2025 %7 19.2.2025 %9 Original Paper %J JMIR Form Res %G English %X Background: Medication nonadherence is a serious problem in cancer, potentially impacts patients’ health outcomes and health care costs. Although technology-based medication adherence (MA) interventions have emerged, evidence supporting their quality and effectiveness remains limited. Objective: This study tested the acceptability, feasibility, and potential effects of Safety and Adherence to Medications and Self-care Advice in Oncology (SAMSON), a digital solution designed to support MA and self-management in cancer. Methods: A 12-week, 2-arm, unblinded, pragmatic pilot randomized controlled trial was conducted. Adults with hematological malignancies who started oral cancer medicines within the last 12 months were recruited from a metropolitan specialized hospital and randomized 1:1 to SAMSON or control (usual care). The SAMSON solution included a smartphone app with tailored alerts and real-time self-care advice, a web-based dashboard for health care professionals (HCPs) to monitor patients’ adherence and symptoms, and motivational interviewing (MI) teleconsultations delivered by oncology nurses and pharmacists at baseline and weeks 1, 4, 8, and 12. Primary outcomes were the patients’ acceptance of SAMSON, measured by the Unified Theory of Acceptance and Use of Technology at 12 weeks, and study feasibility, measured by predefined rates of recruitment, randomization, retention, intervention adherence, and outcome assessment completion. Secondary outcomes were comparison of MA and clinical self-assessments through online questionnaires, including adherence, toxicity self-management, anxiety and depression symptoms, and quality of life, measured at baseline and 12 weeks between the 2 arms. Data retrieved from the SAMSON app (Swinburne University of Technology) was analysed for task completion. Results: A total of 33 patients (79% of those who were approached) consented to participate in the trial. Of those, 31/33 (94%) completed baseline surveys and were randomized to SAMSON (15/31) and control arms (16/31). Of 31 patients, 28 (90%) completed the 12-week surveys (12 SAMSON and 16 control). Overall, patients rated the SAMSON solution as highly acceptable (13/15, 87% app usage; 14/15, 93% MI teleconsultation delivery). They reported that SAMSON was easy to use (10/12, 83%) and helpful in improving their MA (6/12, 50%). All study HCPs reported the SAMSON solution was helpful in supporting patients’ MA. Patients completed an average of 99 tasks over the 12-week study period (71% of scheduled tasks). Most patients (10/12, 83%) completed all 5 scheduled consultations. All study feasibility measures were higher than the predefined upper thresholds, except the rate of patients’ responses to medication reminders. Conclusions: The results demonstrated that the SAMSON solution is acceptable, usable, and useful for oncology HCPs and patients with cancer. The SAMSON solution is feasible in real-life oncology settings. Our next steps involve refining the SAMSON solution based on participants’ feedback, conducting a large-scale randomized controlled trial to evaluate its clinical and economic effectiveness, and exploring potential commercialization. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12623000472673; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=385728 International Registered Report Identifier (IRRID): RR2-10.1136/bmjopen-2023-079122 %M 39969972 %R 10.2196/65302 %U https://formative.jmir.org/2025/1/e65302 %U https://doi.org/10.2196/65302 %U http://www.ncbi.nlm.nih.gov/pubmed/39969972 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 27 %N %P e60256 %T Effects of Individualized Follow-Up With an App Postcardiac Rehabilitation: Five-Year Follow-Up of a Randomized Controlled Trial %A Lunde,Pernille %A Bye,Asta %A Grimsmo,Jostein %A Pripp,Are Hugo %A Ritschel,Vibeke %A Jarstad,Even %A Nilsson,Birgitta Blakstad %+ Department of Rehabilitation Science and Health Technology, Faculty of Health Sciences, OsloMet – Oslo Metropolitan University, PB 4, St. Olavs plass, Oslo, 0130, Norway, 47 48063537, plunde@oslomet.no %K mHealth %K cardiac rehabilitation %K mobile phone app %K smartphone %K lifestyle %D 2025 %7 13.2.2025 %9 Original Paper %J J Med Internet Res %G English %X Background: Adherence to healthy behaviors initiated or adapted during cardiac rehabilitation (CR) remains a significant challenge, with few patients meeting guideline standards for secondary prevention. The use of mobile health (mHealth) interventions has been proposed as a potential solution to improve adherence to healthy behaviors after CR. In particular, app-based interventions have shown promise due to their ability to provide monitoring and feedback anytime and anywhere. Growing evidence supports the use of apps in post-CR settings to enhance adherence. In 2020, we demonstrated that individualized follow-up via an app increased adherence to healthy behaviors 1 year after CR. However, it remains uncertain whether these effects persist once the follow-up is discontinued. Objective: This study aims to evaluate the long-term effects of individualized follow-up using an app, assessed 4 years after the intervention. Methods: A single-blinded multicenter randomized controlled trial was conducted. Patients were recruited from 2 CR centers in eastern Norway. The intervention group (IG) received individualized follow-up through an app for 1 year, while the control group (CG) received usual care. After the 1-year follow-up, the app-based follow-up was discontinued for the IG, and both groups were encouraged to maintain or improve their healthy behaviors based on their individual risk profiles. The primary outcome was the difference in peak oxygen uptake (VO2peak). The secondary outcomes included exercise performance, body weight, blood pressure, lipid profile, exercise habits, health-related quality of life, health status, cardiac events, and physical activity. Linear mixed models for repeated measurements were used to analyze differences between groups. All tests were 2-sided, and P values ≤0.05 were considered statistically significant. Results: At the 5-year follow-up, 101 out of the initial 113 randomized participants were reassessed. Intention-to-treat analyses, using a mixed model for repeated measurements, revealed a statistically significant difference (P=.04) in exercise habits in favor of the IG, with a mean difference of 0.67 (95% CI 0.04-1.29) exercise sessions per week. Statistically significant differences were also observed in triglycerides (mean difference 0.40, 95% CI 0.00-0.79 mmol/l, P=.048) and walking (P=.03), but these were in favor of the CG. No differences were found between the groups for other evaluated outcomes. Conclusions: Most of the benefits derived from the app-based follow-up diminished by 4 years after the intervention. Although the IG reported statistically significantly higher levels of exercise, this did not translate into improved VO2peak or exercise performance. Our study highlights the need for follow-up from health care providers to enhance adherence to healthy behaviors in the long term following CR. Trial Registration: ClinicalTrials.gov NCT03174106; https://clinicaltrials.gov/ct2/show/NCT03174106 (original study protocol) and NCT05697120; https://clinicaltrials.gov/ct2/show/NCT05697120 (updated study protocol) %M 39946716 %R 10.2196/60256 %U https://www.jmir.org/2025/1/e60256 %U https://doi.org/10.2196/60256 %U http://www.ncbi.nlm.nih.gov/pubmed/39946716 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 27 %N %P e56737 %T Smart Pharmaceutical Monitoring System With Personalized Medication Schedules and Self-Management Programs for Patients With Diabetes: Development and Evaluation Study %A Xiao,Jian %A Li,Mengyao %A Cai,Ruwen %A Huang,Hangxing %A Yu,Huimin %A Huang,Ling %A Li,Jingyang %A Yu,Ting %A Zhang,Jiani %A Cheng,Shuqiao %+ Department of Pharmacy, Xiangya Hospital, Central South University, 87 Xiangya Rd, Changsha, 410008, China, 86 15974198203, cheng0203@csu.edu.cn %K pharmaceutical services %K diabetes %K self-management %K intelligent medication scheduling system %K drug database %K GPT-4 %D 2025 %7 11.2.2025 %9 Original Paper %J J Med Internet Res %G English %X Background: With the climbing incidence of type 2 diabetes, the health care system is under pressure to manage patients with this condition properly. Particularly, pharmacological therapy constitutes the most fundamental means of controlling blood glucose levels and preventing the progression of complications. However, its effectiveness is often hindered by factors such as treatment complexity, polypharmacy, and poor patient adherence. As new technologies, artificial intelligence and digital technologies are covering all aspects of the medical and health care field, but their application and evaluation in the domain of diabetes research remain limited. Objective: This study aims to develop and establish a stand-alone diabetes management service system designed to enhance self-management support for patients, as well as to assess its performance with experienced health care professionals. Methods: Diabetes Universal Medication Schedule (DUMS) system is grounded in official medicine instructions and evidence-based data to establish medication constraints and drug-drug interaction profiles. Individualized medication schedules and self-management programs were generated based on patient-specific conditions and needs, using an app framework to build patient-side contact pathways. The system’s ability to provide medication guidance and health management was assessed by senior health care professionals using a 5-point Likert scale across 3 groups: outputs generated by the system (DUMS group), outputs refined by pharmacists (intervention group), and outputs generated by ChatGPT-4 (GPT-4 group). Results: We constructed a cloud-based drug information management system loaded with 475 diabetes treatment–related medications; 684 medication constraints; and 12,351 drug-drug interactions and theoretical supports. The generated personalized medication plan and self-management program included recommended dosing times, disease education, dietary considerations, and lifestyle recommendations to help patients with diabetes achieve correct medication use and active disease management. Reliability analysis demonstrated that the DUMS group outperformed the GPT-4 group in medication schedule accuracy and safety, as well as comprehensiveness and richness of the self-management program (P<.001). The intervention group outperformed the DUMS and GPT-4 groups on all indicator scores. Conclusions: DUMS’s treatment monitoring service can provide reliable self-management support for patients with diabetes. ChatGPT-4, powered by artificial intelligence, can act as a collaborative assistant to health care professionals in clinical contexts, although its performance still requires further training and optimization. %M 39933171 %R 10.2196/56737 %U https://www.jmir.org/2025/1/e56737 %U https://doi.org/10.2196/56737 %U http://www.ncbi.nlm.nih.gov/pubmed/39933171 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e65141 %T Effect of Medication Management at Home via Pharmacist-Led Home Televisits: Protocol for a Cluster Randomized Controlled Trial %A Hossain,Sheikh Rubana %A Samant,Akanksha N %A Balsamo,Briana C %A Hawley,Chelsea E %A Zanchelli,Michael C %A Zhu,Carolyn %A Venegas,Maria D %A Robertson,Marina %A McCullough,Megan B %A Beizer,Judith L %A Boockvar,Kenneth S %A Siu,Albert L %A Moo,Lauren R %A Hung,William W %+ James J Peters VA Medical Center, Geriatric Research Education and Clinical Center, 130 W Kingsbridge Road, 4A-17, Bronx, NY, 10468, United States, 1 7185849000 ext 3821, sheikh.Hossain@va.gov %K older adults %K medication management %K televisit %K polypharmacy %K adverse drug reaction %D 2025 %7 5.2.2025 %9 Protocol %J JMIR Res Protoc %G English %X Background: Older adults are more likely to have multiple chronic conditions, be prescribed multiple medications, and be more susceptible to adverse drug reactions (ADRs) to their medications. In addition, older adults often use over-the-counter medications and supplements, further complicating their medication regimens. Complex medication regimens are potentially harmful to older adults. Interventions aimed at reducing medication discrepancy in the ambulatory clinic setting, such as reviews of medication lists and the implementation of “brown bag” reconciliation, continue to be challenging, with limited success. Pharmacist-led interventions to improve appropriate medication use in older adults have demonstrated effectiveness in reducing ADRs. Video visits have the potential to provide direct visualization of medications in older adults’ homes, thereby reducing medication discrepancy and increasing medication adherence. Pharmacist-led management of older adults’ medication regimens may improve appropriate medication use in older adults. Objective: The objective of this study is to examine the effect of pharmacist-led medication through home televisits compared to usual care on appropriate medication use, medication discrepancies, medication adherence, and ADRs. Methods: We will conduct a 2-site cluster randomized controlled trial (RCT). The intervention will be a pharmacist-led home televisit including medication reconciliation and assessment of actual medication use. The cluster RCT was iteratively adapted after a pilot test. The primary outcome of medication appropriateness of the intervention will be measured using the STOPP (Screening Tool of Older Persons’ Prescriptions) criteria for potentially inappropriate medications (PIMs) at 6 months. Medication lists obtained will be compared against electronic medical records (EMRs) by a clinician to establish discrepancies in medications. The clinician will review medications using the validated Medication Appropriateness Index (MAI). Results: This project has been peer-reviewed and selected for support by the Veterans Affairs (VA) Health Services Research Service. The pilot phase of the study was completed December 2021 with 20 veterans and was primarily informed by the Steinman model of the prescribing process adapted to include system- and provider-level factors. The last date of enrollment was August 6, 2021. We anticipate the completion of the ongoing trial in spring 2025. The first results are expected to be submitted for publication in 2025. Conclusions: The cluster RCT will provide evidence on medication management through televisits. If found effective in improving the use of medications, the intervention has the potential to impact older adults with multiple chronic conditions and polypharmacy. Trial Registration: ClinicalTrials.gov NCT04340570; https://clinicaltrials.gov/study/NCT04340570 International Registered Report Identifier (IRRID): PRR1-10.2196/65141 %M 39908544 %R 10.2196/65141 %U https://www.researchprotocols.org/2025/1/e65141 %U https://doi.org/10.2196/65141 %U http://www.ncbi.nlm.nih.gov/pubmed/39908544 %0 Journal Article %@ 2369-1999 %I JMIR Publications %V 11 %N %P e58938 %T Exploring the Impact of the Multimodal CAPABLE eHealth Intervention on Health-Related Quality of Life in Patients With Melanoma Undergoing Immune-Checkpoint Inhibition: Prospective Pilot Study %A Fraterman,Itske %A Sacchi,Lucia %A Mallo,Henk %A Tibollo,Valentina %A Glaser,Savannah Lucia Catherina %A Medlock,Stephanie %A Cornet,Ronald %A Gabetta,Matteo %A Hisko,Vitali %A Khadakou,Vadzim %A Barkan,Ella %A Del Campo,Laura %A Glasspool,David %A Kogan,Alexandra %A Lanzola,Giordano %A Leizer,Roy %A Ottaviano,Manuel %A Peleg,Mor %A Śniatała,Konrad %A Lisowska,Aneta %A Wilk,Szymon %A Parimbelli,Enea %A Quaglini,Silvana %A Rizzo,Mimma %A Locati,Laura Deborah %A Boekhout,Annelies %A van de Poll-Franse,Lonneke V %A Wilgenhof,Sofie %K eHealth %K melanoma %K cancer %K fatigue %K quality of life %K intervention %K pilot study %K exploratory %K health-related %K interventions %K symptom %K monitoring %K well-being %K immunotherapy %K immune-related %K immune-checkpoint inhibitor %K patient %K feasibility %K smartphone %K app %K smartwatch %K linear regression model %K mobile phone %D 2025 %7 30.1.2025 %9 %J JMIR Cancer %G English %X Background: Patients with melanoma receiving immunotherapy with immune-checkpoint inhibitors often experience immune-related adverse events, cancer-related fatigue, and emotional distress, affecting health-related quality of life (HRQoL) and clinical outcome to immunotherapy. eHealth tools can aid patients with cancer in addressing issues, such as adverse events and psychosocial well-being, from various perspectives. Objective: This study aimed to explore the effect of the Cancer Patients Better Life Experience (CAPABLE) system, accessed through a mobile app, on HRQoL compared with a matched historical control group receiving standard care. CAPABLE is an extensively tested eHealth app, including educational material, remote symptom monitoring, and well-being interventions. Methods: This prospective pilot study compared an exploratory cohort that received the CAPABLE smartphone app and a multisensory smartwatch for 6 months (intervention) to a 2:1 individually matched historical prospective control group. HRQoL data were measured with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 at baseline (T0), 3 months (T1), and 6 months (T2) after start of treatment. Mixed effects linear regression models were used to compare HRQoL between the 2 groups over time. Results: From the 59 eligible patients for the CAPABLE intervention, 31 (53%) signed informed consent to participate. Baseline HRQoL was on average 10 points higher in the intervention group compared with controls, although equally matched on baseline and clinical characteristics. When correcting for sex, age, disease stage, and baseline scores, an adjusted difference in fatigue of −5.09 (95% CI −15.20 to 5.02, P=.32) at month 3 was found. No significant nor clinically relevant adjusted differences on other HRQoL domains over time were found. However, information satisfaction was significantly higher in the CAPABLE group (β=8.71, 95% CI 1.54‐15.88, P=.02). Conclusions: The intervention showed a limited effect on HRQoL, although there was a small improvement in fatigue at 3 months, as well as information satisfaction. When aiming at personalized patient and survivorship care, further optimization and prospective investigation of eHealth tools is warranted. Trial Registration: ClinicalTrials NCT05827289; https://clinicaltrials.gov/study/NCT05827289 International Registered Report Identifier (IRRID): RR2-10.2196/49252 %R 10.2196/58938 %U https://cancer.jmir.org/2025/1/e58938 %U https://doi.org/10.2196/58938 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 13 %N %P e57540 %T Effectiveness of an mHealth Intervention With Short Text Messages to Promote Treatment Adherence Among HIV-Positive Mexican Adults: Randomized Controlled Trial %A Del Moral Trinidad,Luis Eduardo %A Andrade Villanueva,Jaime Federico %A Martínez Ayala,Pedro %A Cabrera Silva,Rodolfo Ismael %A Herrera Godina,Melva Guadalupe %A González-Hernández,Luz Alicia %K HIV %K treatment adherence %K mobile health %K mHealth %K mHealth intervention %K randomized clinical trial %K text messages %K eHealth intervention %K sexual health %K randomized controlled trial %K RCT %D 2025 %7 28.1.2025 %9 %J JMIR Mhealth Uhealth %G English %X Background: HIV continues to be a public health concern in Mexico and Latin America due to an increase in new infections, despite a decrease being observed globally. Treatment adherence is a pillar for achieving viral suppression. It prevents the spread of the disease at a community level and improves the quality and survival of people living with HIV. Thus, it is important to implement strategies to achieve sustained treatment adherence. Objective: The objective of this study is to evaluate the effectiveness of a mobile health (mHealth) intervention based on SMS text messages to increase antiretroviral therapy (ART) adherence for HIV-positive adults. Methods: A randomized controlled trial was performed at the Hospital Civil de Guadalajara – Fray Antonio Alcalde on HIV-positive adults who had initiated ART. The mHealth intervention included the use of SMS text messages as a reminder system for upcoming medical examinations and ART resupply to increase adherence. This intervention was provided to 40 participants for a 6-month period. A control group (n=40) received medical attention by the standard protocol used in the hospital. Intervention effectiveness was assessed by quantifying CD4+ T cells and viral load, as well as a self-report of adherence by the patient. Results: The intervention group had greater adherence to ART than the control group (96% vs 92%; P<.001). In addition, the intervention group had better clinical characteristics, including a lower viral load (141 copies/mL vs 2413 copies/mL; P<.001) and a trend toward higher CD4+ T cells counts (399 cells/μL vs 290 cells/μL; P=.15). Conclusions: These results show that an mHealth intervention significantly improves ART adherence. Implementing mHealth programs could enhance the commitment of HIV-positive adults to their treatment. Trial Registration: ClinicalTrials.gov NCT05187741; https://clinicaltrials.gov/study/NCT05187741 %R 10.2196/57540 %U https://mhealth.jmir.org/2025/1/e57540 %U https://doi.org/10.2196/57540 %0 Journal Article %@ 2152-7202 %I JMIR Publications %V 17 %N %P e50828 %T Value Propositions for Digital Shared Medication Plans to Boost Patient–Health Care Professional Partnerships: Co-Design Study %A Bugnon,Benjamin %A Bosisio,Francesca %A Kaufmann,Alain %A Bonnabry,Pascal %A Geissbuhler,Antoine %A von Plessen,Christian %+ School of pharmaceutical sciences, Institute of Pharmaceutical Sciences of Western Switzerland, University of Geneva, Rue Michel-Servet 1, CMU Bâtiment B, Geneva, 1211, Switzerland, 41 796250180, benjamin.bugnon@gmail.com %K digital shared medication plan %K medication records %K medication list %K e-medication %K interoperability %K electronic patient records %K patient involvement %K partnership %K coproduction %K medication safety %D 2025 %7 28.1.2025 %9 Original Paper %J J Particip Med %G English %X Background: Health authorities worldwide have invested in digital technologies to establish robust information exchange systems for improving the safety and efficiency of medication management. Nevertheless, inaccurate medication lists and information gaps are common, particularly during care transitions, leading to avoidable harm, inefficiencies, and increased costs. Besides fragmented health care processes, the inconsistent incorporation of patient-driven changes contributes to these problems. Concurrently, patient-empowerment tools, such as mobile apps, are often not integrated into health care professional workflows. Leveraging coproduction by allowing patients to update their digital shared medication plans (SMPs) is a promising but underused and challenging approach. Objective: This study aimed to determine the value propositions of a digital tool enabling patients, family caregivers, and health care professionals to coproduce and co-manage medication plans within Switzerland’s national eHealth architecture. Methods: We used an experience-based co-design approach in the French-speaking region of Switzerland. The multidisciplinary research team included 5 patients as co-researchers. We recruited polypharmacy patients, family caregivers, and health care professionals with a broad range of experiences, diseases, and ages. The experience-based co-design had 4 phases: capturing, understanding, and improving experiences, followed by preparing recommendations and next steps. A qualitative, participatory methodology was used to iteratively explore collaborative medication management experiences and identify barriers and enabling mechanisms, including technology. We conducted a thematic analysis of participant interviews to develop value propositions for digital SMPs. Results: In total, 31 persons participated in 9 interviews, 5 focus groups, and 2 co-design workshops. We identified four value propositions for involving patients and family caregivers in digital SMP management: (1) comprehensive, accessible information about patients’ current medication plans and histories, enabling streamlined access and reconciliation on a single platform; (2) patient and health care professional empowerment through the explicit co-ownership of SMPs, fostering coresponsibility, accountability, and transparent collaboration; (3) a means of supporting collaborative interprofessional medication management, including tailored access to information and improved communication across stakeholders; and (4) an opportunity to improve the quality of care and catalyze digital health innovations. Participants discussed types of patient involvement in editing shared information and emphasized the importance of tailoring SMPs to individual abilities and preferences to foster health equity. Integrating co-management into the clinical routine and creating supportive conditions were deemed important. Conclusions: Coproduced SMPs can improve medication management by fostering trust and collaboration between patients and health care professionals. Successful implementation will require eHealth interoperability frameworks that embrace the complexity of medication management and support diverse use configurations. Our findings underscored the shared responsibility of all stakeholders, including policy makers and technology providers, for the effective and safe use of SMPs. The 4 value propositions offer strategic guidance, while highlighting the need for further research in different health care settings. %M 39874569 %R 10.2196/50828 %U https://jopm.jmir.org/2025/1/e50828 %U https://doi.org/10.2196/50828 %U http://www.ncbi.nlm.nih.gov/pubmed/39874569 %0 Journal Article %@ 2561-1011 %I JMIR Publications %V 9 %N %P e50693 %T A Medication Management App (Smart-Meds) for Patients After an Acute Coronary Syndrome: Pilot Pre-Post Mixed Methods Study %A Ehrler,Frederic %A Gschwind,Liliane %A Hagberg,Hamdi %A Meyer,Philippe %A Blondon,Katherine %K medication adherence %K gamified app %K narration %K acute coronary syndrome %K beliefs about medication %K self-reported adherence %K pilot study %K usability evaluation %K storytelling component %D 2025 %7 23.1.2025 %9 %J JMIR Cardio %G English %X Background: Medication nonadherence remains a significant challenge in the management of chronic conditions, often leading to suboptimal treatment outcomes and increased health care costs. Innovative interventions that address the underlying factors contributing to nonadherence are needed. Gamified mobile apps have shown promise in promoting behavior change and engagement. Objective: This pilot study aimed to evaluate the efficacy and usability of a gamified mobile app that used a narrative storytelling approach to enhance medication adherence among patients following acute coronary syndrome (ACS). The study aimed to assess changes in participants’ beliefs about medication and self-reported adherence before and after the intervention. Additionally, user feedback regarding the narrative component of the app was gathered. Methods: Overall, 18 patients who recently experienced ACS were recruited for a 1-month intervention using the gamified app. Participants’ beliefs about medication and self-reported adherence were assessed using standardized scales pre- and postintervention. The app’s usability was also evaluated through a postintervention questionnaire. Statistical analyses were performed to determine the significance of changes in belief and adherence scores. Results: Although 33% (6/18) of the participants did not use the intervention more than once, the remaining 12 remained engaged during the 30 days of the study. The results did not indicate a significant improvement in participants’ beliefs about medication following the intervention. However, self-reported adherence significantly improved (P<.05) after the intervention with a mean score going from 29.1 (SD 6.9) to 32.4 (SD 5.6), with participants demonstrating a greater self-efficacy to their prescribed medication regimen. However, the results did not indicate a significant improvement in participants’ beliefs about medication. With a mean average score of 80.6, the usability evaluation indicates a good usability rating for the gamified app. However, the narrative storytelling component of the app was not favored by the participants, as indicated by their feedback. Conclusions: This pilot study suggests that a gamified mobile app using narration may effectively enhance medication self-efficacy and positively influence patients’ beliefs about medication following ACS. However, the narrative component of the app did not receive favorable feedback from participants. Future research should focus on exploring alternative methods to engage participants in the app’s narrative elements while maintaining the positive impact on adherence and beliefs about medication observed in this study. %R 10.2196/50693 %U https://cardio.jmir.org/2025/1/e50693 %U https://doi.org/10.2196/50693 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e60326 %T Strategies to Improve Health Care Provider Prescription of and Patient Adherence to Guideline-Recommended Cardiovascular Medications for Atherosclerotic Occlusive Disease: Protocol for Two Systematic Reviews and Meta-Analyses of Randomized Controlled Trials %A Kirkham,Aidan M %A Fergusson,Dean A %A Presseau,Justin %A McIsaac,Daniel I %A Shorr,Risa %A Roberts,Derek J %+ Division of Vascular and Endovascular Surgery, Department of Surgery, University of Ottawa, Room A-280, 1053 Carling Avenue, Ottawa, ON, K1Y 4E9, Canada, 1 6137985555 ext 16268, Derek.Roberts01@gmail.com %K coronary artery disease %K cerebrovascular disease %K peripheral artery disease %K polyvascular disease %K underprescription %K nonadherence %K implementation strategy %K adherence-supporting strategy %K statins %K antiplatelets %K antihypertensives %K guideline-recommended medications %K implementation %K atherosclerosis %K patient adherence %K RCT %K randomized controlled trials %K PRISMA %D 2025 %7 16.1.2025 %9 Protocol %J JMIR Res Protoc %G English %X Background: In patients with atherosclerotic occlusive diseases, systematic reviews and meta-analyses of randomized controlled trials (RCTs) report that antiplatelets, statins, and antihypertensives reduce the risk of major adverse cardiac events, need for revascularization procedures, mortality, and health care resource use. However, evidence suggests that these patients are not prescribed these medications adequately or do not adhere to them once prescribed. Objective: We aim to systematically review and meta-analyze RCTs examining the effectiveness of implementation or adherence-supporting strategies for improving health care provider prescription of, or patient adherence to, guideline-recommended cardiovascular medications in patients with atherosclerotic occlusive disease. Methods: We designed and reported the protocol according to the PRISMA-P (Preferred Reporting Items for Systematic Review and Meta-Analysis-Protocols) statement. We will search MEDLINE, Embase, The Cochrane Central Register of Controlled Trials, PsycINFO, and CINAHL from their inception. RCTs examining implementation or adherence-supporting strategies for improving prescription of, or adherence to, guideline-recommended cardiovascular medications in adults with cerebrovascular disease, coronary artery disease, peripheral artery disease, or polyvascular disease (>1 of these diseases) will be included. Two investigators will independently review identified titles/abstracts and full-text studies, extract data, assess the risk of bias (using the Cochrane tool), and classify implementation or adherence-supporting strategies using the refined Cochrane Effective Practice and Organization of Care (EPOC) taxonomy (for strategies aimed at improving prescription) and Behavior Change Wheel (BCW; for adherence-supporting strategies). We will narratively synthesize data describing which implementation or adherence-supporting strategies have been evaluated across RCTs, and their reported effectiveness at improving prescription of, or adherence to, guideline-recommended cardiovascular medications (primary outcomes) and patient-important outcomes and health care resource use (secondary outcomes) within refined EPOC taxonomy levels and BCW interventions and policies. Where limited clinical heterogeneity exists between RCTs, estimates describing the effectiveness of implementation or adherence-supporting strategies within different refined EPOC taxonomy levels and BCW interventions and policies will be pooled using random-effects models. Stratified meta-analyses and meta-regressions will assess if strategy effectiveness varies by recruited patient populations, prescriber types, clinical practice settings, and study design characteristics. GRADE (Grading of Recommendations, Assessment, Development, and Evaluation) will be used to communicate evidence certainty. Results: The search was completed on June 6, 2023. Database searches and the PubMed “related articles” feature identified 4319 unique citations for title/abstract screening. We are currently screening titles/abstracts. Conclusions: These studies will identify which implementation and adherence-supporting strategies are being used (and in which combinations) across RCTs for improving the prescription of, or adherence to, guideline-recommended cardiovascular medications in adults with atherosclerotic occlusive diseases. They will also determine the effectiveness of currently trialed implementation and adherence-supporting strategies, and whether effectiveness varies by patient, prescriber, or clinical practice setting traits. Trial Registration: PROSPERO CRD42023461317; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=461317; PROSPERO CRD42023461299; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=461299 %M 39819842 %R 10.2196/60326 %U https://www.researchprotocols.org/2025/1/e60326 %U https://doi.org/10.2196/60326 %U http://www.ncbi.nlm.nih.gov/pubmed/39819842 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 13 %N %P e57991 %T Effectiveness of a Mobile Health Intervention (DOT Selfie) in Increasing Treatment Adherence Monitoring and Support for Patients With Tuberculosis in Uganda: Randomized Controlled Trial %A Sekandi,Juliet Nabbuye %A Buregyeya,Esther %A Zalwango,Sarah %A Nakkonde,Damalie %A Kaggwa,Patrick %A Quach,Trang Ho Thu %A Asiimwe,David %A Atuyambe,Lynn %A Dobbin,Kevin %+ Department of Epidemiology and Biostatistics, College of Public Health, University of Georgia, 100 Foster Road, Athens, GA, 30602, United States, 1 7065425257, jsekandi@uga.edu %K tuberculosis %K digital adherence technologies %K video-observed treatment %K video directly observed treatment %K directly observed therapy %K adherence %K mHealth %K Uganda %K Africa %D 2025 %7 16.1.2025 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Directly observed therapy (DOT) is the standard method for monitoring adherence to tuberculosis (TB) treatment. However, implementing DOT poses challenges for both patients and providers due to limited financial and human resources. Increasing evidence suggests that emerging digital adherence technologies, such as video directly observed therapy (VDOT), can serve as viable alternatives. Objective: This study aims to evaluate the effectiveness of VDOT compared with usual care directly observed therapy (UCDOT). Methods: Between July 2020 and October 2021, we conducted a 2-arm, parallel-group, open-label randomized trial with a 1:1 assignment to receive either the VDOT intervention (n=72) or UCDOT (n=72) for treatment adherence monitoring at public health clinics in Kampala, Uganda. Each group was further stratified to ensure equal numbers of males and females. Eligible patients were aged 18-65 years, had a confirmed diagnosis of TB, and were undergoing daily treatment. The VDOT group was provided with a smartphone equipped with an app, while the UCDOT group followed the routine monitoring practices outlined by the Uganda National TB Program. We tested the hypothesis that VDOT was more effective than UCDOT for monitoring medication adherence. The primary outcome was adherence, defined as having ≥80% of the expected doses observed during the 6-month treatment period. An intention-to-treat analysis was conducted, and multivariable logistic regression was used to estimate the effect of the intervention on adherence monitoring. Adjusted relative risk ratios and their corresponding 95% CIs are presented. Secondary outcomes included treatment completion, loss to follow-up, death, and reasons for missed videos in the intervention group. Results: The intention-to-treat analysis included 142 participants, with 2 excluded due to discontinuation of medication within the first week after enrollment. The median age of participants was 34 (IQR 26-45) years. The median fraction of expected doses observed (FEDO) was significantly higher in the VDOT group compared with the UCDOT group (100, IQR 80-100 vs 30, IQR 10-60, respectively; P<.001). When using a FEDO cutoff of ≥80% to define optimal adherence, 63 of 142 (44%) patients met the threshold, with a significant difference between the VDOT and UCDOT groups (56/71, 79% vs 7/71, 10%, P<.001). After adjusting for confounders, VDOT users were significantly more likely to achieve ≥80% of their expected doses observed compared with UCDOT users (adjusted risk ratio 8.4, 95% CI 4.16-17.0). The most common reasons for failing to submit videos of medication intake were an uncharged phone battery, forgetting to record videos during medication intake, and losing the smartphone. Conclusions: Enhanced VDOT was more effective than UCDOT in increasing adherence monitoring among patients with TB in Uganda. This evidence highlights the potential of digital technologies to improve treatment adherence monitoring and support in high TB burden settings with limited human resources. Trial Registration: ClinicalTrials.gov NCT04134689; http://clinicaltrials.gov/ct2/show/NCT04134689 %M 39715573 %R 10.2196/57991 %U https://mhealth.jmir.org/2025/1/e57991 %U https://doi.org/10.2196/57991 %U http://www.ncbi.nlm.nih.gov/pubmed/39715573 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 13 %N %P e53971 %T Smoking Cessation Smartphone App for Nondaily Smoking With Telephone Onboarding: Proof-of-Concept Randomized Controlled Trial %A Hoeppner,Bettina B %A Siegel,Kaitlyn R %A Futter,Allison E %A Finley-Abboud,Diadora %A Williamson,Alivia C %A Kahler,Christopher W %A Park,Elyse R %A Hoeppner,Susanne S %+ Health through Flourishing (HtF) program, Department of Psychiatry, Massachusetts General Hospital, 125 Nashua St, 4th Fl., Boston, MA, 02114, United States, 1 617 643 198, bhoeppner@mgh.harvard.edu %K mobile health %K mHealth %K smoking cessation %K nondaily smoking %K smartphone %K smoking %K positive psychology %K mobile phone %D 2025 %7 15.1.2025 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Nondaily smoking is a widespread and increasingly prevalent pattern of use. To date, no effective treatment approach for nondaily smoking has been identified. Objective: This study aimed to conduct an unblinded randomized controlled trial to evaluate proof-of-concept markers of the Smiling instead of Smoking (SiS) app, a smartphone app for smoking cessation, designed specifically for people who smoke less than daily, within the framework of positive psychology. Methods: Overall, 226 adults who smoke less than daily were recruited on the web and asked to undertake a quit attempt while using assigned smoking cessation support materials. Participants were randomly assigned to 1 of 3 materials: the SiS smartphone app, the National Cancer Institute’s smartphone app QuitGuide (QG), or the National Cancer Institute’s smoking cessation brochure, “Clearing the Air” (CtA). All participants engaged in a 15-minute scripted onboarding phone call and were introduced to their support materials to use for the next 7 weeks. Follow-up self-assessment web surveys were sent 2, 6, 12, and 24 weeks after participants’ initially chosen quit date (ie, 1 week after onboarding). The primary outcome for this study was self-efficacy to remain abstinent from smoking at treatment end. Secondary outcomes assessed treatment acceptability, treatment feasibility (eg, number of days of app use, time spent using app, and use of smoking cessation strategies), and secondary proof-of-concept efficacy outcomes (eg, positive affect, craving, and attitudes toward smoking). Smoking outcomes (ie, 30-day point prevalence abstinence and smoking reduction) were also assessed. Results: Results indicated a significant effect of treatment on the primary outcome, where SiS participants (n=80) reported higher self-efficacy to abstain from smoking at the end of treatment than the 2 control groups (QG: n=75; P=.02; Cohen d=0.40 and CtA: n=71; P=.007; Cohen d=0.50). This effect was also significant on both self-efficacy subscales (ie, internal cues and external cues) with effect sizes ranging from Cohen d=0.34 to 0.50 across the pairwise comparisons. The SiS app group also reported lower craving (QG: P=.005; Cohen d=–0.57 and CtA: P=.005; Cohen d=–0.57) and higher positive affect than QG (QG: P=.01; Cohen d=0.44 and CtA: P=.05; Cohen d=0.38); attitudes toward smoking were largely similar across groups. Treatment acceptability was comparable across groups (P values for all groups >.05; Cohen d range 0.06-0.23). Treatment feasibility measures indicated that participants used the SiS app on 33 out of 49 days, for 35 to 40 minutes per week, resulting in greater use of smoking cessation strategies than QG (QG: P=.04; Cohen d=0.38 and CtA: P=.16; Cohen d=0.24). Conclusions: These findings provide strong evidence for the conceptual underpinnings of the SiS app, and thereby provide compelling justification for conducting a large-scale randomized controlled trial that can test the effectiveness of the SiS app on smoking cessation. Trial Registration: ClinicalTrials.gov NCT04672239; https://clinicaltrials.gov/study/NCT04672239 International Registered Report Identifier (IRRID): RR2-10.2196/40867 %M 39814363 %R 10.2196/53971 %U https://mhealth.jmir.org/2025/1/e53971 %U https://doi.org/10.2196/53971 %U http://www.ncbi.nlm.nih.gov/pubmed/39814363 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 12 %N %P e63653 %T Satisfaction and Usability of a Commercially Available Medication Adherence App (Medisafe) Among Medically Underserved Patients With Chronic Illnesses: Survey Study %A Hartch,Christa %A Dietrich,Mary S %A Lancaster,B Jeanette %A Mulvaney,Shelagh A %A Stolldorf,Deonni P %+ School of Nursing and Health Sciences, Manhattanville University, 2900 Purchase Street, Purchase, NY, 10577, United States, 1 914 323 5365, christa.hartch@mville.edu %K medication adherence %K mHealth %K mobile phone %K app %K medically underserved %K chronic disease %K satisfaction %K usage %K health disparities %D 2025 %7 7.1.2025 %9 Original Paper %J JMIR Hum Factors %G English %X Background: Research supports the use of mobile phone apps to promote medication adherence, but the use of and satisfaction with these apps among medically underserved patients with chronic illnesses remain unclear. Objective: This study reports on the overall use of and satisfaction with a medication adherence app (Medisafe) in a medically underserved population. Methods: Medically underserved adults who received care for one or more chronic illnesses at a federally qualified health center (FQHC) were randomized to an intervention group in a larger randomized controlled trial and used the app for 1 month (n=30), after which they completed a web-based survey. Objective data on app usage were provided as secondary data by the app company. Results: The participants were very satisfied with the app, with all participants (30/30, 100%) somewhat or strongly agreeing that they would recommend the app to family and friends. Participants strongly agreed (28/30, 93%) that the reminders helped them remember to take their medications at the correct time each day, and they (28/30, 93%) found the app easy to use. Additional features accessed by some included educational features and the adherence report. Participants noted the helpfulness of having a medication list on their phones, and some used it during medication reconciliation at doctor visits. Use of the Medfriend feature, which alerts a social support person if a medication is missed, was low (n=2), but those who used it were very positive about the feature. Conclusions: A commercially available medication adherence app was found to be useful by participants, and they were satisfied with the app and the additional features provided. The use of medication adherence mobile phone apps has the potential to positively influence chronic disease management in a medically underserved population on a large scale. Trial Registration: ClinicalTrials.gov NCT05098743; https://clinicaltrials.gov/study/NCT05098743 %M 39773694 %R 10.2196/63653 %U https://humanfactors.jmir.org/2025/1/e63653 %U https://doi.org/10.2196/63653 %U http://www.ncbi.nlm.nih.gov/pubmed/39773694 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e57458 %T Use of Extrinsic Motivators to Improve the BMI of Obese or Overweight Adolescents: Systematic Review %A Gonçalves,Ana %A Simões,Pedro Augusto %A Sousa-Pinto,Bernardo %A Taveira-Gomes,Tiago %+ Faculty of Medicine, Universidade do Porto, Alameda Prof. Hernâni Monteiro, Porto, 4200-319, Portugal, 351 225513600, an.goncalves@ubi.pt %K adolescents %K obesity %K overweight %K extrinsic motivators %K body mass index %D 2024 %7 30.12.2024 %9 Review %J J Med Internet Res %G English %X Background: The prevalence of overweight and obesity is increasing at an alarming rate in children and adolescents worldwide. Given the dimensions of the problem, the treatment of childhood obesity is considered extremely important. Current evidence indicates that behavioral and cognitive behavioral strategies combined with diet and physical activity approaches may assist in reducing adolescent obesity. Objective: The purpose of this systematic review was to evaluate the use of extrinsic motivators for improving the BMI of obese or overweight adolescents.  Methods: The inclusion criteria were as follows: (1) overweight or obese adolescents, (2) intervention using extrinsic motivators, and (3) outcome variables related to weight status. The exclusion criterion was the presence of an associated chronic disease. The search process was conducted in PubMed and Web of Science (last searched on April 23, 2023). The risk of bias was evaluated independently by 2 authors using Cochrane tools (RoB2 [randomized controlled trials], ROBINS-I, and ROBINS-E). Results: From 3163 studies identified, 20 articles (corresponding to 18 studies) were included in the analysis. The studies differed in terms of study design, sample size, follow-up duration, outcomes reported, and extrinsic motivators used. Most of the studies had videogames or apps as interventions. Of the 18 studies, 9 (50%) reported a statistically significant decrease in BMI. The most used extrinsic motivators were “motivation” (n=13), “feedback” (n=10), and “rewards” (n=9). Among the motivators, “reminders” (100%) and “peer-support” (80%) appeared to have high impacts on BMI reduction.  Conclusions: The heterogeneity of the included studies made analysis difficult. No study evaluated extrinsic motivators in isolation. Most of the studies had a moderate or high risk of bias. The extrinsic motivators “reminders” and “peer-support” appeared to be useful. Further studies are needed, and these should include well-designed randomized controlled trials and studies involving homogeneity in BMI measures, consistent extrinsic motivator definitions, and longer durations to better understand the long-term impacts of extrinsic motivators on weight management success. %M 39576963 %R 10.2196/57458 %U https://www.jmir.org/2024/1/e57458 %U https://doi.org/10.2196/57458 %U http://www.ncbi.nlm.nih.gov/pubmed/39576963 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e57774 %T mHealth Engagement for Antiretroviral Medication Adherence Among People With HIV and Substance Use Disorders: Observational Study %A Mi,Ranran Z %A Yang,Ellie Fan %A Tahk,Alexander %A Tarfa,Adati %A Cotter,Lynne M %A Lu,Linqi %A Yang,Sijia %A Gustafson Sr,David H %A Westergaard,Ryan %A Shah,Dhavan %+ School of Communication, Illinois State University, 4480 School Of Communication, FEL Fell Hall 434, Normal, IL, 61790, United States, 1 (309) 438 3671, fyang8@ilstu.edu %K information and communication technologies %K ICTs %K mHealth %K medication adherence %K HIV care %K antiretroviral therapy %K substance use %K social support %K patient management %K health disparities %K information technology %K communication technology %K mobile health %K app %K clinic %K United States %K participants %K mobile phone %D 2024 %7 20.12.2024 %9 Original Paper %J J Med Internet Res %G English %X Background: Despite the increasing popularity of mobile health (mHealth) technologies, little is known about which types of mHealth system engagement might affect the maintenance of antiretroviral therapy among people with HIV and substance use disorders. Objective: This study aimed to use longitudinal and detailed system logs and weekly survey data to test a mediation model, where mHealth engagement indicators were treated as predictors, substance use and confidence in HIV management were treated as joint mediators, and antiretroviral therapy adherence was treated as the outcome. We further distinguished the initiation and intensity of system engagement by mode (expression vs reception) and by communication levels (intraindividual vs dyadic vs network). Methods: Tailored for people with HIV living with substance use disorders, the mHealth app was distributed among 208 participants aged >18 years from 2 US health clinics. Supervised by medical professionals, participants received weekly surveys through the app to report their health status and medication adherence data. System use was passively collected through the app, operationalized as transformed click-level data, aggregated weekly, and connected to survey responses with a 7-day lagged window. Using the weekly check-in record provided by participants as the unit of analysis (N=681), linear regression and structure equation models with cluster-robust SEs were used for analyses, controlling within-person autocorrelation and group-level error correlations. Racial groups were examined as moderators in the structure equation models. Results: We found that (1) intensity, not initiation, of system use; (2) dyadic message expression and reception; and (3) network expression positively predicted medication adherence through joint mediators (substance use and confidence in HIV management). However, intraindividual reception (ie, rereading saved entries for personal motivation) negatively predicts medication adherence through joint mediators. We also found Black participants have distinct usage patterns, suggesting the need to tailor mHealth interventions for this subgroup. Conclusions: These findings highlight the importance of considering the intensity of system engagement, rather than initiation alone, when designing mHealth interventions for people with HIV and tailoring these systems to Black communities. %M 39705693 %R 10.2196/57774 %U https://www.jmir.org/2024/1/e57774 %U https://doi.org/10.2196/57774 %U http://www.ncbi.nlm.nih.gov/pubmed/39705693 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 12 %N %P e58920 %T Exploring and Predicting HIV Preexposure Prophylaxis Adherence Patterns Among Men Who Have Sex With Men: Randomized Controlled Longitudinal Study of an mHealth Intervention in Western China %A Lin,Bing %A Li,Jiayan %A Liu,Jiaxiu %A He,Wei %A Pan,Haiying %A Zhong,Xiaoni %K preexposure prophylaxis %K adherence %K trajectory analysis %K men who have sex with men %K mHealth %K mobile health %K mHealth intervention %K decision tree %D 2024 %7 12.12.2024 %9 %J JMIR Mhealth Uhealth %G English %X Background: Preexposure prophylaxis (PrEP) is an effective strategy to reduce the risk of HIV infection. However, the efficacy of PrEP is highly dependent on adherence. Meanwhile, adherence changes over time, making it difficult to manage effectively. Objective: Our study aimed to explore and predict the patterns of change in PrEP adherence among men who have sex with men (MSM) and evaluate the impact of the WeChat-based reminder intervention on adherence, thus providing more information for PrEP implementation strategies. Methods: From November 2019 to June 2023, in a randomized controlled longitudinal study of the PrEP demonstration project in Western China (Chongqing, Sichuan, and Xinjiang) based on a mobile health (mHealth) reminder intervention, participants were randomly divided into reminder and no-reminder groups, with those in the reminder group receiving daily reminders based on the WeChat app. Participants were followed up and self-reported their medication adherence every 12 weeks for a total of 5 follow-up visits. We used the growth mixture model (GMM) to explore potential categories and longitudinal trajectories of adherence among MSM, and patterns of change in PrEP adherence were predicted and evaluated based on the decision tree. Results: A total of 446 MSM were included in the analysis. The GMM identified 3 trajectories of adherence: intermediate adherence group (n=34, 7.62%), low adherence ascending group (n=126, 28.25%), and high adherence decline group (n=286, 64.13%). We included 8 variables that were significant in the univariate analysis in the decision tree prediction model. We found 4 factors and 8 prediction rules, and the results showed that HIV knowledge score, education attainment, mHealth intervention, and HIV testing were key nodes in the patterns of change in adherence. After 10-fold cross-validation, the final prediction model had an accuracy of 75%, and the classification accuracy of low and intermediate adherence was 78.12%. Conclusions: The WeChat-based reminder intervention was beneficial for adherence. A short set of questions and prediction rules, which can be applied in future large-scale validation studies, aimed at developing and validating a short adherence assessment tool and implementing it in PrEP practices among MSM. Trial Registration: Chinese Clinical Trial Registry ChiCTR1900026414; https://www.chictr.org.cn/showproj.html?proj=35077 %R 10.2196/58920 %U https://mhealth.jmir.org/2024/1/e58920 %U https://doi.org/10.2196/58920 %0 Journal Article %@ 2561-1011 %I JMIR Publications %V 8 %N %P e56763 %T Association Between Video-Based Telemedicine Visits and Medication Adherence Among Patients With Heart Failure: Retrospective Cross-Sectional Study %A Zheng,Yaguang %A Adhikari,Samrachana %A Li,Xiyue %A Zhao,Yunan %A Mukhopadhyay,Amrita %A Hamo,Carine E %A Stokes,Tyrel %A Blecker,Saul %K telemedicine %K medication adherence %K heart failure %K systolic dysfunction %K medical therapy %K telehealth %K remote monitoring %K self-management %D 2024 %7 5.12.2024 %9 %J JMIR Cardio %G English %X Background: Despite the exponential growth in telemedicine visits in clinical practice due to the COVID-19 pandemic, it remains unknown if telemedicine visits achieved similar adherence to prescribed medications as in-person office visits for patients with heart failure. Objective: Our study examined the association between telemedicine visits (vs in-person visits) and medication adherence in patients with heart failure. Methods: This was a retrospective cross-sectional study of adult patients with a diagnosis of heart failure or an ejection fraction of ≤40% using data between April 1 and October 1, 2020. This period was used because New York University approved telemedicine visits for both established and new patients by April 1, 2020. The time zero window was between April 1 and October 1, 2020, then each identified patient was monitored for up to 180 days. Medication adherence was measured by the mean proportion of days covered (PDC) within 180 days, and categorized as adherent if the PDC was ≥0.8. Patients were included in the telemedicine exposure group or in-person group if all encounters were video visits or in-person office visits, respectively. Poisson regression and logistic regression models were used for the analyses. Results: A total of 9521 individuals were included in this analysis (telemedicine visits only: n=830 in-person office visits only: n=8691). Overall, the mean age was 76.7 (SD 12.4) years. Most of the patients were White (n=6996, 73.5%), followed by Black (n=1060, 11.1%) and Asian (n=290, 3%). Over half of the patients were male (n=5383, 56.5%) and over half were married or living with partners (n=4914, 51.6%). Most patients’ health insurance was covered by Medicare (n=7163, 75.2%), followed by commercial insurance (n=1687, 17.7%) and Medicaid (n=639, 6.7%). Overall, the average PDC was 0.81 (SD 0.286) and 71.3% (6793/9521) of patients had a PDC≥0.8. There was no significant difference in mean PDC between the telemedicine and in-person office groups (mean 0.794, SD 0.294 vs mean 0.812, SD 0.285) with a rate ratio of 0.99 (95% CI 0.96-1.02; P=.09). Similarly, there was no significant difference in adherence rates between the telemedicine and in-person office groups (573/830, 69% vs 6220/8691, 71.6%), with an odds ratio of 0.94 (95% CI 0.81-1.11; P=.12). The conclusion remained the same after adjusting for covariates (eg, age, sex, race, marriage, language, and insurance). Conclusions: We found similar rates of medication adherence among patients with heart failure who were being seen via telemedicine or in-person visits. Our findings are important for clinical practice because we provide real-world evidence that telemedicine can be an approach for outpatient visits for patients with heart failure. As telemedicine is more convenient and avoids transportation issues, it may be an alternative way to maintain the same medication adherence as in-person visits for patients with heart failure. %R 10.2196/56763 %U https://cardio.jmir.org/2024/1/e56763 %U https://doi.org/10.2196/56763 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 11 %N %P e57652 %T Medication Management Initiatives Using Wearable Devices: Scoping Review %A Iino,Haru %A Kizaki,Hayato %A Imai,Shungo %A Hori,Satoko %K medication adherence %K scoping review %K database search %K integrated medication management %K drug %K pharmacy %K pharmacology %K pharmacotherapy %K pharmaceutics %K medication %K adherence %K wearable %K synthesis %K review methods %K digital health %D 2024 %7 27.11.2024 %9 %J JMIR Hum Factors %G English %X Background: Wearable devices (WDs) have evolved beyond simple fitness trackers to sophisticated health monitors capable of measuring vital signs, such as heart rate and blood oxygen levels. Their application in health care, particularly medication management, is an emerging field poised to significantly enhance patient adherence to treatment regimens. Despite their widespread use and increasing incorporation into clinical trials, a comprehensive review of WDs in terms of medication adherence has not been conducted. Objective: This study aimed to conduct a comprehensive scoping review to evaluate the impact of WDs on medication adherence across a variety of diseases, summarizing key research findings, outcomes, and challenges encountered. Methods: Adhering to PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews) guidelines, a structured search was conducted across MEDLINE, Web of Science, and Embase databases, covering the literature from January 1, 2010, to September 30, 2022. The search strategy was based on terms related to WDs and medication adherence, specifically focusing on empirical studies to ensure the inclusion of original research findings. Studies were selected based on their relevance to medication adherence, usage of WDs in detecting medication-taking actions, and their role in integrated medication management systems. Results: We screened 657 articles and identified 18 articles. The identified studies demonstrated the diverse applications of WDs in enhancing medication adherence across diseases such as Parkinson disease, diabetes, and cardiovascular conditions. The geographical distribution and publication years of these studies indicate a growing interest in this research area. The studies were divided into three types: (1) studies reporting a correlation between data from WDs or their usage and medication adherence or drug usage as outcomes, (2) studies using WDs to detect the act of medication-taking itself, and (3) studies proposing an integrated medication management system that uses WDs in managing medication. Conclusions: WDs are increasingly being recognized for their potential to enhance medication management and adherence. This review underscores the need for further empirical research to validate the effectiveness of WDs in real-life settings and explore their use in predicting adherence based on activity rhythms and activities. Despite technological advancements, challenges remain regarding the integration of WDs into routine clinical practice. Future research should focus on leveraging the comprehensive data provided by WDs to develop personalized medication management strategies that can improve patient outcomes. %R 10.2196/57652 %U https://humanfactors.jmir.org/2024/1/e57652 %U https://doi.org/10.2196/57652 %0 Journal Article %@ 2561-1011 %I JMIR Publications %V 8 %N %P e52266 %T Impact of an mHealth App (Kencom) on Patients With Untreated Hypertension Initiating Antihypertensive Medications: Real-World Cohort Study %A Matsumura,Koichiro %A Nakagomi,Atsushi %A Yagi,Eijiro %A Yamada,Nobuhiro %A Funauchi,Yohei %A Kakehi,Kazuyoshi %A Yoshida,Ayano %A Kawamura,Takayuki %A Ueno,Masafumi %A Nakazawa,Gaku %A Tabuchi,Takahiro %K untreated hypertension %K mobile health app %K antihypertensive medication %K cardiovascular disease %K mHealth %D 2024 %7 26.11.2024 %9 %J JMIR Cardio %G English %X Background: To prevent the further development of cardiovascular diseases, it is a growing global priority to detect untreated hypertension in patients and ensure adequate blood pressure control via drug therapy. However, few effective tools that facilitate the initiation of antihypertensive medications among such patients have been identified. Objective: We aimed to determine whether a mobile health (mHealth) app facilitates the initiation of antihypertensive medications among patients with untreated hypertension. Methods: We analyzed a large longitudinal integrated database mainly comprised of data from middle-aged, employed people and their families. The database contained data from health checkups, health insurance claims, and the mHealth app kencom. kencom is used to manage daily life logs (eg, weight, number of steps) and to provide health information tailored to customers. Patients with untreated hypertension were identified using the baseline health checkup data, and follow-up health checkups were conducted to identify the rate of initiation of antihypertensive medications between mHealth app users and nonusers. Antihypertensive medication status was confirmed via a questionnaire administered during the medical checkup as well as a review of the health insurance claims database. We conducted a modified Poisson regression analysis, weighted by inverse probability of treatment weighting, to examine the effect of mHealth app usage on the initiation of antihypertensive medications. Additionally, data from four lifestyle questionnaires from the baseline and follow-up health checkups were collected to evaluate lifestyle modifications that could be attributed to the mHealth app. Results: Data were collected from 50,803 eligible patients (mean age 49, SD 9 years; men n=39,412, 77.6%; women n=11,391, 22.4%) with a median follow-up period of 3.0 (IQR 2.3‐3.1) years. The rate of initiation of antihypertensive medications was significantly higher in the mHealth app user group than in the nonuser group: 23.4% (3482/14,879) versus 18.5% (6646/35,924; P<.001), respectively. The risk ratio of mHealth app usage for initiated antihypertensive medications was 1.28 (95% CI 1.23‐1.33). Among those who did not intend to improve their lifestyle habits such as exercise and diet at baseline, the rate of lifestyle improvement at follow-up was compared between mHealth app users and nonusers, using data from the questionnaires; mHealth app users demonstrated a significantly higher rate of lifestyle changes than nonusers. Conclusions: For patients with untreated hypertension, the use of the mHealth app kencom, which was not dedicated to hypertension treatment, was associated with a higher initiation of antihypertensive medications. %R 10.2196/52266 %U https://cardio.jmir.org/2024/1/e52266 %U https://doi.org/10.2196/52266 %0 Journal Article %@ 1947-2579 %I JMIR Publications %V 16 %N %P e51424 %T Psychometric Properties of Measuring Antiretroviral Therapy Adherence Among Young Latino Sexual Minority Men With HIV: Ecological Momentary Assessment and Electronic Pill Dispenser Study %A Sheehan,Diana M %A Gwanzura,Tendai %A Ibarra,Cynthia %A Ramirez-Ortiz,Daisy %A Swendeman,Dallas %A Duncan,Dustin T %A Muñoz-Laboy,Miguel %A Devieux,Jessy G %A Trepka,Mary Jo %K human immunodeficiency virus %K HIV %K MSM %K sexual minority %K antiretroviral therapy %K Latino %K Hispanic %K adherence %K psychometric %K ecological momentary assessment %K electronic pill dispenser %K validity %K acceptability %K compliance %K medication dispenser %K reminder %K alert %K digital health %K young adult %D 2024 %7 21.11.2024 %9 %J Online J Public Health Inform %G English %X Background: Increasing HIV rates among young Latino sexual minority men (YLSMM) warrant innovative and rigorous studies to assess prevention and treatment strategies. Ecological momentary assessments (EMAs) and electronic pill dispensers (EPDs) have been used to measure antiretroviral therapy (ART) adherence repeatedly in real time and in participants’ natural environments, but their psychometric properties among YLSMM are unknown. Objective: The study’s objective was to assess the concurrent validity, acceptability, compliance, and behavioral reactivity of EMAs and EPDs among YLSMM with HIV. Methods: A convenience sample of 56 YLSMM with HIV with suboptimal ART adherence, aged 18‐34 years, was recruited into a 28-consecutive-day EMA study. Concurrent validity was analyzed by comparing median ART adherence rates and calculating Spearman correlations between ART adherence measured by EMA, EPD, and baseline retrospective validated 3-item and single-item measures. Acceptability was assessed in exit interviews asking participants to rate EMA and EPD burden. Compliance was assessed by computing the percent lost to follow-up, the percent of EMAs missed, and the percentage of days the EPD was not opened that had corresponding EMA data self-reporting adherence to ARTs. Behavioral reactivity was assessed by computing the median change in ART adherence during the study period, using generalized mixed models to assess whether the cumulative number of EMAs completed and days of EPD use predicted ART adherence over time, and by asking participants to rate perceived reactivity using a Likert scale. Results: EMA ART adherence was significantly correlated with baseline validated 3-item (r=0.41, P=.003) and single-item (r=0.52, P<.001) measures, but correlations were only significant for participants that reported EMA was not burdensome. Correlations for EPD ART adherence were weaker but significant (r=0.36, P=.009; r=0.34, P=.01, respectively). Acceptability was high for EMAs (48/54, 89%) and EPDs (52/54, 96%) per self-report. Loss to follow-up was 4% (2/56), with the remaining participants completing 88.6% (1339/1512) of study-prompted EMAs. The percentage of missed EMA surveys increased from 5.8% (22/378) in week 1 of the study to 16.7% (63/378) in week 4. Of 260 days when EPDs were not opened, 68.8% (179) had a corresponding EMA survey self-reporting ART adherence. Reactivity inferred from the median change in ART adherence over time was 8.8% for EMAs and −0.8% for EPDs. Each completed EMA was associated with 1.03 odds (95% CI 1‐1.07) of EMA ART adherence over time, and each day of EPD use with 0.97 odds (95% CI 0.96‐0.99) of EPD ART adherence over time. Self-reported perceived behavioral reactivity was 39% for EMAs and 35% for EPDs. Conclusions: This study provides evidence of concurrent validity with retrospective validated measures for EMA- and EPD-measured ART adherence among YLSMM, when participant burden is carefully considered, without significant behavioral reactivity. While acceptability and compliance of EMAs and EPDs were high overall, noncompliance increased over time, suggesting respondent fatigue. %R 10.2196/51424 %U https://ojphi.jmir.org/2024/1/e51424 %U https://doi.org/10.2196/51424 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e65010 %T Smartphone App for Improving Self-Awareness of Adherence to Edoxaban Treatment in Patients With Atrial Fibrillation (ADHERE-App Trial): Randomized Controlled Trial %A Yoon,Minjae %A Lee,Ji Hyun %A Kim,In-Cheol %A Lee,Ju-Hee %A Kim,Mi-Na %A Kim,Hack-Lyoung %A Lee,Sunki %A Kim,In Jai %A Choi,Seonghoon %A Park,Sung-Ji %A Hur,Taeho %A Hussain,Musarrat %A Lee,Sungyoung %A Choi,Dong-Ju %+ Division of Cardiology, Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, 82, Gumi-ro 173 Beon-gil,, Bundang-gu, Seongnam, 13620, Republic of Korea, 82 31 787 7007, djchoi.snu@gmail.com %K mobile apps %K digital health %K atrial fibrillation %K anticoagulants %K medication adherence %K mobile phone %D 2024 %7 21.11.2024 %9 Original Paper %J J Med Internet Res %G English %X Background: Adherence to oral anticoagulant therapy is essential to prevent ischemic stroke in patients with atrial fibrillation (AF). Objective: This study aimed to evaluate whether smartphone app–based interventions improve medication adherence in patients with AF. Methods: This open-label, multicenter randomized controlled trial (ADHERE-App [Self-Awareness of Drug Adherence to Edoxaban Using an Automatic App Feedback System] study) enrolled patients with AF treated with edoxaban for stroke prevention. They were randomly assigned to app-conditioned feedback (intervention; n=248) and conventional treatment (control; n=250) groups. The intervention group received daily alerts via a smartphone app to take edoxaban and measure blood pressure and heart rate at specific times. The control group received only standard, guideline-recommended care. The primary end point was edoxaban adherence, measured by pill count at 3 or 6 months. Medication adherence and the proportion of adequate medication adherence, which was defined as ≥95% of continuous medication adherence, were evaluated. Results: Medication adherence at 3 or 6 months was not significantly different between the intervention and control groups (median 98%, IQR 95%-100% vs median 98%, IQR 91%-100% at 3 months, P=.06; median 98%, IQR 94.5%-100% vs median 97.5%, IQR 92.8%-100% at 6 months, P=.15). However, the proportion of adequate medication adherence (≥95%) was significantly higher in the intervention group at both time points (76.8% vs 64.7% at 3 months, P=.01; 73.9% vs 61% at 6 months, P=.007). Among patients aged >65 years, the intervention group showed a higher medication adherence value and a higher proportion of adequate medication adherence (≥95%) at 6 months. Conclusions: There was no difference in edoxaban adherence between the groups. However, the proportion of adequate medication adherence was higher in the intervention group, and the benefit of the smartphone app–based intervention on medication adherence was more pronounced among older patients than among younger patients. Given the low adherence to oral anticoagulants, especially among older adults, using a smartphone app may potentially improve medication adherence. Trial Registration: International Clinical Trials Registry Platform KCT0004754; https://cris.nih.go.kr/cris/search/detailSearch.do?seq=28496&search_page=L International Registered Report Identifier (IRRID): RR2-10.1136/bmjopen-2021-048777 %M 39570659 %R 10.2196/65010 %U https://www.jmir.org/2024/1/e65010 %U https://doi.org/10.2196/65010 %U http://www.ncbi.nlm.nih.gov/pubmed/39570659 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e60787 %T Exploration of Features of Mobile Applications for Medication Adherence in Asia: Narrative Review %A Wang,Tzu %A Huang,Yen-Ming %A Chan,Hsun-Yu %+ Graduate Institute of Clinical Pharmacy, College of Medicine, National Taiwan University, No.33, Linsen S Rd, Zhongzheng Dist, Taipei City, 100025, Taiwan, 886 33668784, yenming927@ntu.edu.tw %K Asia %K adherence %K application %K feature %K medication %K mobile %D 2024 %7 8.11.2024 %9 Review %J J Med Internet Res %G English %X Background: Medication is crucial for managing chronic diseases, yet adherence rates are often suboptimal. With advanced integration of IT and mobile internet into health care, mobile apps present a substantial opportunity for improving adherence by incorporating personalized educational, behavioral, and organizational strategies. However, determining the most effective features and functionalities for these apps within the specific health care context in Asia remains a challenge. Objective: We aimed to review the existing literature, focusing on Asian countries, to identify the optimal features of mobile apps that can effectively enhance medication adherence within the unique context of Asian societies. Methods: We conducted a narrative review with the SPIDER (sample, phenomenon of interest, design, evaluation, research type) tool. We identified studies on mobile apps for medication adherence from January 2019 to August 2024 on PubMed and Scopus. Key search terms included “Asia,” “chronic disease,” “app,” “application,” “survey,” “experiment,” “questionnaire,” “group,” “medical adherence,” “medication adherence,” “case-control,” “cohort study,” “randomized controlled trial,” “clinical trial,” “observational study,” “qualitative research,” “mixed methods,” and “analysis,” combined using logical operators “OR” and “AND.” The features of mobile apps identified in the studies were evaluated, compared, and summarized based on their disease focuses, developers, target users, features, usability, and use. Results: The study identified 14 mobile apps designed to enhance medication adherence. Of these, 11 were developed by research teams, while 3 were created by commercial companies or hospitals. All the apps incorporated multiple features to support adherence, with reminders being the most common, present in 11 apps. Patient community forums were the least common, appearing in only 1 app. In total, 6 apps provided lifestyle modification functions, offering dietary and exercise recommendations, generating individualized plans, and monitoring progress. In addition, 6 apps featured health data recording and monitoring functions, with 4 allowing users to export and share records with researchers or health care professionals. Many apps included communication features, with 10 enabling feedback from researchers or health care professionals and 7 offering web-based consultation services. Educational content was available in 8 apps, and 7 used motivation strategies to encourage adherence. Six studies showed that mobile apps improved clinical outcomes, such as blood glucose, lipid, and pressure, while reducing adverse events and boosting physical activities. Twelve studies noted positive humanistic effects, including better medication adherence, quality of life, and user satisfaction. Conclusions: This review has identified key components integrated into mobile apps to support medication adherence. However, the lack of government and corporate involvement in their development limits the generalizability of any individual app. Beyond basic reminder functions, features such as multiuser support, feedback mechanisms, web-based consultations, motivational tools, and socialization features hold significant promise for improving medication adherence. Further pragmatic research is necessary to validate the effectiveness of these selected apps in enhancing adherence. %M 39514859 %R 10.2196/60787 %U https://www.jmir.org/2024/1/e60787 %U https://doi.org/10.2196/60787 %U http://www.ncbi.nlm.nih.gov/pubmed/39514859 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e56437 %T Virtual Coach–Guided Online Acceptance and Commitment Therapy for Chronic Pain: Pilot Feasibility Randomized Controlled Trial %A Reilly,Erin D %A Kelly,Megan M %A Grigorian,Hannah L %A Waring,Molly E %A Quigley,Karen S %A Hogan,Timothy P %A Heapy,Alicia A %A Drebing,Charles E %A Volonte,Matias %A Kathawalla,Ummul-Kiram %A Robins,Hannah E %A Bernice,Katarina %A Bickmore,Timothy %+ Mental Illness Research, Education, and Clinical Center, Veteran Affairs Bedford Healthcare System, Department of Veteran Affairs, 200 Springs Road, Bedford, MA, 01730, United States, 1 781 687 4191, erin.reilly@va.gov %K chronic pain %K randomized controlled trial %K usability %K acceptance and commitment therapy %K embodied conversational agent %K veterans %D 2024 %7 8.11.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Veterans are disproportionately affected by chronic pain, with high rates of pain diagnoses (47%-56%) and a 40% higher rate of prevalence of severe pain than nonveterans. This is often accompanied by negative functional outcomes and higher mortality. Combined with research suggesting medical treatments for chronic pain are often insufficient, there is an urgent need for nonmedical pain self-management programs. An interactive online platform to deliver an efficacious treatment for chronic pain such as acceptance and commitment therapy (ACT) could be a valuable option to assist veterans with pain care at home. Objective: This study aims to evaluate the virtual coach–guided Veteran ACT for Chronic Pain (VACT-CP) online program compared to a waitlist and treatment as usual (WL+TAU) control group through a small pilot feasibility randomized controlled trial. The primary aim was to evaluate the feasibility and acceptability of VACT-CP and study procedures, such as ease of recruitment, treatment receptivity, attrition and retention, sustained participation, system usability, and assessment of trial procedures. Secondary aims explored differences in the VACT-CP and WL+TAU groups on pre- and posttest (week 7) outcome measures for pain, mental health, functioning, and ACT processes. Methods: Veterans with chronic pain were recruited and randomized to either the VACT-CP (n=20) or the WL+TAU (n=22) group in a parallel group trial design. Self-report surveys were administered to participants at baseline (week 0), at the intervention midpoint (week 3), immediately after the intervention (week 7), and at the 1-month follow-up (week 11). We used Wilcoxon signed rank tests with the intention-to-treat sample to describe changes in secondary outcomes from pre- to postintervention within each group. Results: Study procedures showed good feasibility related to recruitment, enrollment, randomization, and study completion rates. Participants reported that VACT-CP was easy to use (System Usability Scale: mean 79.6, SD 12.8; median 82.5, IQR 70-87.5); they completed an average of 5 of the 7 total VACT-CP modules with high postintervention satisfaction rates. Qualitative feedback suggested a positive response to program usability, content tailoring, veteran centeredness, and perceived impact on pain management. Although the pilot feasibility trial was not powered to detect differences in clinical outcomes and significant findings should be interpreted with caution, the VACT-CP group experienced significant increases in chronic pain acceptance (P<.001) and decreases in depressive symptoms (P=.03). Conclusions: VACT-CP showed encouraging evidence of feasibility, usability, and acceptance, while also providing promising initial results in improving a key process in ACT for chronic pain—chronic pain acceptance—after online program use. A full-scale efficacy trial is needed to assess changes in clinical outcomes. Trial Registration: ClinicalTrials.gov NCT03655132; http://clinicaltrials.gov/ct2/show/NCT03655132 International Registered Report Identifier (IRRID): RR2-10.2196/45887 %M 39514264 %R 10.2196/56437 %U https://formative.jmir.org/2024/1/e56437 %U https://doi.org/10.2196/56437 %U http://www.ncbi.nlm.nih.gov/pubmed/39514264 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e48696 %T Predictors of Engagement in Multiple Modalities of Digital Mental Health Treatments: Longitudinal Study %A Nowels,Molly Aideen %A McDarby,Meghan %A Brody,Lilla %A Kleiman,Evan %A Sagui Henson,Sara %A Castro Sweet,Cynthia %A Kozlov,Elissa %+ Division of Geriatrics and Palliative Medicine, Weill Cornell Medicine, 525 E 68th St, New York, NY, 10065, United States, 1 212 746 4888, mon2007@med.cornell.edu %K digital health %K mental health %K health care benefit %K prediction %K technology %K digital mental health %K employer-based %K teletherapy %K coaching %K utilization %K mobile phone %D 2024 %7 7.11.2024 %9 Original Paper %J J Med Internet Res %G English %X Background: Technology-enhanced mental health platforms may serve as a pathway to accessible and scalable mental health care; specifically, those that leverage stepped care models have the potential to address many barriers to patient care, including low mental health literacy, mental health provider shortages, perceived acceptability of care, and equitable access to evidence-based treatment. Driving meaningful engagement in care through these platforms remains a challenge. Objective: This study aimed to examine predictors of engagement in self-directed digital mental health services offered as part of an employer-based mental health benefit that uses a technology-enabled care platform. Methods: Using a prospective, longitudinal design, we examined usage data from employees who had access to an employer-sponsored mental health care benefit. Participants had access to a digital library of mental health resources, which they could use at any time, including daily exercises, interactive programs, podcasts, and mindfulness exercises. Coaching and teletherapy were also available to. The outcome was engagement with the self-directed digital mental health resources, measured by the number of interactions. Poisson regression models included sociodemographic characteristics, patient activation, mental health literacy, well-being, PHQ-9 and GAD-7 scores at baseline, primary concern for engaging in treatment, and the use of coaching or teletherapy sessions. Results: In total 950 individuals enrolled in the study, with 38% using any self-directed digital mental health resources. Approximately 44% of the sample did not use the app during the study period. Those using both self-directed digital and 1:1 modalities made up about one-quarter of the sample (235/950, 24.7%). Those using only coaching or therapy (170/950, 17.9%) and those using only self-directed digital mental health resources (126/950, 13.3%) make up the rest. At baseline, these groups statistically significantly differed on age, PHQ-9, GAD-7, MHLS, and primary concern. Receipt of coaching and teletherapy was associated with the number of self-directed digital mental health resources interactions in adjusted Poisson regression modeling. Use of any coach visit was associated with 82% (rate ratio [RR] 1.82, 95% CI 1.63-2.03) more self-directed digital mental health resource interactions while use of any teletherapy session was associated with 80% (RR 1.80, 95% CI 1.55-2.07) more digital mental health resources interactions (both P<.001). Each additional year of age was associated with increased digital mental health resources interactions (RR 1.04, 95% CI (1.03-1.05), and women had 23% more self-directed digital resources interactions than men (RR 1.23, 95% CI 1.09-1.39). Conclusions: Our key finding was that the use of coaching or teletherapy was associated with increased self-directed digital mental health resource use. Higher self-directed digital resource engagement among those receiving coaching or therapy may be a result of provider encouragement. On the other hand, when a participant engages with 1 modality in the platform, they may be more likely to begin engaging with others, becoming “super users” of all resources. %R 10.2196/48696 %U https://www.jmir.org/2024/1/e48696 %U https://doi.org/10.2196/48696 %0 Journal Article %@ 2369-2960 %I JMIR Publications %V 10 %N %P e60961 %T Preparing for the Implementation of Long-Acting Injectable Cabotegravir for HIV Pre-Exposure Prophylaxis Within the Brazilian Public Health System (ImPrEP CAB Brasil): Qualitative Study %A Pimenta,M Cristina %A Torres,Thiago Silva %A Hoagland,Brenda %A Cohen,Mirian %A Mann,Claudio Gruber %A Jalil,Cristina M %A Carvalheira,Eduardo %A Freitas,Lucilene %A Fernandes,Nilo %A Castanheira,Debora %A Benedetti,Marcos %A Moreira,Julio %A Simpson,Keila %A Trefiglio,Roberta %A O’Malley,Gabrielle %A Veloso,Valdilea G %A Grinsztejn,Beatriz %+ Instituto Nacional de Infectologia Evandro Chagas, Fundação Oswaldo Cruz, Av Brasil 4365 Manguinhos, Rio de Janeiro, RJ 21040-900, Brazil, 55 21 38659623, thiago.torres@ini.fiocruz.br %K pre-exposure prophylaxis %K PrEP %K implementation %K public health system %K cabotegravir %K HIV prevention %K Latin America %K long-acting PrEP %D 2024 %7 24.10.2024 %9 Original Paper %J JMIR Public Health Surveill %G English %X Background: Although long-acting, injectable cabotegravir (CAB-LA) pre-exposure prophylaxis (PrEP) has proven efficacious for HIV prevention in clinical trials, research is needed to guide effective implementation in real-world settings. Formative work with community members and health care providers (HCPs) is important to provide insight into the needs and contexts of specific populations and reveal potential barriers and facilitators for implementation projects. Objective: We aimed to describe the results from formative work to develop an implementation package for CAB-LA PrEP within the ImPrEP CAB Brasil study. Methods: ImPrEP CAB Brasil is an implementation study of same-day delivery of CAB-LA PrEP for young sexual and gender minority (SGM) groups (aged 18-30 years) in 6 existing oral PrEP public health clinics. We conducted formative research to prepare for the implementation of ImPrEP CAB Brasil through community mobilization, process mapping with HCPs with experience in CAB-LA, and focus group discussions (FGDs) with young SGM groups (n=92) and HCPs (n=20) to identify initial perceptions of facilitators and barriers for CAB-LA PrEP implementation, refine the mobile health (mHealth) educational tool, and evaluate the acceptability of using a text message appointment reminder intervention through WhatsApp. FGDs were recorded, transcribed, systematically coded, and analyzed with thematic categorization by trained researchers using a qualitative data analysis program ATLAS.ti (version 7). Results: A community mobilization team comprising 34 SGM community leaders collaborated in creating a prototype for an mHealth educational tool and contributed to the planning of peer education activities. We created 3 process maps for each site to describe the initial visit, follow-up visits, and laboratory flow. The main challenge identified for same-day CAB-LA PrEP delivery was the extended duration of clinic visits due to the numerous laboratory tests and HIV counseling steps required. Proposed solutions included having point-of-care HIV rapid tests instead of laboratory tests and additional counseling staff. Barriers for CAB-LA PrEP implementation identified through FGDs were the training of HCPs, support for adherence to injection appointments, and stigma or discrimination against SGM groups and persons using PrEP. The mHealth educational tool and WhatsApp reminders were highly acceptable by SGM groups and HCPs, indicating their potential to support PrEP choice and adherence. Content analysis on the cultural appropriateness of the language and overall clarity of the material contributed to the refinement of the mHealth tool. Conclusions: Structured formative work with SGM persons and HCPs generated important refinements to context-specific materials and plans to launch ImPrEP CAB Brasil in public health clinics. Ongoing implementation monitoring will use the process maps to identify additional barriers and potential solutions to same-day delivery of CAB-LA PrEP. Summative evaluations are needed to measure the effectiveness of the mHealth educational tool to support PrEP choice and the use of WhatsApp appointment reminders. %M 39446416 %R 10.2196/60961 %U https://publichealth.jmir.org/2024/1/e60961 %U https://doi.org/10.2196/60961 %U http://www.ncbi.nlm.nih.gov/pubmed/39446416 %0 Journal Article %@ 2291-9694 %I JMIR Publications %V 12 %N %P e63456 %T Exploring Health Care Professionals’ Perspectives on the Use of a Medication and Care Support System and Recommendations for Designing a Similar Tool for Family Caregivers: Interview Study Among Health Care Professionals %A Ashimwe,Aimerence %A Davoody,Nadia %+ Karolinska Institutet, Tomtebodavägen 18 A, Stockholm, S-17177, Sweden, 46 (0)8 524 864 86, nadia.davoody@ki.se %K eHealth %K telemedicine %K mobile health %K mHealth %K medication management %K home care %K family caregivers %K mobile phone %D 2024 %7 23.10.2024 %9 Original Paper %J JMIR Med Inform %G English %X Background: With the aging population on the rise, the demand for effective health care solutions to address adverse drug events is becoming increasingly urgent. Telemedicine has emerged as a promising solution for strengthening health care delivery in home care settings and mitigating drug errors. Due to the indispensable role of family caregivers in daily patient care, integrating digital health tools has the potential to streamline medication management processes and enhance the overall quality of patient care. Objective: This study aims to explore health care professionals’ perspectives on the use of a medication and care support system (MCSS) and collect recommendations for designing a similar tool for family caregivers. Methods: Fifteen interviews with health care professionals in a home care center were conducted. Thematic analysis was used, and 5 key themes highlighting the importance of using the MCSS tool to improve medication management in home care were identified. Results: All participants emphasized the necessity of direct communication between health care professionals and family caregivers and stated that family caregivers need comprehensive information about medication administration, patient conditions, and symptoms. Furthermore, the health care professionals recommended features and functions customized for family caregivers. Conclusions: This study underscored the importance of clear communication between health care professionals and family caregivers and the provision of comprehensive instructions to promote safe medication practices. By equipping family caregivers with essential information via a tool similar to the MCSS, a proactive approach to preventing errors and improving outcomes is advocated. %M 39442168 %R 10.2196/63456 %U https://medinform.jmir.org/2024/1/e63456 %U https://doi.org/10.2196/63456 %U http://www.ncbi.nlm.nih.gov/pubmed/39442168 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e53819 %T A Web-Based Antiretroviral Therapy Adherence Intervention (Thrive With Me) in a Community-Recruited Sample of Sexual Minority Men Living With HIV: Results of a Randomized Controlled Study %A Horvath,Keith J %A Lammert,Sara %A Erickson,Darin %A Amico,K Rivet %A Talan,Ali J %A Shalhav,Ore %A Sun,Christina J %A Rendina,H Jonathon %+ Department of Psychology, San Diego State University, 6363 Alvarado Court, Suite 250, San Deigo, CA, 92120, United States, 1 6196943346, khorvath@sdsu.edu %K HIV %K antiretroviral therapy %K ART %K mobile health %K mHealth %K intervention %K men who have sex with men %D 2024 %7 30.9.2024 %9 Original Paper %J J Med Internet Res %G English %X Background: Most new HIV infections are attributed to male-to-male sexual contact in the United States. However, only two-thirds of sexual minority men living with HIV achieve an undetectable viral load (UVL). We tested a web-based antiretroviral therapy adherence intervention called Thrive with Me (TWM) with core features that included medication self-monitoring and feedback, HIV and antiretroviral therapy information, and a peer-to-peer exchange. Objective: We assessed the efficacy of TWM on HIV UVL among adult (aged ≥18 years) sexual minority men. Moreover, we assessed the impact of overall engagement and engagement with specific intervention features on HIV UVL. Methods: In total, 401 sexual minority men (mean age 39.1, SD 10.8 y; 230/384, 59.9% African American) in New York City were recruited between October 2016 and December 2019 and randomized to receive TWM (intervention) or a weekly email newsletter (control) for 5 months. Computerized assessments occurred at baseline and months 5, 11, and 17. The primary outcome was a dichotomous measure of HIV UVL (≤20 copies/μL). Generalized estimating equations with robust SEs were used to assess the effect of the TWM intervention on HIV UVL over the follow-up period in an unadjusted model and a model adjusted for baseline differences and then stratified by baseline recent drug use urinalysis. In secondary analyses, generalized linear models were used to estimate risk differences in the association of overall engagement with TWM (the sum of the number of days participants accessed ≥1 screen of the TWM intervention out of a possible 150 days) and engagement with specific TWM components on HIV UVL throughout the 17-month intervention period. Results: Participant retention was 88.5% (355/401; month 5), 81.8% (328/401; month 11), and 80.3% (322/401; month 17). No consistent differences in HIV UVL were found between those randomized to receive TWM or the control at the 5- (difference-in-differences [DD]=–7.8, 95% CI –21.1 to 5.5), 11- (DD=–13.9, 95% CI –27.7 to 0.04), or 17-month (DD=–8.2, 95% CI –22.0 to 5.7) time points, or when stratified by baseline recent drug use. However, those TWM-assigned participants with high overall levels of engagement (in the upper 25th percentile) were more likely to have an HIV UVL at the end of the 5-month active intervention period compared to those with low engagement (below the 75th percentile; risk difference=17.8, 95% CI 2.5-33.0) or no engagement (risk difference=19.4, 95% CI 3.3-35.5) in the intervention. Moreover, high engagement with the peer-to-peer exchange was associated with HIV UVL over time in unadjusted models. Conclusions: TWM did not have overall impacts on HIV UVL; however, it may assist some sexual minority men who are highly engaged with this web-based intervention in achieving HIV viral suppression. Trial Registration: ClinicalTrials.gov NCT02704208; https://clinicaltrials.gov/study/NCT02704208 %M 39348677 %R 10.2196/53819 %U https://www.jmir.org/2024/1/e53819 %U https://doi.org/10.2196/53819 %U http://www.ncbi.nlm.nih.gov/pubmed/39348677 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e50508 %T User Engagement With mHealth Interventions to Promote Treatment Adherence and Self-Management in People With Chronic Health Conditions: Systematic Review %A Eaton,Cyd %A Vallejo,Natalie %A McDonald,Xiomara %A Wu,Jasmine %A Rodríguez,Rosa %A Muthusamy,Nishanth %A Mathioudakis,Nestoras %A Riekert,Kristin A %+ Johns Hopkins School of Medicine, 5200 Eastern Avenue, Baltimore, MD, 21224, United States, 1 6673066201, ceaton4@jhmi.edu %K mobile health %K mHealth %K digital health %K treatment adherence %K self-management %K user engagement %K chronic health conditions %K mobile phone %D 2024 %7 24.9.2024 %9 Review %J J Med Internet Res %G English %X Background: There are numerous mobile health (mHealth) interventions for treatment adherence and self-management; yet, little is known about user engagement or interaction with these technologies. Objective: This systematic review aimed to answer the following questions: (1) How is user engagement defined and measured in studies of mHealth interventions to promote adherence to prescribed medical or health regimens or self-management among people living with a health condition? (2) To what degree are patients engaging with these mHealth interventions? (3) What is the association between user engagement with mHealth interventions and adherence or self-management outcomes? (4) How often is user engagement a research end point? Methods: Scientific database (Ovid MEDLINE, Embase, Web of Science, PsycINFO, and CINAHL) search results (2016-2021) were screened for inclusion and exclusion criteria. Data were extracted in a standardized electronic form. No risk-of-bias assessment was conducted because this review aimed to characterize user engagement measurement rather than certainty in primary study results. The results were synthesized descriptively and thematically. Results: A total of 292 studies were included for data extraction. The median number of participants per study was 77 (IQR 34-164). Most of the mHealth interventions were evaluated in nonrandomized studies (157/292, 53.8%), involved people with diabetes (51/292, 17.5%), targeted medication adherence (98/292, 33.6%), and comprised apps (220/292, 75.3%). The principal findings were as follows: (1) >60 unique terms were used to define user engagement; “use” (102/292, 34.9%) and “engagement” (94/292, 32.2%) were the most common; (2) a total of 11 distinct user engagement measurement approaches were identified; the use of objective user log-in data from an app or web portal (160/292, 54.8%) was the most common; (3) although engagement was inconsistently evaluated, most of the studies (99/195, 50.8%) reported >1 level of engagement due to the use of multiple measurement methods or analyses, decreased engagement across time (76/99, 77%), and results and conclusions suggesting that higher engagement was associated with positive adherence or self-management (60/103, 58.3%); and (4) user engagement was a research end point in only 19.2% (56/292) of the studies. Conclusions: The results revealed major limitations in the literature reviewed, including significant variability in how user engagement is defined, a tendency to rely on user log-in data over other measurements, and critical gaps in how user engagement is evaluated (infrequently evaluated over time or in relation to adherence or self-management outcomes and rarely considered a research end point). Recommendations are outlined in response to our findings with the goal of improving research rigor in this area. Trial Registration: PROSPERO International Prospective Register of Systematic Reviews CRD42022289693; https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42022289693 %M 39316431 %R 10.2196/50508 %U https://www.jmir.org/2024/1/e50508 %U https://doi.org/10.2196/50508 %U http://www.ncbi.nlm.nih.gov/pubmed/39316431 %0 Journal Article %@ 2561-7605 %I JMIR Publications %V 7 %N %P e53793 %T Predicting Adherence to Computer-Based Cognitive Training Programs Among Older Adults: Study of Domain Adaptation and Deep Learning %A Singh,Ankita %A Chakraborty,Shayok %A He,Zhe %A Pang,Yuanying %A Zhang,Shenghao %A Subedi,Ronast %A Lustria,Mia Liza %A Charness,Neil %A Boot,Walter %K domain adaptation %K adherence %K cognitive training %K deep neural networks %K early detection of cognitive decline %D 2024 %7 16.9.2024 %9 %J JMIR Aging %G English %X Background: Cognitive impairment and dementia pose a significant challenge to the aging population, impacting the well-being, quality of life, and autonomy of affected individuals. As the population ages, this will place enormous strain on health care and economic systems. While computerized cognitive training programs have demonstrated some promise in addressing cognitive decline, adherence to these interventions can be challenging. Objective: The objective of this study is to improve the accuracy of predicting adherence lapses to ultimately develop tailored adherence support systems to promote engagement with cognitive training among older adults. Methods: Data from 2 previously conducted cognitive training intervention studies were used to forecast adherence levels among older participants. Deep convolutional neural networks were used to leverage their feature learning capabilities and predict adherence patterns based on past behavior. Domain adaptation (DA) was used to address the challenge of limited training data for each participant, by using data from other participants with similar playing patterns. Time series data were converted into image format using Gramian angular fields, to facilitate clustering of participants during DA. To the best of our knowledge, this is the first effort to use DA techniques to predict older adults’ daily adherence to cognitive training programs. Results: Our results demonstrated the promise and potential of deep neural networks and DA for predicting adherence lapses. In all 3 studies, using 2 independent datasets, DA consistently produced the best accuracy values. Conclusions: Our findings highlight that deep learning and DA techniques can aid in the development of adherence support systems for computerized cognitive training, as well as for other interventions aimed at improving health, cognition, and well-being. These techniques can improve engagement and maximize the benefits of such interventions, ultimately enhancing the quality of life of individuals at risk for cognitive impairments. This research informs the development of more effective interventions, benefiting individuals and society by improving conditions associated with aging. %R 10.2196/53793 %U https://aging.jmir.org/2024/1/e53793 %U https://doi.org/10.2196/53793 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e59013 %T Digital Health Applications (DiGAs) on a Fast Track: Insights From a Data-Driven Analysis of Prescribable Digital Therapeutics in Germany From 2020 to Mid-2024 %A Goeldner,Moritz %A Gehder,Sara %+ Working Group for Data-Driven Innovation, Hamburg University of Technology, Am Schwarzenberg-Campus 4, Hamburg, 21073, Germany, 49 40428784777, moritz.goeldner@tuhh.de %K digital health application %K DiGA %K data-driven analysis %K clinical evidence %K health economics %K positive care effect %K medical benefit %K patient-relevant structural and procedural improvements %K pSVV %K digital health care act %D 2024 %7 29.8.2024 %9 Original Paper %J J Med Internet Res %G English %X Background: This study aimed to analyze the rapidly evolving ecosystem of digital health applications (Digitale Gesundheitsanwendung; DiGAs) in Germany, spurred by the 2019 Digital Healthcare Act. With over 73 million people in Germany now having access to DiGAs, these prescribable digital health apps and web-based applications represent a substantial stride in health care modernization, supporting both patients and health care providers with digital solutions for disease management and care improvement. Objective: Through a data-driven approach, this research aimed to unpack the complexities of DiGA market dynamics, economic factors, and clinical evidence, offering insights into their impact over the past years. Methods: The analysis draws from a range of public data sources, including the DiGA directory, statutory health insurance reports, app store feedback, and clinical study results. Results: As of July 1, 2024, there are 56 DiGAs listed by the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte), divided into 35 permanently and 21 preliminarily listed applications. Our findings reveal that a majority of DiGAs extend beyond the intended 1-year period to achieve permanent listing, reflecting the extensive effort required to demonstrate clinical efficacy. Economic analysis uncovered a dynamic pricing landscape, with initial prices ranging from approximately €200 to €700 (€1=US $1.07), averaging at a median of €514 for a 3-month DiGA prescription. Following negotiations or arbitration board decisions, prices typically see a 50% reduction, settling at a median of €221. Prescription data offer valuable insights into DiGA acceptance, with total prescriptions jumping from around 41,000 in the first period to 209,000 in the latest reporting period. The analysis of the top 15 DiGAs, representing 82% of the total prescriptions, shows that these best-performing apps receive from a minimum of 8 to a maximum of 77 daily prescriptions, with native apps and early market entrants achieving higher rates. Clinical evidence from all 35 permanently listed DiGAs indicates a uniform preference for randomized controlled trials to validate primary end points, with no noteworthy use of alternative study designs encouraged in the Digital Healthcare Act and related regulations. Moreover, all evaluated DiGAs focused on medical benefits, with health status improvement as a key end point, suggesting an underuse of patient-relevant structural and procedural improvement in demonstrating health care impact. Conclusions: This study highlights the growth and challenges within the DiGA sector, suggesting areas for future research, such as the exploration of new study designs and the potential impact of patient-relevant structural and procedural improvements. For DiGA manufacturers, the strategic advantage of early market entry is emphasized. Overall, this paper underscores the evolving landscape of digital health, advocating for a nuanced understanding of digital health technology integration in Germany and beyond. %M 39208415 %R 10.2196/59013 %U https://www.jmir.org/2024/1/e59013 %U https://doi.org/10.2196/59013 %U http://www.ncbi.nlm.nih.gov/pubmed/39208415 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e56960 %T Evaluating the Efficacy of a Digital Therapeutic (CT-152) as an Adjunct to Antidepressant Treatment in Adults With Major Depressive Disorder: Protocol for the MIRAI Remote Study %A Rothman,Brian %A Slomkowski,Mary %A Speier,Austin %A Rush,A John %A Trivedi,Madhukar H %A Lawson,Erica %A Fahmy,Michael %A Carpenter,Daniel %A Chen,Dalei %A Forbes,Ainslie %+ Otsuka Pharmaceutical Development & Commercialization, Inc, 508 Carnegie Center Dr, Princeton, NJ, 08540, United States, 1 609 524 6788, brian.rothman@otsuka-us.com %K adherence %K digital placebo %K sham control %K cognitive-emotional training %K Emotional Faces Memory Task %K mobile phone %D 2024 %7 20.8.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Major depressive disorder (MDD) is common worldwide and can be highly disabling. People with MDD face many barriers to treatment and may not experience full symptom relief even when treated. Therefore, new treatment modalities are needed for MDD. Digital therapeutics (DTx) may provide people with MDD an additional treatment option. Objective: This study aimed to describe a phase 3 remote, multicenter, randomized, masked, sham-controlled trial evaluating the efficacy of a smartphone app–based DTx (CT-152) in adult participants diagnosed with MDD, used as an adjunct to antidepressant therapy (ADT). Methods: Participants aged 22-64 years with a current primary diagnosis of MDD and an inadequate response to ADT were included. Participants were randomized 1:1 to CT-152 or a sham DTx. CT-152 is a smartphone app–based DTx that delivers a cognitive-emotional and behavioral therapeutic intervention. The core components of CT-152 are the Emotional Faces Memory Task exercises, brief lessons to learn and apply key therapeutic skills, and SMS text messaging to reinforce lessons and encourage engagement with the app. The sham DTx is a digital working memory exercise with emotionally neutral stimuli designed to match CT-152 for time and attention. Participants took part in the trial for up to 13 weeks. The trial included a screening period of up to 3 weeks, a treatment period of 6 weeks, and an extension period of 4 weeks to assess the durability of the effect. Sites and participants had the option of an in-person or remote screening visit; the remaining trial visits were remote. Efficacy was evaluated using the Montgomery-Åsberg Depression Rating Scale, the Generalized Anxiety Disorder-7, Clinical Global Impression–Severity scale, the Patient Health Questionnaire-9, and the World Health Organization Disability Assessment Schedule 2.0. The durability of the effect was evaluated with the Montgomery-Åsberg Depression Rating Scale and Generalized Anxiety Disorder-7 scale. Adverse events were also assessed. Satisfaction, measured by the Participant and Healthcare Professional Satisfaction Scales, and health status, measured by the EQ-5D-5L, were summarized using descriptive statistics. Results: This study was initiated in February 2021 and had a primary completion date in October 2022. Conclusions: This represents the methodological design for the first evaluation of CT-152 as an adjunct to ADT. This study protocol is methodologically robust and incorporates many aspects of conventional pivotal pharmaceutical phase 3 trial design, such as randomization and safety end points. Novel considerations included the use of a sham comparator, masking considerations for visible app content, and outcome measures relevant to DTx. The rigor of this methodology will provide a more comprehensive understanding of the effectiveness of CT-152. Trial Registration: ClinicalTrials.gov NCT04770285; https://clinicaltrials.gov/study/NCT04770285 International Registered Report Identifier (IRRID): RR1-10.2196/56960 %M 39163592 %R 10.2196/56960 %U https://www.researchprotocols.org/2024/1/e56960 %U https://doi.org/10.2196/56960 %U http://www.ncbi.nlm.nih.gov/pubmed/39163592 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 12 %N %P e53355 %T Efficacy of a Web-Based Home Blood Pressure Monitoring Program in Improving Predialysis Blood Pressure Control Among Patients Undergoing Hemodialysis: Randomized Controlled Trial %A Chen,Tingting %A Zhao,Wenbo %A Pei,Qianqian %A Chen,Yanru %A Yin,Jinmei %A Zhang,Min %A Wang,Cheng %A Zheng,Jing %K hemodialysis %K hypertension %K home blood pressure monitoring %K eHealth %K randomized controlled trial %D 2024 %7 9.8.2024 %9 %J JMIR Mhealth Uhealth %G English %X Background: Hypertension is highly prevalent among patients undergoing hemodialysis, with a significant proportion experiencing poorly controlled blood pressure (BP). Digital BP management in this population has been underused. Objective: This study aimed to explore the efficacy of a web-based home BP monitoring (HBPM) program in improving predialysis BP control and enhancing knowledge, perception, and adherence to HBPM among patients with hypertension undergoing hemodialysis. Methods: A multicenter, open-label, randomized controlled trial was conducted at 2 hemodialysis units. Patients were randomly allocated in a 1:1 ratio to either the web-based HBPM program as the intervention group or to usual care as the control group over a 6-month period. The primary outcomes were the predialysis BP control rate, defined as less than 140/90 mm Hg, and the predialysis systolic and diastolic BP, assessed from baseline to the 6-month follow-up. Secondary outcomes included patient knowledge, perception, and adherence to HBPM, evaluated using the HBPM Knowledge Questionnaire, HBPM Perception Scale, and HBPM Adherence Scale, respectively. A generalized estimating equations analysis was used to analyze the primary outcomes in the intention-to-treat analysis. Results: Of the 165 patients enrolled in the program (n=84, 50.9% in the web-based HBPM group and n=81, 49.1% in the control group), 145 (87.9%) completed the follow-up assessment. During the follow-up period, 11 instances of hypotension occurred in 9 patients in the web-based HBPM group, compared to 15 instances in 14 patients in the control group. The predialysis BP control rate increased from 30% (25/84) to 48% (40/84) in the web-based HBPM group after the 6-month intervention, whereas in the control group, it decreased from 37% (30/81) to 25% (20/81; χ22=16.82, P<.001; odds ratio 5.11, 95% CI 2.14-12.23, P<.001). The web-based HBPM group demonstrated a significant reduction after the 6-month intervention in the predialysis systolic BP (t163=2.46, P=.02; β=−6.09, 95 % CI −10.94 to −1.24, P=.01) and the predialysis diastolic BP (t163=3.20, P=.002; β=−4.93, 95% CI −7.93 to −1.93, P=.001). Scores on the HBPM Knowledge Questionnaire (t163=−9.18, P<.001), HBPM Perception Scale (t163=−10.65, P<.001), and HBPM Adherence Scale (t163=−8.04, P<.001) were significantly higher after 6 months of intervention. Conclusions: The implementation of a web-based HBPM program can enhance predialysis BP control and the knowledge, perception, and adherence to HBPM among patients undergoing hemodialysis. This web-based HBPM program should be promoted in appropriate clinical settings. Trial Registration: China Clinical Trial Registration Center ChiCTR2100051535; https://www.chictr.org.cn/showproj.html?proj=133286 %R 10.2196/53355 %U https://mhealth.jmir.org/2024/1/e53355 %U https://doi.org/10.2196/53355 %0 Journal Article %@ 2561-1011 %I JMIR Publications %V 8 %N %P e57058 %T Analysis of Demographic and Socioeconomic Factors Influencing Adherence to a Web-Based Intervention Among Patients After Acute Coronary Syndrome: Prospective Observational Cohort Study %A Sassone,Biagio %A Fuca',Giuseppe %A Pedaci,Mario %A Lugli,Roberta %A Bertagnin,Enrico %A Virzi',Santo %A Bovina,Manuela %A Pasanisi,Giovanni %A Mandini,Simona %A Myers,Jonathan %A Tolomeo,Paolo %+ Division of Provincial Cardiology, Department of Translational Medicine, University of Ferrara, Via Savonarola, 9, Ferrara, 44121, Italy, 39 0516838219, biagio.sassone@unife.it %K telemedicine %K digital literacy %K digital health %K acute coronary syndrome %K older age %K caregiver %K socioeconomic %K educational %K mobile phone %D 2024 %7 2.8.2024 %9 Original Paper %J JMIR Cardio %G English %X Background: Although telemedicine has been proven to have significant potential for improving care for patients with cardiac problems, there remains a substantial risk of introducing disparities linked to the use of digital technology, especially for older or socially vulnerable subgroups. Objective: We investigated factors influencing adherence to a telemedicine-delivered health education intervention in patients with ischemia, emphasizing demographic and socioeconomic considerations. Methods: We conducted a descriptive, observational, prospective cohort study in consecutive patients referred to our cardiology center for acute coronary syndrome, from February 2022 to January 2023. Patients were invited to join a web-based health educational meeting (WHEM) after hospital discharge, as part of a secondary prevention program. The WHEM sessions were scheduled monthly and used a teleconference software program for remote synchronous videoconferencing, accessible through a standard computer, tablet, or smartphone based on patient preference or availability. Results: Out of the 252 patients (median age 70, IQR 61.0-77.3 years; n=189, 75% male), 98 (38.8%) declined the invitation to participate in the WHEM. The reasons for nonacceptance were mainly challenges in handling digital technology (70/98, 71.4%), followed by a lack of confidence in telemedicine as an integrative tool for managing their medical condition (45/98, 45.9%), and a lack of internet-connected devices (43/98, 43.8%). Out of the 154 patients who agreed to participate in the WHEM, 40 (25.9%) were unable to attend. Univariable logistic regression analysis showed that the presence of a caregiver with digital proficiency and a higher education level was associated with an increased likelihood of attendance to the WHEM, while the converse was true for increasing age and female sex. After multivariable adjustment, higher education level (odds ratio [OR] 2.26, 95% CI 1.53-3.32; P<.001) and caregiver with digital proficiency (OR 12.83, 95% CI 5.93-27.75; P<.001) remained independently associated with the outcome. The model discrimination was good even when corrected for optimism (optimism-corrected C-index=0.812), as was the agreement between observed and predicted probability of participation (optimism-corrected calibration intercept=0.010 and slope=0.948). Conclusions: This study identifies a notable lack of suitability for a specific cohort of patients with ischemia to participate in our telemedicine intervention, emphasizing the risk of digital marginalization for a significant portion of the population. Addressing low digital literacy rates among patients or their informal caregivers and overcoming cultural bias against remote care were identified as critical issues in our study findings to facilitate the broader adoption of telemedicine as an inclusive tool in health care. %M 38912920 %R 10.2196/57058 %U https://cardio.jmir.org/2024/1/e57058 %U https://doi.org/10.2196/57058 %U http://www.ncbi.nlm.nih.gov/pubmed/38912920 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 12 %N %P e55421 %T Efficacy of a Mobile Health App (eMOTIVA) Regarding Compliance With Cardiac Rehabilitation Guidelines in Patients With Coronary Artery Disease: Randomized Controlled Clinical Trial %A Cruz-Cobo,Celia %A Bernal-Jiménez,María Ángeles %A Calle,Germán %A Gheorghe,Livia Luciana %A Gutiérrez-Barrios,Alejandro %A Cañadas,Dolores %A Tur,Josep A %A Vázquez-García,Rafael %A Santi-Cano,María José %+ Faculty of Nursing and Physiotherapy, University of Cádiz, Avda. Ana de Viya, 52, Cádiz, 11009, Spain, 34 956 019042, mariangeles.bernal@uca.es %K coronary event %K coronary heart disease %K eHealth %K lifestyle %K mHealth %K mobile health %D 2024 %7 25.7.2024 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Cardiac rehabilitation is fundamental among patients recovering from a coronary event, and mHealth technology may constitute a useful tool that provides guidelines based on scientific evidence in an entertaining, attractive, and user-friendly format. Objective: This study aimed to compare the efficacy of an mHealth intervention involving the eMOTIVA app and that of usual care regarding compliance with cardiac rehabilitation guidelines in terms of lifestyle, cardiovascular risk factors, and satisfaction among patients with acute coronary syndrome. Methods: A randomized controlled clinical trial with a parallel group design was conducted. It included 300 patients (mHealth group, 150; control group, 150) who underwent percutaneous coronary intervention for acute coronary syndrome. Both groups underwent evaluations initially (during hospitalization) and after 3 and 6 months (face-to-face consultations). The eMOTIVA app incorporates a virtual classroom providing audio and video information about a healthy lifestyle, a section for self-recording cardiovascular risk factors, and a section for feedback messages and gamification. The primary outcome variables were (1) adherence to the Mediterranean diet and the frequency of consumption of food; (2) physical activity level, sedentary time, and exercise capacity; (3) smoking cessation and nicotine dependence; (4) level of knowledge about cardiovascular risk factors; and (5) app satisfaction and usability. Results: The study analyzed 287 patients (mHealth group, 145; control group, 142). Most participants were male (207/300, 69.0%), and the mean age was 62.53 (SD 8.65) years. Significant improvements were observed in the mHealth group compared with the control group at 6 months in terms of (1) adherence to the Mediterranean diet (mean 11.92, SD 1.70 vs 8.92, SD 2.66 points; P<.001) and frequency of eating foods (red meat [≤1/week]: 141/143, 97.9% vs 96/141, 68.1%; industrial pastries [<2/week]: 129/143, 89.6% vs 80/141, 56.8%; oily fish [≥2/week]: 124/143, 86.1% vs 64/141, 41.4%; vegetables [≥2/day]: 130/143, 90.3% vs 78/141, 55.3%; fruit [≥2/day]: 128/143, 88.9% vs 85/141, 60.2%; all P<.001); (2) physical activity (mean 2112.66, SD 1196.67 vs 1372.60, SD 944.62 metabolic equivalents/week; P<.001) and sedentary time (mean 8.38, SD 1.88 vs 9.59, SD 2.09 hours; P<.001); (3) exercise capacity (distance: mean 473.49, SD 102.28 vs 447.25, SD 93.68 meters; P=.04); and (4) level of knowledge (mean 117.85, SD 3.83 vs 111.00, SD 7.11 points; P<.001). App satisfaction was high (mean 42.53, SD 6.38 points), and its usability was excellent (mean 95.60, SD 4.03 points). Conclusions: With the eMOTIVA app, favorable results were obtained in the intervention group in terms of adherence to the Mediterranean diet, frequency of eating certain foods, physical activity, sedentary time, exercise capacity, knowledge level, systolic blood pressure, heart rate, and blood sugar level. Furthermore, participants reported high app satisfaction and rated its usability as excellent. Thus, this innovative tool is very promising. Trial Registration: ClinicalTrials.gov NCT05247606; https://clinicaltrials.gov/study/NCT05247606 %M 39052330 %R 10.2196/55421 %U https://mhealth.jmir.org/2024/1/e55421 %U https://doi.org/10.2196/55421 %U http://www.ncbi.nlm.nih.gov/pubmed/39052330 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 11 %N %P e54117 %T Digital Adherence Technologies and Differentiated Care for Tuberculosis Treatment and Their Acceptability Among Persons With Tuberculosis, Health Care Workers, and Key Informants in the Philippines: Qualitative Interview Study %A Leung,Chung Lam %A Alacapa,Jason %A Tasca,Bianca Gonçalves %A Villanueva,Andre Daniel %A Masulit,Saniata %A Ignacio,Marvin Louie %A Uy,Kathleen Nicole %A Pell,Christopher %A van Kalmthout,Kristian %A Powers,Rachel %A Fielding,Katherine %A Jerene,Degu %+ KNCV Tuberculosis Foundation, Maanweg 174, Den Haag, 2516AB, Netherlands, 31 070 416 7222, adrian.leung@kncvtbc.org %K tuberculosis %K digital adherence technologies %K implementation %K acceptability %K qualitative research %K Philippines %K digital health %K tuberculosis treatment %K support strategy %K support %K medication adherence %K health care workers %K interview %K interviews %K user %K user privacy %K privacy %K digital adherence %D 2024 %7 23.7.2024 %9 Original Paper %J JMIR Hum Factors %G English %X Background: Digital adherence technologies (DATs) are being studied to determine their potential to support tuberculosis (TB) treatment and address the shortcomings of directly observed therapy. Previous research has shown inconclusive results on whether DATs can enhance medication adherence among persons with TB. Objective: This study aims to understand the acceptability of DATs, namely, medication labels and smart pillboxes, among persons with TB, health care workers (HCWs), and key informants (KIs) in the Philippines. The objective is to gain valuable insights that can inform the design and implementation of DATs in the Southeast Asian region, which meet the needs and preferences of end users. Methods: Persons with TB, HCWs, and KIs were recruited from intervention facilities to participate in in-depth interviews conducted between March 2022 and January 2023. These interviews were transcribed and translated into English. A thematic analysis was carried out using NVivo software (Lumivero) to identify and analyze themes. Themes were then structured within a modified social-ecological model. Results: A total of 25 persons with drug-sensitive TB and 20 HCWs or KIs were interviewed. Both groups emphasized that users’ technology literacy level, financial conditions, and motivation to be cured determined how they interacted with the DAT. They also acknowledged that DATs helped foster their relationship with HCWs and enabled efficient treatment support. Concerning technology, persons with TB found DATs easy to use and able to reduce clinic visits. HCWs mentioned that DATs added to their workload but also allowed them to support users who missed doses. However, both groups experienced technical challenges with DATs. Regarding program implementation, users appreciated the clear explanations and demonstrations provided by HCWs. Yet, some users reported inconsistencies between DAT settings and the information provided. HCWs stressed the importance of comprehensive training and sufficient resources for effective program implementation in the future. At the community level, both groups noted that DATs and program design protected users’ privacy and reduced the risk of stigma. Finally, users and HCWs shared various contextual factors that influenced their experience with DAT, including infrastructure challenges and the impact of the COVID-19 pandemic. Conclusions: In the Philippines, persons with TB and HCWs showed a high level of acceptance and satisfaction with the impact of DAT and program design. They expressed a desire for the continuation of DATs. The challenges encountered underscore the need for ongoing technological development to minimize malfunctions, enhance the capacity of health facilities, and improve infrastructure. DATs have demonstrated their ability to strengthen user-HCW relationships and protect users from stigmatization. Additional efforts are required to scale up the DAT program in the Philippines. %M 39042889 %R 10.2196/54117 %U https://humanfactors.jmir.org/2024/1/e54117 %U https://doi.org/10.2196/54117 %U http://www.ncbi.nlm.nih.gov/pubmed/39042889 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e58013 %T Effectiveness of eHealth Interventions in Improving Medication Adherence Among Patients With Cardiovascular Disease: Systematic Review and Meta-Analysis %A Miao,Yiqun %A Luo,Yuan %A Zhao,Yuhan %A Liu,Mingxuan %A Wang,Huiying %A Wu,Ying %+ School of Nursing, Capital Medical University, 10 You-an-men Wai Xi-tou-tiao, Feng-tai District, Beijing, 100069, China, 86 10 8391 17, helenywu@vip.163.com %K eHealth %K medication adherence %K heart %K cardiovascular %K adherence %K cardiology %K digital health %K cardiovascular diseases %K network meta-analysis %K synthesis %K syntheses %K review methods %K review methodology %K search %K searches %K searching %K systematic %K meta-analysis %K meta-analyses %K drug %K drugs %K pharmacy %K pharmacies %K pharmacology %K pharmacotherapy %K pharmaceutic %K pharmaceutics %K pharmaceuticals %K pharmaceutical %K medication %K medications %D 2024 %7 15.7.2024 %9 Review %J J Med Internet Res %G English %X Background: Nonadherence to medication among patients with cardiovascular diseases undermines the desired therapeutic outcomes. eHealth interventions emerge as promising strategies to effectively tackle this issue. Objective: The aim of this study was to conduct a network meta-analysis (NMA) to compare and rank the efficacy of various eHealth interventions in improving medication adherence among patients with cardiovascular diseases (CVDs). Methods: A systematic search strategy was conducted in PubMed, Embase, Web of Science, Cochrane, China National Knowledge Infrastructure Library (CNKI), China Science and Technology Journal Database (Weipu), and WanFang databases to search for randomized controlled trials (RCTs) published from their inception on January 15, 2024. We carried out a frequentist NMA to compare the efficacy of various eHealth interventions. The quality of the literature was assessed using the risk of bias tool from the Cochrane Handbook (version 2.0), and extracted data were analyzed using Stata16.0 (StataCorp LLC) and RevMan5.4 software (Cochrane Collaboration). The certainty of evidence was evaluated using the Grading of Recommendations, Assessment, Development, and Evaluations (GRADE) approach. Results: A total of 21 RCTs involving 3904 patients were enrolled. The NMA revealed that combined interventions (standardized mean difference [SMD] 0.89, 95% CI 0.22-1.57), telephone support (SMD 0.68, 95% CI 0.02-1.33), telemonitoring interventions (SMD 0.70, 95% CI 0.02-1.39), and mobile phone app interventions (SMD 0.65, 95% CI 0.01-1.30) were statistically superior to usual care. However, SMS compared to usual care showed no statistical difference. Notably, the combined intervention, with a surface under the cumulative ranking curve of 79.3%, appeared to be the most effective option for patients with CVDs. Regarding systolic blood pressure and diastolic blood pressure outcomes, the combined intervention also had the highest probability of being the best intervention. Conclusions: The research indicates that the combined intervention (SMS text messaging and telephone support) has the greatest likelihood of being the most effective eHealth intervention to improve medication adherence in patients with CVDs, followed by telemonitoring, telephone support, and app interventions. The results of these network meta-analyses can provide crucial evidence-based support for health care providers to enhance patients’ medication adherence. Given the differences in the design and implementation of eHealth interventions, further large-scale, well-designed multicenter trials are needed. Trial Registration: INPLASY 2023120063; https://inplasy.com/inplasy-2023-12-0063/ %M 39008845 %R 10.2196/58013 %U https://www.jmir.org/2024/1/e58013 %U https://doi.org/10.2196/58013 %U http://www.ncbi.nlm.nih.gov/pubmed/39008845 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e53607 %T Effects of Peer- or Professional-Led Support in Enhancing Adherence to Wearable Monitoring Devices Among Community-Dwelling Older Adults: Systematic Review of Randomized Controlled Trials %A Chan,Colette Sze Wing %A Kan,Mandy Ming Pui %A Wong,Arkers Kwan Ching %+ School of Nursing, The Hong Kong Polytechnic University, GH 502, The Hong Kong Polytechnic University, Hung Hom, 00000, China (Hong Kong), 852 34003805, arkers.wong@polyu.edu.hk %K wearable monitoring device %K older adults %K adherence %K systematic review %K healthy aging %K peer support %K professional help %K support %K peers %K peer %K professionals %K wearable %K monitoring devices %K monitoring device %K community-dwelling %K older adults %K older adult %K aging %K aging %K elderly %D 2024 %7 20.6.2024 %9 Review %J J Med Internet Res %G English %X Background: Despite the well-documented health benefits associated with wearable monitoring devices (WMDs), adherence among community-dwelling older adults remains low. By providing guidance on the purpose and benefits of using WMDs, facilitating goal-setting aligned with the device’s features, promoting comprehension of the health data captured by the device, and assisting in overcoming technological challenges, peers and health care professionals can potentially enhance older adults’ adherence to WMDs. However, the effectiveness of such support mechanisms in promoting adherence to WMDs among older adults remains poorly understood. Objective: The aims of this systematic review were to examine the effects of peer- or professional-led intervention programs designed to improve adherence to WMDs among community-dwelling older adults and to identify the intervention components that may positively influence the effects of the intervention. Methods: We conducted a comprehensive search across 7 electronic databases (Cochrane Central Register of Controlled Trials [CENTRAL], PubMed, EMBASE, PsycINFO, British Nursing Index, Web of Science, and CINAHL) to identify articles published between January 1, 2010, and June 26, 2023. We specifically targeted randomized controlled trials that examined the impact of peer- or professional-led interventions on enhancing adherence to WMDs among individuals aged 60 years and older residing in the community. Two independent reviewers extracted data from the included studies and assessed the potential risk of bias in accordance with the Cochrane Risk of Bias tool for randomized trials, version 2. Results: A total of 10,511 studies were identified through the database search. Eventually, we included 3 randomized controlled trials involving 154 community-dwelling older adults. The participants had a mean age of 65 years. Our review revealed that increasing awareness of being monitored and implementing the SystemCHANGE approach, a habit change tool focusing on personal goals and feedback, were effective strategies for enhancing adherence to WMDs among older adults. All of the included studies exhibited a low risk of bias. Conclusions: By collaboratively designing specific goals related to WMDs with health care professionals, including nurses and physicians, older adults exhibited a higher likelihood of adhering to the prescribed use of WMDs. These goal-setting tools provided a framework for structure and motivation, facilitating the seamless integration of WMDs into their daily routines. Researchers should prioritize interventions that target awareness and goal-setting as effective approaches to enhance adherence to WMDs among older adults, thereby maximizing the realization of associated health benefits. %M 38900546 %R 10.2196/53607 %U https://www.jmir.org/2024/1/e53607 %U https://doi.org/10.2196/53607 %U http://www.ncbi.nlm.nih.gov/pubmed/38900546 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 12 %N %P e50248 %T Effectiveness of a Multifaceted Mobile Health Intervention (Multi-Aid-Package) in Medication Adherence and Treatment Outcomes Among Patients With Hypertension in a Low- to Middle-Income Country: Randomized Controlled Trial %A Arshed,Muhammad %A Mahmud,Aidalina %A Minhat,Halimatus Sakdiah %A Lim,Poh Ying %A Zakar,Rubeena %+ Department of Community Health, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, UPM Serdang, Serdang, 43400, Malaysia, 60 397692416, aidalina@upm.edu.my %K mobile health %K mHealth %K intervention %K medication adherence %K hypertension %K low- to middle-income country %K effectiveness %K randomized controlled trial %K Pakistan %K drug adherence %K tool %K mHealth module %K self-efficacy %K systolic blood pressure %K feedback %D 2024 %7 19.6.2024 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: The high prevalence of uncontrolled hypertension in Pakistan is predominantly attributed to poor medication adherence. As more than 137 million people in Pakistan use cell phones, a suitable mobile health (mHealth) intervention can be an effective tool to overcome poor medication adherence. Objective: We sought to determine whether a novel mHealth intervention is useful in enhancing antihypertensive therapy adherence and treatment outcomes among patients with hypertension in a low- to middle-income country. Methods: A 6-month parallel, single-blinded, superiority randomized controlled trial recruited 439 patients with hypertension with poor adherence to antihypertensive therapy and access to smartphones. An innovative, multifaceted mHealth intervention (Multi-Aid-Package), based on the Health Belief Model and containing reminders (written, audio, visual), infographics, video clips, educational content, and 24/7 individual support, was developed for the intervention group; the control group received standard care. The primary outcome was self-reported medication adherence measured using the Self-Efficacy for Appropriate Medication Adherence Scale (SEAMS) and pill counting; the secondary outcome was systolic blood pressure (SBP) change. Both outcomes were evaluated at baseline and 6 months. Technology acceptance feedback was also assessed at the end of the study. A generalized estimating equation was used to control the covariates associated with the probability of affecting adherence to antihypertensive medication. Results: Of 439 participants, 423 (96.4%) completed the study. At 6 months post intervention, the median SEAMS score was statistically significantly higher in the intervention group compared to the controls (median 32, IQR 11 vs median 21, IQR 6; U=10,490, P<.001). Within the intervention group, there was an increase in the median SEAMS score by 12.5 points between baseline and 6 months (median 19.5, IQR 5 vs median 32, IQR 11; P<.001). Results of the pill-counting method showed an increase in adherent patients in the intervention group compared to the controls (83/220, 37.2% vs 2/219, 0.9%; P<.001), as well as within the intervention group (difference of n=83, 37.2% of patients, baseline vs 6 months; P<.001). There was a statistically significant difference in the SBP of 7 mmHg between the intervention and control groups (P<.001) at 6 months, a 4 mmHg reduction (P<.001) within the intervention group, and a 3 mmHg increase (P=.314) within the controls. Overall, the number of patients with uncontrolled hypertension decreased by 46 in the intervention group (baseline vs 6 months), but the control group remained unchanged. The variables groups (adjusted odds ratio [AOR] 1.714, 95% CI 2.387-3.825), time (AOR 1.837, 95% CI 1.625-2.754), and age (AOR 1.618, 95% CI 0.225-1.699) significantly contributed (P<.001) to medication adherence. Multi-Aid-Package received a 94.8% acceptability score. Conclusions: The novel Multi-Aid-Package is an effective mHealth intervention for enhancing medication adherence and treatment outcomes among patients with hypertension in a low- to middle-income country. Trial Registration: ClinicalTrials.gov NCT04577157; https://clinicaltrials.gov/study/NCT04577157 %M 38896837 %R 10.2196/50248 %U https://mhealth.jmir.org/2024/1/e50248 %U https://doi.org/10.2196/50248 %U http://www.ncbi.nlm.nih.gov/pubmed/38896837 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e56003 %T Smartphone-Based Survey and Message Compliance in Adults Initially Unready to Quit Smoking: Secondary Analysis of a Randomized Controlled Trial %A Ulm,Clayton %A Chen,Sixia %A Fleshman,Brianna %A Benson,Lizbeth %A Kendzor,Darla E %A Frank-Pearce,Summer %A Neil,Jordan M %A Vidrine,Damon %A De La Torre,Irene %A Businelle,Michael S %+ TSET Health Promotion Research Center, Stephenson Cancer Center, University of Oklahoma Health Sciences Center, 655 Research Parkway, Suite 400, Oklahoma City, OK, 73104, United States, 1 405 271 8001, michael-businelle@ouhsc.edu %K just-in-time adaptive intervention %K tailored messaging %K smoking cessation %K mobile health %K survey compliance %K phase-based model %K smoking %K smoker %K survey %K smokers %K messaging %K smartphone %K efficacy %K pilot randomized controlled trial %K adult smokers %K linear regression %K age %K intervention engagement %K engagement %D 2024 %7 7.6.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Efficacy of smartphone-based interventions depends on intervention content quality and level of exposure to that content. Smartphone-based survey completion rates tend to decline over time; however, few studies have identified variables that predict this decline over longer-term interventions (eg, 26 weeks). Objective: This study aims to identify predictors of survey completion and message viewing over time within a 26-week smoking cessation trial. Methods: This study examined data from a 3-group pilot randomized controlled trial of adults who smoke (N=152) and were not ready to quit smoking within the next 30 days. For 182 days, two intervention groups received smartphone-based morning and evening messages based on current readiness to quit smoking. The control group received 2 daily messages unrelated to smoking. All participants were prompted to complete 26 weekly smartphone-based surveys that assessed smoking behavior, quit attempts, and readiness to quit. Compliance was operationalized as percentages of weekly surveys completed and daily messages viewed. Linear regression and mixed-effects models were used to identify predictors (eg, intervention group, age, and sex) of weekly survey completion and daily message viewing and decline in compliance over time. Results: The sample (mean age 50, SD 12.5, range 19-75 years; mean years of education 13.3, SD 1.6, range 10-20 years) was 67.8% (n=103) female, 74.3% (n=113) White, 77% (n=117) urban, and 52.6% (n=80) unemployed, and 61.2% (n=93) had mental health diagnoses. On average, participants completed 18.3 (71.8%) out of 25.5 prompted weekly surveys and viewed 207.3 (60.6%) out of 345.1 presented messages (31,503/52,460 total). Age was positively associated with overall weekly survey completion (P=.003) and daily message viewing (P=.02). Mixed-effects models indicated a decline in survey completion from 77% (114/148) in the first week of the intervention to 56% (84/150) in the last week of the intervention (P<.001), which was significantly moderated by age, sex, ethnicity, municipality (ie, rural/urban), and employment status. Similarly, message viewing declined from 72.3% (1533/2120) in the first week of the intervention to 44.6% (868/1946) in the last week of the intervention (P<.001). This decline in message viewing was significantly moderated by age, sex, municipality, employment status, and education. Conclusions: This study demonstrated the feasibility of a 26-week smartphone-based smoking cessation intervention. Study results identified subgroups that displayed accelerated rates in the decline of survey completion and message viewing. Future research should identify ways to maintain high levels of interaction with mobile health interventions that span long intervention periods, especially among subgroups that have demonstrated declining rates of intervention engagement over time. Trial Registration: ClinicalTrials.gov NCT03405129; https://clinicaltrials.gov/ct2/show/NCT03405129 %M 38848557 %R 10.2196/56003 %U https://formative.jmir.org/2024/1/e56003 %U https://doi.org/10.2196/56003 %U http://www.ncbi.nlm.nih.gov/pubmed/38848557 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e53784 %T Feasibility of Web-Based Single-Session Empowered Relief in Patients With Chronic Pain Taking Methadone or Buprenorphine: Protocol for a Single-Arm Trial %A Klein,Morgan R %A Darnall,Beth D %A You,Dokyoung S %+ Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine, 1070 Arastradero Rd, Suite 200, Palo Alto, CA, 94304, United States, 1 650 724 9320, dsyou@stanford.edu %K chronic pain %K opioid use disorder %K methadone %K buprenorphine %K behavioral medicine %K telehealth %K psychology %D 2024 %7 6.6.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Chronic pain affects tens of millions of US adults and continues to rise in prevalence. Nonpharmacologic behavioral pain treatments are greatly needed and yet are often inaccessible, particularly in settings where medication prescribing is prioritized. Objective: This study aims to test the feasibility of a live-instructor, web-based 1-session pain relief skills class in an underserved and potentially at-risk population: people with chronic pain prescribed methadone or buprenorphine either solely for pain or for comorbid opioid use disorder (OUD). Methods: This is a national, prospective, single-arm, uncontrolled feasibility trial. The trial is untethered from medical care; to enhance participants’ willingness to join the study, no medical records or drug-monitoring records are accessed. At least 45 participants will be recruited from outpatient pain clinics and from an existing research database of individuals who have chronic pain and are taking methadone or buprenorphine. Patient-reported measures will be collected at 6 time points (baseline, immediately post treatment, 2 weeks, and months 1-3) via a web-based platform, paper, or phone formats to include individuals with limited internet or computer access and low literacy skills. At baseline, participants complete demographic questions and 13 study measures (Treatment Expectations, Body Pain Map, Medication Use, Pain Catastrophizing Scale [PCS], Patient-Reported Outcomes Measurement Information System [PROMIS] Measures, and Opioid Craving Scale). Immediately post treatment, a treatment satisfaction and acceptability measure is administered on a 0 (very dissatisfied) to 10 (completely satisfied) scale, with 3 of these items being the primary outcome (perceived usefulness, participant satisfaction, and likelihood of using the skills). At each remaining time point, the participants complete all study measures minus treatment expectations and satisfaction. Participants who do not have current OUD will be assessed for historical OUD, with presence of OUD (yes or no), and history of OUD (yes or no) reported separately. Feasibility threshold is set as an overall group treatment satisfaction rating of 8 of 10. In-depth qualitative interviews will be conducted with about 10 participants to obtain additional data on patient perceptions, satisfactions, needs, and wants. To assess preliminary efficacy, we will examine changes in pain catastrophizing, pain intensity, pain bothersomeness, sleep disturbance, pain interference, depression, anxiety, physical function, global impression of change, and opioid craving at 1 month post treatment. Results: This project opened to enrollment in September 2021 and completed the recruitment in October 2023. The data collection was completed in February 2024. Results are expected to be published in late 2024. Conclusions: Results from this trial will inform the feasibility and preliminary efficacy of Empowered Relief in this population and will inform the design of a future randomized controlled trial testing web-based Empowered Relief in chronic pain and comorbid OUD. Trial Registration: ClinicalTrials.gov NCT05057988; https://clinicaltrials.gov/study/NCT05057988 International Registered Report Identifier (IRRID): DERR1-10.2196/53784 %M 38843513 %R 10.2196/53784 %U https://www.researchprotocols.org/2024/1/e53784 %U https://doi.org/10.2196/53784 %U http://www.ncbi.nlm.nih.gov/pubmed/38843513 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e55918 %T Telemedicine With Wearable Technologies in Patients Undergoing Hematopoietic Cell Transplantation and Chimeric Antigen Receptor T-Cell Therapy (TEL-HEMATO Study): Prospective Noninterventional Single-Center Study %A Hurtado,Lidia %A Gonzalez Concepcion,Melinda %A Flix-Valle,Aida %A Ruiz-Romeo,Marina %A Gonzalez-Rodriguez,Sonia %A Peña,Marta %A Paviglianiti,Annalisa %A Pera Jambrina,Maria Angeles %A Sureda,Anna %A Ochoa-Arnedo,Cristian %A Mussetti,Alberto %+ Clinical Hematology Department, Institut Català d'Oncologia, Hospital Duran i Reynals, Avinguda de la Granvia de l’Hospitalet, 199, Barcelona, 08908, Spain, 34 622188475, amussetti@iconcologia.net %K hematology %K hematopoietic cell transplantation %K telemedicine %K wearables %K chimeric antigen receptor T %K CART %K wearable %K hematopoietic %K transplantation %K transplant %K pilot study %K hematological %K HCT %K telehealth %K therapy %K device %K quality of life %K digital health %K smartphone %K app %K patient %K teenager %K youth %K noninterventional %D 2024 %7 4.6.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Patients with hematological malignancies receiving hematopoietic cell transplantation (HCT) or chimeric antigen receptor (CAR) T-cell therapy are at risk of developing serious clinical complications after discharge. Objective: The aim of the TEL-HEMATO study was to improve our telehealth platform for the follow-up of patients undergoing HCT or CAR T-cell therapy during the first 3 months after discharge with the addition of wearable devices. Methods: Eleven patients who received autologous (n=2) or allogeneic (n=5) HCT or CAR T-cell therapy (n=4) for hematological malignancies were screened from November 2022 to July 2023. Two patients discontinued the study after enrollment. The telehealth platform consisted of the daily collection of vital signs, physical symptoms, and quality of life assessment up to 3 months after hospital discharge. Each patient received a clinically validated smartwatch (ScanWatch) and a digital thermometer, and a dedicated smartphone app was used to collect these data. Daily revision of the data was performed through a web-based platform by a hematologist or a nurse specialized in HCT and CAR T-cell therapy. Results: Vital signs measured through ScanWatch were successfully collected with medium/high adherence: heart rate was recorded in 8/9 (89%) patients, oxygen saturation and daily steps were recorded in 9/9 (100%) patients, and sleeping hours were recorded in 7/9 (78%) patients. However, temperature recorded manually by the patients was associated with lower compliance, which was recorded in 5/9 (55%) patients. Overall, 5/9 (55%) patients reported clinical symptoms in the app. Quality of life assessment was completed by 8/9 (89%) patients at study enrollment, which decreased to 3/9 (33%) at the end of the third month. Usability was considered acceptable through ratings provided on the System Usability Scale. However, technological issues were reported by the patients. Conclusions: While the addition of wearable devices to a telehealth clinical platform could have potentially synergic benefits for HCT and CAR T-cell therapy patient monitoring, noncomplete automation of the platform and the absence of a dedicated telemedicine team still represent major limitations to be overcome. This is especially true in our real-life setting where the target population generally comprises patients of older age with a low digital education level. %M 38833696 %R 10.2196/55918 %U https://formative.jmir.org/2024/1/e55918 %U https://doi.org/10.2196/55918 %U http://www.ncbi.nlm.nih.gov/pubmed/38833696 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 12 %N %P e53411 %T Tuberculosis Treatment Compliance Under Smartphone-Based Video-Observed Therapy Versus Community-Based Directly Observed Therapy: Cluster Randomized Controlled Trial %A Kumwichar,Ponlagrit %A Prappre,Tagoon %A Chongsuvivatwong,Virasakdi %+ Department of Epidemiology, Faculty of Medicine, Prince of Songkla University, 15 Kanjanavanich Rd, Kho Hong, Hat Yai, 90110, Thailand, 66 74451165, cvirasak@medicine.psu.ac.th %K video-enhanced therapy %K tuberculosis %K health care system %K observed therapy %K treatment compliance %K lung disease %K randomized trial %K digital health %K telehealth %K telemedicine %K mobile phone %D 2024 %7 3.6.2024 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: There are no recent studies comparing the compliance rates of both patients and observers in tuberculosis treatment between the video-observed therapy (VOT) and directly observed therapy (DOT) programs. Objective: This study aims to compare the average number of days that patients with pulmonary tuberculosis and their observers were compliant under VOT and DOT. In addition, this study aims to compare the sputum conversion rate of patients under VOT with that of patients under DOT. Methods: Patient and observer compliance with tuberculosis treatment between the VOT and DOT programs were compared based on the average number of VOT and DOT compliance days and sputum conversion rates in a 60-day cluster randomized controlled trial with patients with pulmonary tuberculosis (VOT: n=63 and DOT: n=65) with positive sputum acid-fast bacilli smears and 38 observers equally randomized into the VOT and DOT groups (19 observers per group and n=1-5 patients per observer). The VOT group submitted videos to observers via smartphones; the DOT group followed standard procedures. An intention-to-treat analysis assessed the compliance of both the patients and the observers. Results: The VOT group had higher average compliance than the DOT group (patients: mean difference 15.2 days, 95% CI 4.8-25.6; P=.005 and observers: mean difference 21.2 days, 95% CI 13.5-28.9; P<.001). The sputum conversion rates in the VOT and DOT groups were 73% and 61.5%, respectively (P=.17). Conclusions: Smartphone-based VOT significantly outperformed community-based DOT in ensuring compliance with tuberculosis treatment among observers. However, the study was underpowered to confirm improved compliance among patients with pulmonary tuberculosis and to detect differences in sputum conversion rates. Trial Registration: Thai Clinical Trials Registry (TCTR) TCTR20210624002; https://tinyurl.com/3bc2ycrh International Registered Report Identifier (IRRID): RR2-10.2196/38796 %M 38830205 %R 10.2196/53411 %U https://mhealth.jmir.org/2024/1/e53411 %U https://doi.org/10.2196/53411 %U http://www.ncbi.nlm.nih.gov/pubmed/38830205 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 11 %N %P e47996 %T Digital Adherence Technologies Linked to Mobile Money Incentives for Medication Adherence Among People Living With Tuberculosis: Mixed Methods Feasibility and Acceptability Study %A Musiimenta,Angella %A Tumuhimbise,Wilson %A Atukunda,Esther %A Mugaba,Aaron %A Linnemayr,Sebastian %A Haberer,Jessica %+ Faculty of Computing and Informatics, Mbarara University of Science and Technology, Plot 8-19 Mbarara Kabale Road, Mbarara, P.O. Box 653, Uganda, 256 776820598, amusiimenta@must.ac.ug %K digital adherence technologies %K real-time monitoring %K SMS text message reminders %K mobile money %K financial incentives %K tuberculosis %K medication adherence %K user-centered approach %D 2024 %7 31.5.2024 %9 Original Paper %J JMIR Hum Factors %G English %X Background: Complementing digital adherence technologies (DATs) with mobile money incentives may improve their utility in supporting tuberculosis medication adherence, yet the feasibility and acceptability of this integrated approach remain unclear. Objective: This study aims to describe the feasibility and acceptability of a novel DAT intervention called My Mobile Wallet composed of real-time adherence monitoring, SMS text message reminders, and mobile money incentives for tuberculosis medication adherence in a low-income setting. Methods: We purposively recruited people living with tuberculosis from the Mbarara Regional Referral Hospital in Mbarara, Uganda, who (1) were starting tuberculosis treatment at enrollment or within the past 4 weeks, (2) owned a mobile phone, (3) were able to use SMS test messaging, (4) were aged ≥18 years, and (5) were living in Mbarara district. At study exit (month 6), we used interviews and questionnaires informed by the unified theory of acceptance and use of technology (UTAUT) to collect feasibility and acceptability data, reflecting patients’ experiences of using each component of My Mobile Wallet. Feasibility also included tracking the functionality of the adherence monitor (ie, an electronic pillbox) as well as SMS text message and mobile money delivery. We used a content analytical approach to inductively analyze qualitative data and Stata (version 13; StataCorp LLC) to analyze quantitative data. Results: All 39 participants reported that the intervention was feasible because it was easy for them to use (eg, access and read SMS text messages) and worked as expected. Almost all SMS text messages (6880/7064, 97.4%) were sent as planned. The transmission of adherence data from the monitor worked well, with 98.37% (5682/5776) of the data transmitted as planned. All participants additionally reported that the intervention was acceptable because it helped them take their tuberculosis medication as prescribed; the mobile money incentives relieved them of tuberculosis-related financial burdens; SMS text message reminders and electronic pillbox–based alarms reminded them to take their medication on time; and participants perceived real-time adherence monitoring as “being watched” while taking their medication, which encouraged them to take their medication on time to demonstrate their commitment. The intervention was perceived as a sign of care, which eventually created emotional support and a sense of connectedness to health care. Participants preferred daily SMS text message reminders (32/39, 82%) to reminders linked to missed doses (7/39, 18%), citing the fact that tuberculosis medication is taken daily. Conclusions: The use of real-time adherence monitoring linked to SMS text message reminders and mobile money incentives for tuberculosis medication adherence was feasible and acceptable in a low-resource setting where poverty-based structural barriers heavily constrain tuberculosis treatment and care. %M 38819905 %R 10.2196/47996 %U https://humanfactors.jmir.org/2024/1/e47996 %U https://doi.org/10.2196/47996 %U http://www.ncbi.nlm.nih.gov/pubmed/38819905 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e51013 %T Using a Semiautomated Procedure (CleanADHdata.R Script) to Clean Electronic Adherence Monitoring Data: Tutorial %A Bandiera,Carole %A Pasquier,Jérôme %A Locatelli,Isabella %A Schneider,Marie P %+ School of Pharmaceutical Sciences, University of Geneva, Rue Michel-Servet 1, Geneva, 1205, Switzerland, 41 223795316, marie.schneider@unige.ch %K medication adherence %K digital technology %K digital pharmacy %K electronic adherence monitoring %K data management %K data cleaning %K research methodology %K algorithms %K R %K semiautomated %K code %K coding %K computer science %K computer programming %K medications %K computer script %D 2024 %7 22.5.2024 %9 Tutorial %J JMIR Form Res %G English %X Background: Patient adherence to medications can be assessed using interactive digital health technologies such as electronic monitors (EMs). Changes in treatment regimens and deviations from EM use over time must be characterized to establish the actual level of medication adherence. Objective: We developed the computer script CleanADHdata.R to clean raw EM adherence data, and this tutorial is a guide for users. Methods: In addition to raw EM data, we collected adherence start and stop monitoring dates and identified the prescribed regimens, the expected number of EM openings per day based on the prescribed regimen, EM use deviations, and patients’ demographic data. The script formats the data longitudinally and calculates each day’s medication implementation. Results: We provided a simulated data set for 10 patients, for which 15 EMs were used over a median period of 187 (IQR 135-342) days. The median patient implementation before and after EM raw data cleaning was 83.3% (IQR 71.5%-93.9%) and 97.3% (IQR 95.8%-97.6%), respectively (Δ+14%). This difference is substantial enough to consider EM data cleaning to be capable of avoiding data misinterpretation and providing a cleaned data set for the adherence analysis in terms of implementation and persistence. Conclusions: The CleanADHdata.R script is a semiautomated procedure that increases standardization and reproducibility. This script has broader applicability within the realm of digital health, as it can be used to clean adherence data collected with diverse digital technologies. %M 38776539 %R 10.2196/51013 %U https://formative.jmir.org/2024/1/e51013 %U https://doi.org/10.2196/51013 %U http://www.ncbi.nlm.nih.gov/pubmed/38776539 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 12 %N %P e50851 %T Understanding Patient Perspectives on the Use of Gamification and Incentives in mHealth Apps to Improve Medication Adherence: Qualitative Study %A Tran,Steven %A Smith,Lorraine %A Carter,Stephen %+ School of Pharmacy, Faculty of Medicine and Health, University of Sydney, A15, Science Rd, Camperdown, 2050, Australia, 61 93512222, steventran@hotmail.com.au %K qualitative %K patient %K perspectives %K gamification %K incentives %K mobile app %K mobile health %K mHealth %K medication adherence %K mobile phone %D 2024 %7 14.5.2024 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Medication nonadherence remains a significant health and economic burden in many high-income countries. Emerging smartphone interventions have started to use features such as gamification and financial incentives with varying degrees of effectiveness on medication adherence and health outcomes. A more consistent approach to applying these features, informed by patient perspectives, may result in more predictable and beneficial results from this type of intervention. Objective: This qualitative study aims to identify patient perspectives on the use of gamification and financial incentives in mobile health (mHealth) apps for medication adherence in Australian patients taking medication for chronic conditions. Methods: A total of 19 participants were included in iterative semistructured web-based focus groups conducted between May and December 2022. The facilitator used exploratory prompts relating to mHealth apps, gamification, and financial incentives, along with concepts raised from previous focus groups. Transcriptions were independently coded to develop a set of themes. Results: Three themes were identified: purpose-driven design, trust-based standards, and personal choice. All participants acknowledged gamification and financial incentives as potentially effective features in mHealth apps for medication adherence. However, they also indicated that the effectiveness heavily depended on implementation and execution. Major concerns relating to gamification and financial incentives were perceived trivialization and potential for medication abuse, respectively. Conclusions: The study’s findings provide a foundation for developers seeking to apply these novel features in an app intervention for a general cohort of patients. However, the study highlights the need for standards for mHealth apps for medication adherence, with particular attention to the use of gamification and financial incentives. Future research with patients and stakeholders across the mHealth app ecosystem should be explored to formalize and validate a set of standards or framework. %M 38743461 %R 10.2196/50851 %U https://mhealth.jmir.org/2024/1/e50851 %U https://doi.org/10.2196/50851 %U http://www.ncbi.nlm.nih.gov/pubmed/38743461 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 12 %N %P e51526 %T Assessing the Efficacy of ChatGPT Versus Human Researchers in Identifying Relevant Studies on mHealth Interventions for Improving Medication Adherence in Patients With Ischemic Stroke When Conducting Systematic Reviews: Comparative Analysis %A Ruksakulpiwat,Suebsarn %A Phianhasin,Lalipat %A Benjasirisan,Chitchanok %A Ding,Kedong %A Ajibade,Anuoluwapo %A Kumar,Ayanesh %A Stewart,Cassie %+ Department of Medical Nursing, Faculty of Nursing, Mahidol University, 2 Wang Lang Road, Siriraj, Bangkok Noi, Bangkok, 10700, Thailand, 66 984782692, suebsarn25@gmail.com %K ChatGPT %K systematic reviews %K medication adherence %K mobile health %K mHealth %K ischemic stroke %K mobile phone %D 2024 %7 6.5.2024 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: ChatGPT by OpenAI emerged as a potential tool for researchers, aiding in various aspects of research. One such application was the identification of relevant studies in systematic reviews. However, a comprehensive comparison of the efficacy of relevant study identification between human researchers and ChatGPT has not been conducted. Objective: This study aims to compare the efficacy of ChatGPT and human researchers in identifying relevant studies on medication adherence improvement using mobile health interventions in patients with ischemic stroke during systematic reviews. Methods: This study used the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. Four electronic databases, including CINAHL Plus with Full Text, Web of Science, PubMed, and MEDLINE, were searched to identify articles published from inception until 2023 using search terms based on MeSH (Medical Subject Headings) terms generated by human researchers versus ChatGPT. The authors independently screened the titles, abstracts, and full text of the studies identified through separate searches conducted by human researchers and ChatGPT. The comparison encompassed several aspects, including the ability to retrieve relevant studies, accuracy, efficiency, limitations, and challenges associated with each method. Results: A total of 6 articles identified through search terms generated by human researchers were included in the final analysis, of which 4 (67%) reported improvements in medication adherence after the intervention. However, 33% (2/6) of the included studies did not clearly state whether medication adherence improved after the intervention. A total of 10 studies were included based on search terms generated by ChatGPT, of which 6 (60%) overlapped with studies identified by human researchers. Regarding the impact of mobile health interventions on medication adherence, most included studies (8/10, 80%) based on search terms generated by ChatGPT reported improvements in medication adherence after the intervention. However, 20% (2/10) of the studies did not clearly state whether medication adherence improved after the intervention. The precision in accurately identifying relevant studies was higher in human researchers (0.86) than in ChatGPT (0.77). This is consistent with the percentage of relevance, where human researchers (9.8%) demonstrated a higher percentage of relevance than ChatGPT (3%). However, when considering the time required for both humans and ChatGPT to identify relevant studies, ChatGPT substantially outperformed human researchers as it took less time to identify relevant studies. Conclusions: Our comparative analysis highlighted the strengths and limitations of both approaches. Ultimately, the choice between human researchers and ChatGPT depends on the specific requirements and objectives of each review, but the collaborative synergy of both approaches holds the potential to advance evidence-based research and decision-making in the health care field. %M 38710069 %R 10.2196/51526 %U https://mhealth.jmir.org/2024/1/e51526 %U https://doi.org/10.2196/51526 %U http://www.ncbi.nlm.nih.gov/pubmed/38710069 %0 Journal Article %@ 2291-5222 %I %V 12 %N %P e53596 %T User Experience of Persons Using Ingestible Sensor–Enabled Pre-Exposure Prophylaxis to Prevent HIV Infection: Cross-Sectional Survey Study %A Browne,Sara %A Umlauf,Anya %A Moore,David J %A Benson,Constance A %A Vaida,Florin %K ingestible sensor %K sensor %K sensors %K oral %K UX %K user experience %K HIV prevention %K medication adherence %K HIV %K prevention %K prophylaxis %K STI %K STD %K sexually transmitted %K sexual transmission %K drug %K drugs %K pharmacy %K pharmacies %K pharmacology %K pharmacotherapy %K pharmaceutic %K pharmaceutics %K pharmaceuticals %K pharmaceutical %K medication %K medications %K adherence %K compliance %K sexually transmitted infection %K sexually transmitted disease %D 2024 %7 3.5.2024 %9 %J JMIR Mhealth Uhealth %G English %X Background: A digital health technology’s success or failure depends on how it is received by users. Objectives: We conducted a user experience (UX) evaluation among persons who used the Food and Drug Administration–approved Digital Health Feedback System incorporating ingestible sensors (ISs) to capture medication adherence, after they were prescribed oral pre-exposure prophylaxis (PrEP) to prevent HIV infection. We performed an association analysis with baseline participant characteristics, to see if “personas” associated with positive or negative UX emerged. Methods: UX data were collected upon exit from a prospective intervention study of adults who were HIV negative, prescribed oral PrEP, and used the Digital Health Feedback System with IS-enabled tenofovir disoproxil fumarate plus emtricitabine (IS-Truvada). Baseline demographics; urine toxicology; and self-report questionnaires evaluating sleep (Pittsburgh Sleep Quality Index), self-efficacy, habitual self-control, HIV risk perception (Perceived Risk of HIV Scale 8-item), and depressive symptoms (Patient Health Questionnaire–8) were collected. Participants with ≥28 days in the study completed a Likert-scale UX questionnaire of 27 questions grouped into 4 domain categories: overall experience, ease of use, intention of future use, and perceived utility. Means and IQRs were computed for participant total and domain subscores, and linear regressions modeled baseline participant characteristics associated with UX responses. Demographic characteristics of responders versus nonresponders were compared using the Fisher exact and Wilcoxon rank-sum tests. Results: Overall, 71 participants were enrolled (age: mean 37.6, range 18-69 years; n=64, 90% male; n=55, 77% White; n=24, 34% Hispanic; n=68, 96% housed; and n=53, 75% employed). No demographic differences were observed in the 63 participants who used the intervention for ≥28 days. Participants who completed the questionnaire were more likely to be housed (52/53, 98% vs 8/10, 80%; P=.06) and less likely to have a positive urine toxicology (18/51, 35% vs 7/10, 70%; P=.08), particularly methamphetamine (4/51, 8% vs 4/10, 40%; P=.02), than noncompleters. Based on IQR values, ≥75% of participants had a favorable UX based on the total score (median 3.78, IQR 3.17-4.20), overall experience (median 4.00, IQR 3.50-4.50), ease of use (median 3.72, IQR 3.33-4.22), and perceived utility (median 3.72, IQR 3.22-4.25), and ≥50% had favorable intention of future use (median 3.80, IQR 2.80-4.40). Following multipredictor modeling, self-efficacy was significantly associated with the total score (0.822, 95% CI 0.405-1.240; P<.001) and all subscores (all P<.05). Persons with more depressive symptoms reported better perceived utility (P=.01). Poor sleep was associated with a worse overall experience (−0.07, 95% CI −0.133 to −0.006; P=.03). Conclusions: The UX among persons using IS-enabled PrEP (IS-Truvada) to prevent HIV infection was positive. Association analysis of baseline participant characteristics linked higher self-efficacy with positive UX, more depressive symptoms with higher perceived utility, and poor sleep with negative UX. Trial Registration: ClinicalTrials.gov NCT03693040; https://clinicaltrials.gov/study/NCT03693040 %R 10.2196/53596 %U https://mhealth.jmir.org/2024/1/e53596 %U https://doi.org/10.2196/53596 %0 Journal Article %@ 2291-5222 %I %V 12 %N %P e49024 %T Cross-Cutting mHealth Behavior Change Techniques to Support Treatment Adherence and Self-Management of Complex Medical Conditions: Systematic Review %A Eaton,Cyd K %A McWilliams,Emma %A Yablon,Dana %A Kesim,Irem %A Ge,Renee %A Mirus,Karissa %A Sconiers,Takeera %A Donkoh,Alfred %A Lawrence,Melanie %A George,Cynthia %A Morrison,Mary Leigh %A Muther,Emily %A Oates,Gabriela R %A Sathe,Meghana %A Sawicki,Gregory S %A Snell,Carolyn %A Riekert,Kristin %K cystic fibrosis %K mobile health %K technology %K self-management %K patient adherence %K behavior intervention %K mHealth intervention %K systematic review %K evaluation of mHealth %K treatment adherence %K mHealth %D 2024 %7 1.5.2024 %9 %J JMIR Mhealth Uhealth %G English %X Background: Mobile health (mHealth) interventions have immense potential to support disease self-management for people with complex medical conditions following treatment regimens that involve taking medicine and other self-management activities. However, there is no consensus on what discrete behavior change techniques (BCTs) should be used in an effective adherence and self-management–promoting mHealth solution for any chronic illness. Reviewing the extant literature to identify effective, cross-cutting BCTs in mHealth interventions for adherence and self-management promotion could help accelerate the development, evaluation, and dissemination of behavior change interventions with potential generalizability across complex medical conditions. Objective: This study aimed to identify cross-cutting, mHealth-based BCTs to incorporate into effective mHealth adherence and self-management interventions for people with complex medical conditions, by systematically reviewing the literature across chronic medical conditions with similar adherence and self-management demands. Methods: A registered systematic review was conducted to identify published evaluations of mHealth adherence and self-management interventions for chronic medical conditions with complex adherence and self-management demands. The methodological characteristics and BCTs in each study were extracted using a standard data collection form. Results: A total of 122 studies were reviewed; the majority involved people with type 2 diabetes (28/122, 23%), asthma (27/122, 22%), and type 1 diabetes (19/122, 16%). mHealth interventions rated as having a positive outcome on adherence and self-management used more BCTs (mean 4.95, SD 2.56) than interventions with no impact on outcomes (mean 3.57, SD 1.95) or those that used >1 outcome measure or analytic approach (mean 3.90, SD 1.93; P=.02). The following BCTs were associated with positive outcomes: self-monitoring outcomes of behavior (39/59, 66%), feedback on outcomes of behavior (34/59, 58%), self-monitoring of behavior (34/59, 58%), feedback on behavior (29/59, 49%), credible source (24/59, 41%), and goal setting (behavior; 14/59, 24%). In adult-only samples, prompts and cues were associated with positive outcomes (34/45, 76%). In adolescent and young adult samples, information about health consequences (1/4, 25%), problem-solving (1/4, 25%), and material reward (behavior; 2/4, 50%) were associated with positive outcomes. In interventions explicitly targeting medicine taking, prompts and cues (25/33, 76%) and credible source (13/33, 39%) were associated with positive outcomes. In interventions focused on self-management and other adherence targets, instruction on how to perform the behavior (8/26, 31%), goal setting (behavior; 8/26, 31%), and action planning (5/26, 19%) were associated with positive outcomes. Conclusions: To support adherence and self-management in people with complex medical conditions, mHealth tools should purposefully incorporate effective and developmentally appropriate BCTs. A cross-cutting approach to BCT selection could accelerate the development of much-needed mHealth interventions for target populations, although mHealth intervention developers should continue to consider the unique needs of the target population when designing these tools. Trial Registration: PROSPERO CRD42021224407; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=224407 %R 10.2196/49024 %U https://mhealth.jmir.org/2024/1/e49024 %U https://doi.org/10.2196/49024 %0 Journal Article %@ 2291-5222 %I %V 12 %N %P e44463 %T Effects of a Planned Web-Based Educational Intervention Based on the Health Belief Model for Patients With Ischemic Stroke in Promoting Secondary Prevention During the COVID-19 Lockdown in China: Quasi-Experimental Study %A Liu,Zhuo %A Sun,Xin %A Guo,Zhen-Ni %A Sun,Ye %A Yang,Yi %A Yan,Xiuli %K health belief model %K health education %K secondary prevention %K stroke %K medication adherence %K patient education %K web-based education %K digital intervention %K promotion %K stroke patients %K ischemic %K prevention %K quasi-experimental study %K education %K control group %K health management %K management %K systolic blood pressure %K blood pressure %K effectiveness %K medication adherence %D 2024 %7 24.4.2024 %9 %J JMIR Mhealth Uhealth %G English %X Background: Some common modified vascular risk factors remain poorly controlled among stroke survivors, and educational programs may help improve these conditions. Objective: This study aimed to evaluate the effect of a planned web-based educational intervention based on the health belief model (HBM) in promoting secondary prevention among patients with ischemic stroke. Methods: An evaluation-blinded quasi-experimental trial with a historical control group was conducted. Patients admitted from March to June 2020 were assigned to the historical control group, and patients admitted from July to October 2020 were assigned to the intervention group. The control group received routine health management. The intervention group received 6 additional sessions based on the HBM via Tencent Meeting, an audio and video conferencing application, within 3 months after discharge. Sessions were held every 2 weeks, with each session lasting approximately 40 minutes. These sessions were conducted in small groups, with about 8 to 10 people in each group. The primary outcomes were changes in blood pressure (BP), low-density lipoprotein cholesterol (LDL-C), hemoglobin A1c (HbA1c), and the proportion of patients achieving the treatment target. The secondary outcomes were medication adherence, assessed with the Morisky Medicine Adherence Scale (MMAS), and disability, assessed with the modified Rankin scale. Results: In total, 315 patients experiencing their first-ever stroke were analyzed. More patients in the intervention group had controlled BP (41.9% vs 28.4%; adjusted odds ratio [aOR] 1.93; P=.01), LDL-C (83.1% vs 67.7%; aOR 2.66; P=.001), and HbA1c (91.9% vs 83.9%; aOR: 3.37; P=.04) levels as well as a significant postintervention decrease in the systolic BP (adjusted β −3.94; P=.02), LDL-C (adjusted β −0.21; P=.008), and HbA1c (adjusted β −0.27; P<.001), compared with control groups. Significant between-group differences were observed in medication adherence (79.4% vs 63.2%; aOR 2.31; P=.002) but not in favorable functional outcomes. Conclusions: A web-based education program based on the HBM may be more effective than current methods used to educate patients having strokes on optimal vascular risk factors and medication adherence. Trial Registration: Chinese Clinical Trial Registry ChiCTR2000040804; https://www.chictr.org.cn/showproj.html?proj=62431 %R 10.2196/44463 %U https://mhealth.jmir.org/2024/1/e44463 %U https://doi.org/10.2196/44463 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e49512 %T Momentary Factors and Study Characteristics Associated With Participant Burden and Protocol Adherence: Ecological Momentary Assessment %A Tate,Allan D %A Fertig,Angela R %A de Brito,Junia N %A Ellis,Émilie M %A Carr,Christopher Patrick %A Trofholz,Amanda %A Berge,Jerica M %+ Department of Epidemiology and Biostatistics, College of Public Health, University of Georgia, 202 Miller Hall, 101 Buck Rd, Health Sciences Campus, Athens, GA, 30602, United States, 1 706 542 6317, allan.tate@uga.edu %K adherence %K burden %K data quality %K ecological momentary assessment %K mental health %K mHealth %K mobile health %K participant adherence %K public health %K stress %K study design %K survey burden %K survey %D 2024 %7 24.4.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Ecological momentary assessment (EMA) has become a popular mobile health study design to understand the lived experiences of dynamic environments. The numerous study design choices available to EMA researchers, however, may quickly increase participant burden and could affect overall adherence, which could limit the usability of the collected data. Objective: This study quantifies what study design, participant attributes, and momentary factors may affect self-reported burden and adherence. Methods: The EMA from the Phase 1 Family Matters Study (n=150 adult Black, Hmong, Latino or Latina, Native American, Somali, and White caregivers; n=1392 observation days) was examined to understand how participant self-reported survey burden was related to both design and momentary antecedents of adherence. The daily burden was measured by the question “Overall, how difficult was it for you to fill out the surveys today?” on a 5-item Likert scale (0=not at all and 4=extremely). Daily protocol adherence was defined as completing at least 2 signal-contingent surveys, 1 event-contingent survey, and 1 end-of-day survey each. Stress and mood were measured earlier in the day, sociodemographic and psychosocial characteristics were reported using a comprehensive cross-sectional survey, and EMA timestamps for weekends and weekdays were used to parameterize time-series models to evaluate prospective correlates of end-of-day study burden. Results: The burden was low at 1.2 (SD 1.14) indicating “a little” burden on average. Participants with elevated previous 30-day chronic stress levels (mean burden difference: 0.8; P=.04), 1 in 5 more immigrant households (P=.02), and the language primarily spoken in the home (P=.04; 3 in 20 more non-English–speaking households) were found to be population attributes of elevated moderate-high burden. Current and 1-day lagged nonadherence were correlated with elevated 0.39 and 0.36 burdens, respectively (P=.001), and the association decayed by the second day (β=0.08; P=.47). Unit increases in momentary antecedents, including daily depressed mood (P=.002) and across-day change in stress (P=.008), were positively associated with 0.15 and 0.07 higher end-of-day burdens after controlling for current-day adherence. Conclusions: The 8-day EMA implementation appeared to capture momentary sources of stress and depressed mood without substantial burden to a racially or ethnically diverse and immigrant or refugee sample of parents. Attention to sociodemographic attributes (eg, EMA in the primary language of the caregiver) was important for minimizing participant burden and improving data quality. Momentary stress and depressed mood were strong determinants of participant-experienced EMA burden and may affect adherence to mobile health study protocols. There were no strong indicators of EMA design attributes that created a persistent burden for caregivers. EMA stands to be an important observational design to address dynamic public health challenges related to human-environment interactions when the design is carefully tailored to the study population and to study research objectives. %M 38656787 %R 10.2196/49512 %U https://formative.jmir.org/2024/1/e49512 %U https://doi.org/10.2196/49512 %U http://www.ncbi.nlm.nih.gov/pubmed/38656787 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e54833 %T Impact of Digital Interventions on the Treatment Burden of Patients With Chronic Conditions: Protocol for a Systematic Review %A Polus,Manria %A Keikhosrokiani,Pantea %A Korhonen,Olli %A Behutiye,Woubshet %A Isomursu,Minna %+ Faculty of Information Technology and Electrical Engineering, University of Oulu, Pentti Kaiteran Katu 1, Oulu, 90570, Finland, 358 294 48 0000, manria.polus@oulu.fi %K chronic illness %K treatment burden %K eHealth %K mHealth %K digital health %K mobile health %D 2024 %7 23.4.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: There is great potential for delivering cost-effective, quality health care for patients with chronic conditions through digital interventions. Managing chronic conditions often includes a substantial workload required for adhering to the treatment regimen and negative consequences on the patient’s function and well-being. This treatment burden affects adherence to treatment and disease outcomes. Digital interventions can potentially exacerbate the burden but also alleviate it. Objective: The objective of this review is to identify, summarize, and synthesize the evidence of how digital interventions impact the treatment burden of people with chronic conditions. Methods: The search, selection, and data synthesis processes were designed according to the PRISMA-P (Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols) 2015. A systematic search was conducted on October 16, 2023, from databases PubMed, Scopus, Web of Science, ACM, PubMed Central, and CINAHL. Results: Preliminary searches have been conducted, and screening has been started. The review is expected to be completed in October 2024. Conclusions: As the number of patients with chronic conditions is increasing, it is essential to design new digital interventions for managing chronic conditions in a way that supports patients with their treatment burden. To the best of our knowledge, the proposed systematic review will be the first review that investigates the impact of digital interventions on the treatment burden of patients. The results of this review will contribute to the field of health informatics regarding knowledge of the treatment burden associated with digital interventions and practical implications for developing better digital health care for patients with chronic conditions. Trial Registration: PROSPERO CRD42023477605; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=477605 International Registered Report Identifier (IRRID): DERR1-10.2196/54833 %M 38652531 %R 10.2196/54833 %U https://www.researchprotocols.org/2024/1/e54833 %U https://doi.org/10.2196/54833 %U http://www.ncbi.nlm.nih.gov/pubmed/38652531 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 12 %N %P e48756 %T Effectiveness of an Interactive mHealth App (EVITE) in Improving Lifestyle After a Coronary Event: Randomized Controlled Trial %A Bernal-Jiménez,María Ángeles %A Calle,German %A Gutiérrez Barrios,Alejandro %A Gheorghe,Livia Luciana %A Cruz-Cobo,Celia %A Trujillo-Garrido,Nuria %A Rodríguez-Martín,Amelia %A Tur,Josep A %A Vázquez-García,Rafael %A Santi-Cano,María José %+ Faculty of Nursing and Physiotherapy, University of Cádiz, Avda. Ana de Viya, 52, Cádiz, 11009, Spain, 34 956019042, mariajose.santi@uca.es %K coronary artery disease %K healthy lifestyle %K mHealth %K mobile health %K percutaneous coronary intervention %K randomized controlled trial %K secondary prevention %K therapeutic adherence %D 2024 %7 22.4.2024 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Coronary heart disease is one of the leading causes of mortality worldwide. Secondary prevention is essential, as it reduces the risk of further coronary events. Mobile health (mHealth) technology could become a useful tool to improve lifestyles. Objective: This study aimed to evaluate the effect of an mHealth intervention on people with coronary heart disease who received percutaneous coronary intervention. Improvements in lifestyle regarding diet, physical activity, and smoking; level of knowledge of a healthy lifestyle and the control of cardiovascular risk factors (CVRFs); and therapeutic adherence and quality of life were analyzed. Methods: This was a randomized controlled trial with a parallel group design assigned 1:1 to either an intervention involving a smartphone app (mHealth group) or to standard health care (control group). The app was used for setting aims, the self-monitoring of lifestyle and CVRFs using measurements and records, educating people with access to information on their screens about healthy lifestyles and adhering to treatment, and giving motivation through feedback about achievements and aspects to improve. Both groups were assessed after 9 months. The primary outcome variables were adherence to the Mediterranean diet, frequency of food consumed, patient-reported physical activity, smoking, knowledge of healthy lifestyles and the control of CVRFs, adherence to treatment, quality of life, well-being, and satisfaction. Results: The study analyzed 128 patients, 67 in the mHealth group and 61 in the control group; most were male (92/128, 71.9%), with a mean age of 59.49 (SD 8.97) years. Significant improvements were observed in the mHealth group compared with the control group regarding adherence to the Mediterranean diet (mean 11.83, SD 1.74 points vs mean 10.14, SD 2.02 points; P<.001), frequency of food consumption, patient-reported physical activity (mean 619.14, SD 318.21 min/week vs mean 471.70, SD 261.43 min/week; P=.007), giving up smoking (25/67, 75% vs 11/61, 42%; P=.01), level of knowledge of healthy lifestyles and the control of CVRFs (mean 118.70, SD 2.65 points vs mean 111.25, SD 9.05 points; P<.001), and the physical component of the quality of life 12-item Short Form survey (SF-12; mean 45.80, SD 10.79 points vs mean 41.40, SD 10.78 points; P=.02). Overall satisfaction was higher in the mHealth group (mean 48.22, SD 3.89 vs mean 46.00, SD 4.82 points; P=.002) and app satisfaction and usability were high (mean 44.38, SD 6.18 out of 50 points and mean 95.22, SD 7.37 out of 100). Conclusions: The EVITE app was effective in improving the lifestyle of patients in terms of adherence to the Mediterranean diet, frequency of healthy food consumption, physical activity, giving up smoking, knowledge of healthy lifestyles and controlling CVRFs, quality of life, and overall satisfaction. The app satisfaction and usability were excellent. Trial Registration: Clinicaltrials.gov NCT04118504; https://clinicaltrials.gov/study/NCT04118504 %M 38648103 %R 10.2196/48756 %U https://mhealth.jmir.org/2024/1/e48756 %U https://doi.org/10.2196/48756 %U http://www.ncbi.nlm.nih.gov/pubmed/38648103 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 12 %N %P e53006 %T Development of a Health Behavioral Digital Intervention for Patients With Hypertension Based on an Intelligent Health Promotion System and WeChat: Randomized Controlled Trial %A Sun,Ting %A Xu,Xuejie %A Ding,Zenghui %A Xie,Hui %A Ma,Linlin %A Zhang,Jing %A Xia,Yuxin %A Zhang,Guoli %A Ma,Zuchang %+ Hefei Institutes of Physical Science, Chinese Academy of Sciences, #350 Shushan Lake Road, Shushan District, Hefei, 230031, China, 86 13956984669, ZCMa121@126.com %K adherence %K hypertension %K health behavior %K mHealth %K digital health %D 2024 %7 5.4.2024 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: The effectiveness of timely medication, physical activity (PA), a healthy diet, and blood pressure (BP) monitoring for promoting health outcomes and behavioral changes among patients with hypertension is supported by a substantial amount of literature, with “adherence” playing a pivotal role. Nevertheless, there is a lack of consistent evidence regarding whether digital interventions can improve adherence to healthy behaviors among individuals with hypertension. Objective: The aim was to develop a health behavioral digital intervention for hypertensive patients (HBDIHP) based on an intelligent health promotion system and WeChat following the behavior change wheel (BCW) theory and digital micro-intervention care (DMIC) model and assess its efficacy in controlling BP and improving healthy behavior adherence. Methods: A 2-arm, randomized trial design was used. We randomly assigned 68 individuals aged >60 years with hypertension in a 1:1 ratio to either the control or experimental group. The digital intervention was established through the following steps: (1) developing digital health education materials focused on adherence to exercise prescriptions, Dietary Approaches to Stop Hypertension (DASH), prescribed medication, and monitoring of BP; (2) using the BCW theory to select behavior change techniques; (3) constructing the intervention's logic following the guidelines of the DMIC model; (4) creating an intervention manual including the aforementioned elements. Prior to the experiment, participants underwent physical examinations at the community health service center's intelligent health cabin and received intelligent personalized health recommendations. The experimental group underwent a 12-week behavior intervention via WeChat, while the control group received routine health education and a self-management manual. The primary outcomes included BP and adherence indicators. Data analysis was performed using SPSS, with independent sample t tests, chi-square tests, paired t tests, and McNemar tests. A P value <.05 was considered statistically significant. Results: The final analysis included 54 participants with a mean age of 67.24 (SD 4.19) years (n=23 experimental group, n=31 control group). The experimental group had improvements in systolic BP (–7.36 mm Hg, P=.002), exercise time (856.35 metabolic equivalent [MET]-min/week, P<.001), medication adherence (0.56, P=.001), BP monitoring frequency (P=.02), and learning performance (3.23, P<.001). Both groups experienced weight reduction (experimental: 1.2 kg, P=.002; control: 1.11 kg, P=.009) after the intervention. The diet types and quantities for both groups (P<.001) as well as the subendocardial viability ratio (0.16, P=.01) showed significant improvement. However, there were no statistically significant changes in other health outcomes. Conclusions: The observations suggest our program may have enhanced specific health outcomes and adherence to health behaviors in older adults with hypertension. However, a longer-term, larger-scale trial is necessary to validate the effectiveness. Trial Registration: Chinese Clinical Trial Registry ChiCTR2200062643; https://www.chictr.org.cn/showprojEN.html?proj=172782 International Registered Report Identifier (IRRID): RR2-10.2196/46883 %M 38578692 %R 10.2196/53006 %U https://mhealth.jmir.org/2024/1/e53006 %U https://doi.org/10.2196/53006 %U http://www.ncbi.nlm.nih.gov/pubmed/38578692 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 12 %N %P e54866 %T Quality Assessment of Smartphone Medication Management Apps in France: Systematic Search %A Toïgo,Mickael %A Marc,Julie %A Hayot,Maurice %A Moulis,Lionel %A Carbonnel,Francois %+ Desbrest Institute of Epidemiology and Public Health, Univ Montpellier, INSERM, Campus Santé, IURC, 641 avenue du Doyen Gaston Giraud, Montpellier, 34090, France, 33 684014834, Francois.carbonnel@umontpellier.fr %K medication adherence %K mobile apps %K telemedicine %K reminder system %K behavioral therapy %K mHealth %K mobile health %K app %K apps %K applications %K smartphone apps %K medication %K medications %K adherence %K search %K searches %K searching %K systematic %K App Store %K Google Play %K French %K reminder %K reminders %K MARS %K quality %K Mobile App Rating Scale %K mobile phone %D 2024 %7 18.3.2024 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Adherence to medication is estimated to be around 50% for chronically ill patients in high-income countries. Improving the effectiveness of adherence interventions could have a far greater impact on population health than any improvement in specific medical treatments. Mobile health (mHealth) is one of the most effective solutions for helping patients improve their medication intake, notably through the use of mobile apps with reminder systems. With more than 327,000 apps available in the mHealth field, it is difficult for health care professionals and patients alike to choose which apps to recommend and use. Objective: We aim to carry out a systematic search of medication management smartphone apps available in France that send reminders to patients and assess their quality using a validated scale. Methods: Mobile apps were identified in October and November 2022 after a systematic keyword search on the 2 main app download platforms: App Store (Apple Inc) and Google Play Store. Inclusion criteria were free availability, date of last update, and availability in French. Next, 2 health care professionals independently evaluated the included apps using the French version of the Mobile App Rating Scale (MARS-F), an objective scoring system validated for assessing the overall quality of apps in the mHealth field. An intraclass correlation coefficient was calculated to determine interrater reliability. Results: In total, 960 apps were identified and 49 were selected (25 from the App Store and 24 from the Google Play Store). Interrater reliability was excellent (intraclass correlation coefficient 0.92; 95% CI 0.87-0.95; P<.001). The average MARS-F score was 3.56 (SD 0.49) for apps on the App Store and 3.51 (SD 0.46) for those on the Google Play Store, with 10 apps scoring above 4 out of 5. Further, 2 apps were tested in at least one randomized controlled trial and showed positive results. The 2 apps with the highest ratings were Mediteo rappel de médicaments (Mediteo GmbH) and TOM rappel medicaments, pilule (Innovation6 GmbH), available on both platforms. Each app’s MARS-F score was weakly correlated with user ratings on the App Store and moderately correlated on the Google Play Store. Conclusions: To our knowledge, this is the first study that used a validated scoring system to evaluate medication management apps that send medication reminders. The quality of the apps was heterogeneous, with only 2 having been studied in a randomized controlled trial with positive results. The evaluation of apps in real-life conditions by patients is necessary to determine their acceptability and effectiveness. Certification of apps is also essential to help health care professionals and patients identify validated apps. %M 38498042 %R 10.2196/54866 %U https://mhealth.jmir.org/2024/1/e54866 %U https://doi.org/10.2196/54866 %U http://www.ncbi.nlm.nih.gov/pubmed/38498042 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e54635 %T An mHealth Intervention to Address Depression and Improve Antiretroviral Therapy Adherence Among Youths Living With HIV in Uganda: Protocol for a Pilot Randomized Controlled Trial %A Nabunya,Proscovia %A Cavazos-Rehg,Patricia %A Mugisha,James %A Kasson,Erin %A Namuyaba,Olive Imelda %A Najjuuko,Claire %A Nsubuga,Edward %A Filiatreau,Lindsey M %A Mwebembezi,Abel %A Ssewamala,Fred M %+ International Center for Child Health and Development, Brown School, Washington University in St. Louis, One Brookings Drive, Campus Box 1196, St. Louis, MO, 63130, United States, 1 3149359087, nabunyap@wustl.edu %K depression %K adherence %K mHealth %K cognitive behavioral therapy %K antiretroviral therapy %K youth living with HIV %K Uganda %D 2024 %7 8.3.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: People living with HIV often struggle with mental health comorbidities that lower their antiretroviral therapy (ART) adherence. There is growing evidence that depression treatment may improve ART adherence and result in improved HIV outcomes. Given that mental health services are severely underequipped in low-resource settings, including in Uganda, new solutions to increase access to mental health care and close the treatment gap are urgently needed. This protocol paper presents the Suubi-Mhealth study, which proposed to develop a mobile health (mHealth) intervention for use among Ugandan youths (14-17 years) with comorbid HIV and depression, taking into account their unique contextual, cultural, and developmental needs. Objective: The proposed study is guided by the following objectives: (1) to develop and iteratively refine an intervention protocol for Suubi-Mhealth based on formative work to understand the needs of youths living with HIV; (2) to explore the feasibility and acceptability of Suubi-Mhealth on a small scale to inform subsequent refinement; (3) to test the preliminary impact of Suubi-Mhealth versus a waitlist control group on youths’ outcomes, including depression and treatment adherence; and (4) to examine barriers and facilitators for integrating Suubi-Mhealth into health care settings. Methods: Youths will be eligible to participate in the study if they are (1) 14-17 years of age, (2) HIV-positive and aware of their status, (3) receiving care and ART from one of the participating clinics, and (4) living within a family. The study will be conducted in 2 phases. In phase 1, we will conduct focus group discussions with youths and health care providers, for feedback on the proposed intervention content and methods, and explore the feasibility and acceptability of the intervention. In phase II, we will pilot-test the preliminary impact of the intervention on reducing depression and improving ART adherence. Assessments will be conducted at baseline, 1-, 2-, and 6-months post intervention completion. Results: Participant recruitment for phase 1 is completed. Youths and health care providers participated in focus group discussions to share their feedback on the proposed Suubi-Mhealth intervention content, methods, design, and format. Transcription and translation of focus group discussions have been completed. The team is currently developing Suubi-Mhealth content based on participants’ feedback. Conclusions: This study will lay important groundwork for several initiatives at the intersection of digital therapeutics, HIV treatment, and mental health, especially among sub-Saharan African youths, as they transition through adolescence and into adult HIV care settings. Trial Registration: ClinicalTrials.gov NCT05965245; https://clinicaltrials.gov/study/NCT05965245 International Registered Report Identifier (IRRID): DERR1-10.2196/54635 %M 38457202 %R 10.2196/54635 %U https://www.researchprotocols.org/2024/1/e54635 %U https://doi.org/10.2196/54635 %U http://www.ncbi.nlm.nih.gov/pubmed/38457202 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e50528 %T A Mobile Applet for Assessing Medication Adherence and Managing Adverse Drug Reactions Among Patients With Cancer: Usability and Utility Study %A Ni,Chenxu %A Wang,Yi-fu %A Zhang,Yun-ting %A Yuan,Min %A Xu,Qing %A Shen,Fu-ming %A Li,Dong-Jie %A Huang,Fang %+ Shanghai Tenth People’s Hospital, 301 Middle Yanchang Road, Shanghai, 200072, China, 86 66302570, hazel_huang@126.com %K WeChat applet %K usability testing %K utility testing %K cancer patients %K patients %K cancer %K qualitative study %D 2024 %7 29.2.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Medication adherence and the management of adverse drug reactions (ADRs) are crucial to the efficacy of antitumor drugs. A WeChat applet, also known as a “Mini Program,” is similar to the app but has marked advantages. The development and use of a WeChat applet makes follow-up convenient for patients with cancer. Objective: This study aimed to assess the usability and utility of a newly developed WeChat applet, “DolphinCare,” among patients with cancer in Shanghai. Methods: A qualitative methodology was used to obtain an in-depth understanding of the experiences of patients with cancer when using DolphinCare from the usability and utility aspects. The development phase consisted of 2 parts: alpha and beta testing. Alpha testing combined the theory of the Fogg Behavior Model and the usability model. Alpha testing also involved testing the design of DolphinCare using a conceptual framework, which included factors that could affect medication adherence and ADRs. Beta testing was conducted using in-depth interviews. In-depth interviews allowed us to assist the patients in using DolphinCare and understand whether they liked or disliked DolphinCare and found it useful. Results: We included participants who had an eHealth Literacy Scale (eHEALS) score of ≥50%, and a total of 20 participants were interviewed consecutively. The key positive motivators described by interviewers were to be reminded to take their medications and to alleviate their ADRs. The majority of the patients were able to activate and use DolphinCare by themselves. Most patients indicated that their trigger to follow-up DolphinCare was the recommendation of their known and trusted health care professionals. All participants found that labels containing the generic names of their medication and the medication reminders were useful, including timed pop-up push notifications and text alerts. The applet presented the corresponding information collection forms of ADRs to the patient to fill out. The web-based consultation system enables patients to consult pharmacists or physicians in time when they have doubts about medications or have ADRs. The applet had usabilities and utilities that could improve medication adherence and the management of ADRs among patients with cancer. Conclusions: This study provides preliminary evidence regarding the usability and utility of this type of WeChat applet among patients with cancer, which is expected to be promoted for managing follow-up among other patients with other chronic disease. %M 38421700 %R 10.2196/50528 %U https://formative.jmir.org/2024/1/e50528 %U https://doi.org/10.2196/50528 %U http://www.ncbi.nlm.nih.gov/pubmed/38421700 %0 Journal Article %@ 2561-1011 %I JMIR Publications %V 8 %N %P e48971 %T Formative Perceptions of a Digital Pill System to Measure Adherence to Heart Failure Pharmacotherapy: Mixed Methods Study %A Chai,Peter R %A Kaithamattam,Jenson J %A Chung,Michelle %A Tom,Jeremiah J %A Goodman,Georgia R %A Hasdianda,Mohammad Adrian %A Carnes,Tony Christopher %A Vaduganathan,Muthiah %A Scirica,Benjamin M %A Schnipper,Jeffrey L %+ Department of Emergency Medicine, Brigham and Women’s Hospital, 75 Francis Street, Boston, MA, 02115, United States, 1 617 732 5640, pchai@bwh.harvard.edu %K behavioral interventions %K cardiac treatment %K digital pill system %K heart failure medication %K heart failure %K ingestible sensors %K medication adherence %D 2024 %7 15.2.2024 %9 Original Paper %J JMIR Cardio %G English %X Background: Heart failure (HF) affects 6.2 million Americans and is a leading cause of hospitalization. The mainstay of the management of HF is adherence to pharmacotherapy. Despite the effectiveness of HF pharmacotherapy, effectiveness is closely linked to adherence. Measuring adherence to HF pharmacotherapy is difficult; most clinical measures use indirect strategies such as calculating pharmacy refill data or using self-report. While helpful in guiding treatment adjustments, indirect measures of adherence may miss the detection of suboptimal adherence and co-occurring structural barriers associated with nonadherence. Digital pill systems (DPSs), which use an ingestible radiofrequency emitter to directly measure medication ingestions in real-time, represent a strategy for measuring and responding to nonadherence in the context of HF pharmacotherapy. Previous work has demonstrated the feasibility of using DPSs to measure adherence in other chronic diseases, but this strategy has yet to be leveraged for individuals with HF. Objective: We aim to explore through qualitative interviews the facilitators and barriers to using DPS technology to monitor pharmacotherapy adherence among patients with HF. Methods: We conducted individual, semistructured qualitative interviews and quantitative assessments between April and August 2022. A total of 20 patients with HF who were admitted to the general medical or cardiology service at an urban quaternary care hospital participated in this study. Participants completed a qualitative interview exploring the overall acceptability of and willingness to use DPS technology for adherence monitoring and perceived barriers to DPS use. Quantitative assessments evaluated HF history, existing medication adherence strategies, and attitudes toward technology. We analyzed qualitative data using applied thematic analysis and NVivo software (QSR International). Results: Most participants (12/20, 60%) in qualitative interviews reported a willingness to use the DPS to measure HF medication adherence. Overall, the DPS was viewed as useful for increasing accountability and reinforcing adherence behaviors. Perceived barriers included technological issues, a lack of need, additional costs, and privacy concerns. Most were open to sharing adherence data with providers to bolster clinical care and decision-making. Reminder messages following detected nonadherence were perceived as a key feature, and customization was desired. Suggested improvements are primarily related to the design and usability of the Reader (a wearable device). Conclusions: Overall, individuals with HF perceived the DPS to be an acceptable and useful tool for measuring medication adherence. Accurate, real-time ingestion data can guide adherence counseling to optimize adherence management and inform tailored behavioral interventions to support adherence among patients with HF. %M 38358783 %R 10.2196/48971 %U https://cardio.jmir.org/2024/1/e48971 %U https://doi.org/10.2196/48971 %U http://www.ncbi.nlm.nih.gov/pubmed/38358783 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 12 %N %P e52573 %T Evaluation of Chinese HIV Mobile Apps by Researchers and Patients With HIV: Quality Evaluation Study %A Liu,Peng %A Wang,Lingmeng %A Wang,Fuzhi %+ School of Health Management, Bengbu Medical College, 2600 Donghai Road, Bengbu, 233030, China, 86 0552 3173195, wfz.bbmc@foxmail.com %K HIV %K mobile app %K evaluation %K mobile phone %D 2024 %7 26.1.2024 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Against the backdrop of globalization, China remains one of the most heavily burdened countries in Asia with regard to AIDS. However, many high-risk groups and patients affected by AIDS may be less likely to actively seek care from medical institutions because of fear of experiencing shame or discrimination. Mobile apps provide a promising avenue for supporting the prevention, diagnosis, and treatment of AIDS. However, a comprehensive systematic evaluation of these mobile apps’ functionality and quality has not been conducted yet. Objective: This study aims to identify the available mobile apps for AIDS in China, assess and discuss the functional features and quality of these Chinese AIDS mobile apps, and offer decision support for patients and clinical practitioners in accessing high-quality AIDS mobile apps. Furthermore, based on the evaluation results, recommendations for improvement will be provided. Methods: A systematic search was conducted on the Qimai app data platform, the Aladdin WeChat applet data platform, and WeChat to identify mobile apps related to AIDS. A snowball sampling method was used to supplement the potentially overlooked apps. The selected mobile apps underwent a rigorous screening process based on unified criteria. Subsequently, assessments were independently undertaken by 3 separate researchers and 2 patients with HIV, using both the Mobile App Rating Scale (MARS) and the User Mobile App Rating Scale (uMARS). Quantitative interpretations of the data were facilitated by the MedCalc statistical software (version 20.217, MedCalc Software). Results: A total of 2901 AIDS mobile apps were included in the study, with 2897 identified through information retrieval and an additional 4 added via snowball sampling. After a rigorous selection process, 21 apps were determined to be usable. Among them, the Hong Feng Wan app achieved the highest combined average score, calculated based on the MARS (3.96, SD 0.33) and uMARS (4.47, SD 0.26). Overall, there was no significant correlation between MARS and uMARS (rapp quality total score=0.41; P=.07; rsubjective quality=0.39; P=.08). A notable issue was the widespread lack of user privacy protection, with only 24% (5/21) of the apps offering this feature. Conclusions: The number of available Chinese AIDS mobile apps is limited, with WeChat applets dominating the market. Nonetheless, the performance of WeChat mini-apps is generally inferior to that of independent apps, and there may be significant discrepancies between assessments conducted by researchers and those provided by genuine end users, emphasizing the necessity of involving real users in the development and evaluation of HIV mobile apps. In addition, developers of these Chinese HIV mobile apps need to devote attention to improving privacy protection mechanisms, in addition to considering the evaluations of researchers and real users. This will help attract more users and increase user loyalty. %M 38277215 %R 10.2196/52573 %U https://mhealth.jmir.org/2024/1/e52573 %U https://doi.org/10.2196/52573 %U http://www.ncbi.nlm.nih.gov/pubmed/38277215 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 12 %N %P e47295 %T Functionality and Quality of Asthma mHealth Apps and Their Consistency With International Guidelines: Structured Search and Evaluation %A Robinson,Billy %A Proimos,Eleni %A Zou,Daniel %A Gong,Enying %A Oldenburg,Brian %A See,Katharine %+ Department of Respiratory Medicine, Northern Health, 185 Cooper St, Epping, 3076, Australia, 61 38405 8000, billymed1994@gmail.com %K asthma %K mobile health %K mHealth %K app %K mobile %K chronic disease %K systematic review %K smartphone %K review methodology %K respiratory %K compliance %K guideline %K guidelines %K review of apps %K evaluation %K quality %K best practices %K apps %K mobile phone %D 2024 %7 10.1.2024 %9 Review %J JMIR Mhealth Uhealth %G English %X Background: Asthma is a chronic respiratory disorder requiring long-term pharmacotherapy and judicious patient self-management. Few studies have systematically evaluated asthma mobile health (mHealth) apps for quality and functionality; however, none have systematically assessed these apps for their content alignment with international best practice guidelines. Objective: This review aims to conduct a systematic search and evaluation of current mHealth apps in the Australian marketplace for their functionality, quality, and consistency with best practice guidelines. Methods: The most recent Global Initiative for Asthma (GINA) guidelines were reviewed to identify key recommendations that could be feasibly incorporated into an mHealth app. We developed a checklist based on these recommendations and a modified version of a previously developed framework. App stores were reviewed to identify potential mHealth apps based on predefined criteria. Evaluation of suitable apps included the assessment of technical information, an app quality assessment using the validated Mobile App Rating Scale (MARS) framework, and an app functionality assessment using the Intercontinental Medical Statistics Institute for Health Informatics (IMS) Functionality Scoring System. Finally, the mHealth apps were assessed for their content alignment with the GINA guidelines using the checklist we developed. Results: Of the 422 apps initially identified, 53 were suitable for further analysis based on inclusion and exclusion criteria. The mean number of behavioral change techniques for a single app was 3.26 (SD 2.27). The mean MARS score for all the reviewed apps was 3.05 (SD 0.54). Of 53 apps, 27 (51%) achieved a total MARS score of ≥3. On average, the reviewed apps achieved 5.1 (SD 2.79) functionalities on the 11-point IMS functionality scale. The median number of functionalities identified was 5 (IQR 2-7). Overall, 10 (22%) of the 45 apps with reviewer consensus in this domain provided general knowledge regarding asthma. Of 53 apps, skill training in peak flow meters, inhaler devices, recognizing or responding to exacerbations, and nonpharmacological asthma management were identified in 8 (17%), 12 (25%), 11 (28%), and 14 (31%) apps, respectively; 19 (37%) apps could track or record “asthma symptoms,” which was the most commonly recorded metric. The most frequently identified prompt was for taking preventive medications, available in 9 (20%) apps. Five (10%) apps provided an area for patients to store or enter their asthma action plan. Conclusions: This study used a unique checklist developed based on the GINA guidelines to evaluate the content alignment of asthma apps. Good-quality asthma apps aligned with international best practice asthma guidelines are lacking. Future app development should target the currently lacking key features identified in this study, including the use of asthma action plans and the deployment of behavioral change techniques to engage and re-engage with users. This study has implications for clinicians navigating the ever-expanding mHealth app market for chronic diseases. Trial Registration: PROSPERO CRD42021269894; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=269894 International Registered Report Identifier (IRRID): RR2-10.2196/33103 %M 38198204 %R 10.2196/47295 %U https://mhealth.jmir.org/2024/1/e47295 %U https://doi.org/10.2196/47295 %U http://www.ncbi.nlm.nih.gov/pubmed/38198204 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 12 %N %P e49302 %T Short-Term Effect of a Health Promotion Intervention Based on the Electronic 12-Hour Dietary Recall (e-12HR) Smartphone App on Adherence to the Mediterranean Diet Among Spanish Primary Care Professionals: Randomized Controlled Clinical Trial %A Béjar,Luis María %A Mesa-Rodríguez,Pedro %A García-Perea,María Dolores %+ Department of Preventive Medicine and Public Health, Institute of Anatomy, School of Medicine, University of Seville, 3rd Floor, Sánchez-Pizjuán Avenue, Seville, 41009, Spain, 34 954551771, lmbprado@us.es %K primary care professionals %K Mediterranean diet %K smartphone applications %K smartphone apps %K health promotion %K Mediterranean diet adherence %K food group %D 2024 %7 8.1.2024 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: The World Health Organization has called for addressing the growing burden of noncommunicable diseases (NCDs) by promoting healthy lifestyles among the population. Regarding patient health, primary care professionals (PCPs) are the first line of care who can positively influence patients’ behavior and lifestyle habits. However, a significant percentage of PCPs do not lead a healthy lifestyle. Therefore, addressing their health behaviors may be the key to substantially increasing health promotion advice in general practice. The Mediterranean diet has been extensively studied, and there is strong evidence of it being a dietary pattern for the prevention of NCDs, in addition to its significant environmental, sociocultural, and local economics benefits. Objective: This study focused only on the dietary aspect of the PCPs’ lifestyle. The primary objective was to evaluate the effect of using the Electronic 12-Hour Dietary Recall (e-12HR) smartphone app to improve diet, specifically to promote adherence to the Mediterranean diet (AMD), among PCPs. The secondary objectives were to establish the usability of the e-12HR app and to determine AMD among PCPs. Methods: An individual-level randomized, controlled, and single-blind clinical trial was conducted with 2 parallel groups: a control group (CG), using the nonfeedback version of the e-12HR app, and an intervention group (IG), using the feedback version of the e-12HR app. The level of human involvement was fully automated through the use of the app. There was a 28-day follow-up period. Participants were PCPs (medicine or nursing) recruited offline at one of the selected primary care centers (Andalusia, Spain, Southern Europe), of both sexes, over 18 years old, possessing a smartphone, and having smartphone literacy. Results: The study response rate was 73% (71 of 97 PCPs), with 27 (38%) women and 44 (62%) men: 40 (56%) PCPs in the CG and 31 (44%) in the IG. At baseline, AMD was medium (mean Mediterranean Diet Serving Score [MDSS] index 9.45, range 0-24), with 47 (66%) PCPs with a medium/high MDSS index. There were significant statistical improvements (CG vs IG, in favor of the IG) at week 4 (no significant statistical differences at baseline): +25.6% for the MDSS index (P=.002) and +213.1% for the percentage with a medium/high MDSS index (P=.001). In relation to specific food groups, there were significant statistical improvements for fruits (+33.8%, P=.02), vegetables (+352%, P=.001), nuts (+184%, P=.02), and legumes (+75.1%, P=.03). The responses to the usability rating questionnaire were satisfactory. Conclusions: The results support recommending the use of the e-12HR app as a tool to contribute to improving diet and preventing NCDs among PCPs, while positively influencing patient dietary behavior and preventing diet-related NCDs among patients. Trial Registration: ClinicalTrials.gov NCT05532137; https://clinicaltrials.gov/study/NCT05532137 %M 38190226 %R 10.2196/49302 %U https://mhealth.jmir.org/2024/1/e49302 %U https://doi.org/10.2196/49302 %U http://www.ncbi.nlm.nih.gov/pubmed/38190226 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 12 %N %P e48716 %T Application of eHealth Tools in Anticoagulation Management After Cardiac Valve Replacement: Scoping Review Coupled With Bibliometric Analysis %A Wu,Ying %A Wang,Xiaohui %A Zhou,Mengyao %A Huang,Zhuoer %A Liu,Lijuan %A Cong,Li %+ School of Medicine, Hunan Normal University, 371 Tongzipo Road, Changsha, 410013, China, 86 0731 889124, congli@hunnu.edu.cn %K eHealth tool %K cardiac valve replacement %K anticoagulation management %K scoping review %K bibliometrics analysis %K rehabilitation %D 2024 %7 5.1.2024 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Anticoagulation management can effectively prevent complications in patients undergoing cardiac valve replacement (CVR). The emergence of eHealth tools provides new prospects for the management of long-term anticoagulants. However, there is no comprehensive summary of the application of eHealth tools in anticoagulation management after CVR. Objective: Our objective is to clarify the current state, trends, benefits, and challenges of using eHealth tools in the anticoagulation management of patients after CVR and provide future directions and recommendations for development in this field. Methods: This scoping review follows the 5-step framework developed by Arksey and O’Malley. We searched 5 databases such as PubMed, MEDLINE, Web of Science, CINAHL, and Embase using keywords such as “eHealth,” “anticoagulation,” and “valve replacement.” We included papers on the practical application of eHealth tools and excluded papers describing the underlying mechanisms for developing eHealth tools. The search time ranged from the database inception to March 1, 2023. The study findings were reported according to the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews). Additionally, VOSviewer (version 1.6.18) was used to construct visualization maps of countries, institutions, authors, and keywords to investigate the internal relations of included literature and to explore research hotspots and frontiers. Results: This study included 25 studies that fulfilled the criteria. There were 27,050 participants in total, with the sample size of the included studies ranging from 49 to 13,219. The eHealth tools mainly include computer-based support systems, electronic health records, telemedicine platforms, and mobile apps. Compared to traditional anticoagulation management, eHealth tools can improve time in therapeutic range and life satisfaction. However, there is no significant impact observed in terms of economic benefits and anticoagulation-related complications. Bibliometric analysis suggests the potential for increased collaboration and opportunities among countries and academic institutions. Italy had the widest cooperative relationships. Machine learning and artificial intelligence are the popular research directions in anticoagulation management. Conclusions: eHealth tools exhibit promise for clinical applications in anticoagulation management after CVR, with the potential to enhance postoperative rehabilitation. Further high-quality research is needed to explore the economic benefits of eHealth tools in long-term anticoagulant therapy and the potential to reduce the occurrence of adverse events. %M 38180783 %R 10.2196/48716 %U https://mhealth.jmir.org/2024/1/e48716 %U https://doi.org/10.2196/48716 %U http://www.ncbi.nlm.nih.gov/pubmed/38180783 %0 Journal Article %@ 2561-1011 %I JMIR Publications %V 7 %N %P e52697 %T Efficacy of eHealth Technologies on Medication Adherence in Patients With Acute Coronary Syndrome: Systematic Review and Meta-Analysis %A Bhagavathula,Akshaya Srikanth %A Aldhaleei,Wafa Ali %A Atey,Tesfay Mehari %A Assefa,Solomon %A Tesfaye,Wubshet %+ Department of Public Health, College of Health and Human Services, North Dakota State University, 640 Aldevron Tower, Fargo, ND, 58102, United States, 1 7012316549, akshaya.bhagavathula@ndsu.edu %K medication adherence %K eHealth %K secondary prevention %K acute coronary syndrome %K heart disease %K text messaging %K mobile app %K cardiology %K cardioprotective %K prevention %K efficacy %K statins %D 2023 %7 19.12.2023 %9 Review %J JMIR Cardio %G English %X Background: Suboptimal adherence to cardiac pharmacotherapy, recommended by the guidelines after acute coronary syndrome (ACS) has been recognized and is associated with adverse outcomes. Several randomized controlled trials (RCTs) have shown that eHealth technologies are useful in reducing cardiovascular risk factors. However, little is known about the effect of eHealth interventions on medication adherence in patients following ACS. Objective: The aim of this study is to examine the efficacy of the eHealth interventions on medication adherence to selected 5 cardioprotective medication classes in patients with ACS. Methods: A systematic literature search of PubMed, Embase, Scopus, and Web of Science was conducted between May and October 2022, with an update in October 2023 to identify RCTs that evaluated the effectiveness of eHealth technologies, including texting, smartphone apps, or web-based apps, to improve medication adherence in patients after ACS. The risk of bias was evaluated using the modified Cochrane risk-of-bias tool for RCTs. A pooled meta-analysis was performed using a fixed-effect Mantel-Haenszel model and assessed the medication adherence to the medications of statins, aspirin, P2Y12 inhibitors, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and β-blockers. Results: We identified 5 RCTs, applicable to 4100 participants (2093 intervention vs 2007 control), for inclusion in the meta-analysis. In patients who recently had an ACS, compared to the control group, the use of eHealth intervention was not associated with improved adherence to statins at different time points (risk difference [RD] –0.01, 95% CI –0.03 to 0.03 at 6 months and RD –0.02, 95% CI –0.05 to 0.02 at 12 months), P2Y12 inhibitors (RD –0.01, 95% CI –0.04 to 0.02 and RD –0.01, 95% CI –0.03 to 0.02), aspirin (RD 0.00, 95% CI –0.06 to 0.07 and RD –0.00, 95% CI –0.07 to 0.06), angiotensin-converting enzyme inhibitors or angiotensin receptor blockers (RD –0.01, 95% CI –0.04 to 0.02 and RD 0.01, 95% CI –0.04 to 0.05), and β-blockers (RD 0.00, 95% CI –0.03 to 0.03 and RD –0.01, 95% CI –0.05 to 0.03). The intervention was also not associated with improved adherence irrespective of the adherence assessment method used (self-report or objective). Conclusions: This review identified limited evidence on the effectiveness of eHealth interventions on adherence to guideline-recommended medications after ACS. While the pooled analyses suggested a lack of effectiveness of such interventions on adherence improvement, further studies are warranted to better understand the role of different eHealth approaches in the post-ACS context. %M 38113072 %R 10.2196/52697 %U https://cardio.jmir.org/2023/1/e52697 %U https://doi.org/10.2196/52697 %U http://www.ncbi.nlm.nih.gov/pubmed/38113072 %0 Journal Article %@ 2561-7605 %I JMIR Publications %V 6 %N %P e50990 %T Key Features of Smart Medication Adherence Products: Updated Scoping Review %A Faisal,Sadaf %A Samoth,Devine %A Aslam,Yusra %A Patel,Hawa %A Park,SooMin %A Baby,Bincy %A Patel,Tejal %+ School of Pharmacy, University of Waterloo, 10 Victoria St. S, Kitchener, ON, N2G 1C5, Canada, 1 519 888 4567 ext 21337, T5patel@uwaterloo.ca %K technology %K medication %K aging %K adherence %K smart medication %K digital technology %K self-management %K older adult %K mobile health %K mHealth %K apps %K digital health %K geriatrics %K older adults %K mHealth app %K application %K management %K scoping review %K medication adherence %K consumer %K use %K mobile phone %D 2023 %7 19.12.2023 %9 Review %J JMIR Aging %G English %X Background: Older adults often face challenges in self-managing their medication owing to physical and cognitive limitations, complex medication regimens, and packaging of medications. Emerging smart medication dispensing and adherence products (SMAPs) offer the options of automated dispensing, tracking medication intake in real time, and reminders and notifications. A 2021 review identified 51 SMAPs owing to the rapid influx of digital technology; an update to this review is required. Objective: This review aims to identify new products and summarize and compare the key features of SMAPs. Methods: Gray and published literature and videos were searched using Google, YouTube, PubMed, Embase, and Scopus. The first 10 pages of Google and the first 100 results of YouTube were screened using 4 and 5 keyword searches, respectively. SMAPs were included if they were able to store and allowed for the dispensation of medications, tracked real-time medication intake data, and could automatically analyze data. Products were excluded if they were stand-alone software applications, not marketed in English, not for in-home use, or only used in clinical trials. In total, 5 researchers independently screened and extracted the data. Results: This review identified 114 SMAPs, including 80 (70.2%) marketed and 34 (29.8%) prototypes, grouped into 15 types. Among the marketed products, 68% (54/80) were available for consumer purchase. Of these products, 26% (14/54) were available worldwide and 78% (42/54) were available in North America. There was variability in the hardware, software, data collection and management features, and cost of the products. Examples of hardware features include battery life, medication storage capacity, availability of types and number of alarms, locking features, and additional technology required for use of the product, whereas software features included reminder and notification capabilities and availability of manufacturer support. Data capture methods included the availability of sensors to record the use of the product and data-syncing capabilities with cloud storage with short-range communications. Data were accessible to users via mobile apps or web-based portals. Some SMAPs provided data security assurance with secure log-ins (use of personal identification numbers or facial recognition), whereas other SMAPs provided data through registered email addresses. Although some SMAPs were available at set prices or free of cost to end users, the cost of other products varied based on availability, shipping fees, and subscription fees. Conclusions: An expanding market for SMAPs with features specific to at-home patient use is emerging. Health care professionals can use these features to select and suggest products that meet their patients’ unique requirements. %M 38113067 %R 10.2196/50990 %U https://aging.jmir.org/2023/1/e50990 %U https://doi.org/10.2196/50990 %U http://www.ncbi.nlm.nih.gov/pubmed/38113067 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e49352 %T Mobile Phone Technology for Preventing HIV and Related Youth Health Problems, Sexual Health, Mental Health, and Substance Use Problems in Southwest Uganda (Youth Health SMS): Protocol for a Pilot Randomized Controlled Trial %A Kreniske,Philip %A Namuyaba,Olive Imelda %A Kasumba,Robert %A Namatovu,Phionah %A Ssewamala,Fred %A Wingood,Gina %A Wei,Ying %A Ybarra,Michele L %A Oloya,Charlotte %A Tindyebwa,Costella %A Ntulo,Christina %A Mujune,Vincent %A Chang,Larry W %A Mellins,Claude A %A Santelli,John S %+ Community Health and Social Sciences Department, Graduate School of Public Health and Health Policy, City University of New York, 55 W 125th Street, New York, NY, 10027, United States, 1 (646) 364 9600, philip.kreniske@sph.cuny.edu %K adolescence %K PrEP %K pre-exposure prophylaxis %K HIV %K mental health %K substance use %K sexual health %K mobile phones %K randomized controlled trial %K adaptation %K Uganda %D 2023 %7 19.12.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: East and Southern Africa have the highest HIV incidence and prevalence in the world, with adolescents and young adults being at the greatest risk. Despite effective combination prevention tools, including the recently available pre-exposure prophylaxis (PrEP), HIV incidence among adolescents and young adults in Uganda remains high, and PrEP use remains low. Mental health and substance use (behavioral health) play a role in sexual behavior and decision-making, contributing to an increase in the risk for acquiring HIV. Interventions that target multiple HIV risk factors, including sexual and mental health and problematic substance use, are crucial to ending the HIV epidemic. Yet few interventions addressing HIV related health disparities and comorbidities among adolescents and young adults in East and Southern Africa currently exist. Objective: This study aims to evaluate the acceptability and feasibility of Kirabo, an SMS text message intervention informed by the information, motivation, and behavior model and to be disseminated through secondary schools. The study will gather preliminary estimates of Kirabo’s effectiveness in increasing HIV testing and linking users to mental health counselors. Methods: We identified Mobile 4 Reproductive Health for adaptation using the assessment, decision, administration, production, topical experts, integration, training, testing (ADAPT-ITT) framework. Mobile 4 Reproductive Health is an evidence-based automated 2-way SMS text messaging and interactive voice response platform that offers sexual and reproductive health information and links users to HIV clinics in East Africa. Through ADAPT-ITT we refined our approach and created Kirabo, an SMS text message–based intervention for linking adolescents and young adults to health services, including HIV testing and mental health counseling. We will conduct a 2-arm randomized controlled trial in Masaka, Uganda. Adolescents (N=200) will be recruited from local schools. Baseline sociodemographic characteristics, HIV test history, and behavioral health symptoms will be assessed. We will evaluate acceptability and feasibility using surveys, interviews, and mobile phone data. The preliminary efficacy of Kirabo in increasing HIV testing and linking users to mental health counselors will be evaluated immediately after the intervention and at the 3-month follow-up. We will also assess the intervention’s impact on self-efficacy in testing for HIV, adopting PrEP, and contacting a mental health counselor. Results: Intervention adaptation began in 2019. A pretest was conducted in 2021. The randomized controlled trial, including usability and feasibility assessments and effectiveness measurements, commenced in August 2023. Conclusions: Kirabo is a tool that assists in the efforts to end the HIV epidemic by targeting the health disparities and comorbidities among adolescents in Uganda. The intervention includes local HIV clinic information, PrEP information, and behavioral health screening, with referrals as needed. Increasing access to prevention strategies and mitigating factors that make adolescents and young adults susceptible to HIV acquisition can contribute to global efforts to end the HIV epidemic. Trial Registration: ClinicalTrials.gov NCT05130151; https://clinicaltrials.gov/study/NCT05130151 International Registered Report Identifier (IRRID): DERR1-10.2196/49352 %M 38113102 %R 10.2196/49352 %U https://www.researchprotocols.org/2023/1/e49352 %U https://doi.org/10.2196/49352 %U http://www.ncbi.nlm.nih.gov/pubmed/38113102 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 10 %N %P e50806 %T Efficacy of a Smartphone App in Enhancing Medication Adherence and Accuracy in Individuals With Schizophrenia During the COVID-19 Pandemic: Randomized Controlled Trial %A Chen,Huan Hwa %A Hsu,Hsin Tien %A Lin,Pei Chao %A Chen,Chin-Yin %A Hsieh,Hsiu Fen %A Ko,Chih Hung %+ College of Nursing, Kaohsiung Medical University, 100 Shih-Chuan 1st Rd., Sanmin District, Kaohsiung, 80708, Taiwan, 886 7 3121101 ext 2626, hsiufen96@kmu.edu.tw %K cognitive functions %K medication adherence %K psychiatric symptoms %K schizophrenia %K smartphone app %D 2023 %7 14.12.2023 %9 Original Paper %J JMIR Ment Health %G English %X Background: Poor medication adherence or inaccuracy in taking prescribed medications plays an important role in the recurrence or worsening of psychiatric symptoms in patients with schizophrenia, and the COVID-19 pandemic impacted their medication adherence with exacerbated symptoms or relapse. The use of mobile health services increased during the COVID-19 pandemic, and their role in improving mental health is becoming clearer. Objective: This study aimed to explore the effectiveness of a smartphone app (MedAdhere) on medication adherence and accuracy among patients with schizophrenia and to measure their psychiatric symptoms and cognitive functions. Methods: In this 12-week experimental study, participants were provided interventions with the MedAdhere app, and data were collected between June 2021 and September 2022. A total of 105 participants were randomly assigned to either the experimental or control groups. We used the Positive and Negative Syndrome Scale and Mini-Mental State Examination to measure the participants’ psychiatric symptoms and cognitive functions. Generalized estimating equations were used for data analysis. Results: A total of 94 participants met the inclusion criteria and completed the protocol, and the medication adherence rate of the experimental group was 94.72% (2785/2940) during the intervention. Psychotic symptoms (positive, negative, and general psychopathology symptoms) and cognitive functions (memory, language, and executive function) were significantly improved in the experimental group compared to the control group after the intervention. Conclusions: The MedAdhere app effectively and significantly improved medication adherence and, thereby, the psychiatric symptoms of patients with schizophrenia. This artificial intelligence assisted app could be extended to all patients who need to be reminded to take medication on schedule. Trial Registration: ClinicalTrials.gov NCT05892120; https://clinicaltrials.gov/study/NCT05892120 %M 38096017 %R 10.2196/50806 %U https://mental.jmir.org/2023/1/e50806 %U https://doi.org/10.2196/50806 %U http://www.ncbi.nlm.nih.gov/pubmed/38096017 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e50579 %T Effect of a Medication Adherence Mobile Phone App on Medically Underserved Patients with Chronic Illness: Preliminary Efficacy Study %A Hartch,Christa E %A Dietrich,Mary S %A Stolldorf,Deonni P %+ School of Nursing and Health Sciences, Manhattanville College, 2900 Purchase Street, Purchase, NY, 10577, United States, 1 914 323 5365, christa.hartch@mville.edu %K medication adherence %K medication self-efficacy %K mobile phone applications %K medically underserved populations %K mHealth %K mobile health %K app %K apps %K applications %K underserved %K adherence %K survey %K surveys %K chronic illness %D 2023 %7 11.12.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Medication adherence is vital in the treatment of patients with chronic illness who require long-term medication therapies to maintain optimal health. Medication adherence, a complex and widespread problem, has been difficult to solve. Additionally, lower-income, medically underserved communities have been found to have higher rates of inadequate adherence to oral medications. Even so, this population has been underrepresented in studies using mobile medication adherence app interventions. Federally qualified health centers provide care for medically underserved populations, defined as communities and populations where there is a demonstrable unmet need for health services. These centers have been reporting an increase in a more complex chronic disease population. Including medically underserved individuals in mobile health studies provides opportunities to support this disproportionately affected group, work toward reducing health disparities in access to health care, and understand barriers to mobile health uptake. Objective: The aim of this preliminary efficacy study was to evaluate the effects and feasibility of a commercially available medication adherence app, Medisafe, in a medically underserved adult population with various chronic illnesses seeking care in a federally qualified health center. Methods: Participants in this single-arm pre-post intervention preliminary efficacy study (N=10) completed a baseline survey, used the app for 2 weeks, and completed an end-of-study survey. The primary outcome measures were medication adherence and medication self-efficacy. Feedback on the use of the app was also gathered. Results: A statistically significant median increase of 8 points on the self-efficacy for adherence to medications scale was observed (P=.03, Cohen d=0.69). Though not significant, the adherence to refills and medications scale demonstrated a median change of 2.5 points in the direction of increased medication adherence (P=.21, Cohen d=0.41). Feedback about the app was positive. Conclusions: Use of the Medisafe app is a viable option to improve medication self-efficacy and medication adherence in medically underserved patients in an outpatient setting with a variety of chronic illnesses. %M 38079192 %R 10.2196/50579 %U https://formative.jmir.org/2023/1/e50579 %U https://doi.org/10.2196/50579 %U http://www.ncbi.nlm.nih.gov/pubmed/38079192 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e51277 %T Secure Messaging Intervention in Patients Starting New Antidepressant to Promote Adherence: Pilot Randomized Controlled Trial %A Turvey,Carolyn %A Fuhrmeister,Lindsey %A Klein,Dawn %A McCoy,Kimberly %A Moeckli,Jane %A Stewart Steffensmeier,Kenda R %A Suiter,Natalie %A Van Tiem,Jen %+ Center for Access and Delivery Research and Evaluation, Iowa City VA Health Care System, 601 Highway 6 West, Iowa City, IA, 52246, United States, 1 3193216799, Carolyn.Turvey@va.gov %K depression %K text messaging %K medication adherence %K medication %K medications %K adherence %K antidepressant %K antidepressants %K depressive %K text message %K text messages %K messaging %K SMS %K veteran %K veterans %K military %K randomized controlled trial %K RCT %K controlled trials %K mental health %K psychiatry %K mobile phone %D 2023 %7 8.12.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: There are a range of effective pharmacological and behavioral treatments for depression. However, approximately one-third of patients discontinue antidepressants within the first month of treatment and 44% discontinue them by the third month of treatment. The major reasons reported for discontinuation were side effect burden, patients experiencing that the medications were not working, and patients wanting to resolve their depression without using medication. Objective: This study tested the acceptability, feasibility, and preliminary effectiveness of an SMS messaging intervention designed to improve antidepressant adherence and depression outcomes in veterans. The intervention specifically targeted the key reasons for antidepressant discontinuation. For example, the secure message included reminders that it can take up to 6 weeks for an antidepressant to work, or prompts to call their provider should the side effect burden become significant. Methods: This pilot was a 3-armed randomized controlled trial of 53 veterans undergoing depression treatment at the Iowa City Veterans Affairs Health Care System. Veterans starting a new antidepressant were randomized to secure messaging only (SM-Only), secure messaging with coaching (SM+Coach), or attention control (AC) groups. The intervention lasted 12 weeks with follow-up assessments of key outcomes at 6 and 12-weeks. This included a measure of antidepressant adherence, depressive symptom severity, and side effect burden. Results: The 2 active interventions (SM-Only and SM+Coach) demonstrated small to moderate effect sizes (ESs) in improving antidepressant adherence and reducing side effect burden. They did not appear to reduce the depressive symptom burden any more than in the AC arm. Veteran participants in the SM arms demonstrated improved medication adherence from baseline to 12 weeks on the Medication Adherence Rating Scale compared with those in the AC arm, who had a decline in adherence (SM-Only: ES=0.09; P=.19; SM+Coach: ES=0.85; P=.002). Depression scores on the 9-Item Patient Health Questionnaire decreased for all 3 treatment arms, although the decline was slightly larger for the SM-Only (ES=0.32) and the SM+Coach (ES=0.24) arms when compared with the AC arm. The 2 intervention arms indicated a decrease in side effects on the Frequency, Intensity, and Burden of Side Effects Ratings, whereas the side effect burden for the AC arm increased. These differences indicated moderate ES (SM-Only vs AC: ES=0.40; P=.07; SM+Coach: ES=0.54; P=.07). Conclusions: A secure messaging program targeting specific reasons for antidepressant discontinuation had small-to-moderate ES in improving medication adherence. Consistent with prior research, the intervention that included brief synchronic meetings with a coach appeared to have a greater benefit than the SMS-alone intervention. Veterans consistently engaged with the SMS messaging in both treatment arms throughout the study period. They additionally provided feedback on which texts were most helpful, tending to prefer messages providing overall encouragement rather than specific wellness recommendations. Trial Registration: ClinicalTrials.gov NCT03930849; https://clinicaltrials.gov/study/NCT03930849 %M 38064267 %R 10.2196/51277 %U https://formative.jmir.org/2023/1/e51277 %U https://doi.org/10.2196/51277 %U http://www.ncbi.nlm.nih.gov/pubmed/38064267 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e46830 %T Repetitive Transcranial Magnetic Stimulation With and Without Text4Support for the Treatment of Resistant Depression: Protocol for a Patient-Centered Multicenter Randomized Controlled Pilot Trial %A Adu,Medard Kofi %A Dias,Raquel da Luz %A Agyapong,Belinda %A Eboreime,Ejemai %A Sapara,Adegboyega O %A Lawal,Mobolaji A %A Chew,Corina %A Diamond Frost,Karen %A Li,Daniel %A Flynn,Michael %A Hassan,Sameh %A Saleh,Ahmed %A Sridharan,Sanjana %A White,Matt %A Agyapong,Vincent IO %+ Department of Psychiatry, Dalhousie University, 5909 Veterans Memorial Lane, 8th Floor, Abbie J. Lane Memorial Building, QEII Health Sciences Centre, Halifax, NS, B3H 2E2, Canada, 1 780 215 7771, vn602367@dal.ca %K repetitive transcranial magnetic stimulation %K treatment-resistant depression %K cognitive behavioral therapy %K Text4Support %K text messaging %K major depressive disorder %D 2023 %7 7.12.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Treatment-resistant depression (TRD) is the inability of a patient with major depressive disorder (MDD) to accomplish or achieve remission after an adequate trial of antidepressant treatments. Several combinations and augmentation treatment strategies for TRD exist, including the use of repetitive transcranial magnetic stimulation (rTMS), and new therapeutic options are being introduced. Text4Support, a text message–based form of cognitive behavioral therapy that allows patients with MDD to receive daily supportive text messages for correcting or altering negative thought patterns through positive reinforcement, may be a useful augmentation treatment strategy for patients with TRD. It is however currently unknown if adding the Text4Support intervention will enhance the response of patients with TRD to rTMS treatment. Objective: This study aims to assess the initial comparative clinical effectiveness of rTMS with and without the Text4Support program as an innovative patient-centered intervention for the management of patients diagnosed with TRD. Methods: This study is a multicenter, prospective, parallel-design, 2-arm, rater-blinded randomized controlled pilot trial. The recruitment process is scheduled to last 12 months. It will involve active treatment for 6 weeks, observation, and a follow-up period of 6 months for participants in the study arms. In total, 200 participants diagnosed with TRD at rTMS care clinics in Edmonton, Alberta, and rTMS clinics in Halifax, Nova Scotia will be randomized to 1 of 2 treatment arms (rTMS sessions alone or rTMS sessions plus Text4Support intervention). Participants in each group will be made to complete evaluation measures at baseline, and 1, 3, and 6 months. The primary outcome measure will be the mean change in the scores of the Patient Health Questionnaire-9 (PHQ-9). The secondary outcome measures will involve the scores of the 7-item Generalized Anxiety Disorders Scale (GAD-7), Columbia-Suicide Severity Rating Scale (CSSRS), and World Health Organization-Five Well-Being Index (WHO-5). Patient data will be analyzed with descriptive statistics, repeated measures, and correlational analyses. Qualitative data will be analyzed using the thematic analysis framework. Results: The results of the study are expected to be available 18 months from the start of recruitment. We hypothesize that participants enrolled in the rTMS plus Text4Support intervention treatment arm of the study will achieve superior outcomes compared with the outcomes of participants enrolled in the rTMS alone arm. Conclusions: The application of the combination of rTMS and Text4Support has not been investigated previously. Therefore, we hope that this study will provide a concrete base of data to evaluate the practical application and efficacy of using the novel combination of these 2 treatment modalities. International Registered Report Identifier (IRRID): PRR1-10.2196/46830 %M 38060308 %R 10.2196/46830 %U https://www.researchprotocols.org/2023/1/e46830 %U https://doi.org/10.2196/46830 %U http://www.ncbi.nlm.nih.gov/pubmed/38060308 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 11 %N %P e45947 %T Exploring Adherence to Pelvic Floor Muscle Training in Women Using Mobile Apps: Scoping Review %A Harper,Rosie C %A Sheppard,Sally %A Stewart,Carly %A Clark,Carol J %+ Faculty of Health and Social Sciences, Bournemouth University, Bournemouth Gateway Building, 12 St Paul’s Lane, Bournemouth, BH8 8GP, United Kingdom, 44 01202 524111, rharper1@bournemouth.ac.uk %K adherence %K behavior change %K mHealth %K mobile apps %K pelvic floor muscle training %K women %D 2023 %7 30.11.2023 %9 Review %J JMIR Mhealth Uhealth %G English %X Background: Pelvic floor dysfunction is a public health issue, with 1 in 3 women experiencing symptoms at some point in their lifetime. The gold standard of treatment for pelvic floor dysfunction is supervised pelvic floor muscle training (PFMT); however, adherence to PFMT in women is poor. Mobile apps are increasingly being used in the National Health Service to enable equity in the distribution of health care and increase accessibility to services. However, it is unclear how PFMT mobile apps influence PFMT adherence in women. Objective: We aimed to identify which behavior change techniques (BCTs) have been used in PFMT mobile apps, to distinguish the core “capability, opportunity, and motivation” (COM) behaviors targeted by the BCTs used in PFMT mobile apps, and to compare the levels of PFMT adherence in women between those using PFMT mobile apps and those receiving usual care. Methods: We conducted a scoping review of the literature. Published quantitative literature that compared the use of a PFMT mobile app to a control group was included to address the objectives of the study. The electronic bibliographic databases searched included MEDLINE, CINAHL, Scopus, Web of Science, and PEDro, along with CENTRAL. Studies were also identified from reference searching of systematic reviews. Original articles written in English from 2006 onward were included. Nonexperimental quantitative studies, qualitative studies, studies that use male participants, case studies, web-based interventions, and interventions that use vaginal probes were excluded. Narrative synthesis was conducted on eligible articles based on the aims of the study. Results: Of the 114 records retrieved from the search, a total of 6 articles met the eligibility and inclusion criteria. The total number of participants in the studies was 471. All PFMT mobile apps used the BCT “prompts and cues.” Opportunity was the core COM behavior targeted by the PFMT mobile apps. Higher levels of adherence to PFMT were observed among women using PFMT mobile apps. Conclusions: Digital “prompts and cues” are a BCT commonly used in PFMT mobile apps, and further research is required to practically assess whether a future randomized controlled trial that investigates the effectiveness of digital “prompts and cues” on PFMT adherence in women can be conducted. %M 38032694 %R 10.2196/45947 %U https://mhealth.jmir.org/2023/1/e45947 %U https://doi.org/10.2196/45947 %U http://www.ncbi.nlm.nih.gov/pubmed/38032694 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 10 %N %P e48843 %T Patient Experience of Digitalized Follow-up of Antidepressant Treatment in Psychiatric Outpatient Care: Qualitative Analysis %A Hamlin,Matilda %A Holmén,Joacim %A Wentz,Elisabet %A Aiff,Harald %A Ali,Lilas %A Steingrimsson,Steinn %+ Institute of Neuroscience and Physiology, Sahlgrenska Academy, University of Gothenburg, Universitetsplatsen 1, Gothenburg, 405 30, Sweden, 46 31786 00 00, steinn.steingrimsson@vgregion.se %K major depressive disorder %K digital psychiatry %K mobile app %K adherence %K antidepressant %K antidepressants %K depressive %K depression %K mHealth %K mobile health %K app %K apps %K application %K applications %K experience %K interview %K interviews %K medication %K prescribe %K prescription %K dose %D 2023 %7 11.10.2023 %9 Original Paper %J JMIR Ment Health %G English %X Background: Nonadherence to pharmaceutical antidepressant treatment is common among patients with depression. Digitalized follow-up (ie, self-monitoring systems through mobile apps) has been suggested as an effective adjunct to conventional antidepressant treatment to increase medical adherence, improve symptoms of depression, and reduce health care resource use. Objective: The aim of this study was to determine patients’ experience of digitalized follow-up using a mobile app as an adjunct to treatment concurrent with a new prescription, a change of antidepressant, or a dose increase. Methods: This was a qualitative, descriptive study. Patients at 2 psychiatric outpatient clinics were recruited at the time of changing antidepressant medication. After using a mobile app (either a commercial app or a public app) for 4-6 weeks with daily registrations of active data, such as medical intake and questions concerning general mental health status, individual semistructured interviews were conducted. Recorded data were transcribed and then analyzed using content analysis. Results: In total, 13 patients completed the study. The mean age was 35 (range 20-67) years, 8 (61.5%) were female, and all reported high digital literacy. Overall, the emerging themes indicated that the patients found the digital app to be a valuable adjunct to antidepressant treatment but with potential for improvement. Both user adherence and medical adherence were positively affected by a daily reminder and the app’s ease of use. User adherence was negatively affected by the severity of depression. The positive experience of visually presented data as graphs was a key finding, which was beneficial for self-awareness, the patient-physician relationship, and user adherence. Finally, the patients had mixed reactions to the app’s content and requested tailored content. Conclusions: The patients identified several factors addressing both medical adherence and user adherence to a digital app when using it for digitalized follow-up concurrent with the critical time related to changes in antidepressant medication. The findings highlight the need for rigorous evidence-based empirical studies to generate sustainable research results. %M 37819697 %R 10.2196/48843 %U https://mental.jmir.org/2023/1/e48843 %U https://doi.org/10.2196/48843 %U http://www.ncbi.nlm.nih.gov/pubmed/37819697 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e49252 %T An eHealth App (CAPABLE) Providing Symptom Monitoring, Well-Being Interventions, and Educational Material for Patients With Melanoma Treated With Immune Checkpoint Inhibitors: Protocol for an Exploratory Intervention Trial %A Fraterman,Itske %A Wollersheim,Barbara M %A Tibollo,Valentina %A Glaser,Savannah Lucia Catherina %A Medlock,Stephanie %A Cornet,Ronald %A Gabetta,Matteo %A Gisko,Vitali %A Barkan,Ella %A di Flora,Nicola %A Glasspool,David %A Kogan,Alexandra %A Lanzola,Giordano %A Leizer,Roy %A Mallo,Henk %A Ottaviano,Manuel %A Peleg,Mor %A van de Poll-Franse,Lonneke V %A Veggiotti,Nicole %A Śniatała,Konrad %A Wilk,Szymon %A Parimbelli,Enea %A Quaglini,Silvana %A Rizzo,Mimma %A Locati,Laura Deborah %A Boekhout,Annelies %A Sacchi,Lucia %A Wilgenhof,Sofie %+ Department of Psychosocial Research and Epidemiology, The Netherlands Cancer Institute, Plesmanlaan 121, Amsterdam, 1066CX, Netherlands, 31 621885919, i.fraterman@nki.nl %K eHealth %K melanoma %K fatigue %K quality of life %K intervention %K pilot study %K QoL %K cancer %K oncology %K HRQoL %K fatigue %K symptom %K symptoms %K monitoring %K adoption %K acceptance %K patient education %K digital health %K immune checkpoint inhibitors %K immunotherapy %D 2023 %7 11.10.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Since treatment with immune checkpoint inhibitors (ICIs) is becoming standard therapy for patients with high-risk and advanced melanoma, an increasing number of patients experience treatment-related adverse events such as fatigue. Until now, studies have demonstrated the benefits of using eHealth tools to provide either symptom monitoring or interventions to reduce treatment-related symptoms such as fatigue. However, an eHealth tool that facilitates the combination of both symptom monitoring and symptom management in patients with melanoma treated with ICIs is still needed. Objective: In this pilot study, we will explore the use of the CAPABLE (Cancer Patients Better Life Experience) app in providing symptom monitoring, education, and well-being interventions on health-related quality of life (HRQoL) outcomes such as fatigue and physical functioning, as well as patients’ acceptance and usability of using CAPABLE. Methods: This prospective, exploratory pilot study will examine changes in fatigue over time in 36 patients with stage III or IV melanoma during treatment with ICI using CAPABLE (a smartphone app and multisensory smartwatch). This cohort will be compared to a prospectively collected cohort of patients with melanoma treated with standard ICI therapy. CAPABLE will be used for a minimum of 3 and a maximum of 6 months. The primary endpoint in this study is the change in fatigue between baseline and 3 and 6 months after the start of treatment. Secondary end points include HRQoL outcomes, usability, and feasibility parameters. Results: Study inclusion started in April 2023 and is currently ongoing. Conclusions: This pilot study will explore the effect, usability, and feasibility of CAPABLE in patients with melanoma during treatment with ICI. Adding the CAPABLE system to active treatment is hypothesized to decrease fatigue in patients with high-risk and advanced melanoma during treatment with ICIs compared to a control group receiving standard care. The Medical Ethics Committee NedMec (Amsterdam, The Netherlands) granted ethical approval for this study (reference number 22-981/NL81970.000.22). Trial Registration: ClinicalTrials.gov NCT05827289; https://clinicaltrials.gov/study/NCT05827289 International Registered Report Identifier (IRRID): DERR1-10.2196/49252 %M 37819691 %R 10.2196/49252 %U https://www.researchprotocols.org/2023/1/e49252 %U https://doi.org/10.2196/49252 %U http://www.ncbi.nlm.nih.gov/pubmed/37819691 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e47137 %T MASI, a Smartphone App to Improve Treatment Adherence Among South African Adolescents and Young Adults With HIV: Protocol for a Pilot Randomized Controlled Trial %A Mulawa,Marta I %A Hoare,Jacqueline %A Knippler,Elizabeth T %A Mtukushe,Bulelwa %A Matiwane,Mluleki %A Muessig,Kathryn E %A Al-Mujtaba,Maryam %A Wilkinson,T Harper %A Platt,Alyssa %A Egger,Joseph R %A Hightow-Weidman,Lisa B %+ School of Nursing, Duke University, DUMC 3322, 307 Trent Drive, Durham, NC, 27710, United States, 1 (919) 6849555, marta.mulawa@duke.edu %K HIV %K adherence %K mHealth %K digital health %K smartphone %K adolescents and young adults %K youths %K South Africa %K social support %K randomized %K controlled trial %K pilot %K antiretroviral therapy %K sexually transmitted %K app %K apps %K mobile phone %D 2023 %7 19.9.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Adolescents and young adults with HIV repeatedly demonstrate low rates of antiretroviral therapy (ART) adherence as well as low rates of viral suppression. Digital health interventions are a promising way to engage adolescents and young adults with HIV to support ART adherence. However, few digital health interventions have been developed and tested with adolescents and young adults in countries like South Africa, where the HIV burden among adolescents and young adults is greatest. Masakhane Siphucule Impilo Yethu (MASI; Xhosa for “Let's empower each other and improve our health”) is a comprehensive ART adherence-supporting app for South African adolescents and young adults with HIV. It was culturally adapted using the HealthMpowerment platform. Objective: The aim of this paper is to describe the protocol for a pilot randomized controlled trial examining the feasibility, acceptability, and preliminary efficacy of MASI on self-reported ART adherence and social support. Methods: We will enroll 50 adolescents and young adults with HIV ages 15-21 years. Participants will be recruited from public ART clinics linked to a large government-funded teaching hospital in Cape Town, South Africa. Participants will be randomized 1:1 into either the intervention arm receiving a full version of MASI or the control arm receiving an information-only version of the app (n=25 per arm). Participants will be asked to engage with MASI daily for 6 months. All participants will complete baseline and follow-up assessments at 3 and 6 months. Results: Study screening began in May 2022 and the first participant was enrolled on June 21, 2022. As of June 12, 2023, 81 participants have completed screeners, and 36 eligible participants have been enrolled in the pilot randomized controlled trial. Recruitment is anticipated to last through August 31, 2023, with study activities anticipated through February 29, 2024. Conclusions: There is an urgent need for innovative interventions to improve ART adherence among adolescents and young adults in settings like South Africa. If found to be feasible and acceptable, MASI could be implemented with adolescents and young adults with HIV in other parts of the country. Trial Registration: ClinicalTrials.gov NCT04661878; https://clinicaltrials.gov/ct2/show/study/NCT04661878 International Registered Report Identifier (IRRID): DERR1-10.2196/47137 %M 37725409 %R 10.2196/47137 %U https://www.researchprotocols.org/2023/1/e47137 %U https://doi.org/10.2196/47137 %U http://www.ncbi.nlm.nih.gov/pubmed/37725409 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e45986 %T A Bespoke Electronic Health Journal for Monitoring Response to Botulinum Toxin in Treatment of Cervical Dystonia: Open-Label Observational Study of User Experience %A Edwards,Colin %A Borton,Rebecca %A Ross,Anita %A Molloy,Fiona %+ patientMpower Ltd, 10-13 Thomas St, The Digital Hub, Dublin, D08PX8H, Ireland, 353 872599131, colin.edwards@merlinconsulting.ie %K cervical dystonia %K electronic health journal %K user experience %K user acceptance testing %K botulinum toxin %K diary %K acceptability %K user testing %K symptom control %K spasm %K muscle pain %K spasmodic torticollis %D 2023 %7 23.8.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: The mainstay of treatment for cervical dystonia (CD) is regular botulinum toxin injections every 3-4 months. Clinical evaluation of response is dependent on the patient’s recall of how well symptoms responded to the previous injection. A mobile health app could assist both patients and health care professionals to monitor treatment benefits and side effects to assist with the selection of muscle and toxin dose to be injected at the next visit. The DystoniaDiary is a bespoke electronic health journal for monitoring symptoms of CD and response to treatment. Objective: The objective of this study was to assess the acceptability and utility of the DystoniaDiary in patients with CD treated with botulinum toxins as part of their usual care. Methods: In this open-label, single-center, single-arm observational study, patients attending a botulinum toxin injection clinic were invited to download the DystoniaDiary app. Patients selected up to 3 of their most troublesome CD symptoms (from a predefined list) and were prompted every 3 days to rate the control of these symptoms on a scale from 0 (very badly) to 100 (very well). Dates of onset and wearing off of response to injected botulinum toxin and responses to the Cervical Dystonia Impact Profile (CDIP-58) questionnaire at baseline and week 6 were also recorded in the app. Results: A total of 34 patients installed DystoniaDiary. Twenty-five patients (25/34, 74%) recorded data for ≥12 weeks and 21 patients (21/34, 62%) for ≥16 weeks. Median time between the first and last data input was 140 days with a median of 13 recordings per patient. User experience questionnaires at weeks 4 and 12 (20 respondents) indicated that the majority of respondents found the DystoniaDiary app easy to install and use, liked using it, would recommend it to others (19/20), and wished to continue using it (16/20). A smaller proportion indicated that the DystoniaDiary gave a greater sense of control in managing their CD (13/20). There was interindividual variation in patients’ perceptions of control of their symptoms after botulinum toxin injection. Response to treatment was apparent in the symptom control scores for some patients, whereas the severity of other patients’ symptoms did not appear to change after treatment. Conclusions: This observational study demonstrated that the DystoniaDiary app was perceived as useful and acceptable for a large proportion of this sample of patients with CD attending a botulinum toxin clinic. Patients with CD appear to be willing to regularly record symptom severity for at least the duration of a botulinum injection treatment cycle (12-16 weeks). This app may be useful in monitoring and optimizing individual patient responses to botulinum toxin injection. %M 37610807 %R 10.2196/45986 %U https://formative.jmir.org/2023/1/e45986 %U https://doi.org/10.2196/45986 %U http://www.ncbi.nlm.nih.gov/pubmed/37610807 %0 Journal Article %@ 2371-4379 %I JMIR Publications %V 8 %N %P e44297 %T Use of a Smartphone-Based Medication Adherence Platform to Improve Outcomes in Uncontrolled Type 2 Diabetes Among Veterans: Prospective Case-Crossover Study %A Rai,Amneet %A Riddle,Mark %A Mishra,Rajendra %A Nguyen,Nhien %A Valine,Kelly %A Fenney,Megan %+ Veterans Affairs Sierra Nevada Healthcare System, 975 Kirman Ave, Reno, NV, 89502, United States, 1 775 326 2796, amneetrai@gmail.com %K application %K biguanide %K blood glucose %K case-crossover %K diabetes management %K diabetes %K diabetic %K digital health intervention %K epidemiology %K glucose monitoring %K glucose %K HbgA1c %K hemoglobin A1c %K hemoglobin %K hyperlipidemia %K hypertension %K interquartile range %K IQR %K MAS %K Medication Adherence Scores %K medication adherence %K mobile health intervention %K mobile phone %K odds ratio %K paired t test %K quasi experimental %K SEAMS %K Self-Efficacy for Appropriate Medication Use Scale %K smartphone %K sulfonylurea %K T2DM %K Type 2 Diabetes Mellitus %K veteran %D 2023 %7 10.8.2023 %9 Original Paper %J JMIR Diabetes %G English %X Background: Medication nonadherence is a problem that impacts both the patient and the health system. Objective: The objective of this study was to evaluate the impact of a novel smartphone app with patient-response-directed clinical intervention on medication adherence and blood glucose control in noninsulin-dependent patients with type 2 diabetes mellitus (T2DM). Methods: We enrolled 50 participants with T2DM not on insulin with smartphones from a rural health care center in Northern Nevada for participation in this case-crossover study. Participants underwent a standard of care arm and an intervention arm. Each study arm was 3 months long, for a total of 6 months of follow-up. Participants had a hemoglobin A1c (HbA1c) lab draw at enrollment, 3 months, and 6 months. Participants had monthly “medication adherence scores” (MAS) and “Self-Efficacy for Appropriate Medication Use Scale” (SEAMS) questionnaires completed at baseline and monthly for the duration of the study. Our primary outcomes of interest were the changes in HbA1c between study arms. Secondary outcomes included the evaluation of the difference in the proportion of participants achieving a clinically meaningful reduction in HbA1c and the difference in the number of participants requiring diabetes therapy escalation between study arms. Exploratory outcomes included the analysis of the variation in medication possession ratio (MPR), MAS, and SEAMS during each study arm. Results: A total of 30 participants completed both study arms and were included in the analysis. Dropouts were higher in participants enrolled in the standard of care arm first (9/25, 36% vs 4/25, 16%). Participants had a median HbA1c of 9.1%, had been living with T2DM for 6 years, had a median age of 66 years, and had a median of 8.5 medications. HbA1c reduction was 0.69% in the intervention arm versus 0.35% in the standard of care arm (P=.30). A total of 70% (21/30) of participants achieved a clinically meaningful reduction in HbA1c of 0.5% in the app intervention arm versus 40% (12/30) in the standard of care arm (odds ratio 2.29, 95% CI 0.94-5.6; P=.09). Participants had higher odds of a therapy escalation while in the standard of care arm (18/30, 60% vs 5/30, 16.7%, odds ratio 4.3, 95% CI 1.2-15.2; P=.02). The median MPR prior to enrollment was 109%, 112% during the study’s intervention arm, and 102% during the standard of care arm. The median real-time MAS was 93.2%. The change in MAS (1 vs –0.1; P=.02) and SEAMS (1.9 vs –0.2; P<.001) from baseline to month 3 was higher in the intervention arm compared to standard of care. Conclusions: A novel smartphone app with patient-response-directed provider intervention holds promise in the ability to improve blood glucose control in complex non–insulin-dependent T2DM and is worthy of additional study. %M 37561555 %R 10.2196/44297 %U https://diabetes.jmir.org/2023/1/e44297 %U https://doi.org/10.2196/44297 %U http://www.ncbi.nlm.nih.gov/pubmed/37561555 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e47018 %T Testing the Impact of Phone Texting Reminders for Children's Immunization Appointments in Rural Cameroon: Protocol for a Nonrandomized Controlled Trial %A Ngah,Yayah Emerencia %A Raoufi,Ghazal %A Amirkhani,Maral %A Esmaeili,Ashkan %A Nikooifard,Rasa %A Ghaemi Mood,Shidrokh %A Rahmanian,Ava %A Boltena,Minyahil Tadesse %A Aga,Eresso %A Neogi,Ujjwal %A Ikomey Mondinde,George %A El-Khatib,Ziad %+ Department of Global Public Health, Karolinska Institutet, Norrbackagatan 4, Stockholm, 171 76, Sweden, 43 6643461861, ziad.khatib@gmail.com %K immunization %K children %K Cameroon %K digital health %K global health %K nonrandomized controlled trial %K child vaccination %D 2023 %7 9.8.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Globally, over 20 million children are unvaccinated and over 25 million missed their follow-up doses during the COVID-19 pandemic; thus, they face vaccine-preventable diseases and unnecessary deaths. This is especially the case for those with HIV or living in vulnerable settings. Using cell phones to send reminders to parents has been shown to improve vaccination rates. Objective: We aim to determine whether implementation of an automated SMS reminder will improve child vaccination rates in a turbulent, semiurban/semirural setting in a low-income country. Methods: This will be a nonrandomized controlled trial that will be conducted at Azire Integrated Health Centre, Bamenda, Cameroon. Results: A total of 200 parents per study group (aged over 18 years) who are registered at the clinic at least one month prior to the study will be recruited. The intervention group will receive 2 reminders: 1 week and 2 days prior to the scheduled vaccination. For those who miss their appointments, a reminder will be sent 1 week after their missed appointment. The control group will receive the regular care provided at the clinic. Baseline information, clinical visit data, and vaccination records will be collected for both groups. Descriptive statistics will be used to summarize baseline characteristics between and within clusters and groups. The Fisher exact test will be used to compare parent-child units who return for follow-up visits (as a percentage) and children vaccinated as scheduled (as a percentage) between the study groups. Finally, we will compare how many members of both study groups return for 1 follow-up visit using Kaplan-Meier survival analysis. Conclusions: Due to limited effective child vaccination interventions in unstable settings, this study will be of high importance for suggesting a holistic approach to improve child vaccination and public health. International Registered Report Identifier (IRRID): DERR1-10.2196/47018 %M 37556178 %R 10.2196/47018 %U https://www.researchprotocols.org/2023/1/e47018 %U https://doi.org/10.2196/47018 %U http://www.ncbi.nlm.nih.gov/pubmed/37556178 %0 Journal Article %@ 2561-1011 %I JMIR Publications %V 7 %N %P e46533 %T A Web-Based Application for Risk Stratification and Optimization in Patients With Cardiovascular Disease: Pilot Study %A Pandey,Avinash %A D'Souza,Marie Michelle %A Pandey,Amritanshu Shekhar %A Mir,Hassan %+ Department of Medicine, University of Ottawa, 451 Smyth Rd #2044, Ottawa, ON, K1H 8M5, Canada, 1 (613) 562 5409, avinash.pandey@medportal.ca %K atherosclerotic cardiovascular disease %K guideline-directed medical therapy %K mHealth %K mobile health %K risk stratification %K secondary prevention %K web application %D 2023 %7 3.8.2023 %9 Original Paper %J JMIR Cardio %G English %X Background: In addition to aspirin, angiotensin-converting enzyme inhibitors, statins, and lifestyle modification interventions, novel pharmacological agents have been shown to reduce morbidity and mortality in atherosclerotic cardiovascular disease patients, including new antithrombotics, antihyperglycemics, and lipid-modulating therapies. Despite their benefits, the uptake of these guideline-directed therapies remains a challenge. There is a need to develop strategies to support knowledge translation for the uptake of secondary prevention therapies. Objective: The goal of this study was to test the feasibility and usability of Stratification and Optimization in Patients With Cardiovascular Disease (STOP-CVD), a point-of-care application that was designed to facilitate knowledge translation by providing individualized risk stratification and optimization guidance. Methods: Using the REACH (Reduction of Atherothrombosis for Continued Health) Registry trial and predictive modeling (which included 67,888 patients), we designed a free web-based secondary risk calculator. Based on demographic and comorbidity profiles, the application was used to predict an individual’s 20-month risk of cardiovascular events and cardiovascular mortality and provides a comparison to an age-matched control with an optimized cardiovascular risk profile to illustrate the modifiable residual risk. Additionally, the application used the patient’s risk profile to provide specific guidance for possible therapeutic interventions based on a novel algorithm. During an initial 3-month adoption phase, 1-time invitations were sent through email and telephone to 240 physicians that refer to a regional cardiovascular clinic. After 3 months, a survey of user experience was sent to all users. Following this, no further marketing of the application was performed. Google Analytics was collected postimplementation from January 2021 to December 2021. These were used to tabulate the total number of distinct users and the total number of monthly uses of the application. Results: During the 1-year pilot, 47 of the 240 invited clinicians used the application 1573 times, an average of 131 times per month, with sustained usage over time. All 24 postimplementation survey respondents confirmed that the application was functional, easy to use, and useful. Conclusions: This pilot suggests that the STOP-CVD application is feasible and usable, with high clinician satisfaction. This tool can be easily scaled to support the uptake of guideline-directed medical therapy, which could improve clinical outcomes. Future research will be focused on evaluating the impact of this tool on clinician management and patient outcomes. %M 37535400 %R 10.2196/46533 %U https://cardio.jmir.org/2023/1/e46533 %U https://doi.org/10.2196/46533 %U http://www.ncbi.nlm.nih.gov/pubmed/37535400 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e47516 %T Feasibility, Engagement, and Usability of a Remote, Smartphone-Based Contingency Management Program as a Treatment Add-On for Patients Who Use Methamphetamine: Single-Arm Pilot Study %A Hallgren,Kevin A %A Duncan,Mark H %A Iles-Shih,Matthew D %A Cohn,Eliza B %A McCabe,Connor J %A Chang,Yanni M %A Saxon,Andrew J %+ Department of Psychiatry and Behavioral Sciences, University of Washington, Box 356560, 1959 NE Pacific St., Seattle, WA, 98195, United States, 1 206 616 2906, khallgre@uw.edu %K contingency management %K methamphetamine use disorder %K mobile health %K mHealth %K mobile phone %D 2023 %7 6.7.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: In the United States, methamphetamine-related overdoses have tripled from 2015 to 2020 and continue to rise. However, efficacious treatments such as contingency management (CM) are often unavailable in health systems. Objective: We conducted a single-arm pilot study to evaluate the feasibility, engagement, and usability of a fully remotely delivered mobile health CM program offered to adult outpatients who used methamphetamine and were receiving health care within a large university health system. Methods: Participants were referred by primary care or behavioral health clinicians between September 2021 and July 2022. Eligibility criteria screening was conducted by telephone and included self-reported methamphetamine use on ≥5 out of the past 30 days and a goal of reducing or abstaining from methamphetamine use. Eligible participants who agreed to take part then completed an initial welcome phase that included 2 videoconference calls to register for and learn about the CM program and 2 “practice” saliva-based substance tests prompted by a smartphone app. Participants who completed these welcome phase activities could then receive the remotely delivered CM intervention for 12 consecutive weeks. The intervention included approximately 24 randomly scheduled smartphone alerts requesting a video recording of themselves taking a saliva-based substance test to verify recent methamphetamine abstinence, 12 weekly calls with a CM guide, 35 self-paced cognitive behavioral therapy modules, and multiple surveys. Financial incentives were disbursed via reloadable debit cards. An intervention usability questionnaire was completed at the midpoint. Results: Overall, 37 patients completed telephone screenings, with 28 (76%) meeting the eligibility criteria and consenting to participate. Most participants who completed a baseline questionnaire (21/24, 88%) self-reported symptoms consistent with severe methamphetamine use disorder, and most had other co-occurring non-methamphetamine substance use disorders (22/28, 79%) and co-occurring mental health disorders (25/28, 89%) according to existing electronic health records. Overall, 54% (15/28) of participants successfully completed the welcome phase and were able to receive the CM intervention. Among these participants, engagement with substance testing, calls with CM guides, and cognitive behavioral therapy modules varied. Rates of verified methamphetamine abstinence in substance testing were generally low but varied considerably across participants. Participants reported positive opinions about the intervention’s ease of use and satisfaction with the intervention. Conclusions: Fully remote CM can be feasibly delivered within health care settings lacking existing CM programs. Although remote delivery may help reduce barriers to treatment access, many patients who use methamphetamine may struggle to engage with initial onboarding. High rates of co-occurring psychiatric conditions in the patient population may also contribute to uptake and engagement challenges. Future efforts could leverage greater human-to-human connection, more streamlined onboarding procedures, larger incentives, longer durations, and the incentivization of non–abstinence-based recovery goals to increase uptake and engagement with fully remote mobile health–based CM. %M 37410529 %R 10.2196/47516 %U https://formative.jmir.org/2023/1/e47516 %U https://doi.org/10.2196/47516 %U http://www.ncbi.nlm.nih.gov/pubmed/37410529 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 10 %N %P e40173 %T Toward the Design of Sensing-Based Medication Adherence Aids That Support Individualized Activities of Daily Living: Survey and Interviews With Patients and Providers %A Biehl,Jacob T %A Patel,Ravi %A Lee,Adam J %+ School of Computing and Information, University of Pittsburgh, 135 N Bellefield Ave, Pittsburgh, PA, 15260, United States, biehl@pitt.edu %K sensing %K medication adherence %K active intervention %K self-management %K patient care %K medication %K qualitative study %K successful intervention %K patient support %D 2023 %7 4.7.2023 %9 Original Paper %J JMIR Hum Factors %G English %X Background: Nearly half of Americans taking prescription medications do not take them properly. The resulting implications have a broad impact. Nonadhering patients develop worsened medical conditions and increased comorbidity of disease or die. Objective: Clinical studies have shown that the most effective strategies for addressing adherence are those that are individualized to the context that each patient and situation require. However, existing aids for adherence are relatively ridged and poorly support adaptation to individual behaviors and lifestyles. The aim of our study was to better understand this design tension. Methods: A series of 3 qualitative studies was conducted: a web-based survey of 200 Americans that investigated existing adherence strategies and behaviors and perception of how hypothetical in-home tracking technologies would assist adherence; in-person semistructured interviews with 20 medication takers from Pittsburgh, PA, that investigated personal adherence behaviors, which included demonstration of medication locations and routines as well as an assessment of hypothetical technologies; and semistructured interviews with 6 pharmacists and 3 family physicians to gain a provider perspective on patient adherence strategies, which included feedback on hypothetical technologies in the context of their patient populations. Inductive thematic coding of all interview data was performed. Studies were conducted consecutively, with the results informing the subsequent studies. Results: Synthesized, the studies identified key medication adherence behaviors amenable to technological interventions, distilled important home-sensing literacy considerations, and detailed critical privacy considerations. Specifically, 4 key insights were obtained: medication routines are heavily influenced and adapted by and through the physical location and placement of medications relative to activities of daily living, routines are chosen to be inconspicuous to maintain privacy, the value of provider-involved routines is motivated by a desire to build trust in shared decision-making, and the introduction of new technologies can create further burden on patients and providers. Conclusions: There is considerable potential to improve individual medication adherence by creating behavior-focused interventions that leverage emerging artificial intelligence (AI), machine learning (ML), and in-home Internet of Things (IoT) sensing technologies. However, success will be dependent on the technology’s ability to learn effectively and accurately from individual behaviors, needs, and routines and tailor interventions accordingly. Patient routines and attitudes toward adherence will likely affect the use of proactive (eg, AI-assistant routine modification) versus reactive (eg, notification of associated behaviors with missed dosages) intervention strategies. Successful technological interventions must support the detection and tracking of patient routines that can adjust to variations in patient location, schedule, independence, and habituation. %M 37402141 %R 10.2196/40173 %U https://humanfactors.jmir.org/2023/1/e40173 %U https://doi.org/10.2196/40173 %U http://www.ncbi.nlm.nih.gov/pubmed/37402141 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 11 %N %P e45414 %T Usage and Daily Attrition of a Smartphone-Based Health Behavior Intervention: Randomized Controlled Trial %A Egilsson,Erlendur %A Bjarnason,Ragnar %A Njardvik,Urdur %+ Department of Psychology, University of Iceland, Saemundargata 12, Reykjavik, 102, Iceland, 354 5254240, erlendu@hi.is %K mHealth intervention %K mobile health %K adolescent %K attrition %K mental health %K physical activity %D 2023 %7 26.6.2023 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Although most adolescents have access to smartphones, few of them use mobile health (mHealth) apps for health improvement, highlighting the apparent lack of interest in mHealth apps among adolescents. Adolescent mHealth interventions have been burdened with high attrition rates. Research on these interventions among adolescents has frequently lacked detailed time-related attrition data alongside analysis of attrition reasons through usage. Objective: The objective was to obtain daily attrition rates among adolescents in an mHealth intervention to gain a deeper understanding of attrition patterns, including the role of motivational support, such as altruistic rewards, through analysis of app usage data. Methods: A randomized controlled trial was conducted with 304 adolescent participants (152 boys and 152 girls) aged 13-15 years. Based on 3 participating schools, participants were randomly assigned to control, treatment as usual (TAU), and intervention groups. Measures were obtained at baseline, continuously throughout the 42-day trial period (research groups), and at the trial end. The mHealth app is called SidekickHealth and is a social health game with the following 3 main categories: nutrition, mental health, and physical health. Primary measures were attrition based on time from launch, and the type, frequency, and time of health behavior exercise usage. Outcome differences were obtained through comparison tests, while regression models and survival analyses were used for attrition measures. Results: Attrition differed significantly between the intervention and TAU groups (44.4% vs 94.3%; χ21=61.220; P<.001). The mean usage duration was 6.286 days in the TAU group and 24.975 days in the intervention group. In the intervention group, male participants were active significantly longer than female participants (29.155 vs 20.433 days; χ21=6.574; P<.001). Participants in the intervention group completed a larger number of health exercises in all trial weeks, and a significant decrease in usage was observed from the first to second week in the TAU group (t105=9.208; P<.001) but not in the intervention group. There was a significant increase in health exercises in the intervention group from the fifth to sixth week (t105=3.446; P<.001). Such a significant increase in usage was not evident in the TAU group. The research group was significantly related to attrition time (hazard ratio 0.308, 95% CI 0.222-0.420), as well as the numbers of mental health exercises (P<.001) and nutrition exercises (P<.001). Conclusions: Differences in attrition rates and usage between groups of adolescents were identified. Motivational support is a significant factor for lowering attrition in adolescent mHealth interventions. The results point to sensitivity periods in the completion of diverse health tasks, and emphasis on time-specific attrition, along with the type, frequency, and time of health behavior exercise usage, is likely a fruitful avenue for further research on mHealth interventions for adolescent populations, in which attrition rates remain excessive. Trial Registration: ClinicalTrials.gov NCT05912439; https://clinicaltrials.gov/study/NCT05912439 %M 37358888 %R 10.2196/45414 %U https://mhealth.jmir.org/2023/1/e45414 %U https://doi.org/10.2196/45414 %U http://www.ncbi.nlm.nih.gov/pubmed/37358888 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e45254 %T Mobile Assessments of Mood, Cognition, Smartphone-Based Sensor Activity, and Variability in Craving and Substance Use in Patients With Substance Use Disorders in Norway: Prospective Observational Feasibility Study %A Lauvsnes,Anders Dahlen Forsmo %A Hansen,Tor Ivar %A Ankill,Sebastian Øiungen %A Bae,Sang Won %A Gråwe,Rolf W %A Braund,Taylor A %A Larsen,Mark %A Langaas,Mette %+ Department of Mental Health, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology, PO Box 8905, Trondheim, 7491, Norway, 47 99592222, anders.d.f.lauvsnes@ntnu.no %K executive functioning %K substance use disorder %K ecological momentary assessment %K clinical inference %K substance use %K pilot study %K mood %K mental health %K neurocognitive functioning %K smartphone use %K mobile sensor %K sensor %K decision support %K mobile phone %D 2023 %7 23.6.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Patients with substance use disorders (SUDs) are at increased risk for symptom deterioration following treatment, with up to 60% resuming substance use within the first year posttreatment. Substance use craving together with cognitive and mental health variables play important roles in the understanding of the trajectories from abstinence to substance use. Objective: This prospective observational feasibility study aims to improve our understanding of specific profiles of variables explaining SUD symptom deterioration, in particular, how individual variability in mental health, cognitive functioning, and smartphone use is associated with craving and substance use in a young adult clinical population. Methods: In this pilot study, 26 patients with SUDs were included at about 2 weeks prior to discharge from inpatient SUD treatment from 3 different treatment facilities in Norway. Patients underwent baseline neuropsychological and mental health assessments; they were equipped with smartwatches and they downloaded an app for mobile sensor data collection in their smartphones. Every 2 days for up to 8 weeks, the patients were administered mobile ecological momentary assessments (EMAs) to evaluate substance use, craving, mental health, cognition, and a mobile Go/NoGo performance task. Repeated EMAs as well as the smartphone’s battery use data were averaged across all days per individual and used as candidate input variables together with the baseline measures in models of craving intensity and the occurrence of any substance use episodes. Results: A total of 455 momentary assessments were completed out of a potential maximum of 728 assessments. Using EMA and baseline data as candidate input variables and craving and substance use as responses, model selection identified mean craving intensity as the most important predictor of having one or more substance use episodes and with variabilities in self-reported impulsivity, mental health, and battery use as significant explanatory variables of craving intensity. Conclusions: This prospective observational feasibility study adds novelty by collecting high-intensity data for a considerable period of time, including mental health data, mobile cognitive assessments, and mobile sensor data. Our study also contributes to our knowledge about a clinical population with the most severe SUD presentations in a vulnerable period during and after discharge from inpatient treatment. We confirmed the importance of variability in cognitive function and mood in explaining variability in craving and that smartphone usage may possibly add to this understanding. Further, we found that craving intensity is an important explanatory variable in understanding substance use episodes. %M 37351934 %R 10.2196/45254 %U https://formative.jmir.org/2023/1/e45254 %U https://doi.org/10.2196/45254 %U http://www.ncbi.nlm.nih.gov/pubmed/37351934 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e43527 %T A Mobile Medication Support App and Its Impact on People Living With HIV: 12-Week User Experience and Medication Compliance Pilot Study %A Suzuki,Mai %A Yamanaka,Kou %A Fukushima,Shinichi %A Ogawa,Mayu %A Nagaiwa,Yuki %A Naito,Toshio %+ Department of General Medicine, Juntendo University Faculty of Medicine, 3-1-3 Hongo Bunkyo-ku, Tokyo, 113-0033, Japan, 81 3 3813 3111, naito@juntendo.ac.jp %K human immunodeficiency virus %K HIV %K acquired immunodeficiency syndrome %K mobile health %K mHealth %K medication compliance %K satisfaction survey %D 2023 %7 22.6.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: The continuity of care between hospital visits conducted through mobile apps creates new opportunities for people living with HIV in situations where face-to-face interventions are difficult. Objective: This study investigated the user experience of a mobile medication support app and its impact on improving antiretroviral therapy compliance and facilitating teleconsultations between people living with HIV and medical staff. Methods: Two clinics in Japan were invited to participate in a 12-week trial of the medication support app between July 27, 2018, and March 31, 2021. Medication compliance was assessed based on responses to scheduled medication reminders; users, including people living with HIV and medical staff, were asked to complete an in-app satisfaction survey to rate their level of satisfaction with the app and its specific features on a 5-point Likert scale. Results: A total of 10 people living with HIV and 11 medical staff were included in this study. During the trial, the medication compliance rate was 90%, and the mean response rates to symptom and medication alerts were 73% and 76%, respectively. Overall, people living with HIV and medical staff were satisfied with the medication support app (agreement rate: mean 81% and 65%, respectively). Over 80% of medical staff and people living with HIV were satisfied with the ability to record medications taken (9/11 and 8/10 medical staff and people living with HIV, respectively), record symptoms of concern (10/11 and 8/10),and inquire about drug combinations (8/10, 10/10). And further, 90% of people living with HIV were satisfied with the function for communication with medical staff (9/10). Conclusions: Our preliminary results demonstrate the feasibility of the medication support app in improving medication compliance and enhancing communication between people living with HIV and medical staff. %M 37021843 %R 10.2196/43527 %U https://formative.jmir.org/2023/1/e43527 %U https://doi.org/10.2196/43527 %U http://www.ncbi.nlm.nih.gov/pubmed/37021843 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e47575 %T Supporting Adolescents With HIV in South Africa Through an Adherence-Supporting App: Mixed Methods Beta-Testing Study %A Mulawa,Marta I %A Mtukushe,Bulelwa %A Knippler,Elizabeth T %A Matiwane,Mluleki %A Al-Mujtaba,Maryam %A Muessig,Kathryn E %A Hoare,Jacqueline %A Hightow-Weidman,Lisa B %+ School of Nursing, Duke University, DUMC 3322, Durham, NC, 27710, United States, 1 919 684 9555, marta.mulawa@duke.edu %K adolescents %K HIV %K adherence %K mHealth %K mobile health %K technology %K smartphone app %K health app %K beta testing %K implementation %K digital health intervention %K usability %K HIV treatment %D 2023 %7 1.6.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Novel smartphone app–delivered interventions have the potential to improve HIV treatment adherence among adolescents with HIV, although such interventions are limited. Our team has developed Masakhane Siphucule Impilo Yethu (MASI; Xhosa for “Let's empower each other and improve our health”), a smartphone app–delivered intervention to improve treatment adherence among adolescents with HIV in South Africa. MASI was adapted to the South African cultural context using the HealthMpowerment platform, an evidence-based digital health intervention developed for and with youth in the United States. Objective: We conducted this beta-testing study to (1) explore the initial usability of MASI, (2) examine engagement and experiences using MASI features, and (3) inform refinements to the app and intervention implementation plan prior to a subsequent pilot randomized controlled trial (RCT). Methods: This study was conducted from August 2021 to December 2021 in Cape Town, South Africa. Beta-testing participants received access to MASI for 3 weeks. A mixed methods approach was used, with brief questionnaires and semistructured in-depth interviews conducted prior to app installation and after 1 week to 2 weeks of app testing. Engagement with MASI was measured through analysis of back-end app paradata, and follow-up in-depth interview guides were tailored to each participant based on their app use. Results: Participants in the beta-testing study (6 male participants, 6 female participants; ages 16-19 years) collectively spent 4.3 hours in MASI, averaging 21.4 minutes per participant over the 3-week period (range 1-51.8 minutes). Participants logged into MASI an average of 24.1 (range 10-75) times during the study period. The mean System Usability Scale score was 69.5 (SD 18), which is considered slightly above average for digital health apps. Thematic analysis of qualitative results revealed generally positive experiences across MASI features, although opportunities to refine the app and intervention delivery were identified. Conclusions: Initial usability of MASI was high, and participants described having a generally positive experience across MASI features. Systematically analyzing paradata and using the interview findings to explore participant experiences allowed us to gain richer insights into patterns of participant engagement, enabling our team to further enhance MASI. The results from this study led to a few technological refinements to improve the user experience. Enhancements were also made to the intervention implementation plan in preparation for a pilot RCT. Lessons learned from the conduct of this beta-testing study may inform the development, implementation, and evaluation of similar app-delivered interventions in the future. %M 37261883 %R 10.2196/47575 %U https://formative.jmir.org/2023/1/e47575 %U https://doi.org/10.2196/47575 %U http://www.ncbi.nlm.nih.gov/pubmed/37261883 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e42978 %T Long-Term Impact of a Smartphone App on Prescriber Adherence to Antibiotic Guidelines for Adult Patients With Community-Acquired Pneumonia: Interrupted Time-Series Study %A Yoon,Chang Ho %A Nolan,Imogen %A Humphrey,Gayl %A Duffy,Eamon J %A Thomas,Mark G %A Ritchie,Stephen R %+ Big Data Institute, Old Campus Road, Oxford, OX3 7LF, United Kingdom, 44 7925818791, changho.yoon@sjc.ox.ac.uk %K app %K antimicrobial stewardship %K antibiotic adherence %K community %K pneumonia %K smartphone %K mobile health %K mHealth %K antibiotic %K behavior %K adults %K diagnosis %K pulmonary %K patient %D 2023 %7 2.5.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: Mobile health platforms like smartphone apps that provide clinical guidelines are ubiquitous, yet their long-term impact on guideline adherence remains unclear. In 2016, an antibiotic guidelines app, called SCRIPT, was introduced in Auckland City Hospital, New Zealand, to provide local antibiotic guidelines to clinicians on their smartphones. Objective: We aimed to assess whether the provision of antibiotic guidelines in a smartphone app resulted in sustained changes in antibiotic guideline adherence by prescribers. Methods: We analyzed antibiotic guideline adherence rates during the first 24 hours of hospital admission in adults diagnosed with community-acquired pneumonia using an interrupted time-series study with 3 distinct periods post app implementation (ie, 3, 12, and 24 months). Results: Adherence increased from 23% (46/200) at baseline to 31% (73/237) at 3 months and 34% (69/200) at 12 months, reducing to 31% (62/200) at 24 months post app implementation (P=.07 vs baseline). However, increased adherence was sustained in patients with pulmonary consolidation on x-ray (9/63, 14% at baseline; 23/77, 30% after 3 months; 32/92, 35% after 12 month; and 32/102, 31% after 24 months; P=.04 vs baseline). Conclusions: An antibiotic guidelines app increased overall adherence, but this was not sustained. In patients with pulmonary consolidation, the increased adherence was sustained. %M 37129941 %R 10.2196/42978 %U https://www.jmir.org/2023/1/e42978 %U https://doi.org/10.2196/42978 %U http://www.ncbi.nlm.nih.gov/pubmed/37129941 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e45856 %T mHealth to Improve Experience, Adherence to Pharmacological Treatment, and Positive Mental Health in Patients Diagnosed With Femur Fractures: Protocol for a Quasi-Experimental Study %A Marcos Anton,Gemma %A Puig Llobet,Montserrat %A Lluch Canut,Teresa %A Sanchez Ortega,Maria Aurelia %A Piazuelo Pont,Mercè %A Moreno-Arroyo,MªCarmen %+ Department of Public Health Nursing, University of Barcelona, Feixa Llarga s/n, L'Hospitalet de Llobregat (Barcelona), 08907, Spain, 34 934024237, monpuigllob@ub.edu %K education %K patient experience %K medication adherence %K mental health %K nurse %K mHealth %K mobile health %K protocol %K prognosis %K pharmacological treatment %K femur fracture %K femur %K diagnosis %K quality of care %K care %K psychological %K efficacy %K training %K pathology %D 2023 %7 28.4.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Considering the prognosis of femur fractures worldwide, the ageing of our society, and the problems in adherence to treatment found in these patients, it is believed that mobile health can have a positive impact on the process and quality of care. Objective: We aim to evaluate the effectiveness of a pharmacological educational nurse intervention with Myplan app with regard to knowledge, adherence to pharmacological treatment, and positive mental health of patients with femur fractures. Methods: A nonrandomized, quasi-experimental study will be carried out with a pretest-posttest control group. It will include 278 older patients diagnosed with femur fractures, with a Glasgow Coma Scale of 15 and access to mobile devices. Patients with psychological pathologies and cognitive impairment or patients treated in isolation will be excluded. Study variables are as follows: sociodemographic variables (AdHoc Form), patient experience (Patient Experience Questionnaire-15), adherence to pharmacological treatment (Morisky-Green questionnaire), and positive mental health (Positive Mental Health questionnaire). The measurements will be taken 24 hours after admission, upon discharge, and 25 days after discharge. Results: Enrollment commenced in October 2022. Data collection will be completed in April 2023. Conclusions: The results of this study will offer evidence of the effectiveness of a pharmacological educational nurse intervention by means of a free smartphone app. If its efficacy is demonstrated and the results are acceptable, it could mean an improvement in the care of patients with femur fractures, and this technology could be used to guide other training interventions in patients with other pathologies. Trial Registration: ClinicalTrials.gov NCTT05669040; https://clinicaltrials.gov/ct2/show/NCTT05669040 International Registered Report Identifier (IRRID): DERR1-10.2196/45856 %M 37115614 %R 10.2196/45856 %U https://www.researchprotocols.org/2023/1/e45856 %U https://doi.org/10.2196/45856 %U http://www.ncbi.nlm.nih.gov/pubmed/37115614 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e39930 %T Combining Behavioral Economics–Based Incentives With the Anchoring Strategy: Protocol for a Randomized Controlled Trial %A Stecher,Chad %A Cloonan,Sara %A Linnemayr,Sebastian %A Huberty,Jennifer %+ Arizona State University, 500 N 3rd Street, Phoenix, AZ, 85004, United States, 1 602 496 0957, chad.stecher@asu.edu %K habits %K mindfulness meditation %K mobile apps %K mobile health %K mHealth %K adherence %K meditation %K mindfulness %K intervention %K apps %K smartphone apps %K stress %K management %K mobile phone %D 2023 %7 28.4.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Chronic (ie, long-term) elevated stress is associated with a number of mental and physical health conditions. Mindfulness meditation mobile apps are a promising tool for stress self-management that can overcome several barriers associated with in-person interventions; however, to date, poor app-based intervention adherence has limited the efficacy of these mobile health tools. Anchoring, or pairing, a new behavior with an existing routine has been shown to effectively establish habits that are maintained over time, but this strategy typically only works for those with high initial motivation and has yet to be tested for maintaining meditation with a mobile app. Objective: This study will test novel combinations of behavioral economics–based incentives with the anchoring strategy for establishing and maintaining adherence to an effective dose of meditation with a mobile app. Methods: This 16-week study will use a 5-arm, parallel, partially blinded (participants only), randomized controlled design. We will implement a fractional factorial study design that varies the use of self-monitoring messages and financial incentives to support participants’ use of their personalized anchoring strategy for maintaining adherence to a ≥10 minute-per-day meditation prescription during an 8-week intervention period, followed by an 8-week postintervention observation period. Specifically, we will vary the use of self-monitoring messages of either the target behavior (ie, meditation tracking) or the outcome associated with the target behavior (ie, mood symptom tracking). We will also vary the use of financial incentives conditional on either meditation at any time of day or meditation performed at approximately the same time of day as participants’ personalized anchors. Results: Continuous meditation app use data will be used to measure weekly meditation adherence over the 16-week study period as a binary variable equal to 1 if participants complete ≥10 minutes of meditation for ≥4 days per week and 0 otherwise. We will measure weekly anchoring plan adherence as a binary variable equal to 1 if participants complete ≥10 minutes of meditation within +1 or −1 hour of the timing of their chosen anchor on ≥4 days per week and 0 otherwise. In addition to these primary measures of meditation and anchoring plan adherence, we will also assess the secondary measures of stress, anxiety, posttraumatic stress disorder, sleep disturbance, and meditation app habit strength at baseline, week 8, and week 16. Conclusions: This study will fill an important gap in the mobile health literature by testing novel intervention approaches for establishing and maintaining adherence to app-based mindfulness meditation. If successful, this study will identify an accessible and scalable stress self-management intervention that can help combat stress in the United States. Trial Registration: ClinicalTrials.gov NCT05217602; https://clinicaltrials.gov/ct2/show/NCT05217602 International Registered Report Identifier (IRRID): DERR1-10.2196/39930 %M 37115610 %R 10.2196/39930 %U https://www.researchprotocols.org/2023/1/e39930 %U https://doi.org/10.2196/39930 %U http://www.ncbi.nlm.nih.gov/pubmed/37115610 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e40437 %T Patient Feedback on a Mobile Medication Adherence App for Buprenorphine and Naloxone: Closed and Open-Ended Survey on Feasibility and Acceptability %A Smith,Crystal L %A Keever,Abigail %A Bowden,Theresa %A Olson,Katie %A Rodin,Nicole %A McDonell,Michael G %A Roll,John M %A Smoody,Gillian %A LeBrun,Jeff %A Miguel,Andre QC %A McPherson,Sterling M %+ Department of Community and Behavioral Health, Elson S Floyd College of Medicine, Washington State University, 412 E Spokane Falls Blvd, Spokane, WA, 99202-2131, United States, 1 509 368 6876, crystal.lederhos@wsu.edu %K opioids %K mobile technology %K medication adherence %K buprenorphine %K naloxone %K opioid use disorder %K opioid agonist therapy %K medication-assisted treatment %K medications for opioid use disorder %K opioid %K opioid use %K well-being %K quality of life %K clinic %K technology %K medication %K remote %K coaching %K tracking %K stress %K incentive %K tool %K mobile phone %D 2023 %7 19.4.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Opioid use disorders impact the health and well-being of millions of Americans. Buprenorphine and naloxone (BUP and NAL) can reduce opioid overdose deaths, decrease misuse, and improve quality of life. Unfortunately, poor medication adherence is a primary barrier to the long-term efficacy of BUP and NAL. Objective: We aimed to examine patient feedback on current and potential features of a Bluetooth-enabled pill bottle cap and associated mobile app for patients prescribed BUP and NAL for an opioid use disorder, and to solicit recommendations for improvement to effectively and appropriately tailor the technology for people in treatment for opioid use disorder. Methods: A convenience sample of patients at an opioid use disorder outpatient clinic were asked about medication adherence, opioid cravings, experience with technology, motivation for treatment, and their existent support system through a brief e-survey. Patients also provided detailed feedback on current features and features being considered for inclusion in a technology designed to increase medication adherence (eg, inclusion of a personal motivational factor, craving and stress tracking, incentives, and web-based coaching). Participants were asked to provide suggestions for improvement and considerations specifically applicable to people in treatment for opioid use disorder with BUP and NAL. Results: Twenty people with an opioid use disorder who were prescribed BUP and NAL participated (mean age 34, SD 8.67 years; 65% female; 80% White). Participants selected the most useful, second-most useful, and least useful features presented; 42.1% of them indicated that motivational reminders would be most useful, followed by craving and stress tracking (26.3%) and web-based support forums (21.1%). Every participant indicated that they had at least 1 strong motivating factor for staying in treatment, and half (n=10) indicated children as that factor. All participants indicated that they had, at some point in their lives, the most extreme craving a person could have; however, 42.1% indicated that they had no cravings in the last month. Most respondents (73.7%) stated that tracking cravings would be helpful. Most respondents (84.2%) also indicated that they believed reinforcers or prizes would help them achieve their treatment goals. Additionally, 94.7% of respondents approved of adherence tracking to accommodate this feature using smart packaging, and 78.9% of them approved of selfie videos of them taking their medication. Conclusions: Engaging patients taking treatment for opioid use disorder with BUP and NAL allowed us to identify preferences and considerations that are unique to this treatment area. As the technology developer of the pill cap and associated mobile app is able to take into consideration or integrate these preferences and suggestions, the smart cap and associated mobile app will become tailored to this population and more useful for them, which may encourage patient use of the smart cap and associated mobile app. %M 37074780 %R 10.2196/40437 %U https://formative.jmir.org/2023/1/e40437 %U https://doi.org/10.2196/40437 %U http://www.ncbi.nlm.nih.gov/pubmed/37074780 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e45301 %T Digital Adherence Technologies and Mobile Money Incentives for Management of Tuberculosis Medication Among People Living With Tuberculosis: Mixed Methods Formative Study %A Musiimenta,Angella %A Tumuhimbise,Wilson %A Atukunda,Esther %A Mugaba,Aaron %A Linnemayr,Sebastian %A Haberer,Jessica %+ Faculty of Computing and Informatics, Mbarara University of Science and Technology, P.O. Box 1410, Mbarara, Uganda, 256 776820598, amusiimenta@must.ac.ug %K digital adherence technologies %K real-time monitoring %K SMS reminders %K mobile money %K financial incentives %K tuberculosis %K medication adherence %K user-centered approach %K mobile wallet %K support medication %K mobile phone %D 2023 %7 12.4.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Although there is an increasing use of digital adherence technologies (DATs), such as real-time monitors and SMS reminders in tuberculosis medication adherence, suboptimal patient engagement with various DATs has been reported. Additionally, financial constraints can limit DAT’s utility. The perceived usefulness and the design mechanisms of DATs linked to mobile money financial incentives for tuberculosis medication management remain unclear. Objective: The aim of this study is to describe the perceived usefulness and design mechanisms for a DAT intervention called My Mobile Wallet, which is composed of real-time adherence monitors, SMS reminders, and mobile money incentives to support tuberculosis medication adherence in a low-income setting. Methods: This study used mixed methods approaches among persons with tuberculosis recruited from the Tuberculosis Clinic in the Mbarara Regional Referral Hospital. We purposively sampled 21 persons with tuberculosis aged 18 years and older, who owned cell phones and were able to use SMS text messaging interventions. We also enrolled 9 participants who used DATs in our previous study. We used focus group discussions with the 30 participants to solicit perceptions about the initial version of the My Mobile Wallet intervention, and then iteratively refined subsequent versions of the intervention following a user-centered design approach until the beta version of the intervention that suited their needs was developed. Surveys eliciting information about participants’ cell phone use and perceptions of the intervention were also administered. Content analysis was used to inductively analyze qualitative data to derive categories describing the perceived usefulness of the intervention, concerns, and design mechanisms. Stata (version 13; StataCorp) was used to analyze survey data. Results: Participants expressed the perceived usefulness of the My Mobile Wallet intervention in terms of being reminded to take medication, supported with transport to the clinic, and money to meet other tuberculosis medication–related costs, all of which were perceived to imply care, which could create a sense of connectedness to health care workers. This could consequently cause participants to develop a self-perceived need to prove their commitment to adherence to health care workers who care for them, thereby motivating medication adherence. For fear of unintended tuberculosis status disclosure, 20 (67%) participants suggested using SMS language that is confidential—not easily related to tuberculosis. To reduce the possibilities of using the money for other competing demands, 25 (83%) participants preferred sending the money 1-2 days before the appointment to limit the time lag between receiving the money and visiting the clinic. Conclusions: DATs complemented with mobile money financial incentives could potentially provide acceptable approaches to remind, support, and motivate patients to adhere to taking their tuberculosis medication. Trial Registration: ClinicalTrials.gov NCT05656287; https://clinicaltrials.gov/ct2/show/NCT05656287 %M 37043263 %R 10.2196/45301 %U https://formative.jmir.org/2023/1/e45301 %U https://doi.org/10.2196/45301 %U http://www.ncbi.nlm.nih.gov/pubmed/37043263 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e35112 %T Developing a Digital Medication Adherence Intervention for and With Patients With Asthma and Low Health Literacy: Protocol for a Participatory Design Approach %A Faber,Jasper S %A Poot,Charlotte C %A Dekkers,Tessa %A Romero Herrera,Natalia %A Chavannes,Niels H %A Meijer,Eline %A Visch,V T %+ Department of Human-Centered Design, Faculty of Industrial Design Engineering, Delft University of Technology, Landbergstraat 15, Delft, 2628 CE, Netherlands, 31 640850881, j.s.faber@tudelft.nl %K participatory design %K low health literacy %K eHealth %K medication adherence %K asthma %K mHealth %K health literacy %K participatory medicine %K health care %K medication %D 2023 %7 12.4.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Current eHealth interventions are poorly adopted by people with low health literacy (LHL) as they often fail to meet their needs, skills, and preferences. A major reason for this poor adoption is the generic, one-size-fits-all approach taken by designers of these interventions, without addressing the needs, skills, and preferences of disadvantaged groups. Participatory design approaches are effective for developing interventions that fit the needs of specific target groups; yet, very little is known about the practical implications of executing a participatory design project for and with people with LHL. Objective: This study aimed to demonstrate the application of participatory design activities specifically selected to fit the needs and skills of people with LHL and how these were manifested within an overarching eHealth design process. In addition, the study aims to present reflections and implications of these activities that could support future designers to engage people with LHL in their design processes. Methods: We used the design process of a smart asthma inhaler for people with asthma and LHL to demonstrate participatory design activities. The study was framed under 5 stages of design thinking: empathize, define, ideate, prototype, and test within 2 major iteration cycles. We integrated 3 participatory design activities deemed specifically appropriate for people with LHL: co-constructing stories, experience prototype exhibition, and video prototype evaluation. Results: Co-constructing stories was found to deepen the understanding of the participant’s motivation to use or not to use maintenance medication. This understanding informed and facilitated the subsequent development of diverse preliminary prototypes of possible interventions. Discussing these prototypes in the experience prototype exhibition helped provoke reactions, thoughts, and feelings about the interventions, and potential scenarios of use. Through the video prototype evaluation, we were able to clearly communicate the goal and functionality of the final version of our intervention and gather appropriate responses from our participants. Conclusions: This study demonstrates a participatory design approach for and with patients with asthma and LHL. We demonstrated that careful consideration and selection of activities can result in participants that are engaged and feel understood. This paper provides insight into the practical implications of participatory activities with people with LHL and supports and inspires future designers to engage with this disadvantaged target group. %M 37043260 %R 10.2196/35112 %U https://formative.jmir.org/2023/1/e35112 %U https://doi.org/10.2196/35112 %U http://www.ncbi.nlm.nih.gov/pubmed/37043260 %0 Journal Article %@ 2369-2529 %I JMIR Publications %V 10 %N %P e43507 %T The Effect of a Mobile Health App on Treatment Adherence and Revenue at Physical Health Clinics: Retrospective Record Review %A Topp,Robert %A Greenstein,Jay %A Etnoyer-Slaski,Jena %+ College of Nursing, The University of Toledo, 3000 Arlington Ave, Toledo, OH, 43614, United States, 1 419 530 4847, robert.topp@utoledo.edu %K physical health %K completion of therapy %K phone app %K clinic charges and payments %K payment %K cost %K physiotherapy %K physical therapy %K adherence %K attrition %K mobile phone %K reminder %K mobile health %K mHealth %K health app %K mobile app %D 2023 %7 28.3.2023 %9 Original Paper %J JMIR Rehabil Assist Technol %G English %X Background: A significant number of patients do not adhere to their prescribed course of physical therapy or discharge themselves from care. Adhering to prescribed physical therapy, including attending physical therapy clinic appointments, contributes to patients achieving the goals of therapy including reducing pain and increasing functionality. Web-based platforms have been demonstrated to be effective means for managing clinical patients with musculoskeletal pain, similar to managing them in person. Behavior change techniques introduced through digital or web-based platforms can reduce nonadherence with prescribed physical therapy and improve patient outcomes. Literature also indicates that a phone-based app provided to patients, which includes a reward-incentive gamification to complement their care, contributed to a greater number of kept appointments in a physical therapy clinic. Objective: This study aims to compare the rate of provider discharge with self-discharge and the number of clinic visits among patients attending a physical health clinic who did and did not choose to adopt a phone-based app to complement their care. A secondary purpose was to compare the revenue generated by patients attending a physical health clinic who did and did not choose to adopt a phone-based app to complement their care. Methods: A retrospective analysis of all new outpatient medical records (N=5328) from a multisite physical health practice was conducted between January 2018 and December 2019. Patients in the sample self-selected the 2018 Usual Care, the 2019 Usual Care, or the 2019 Kanvas App groups. Kanvas is a customized private practice app, designed for patient engagement with their specific health care provider. This app included a gamification system that provided rewards to the patient for attending their scheduled clinic appointments. According to their medical record, each patient was classified as completing their prescribed therapy (provider discharged) or not completing their prescribed therapy (self-discharged). Additionally, the total number of clinic visits each patient attended, the total charges for services, and the total payments received by the clinic per patient were extracted from each patient’s medical record. Results: Patients in the 2019 Kanvas App Group exhibited a higher rate of provider discharge compared to patients who did not adopt the app. This greater rate of provider discharges among the patients who adopted the Kanvas app likely contributed to this group attending more clinic visits (13.21, SD 12.09) than the other study groups who did not download the app (10.72, SD 9.80 to 11.35, SD 11.10). This greater number of clinic visits in turn contributed to the patients who adopted the app generating more clinic charges and payments. Conclusions: Future investigators need to employ more rigorous methods to confirm these findings, and clinicians need to weigh the anticipated benefits against the cost and staff involvement in managing the Kanvas app. %M 36889337 %R 10.2196/43507 %U https://rehab.jmir.org/2023/1/e43507 %U https://doi.org/10.2196/43507 %U http://www.ncbi.nlm.nih.gov/pubmed/36889337 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e40595 %T Electronic Health Record–Nested Reminders for Serum Lithium Level Monitoring in Patients With Mood Disorder: Randomized Controlled Trial %A Seki,Tomotsugu %A Aki,Morio %A Furukawa,Toshi A %A Kawashima,Hirotsugu %A Miki,Tomotaka %A Sawaki,Yujin %A Ando,Takaaki %A Katsuragi,Kentaro %A Kawashima,Takahiko %A Ueno,Senkei %A Miyagi,Takashi %A Noma,Shun'ichi %A Tanaka,Shiro %A Kawakami,Koji %+ Department of Health Promotion and Human Behavior, School of Public Health, Graduate School of Medicine, Kyoto University, Yoshida Konoe-cho, Sakyo-ku, Kyoto, 606-8501, Japan, 81 75 753 9491, furukawa@kuhp.kyoto-u.ac.jp %K electronic health record %K lithium %K mood disorders %K randomized controlled trial %K quality of health care %D 2023 %7 22.3.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: Clinical guidelines recommend regular serum lithium monitoring every 3 to 6 months. However, in the real world, only a minority of patients receive adequate monitoring. Objective: This study aims to examine whether the use of the electronic health record (EHR)–nested reminder system for serum lithium monitoring can help achieve serum lithium concentrations within the therapeutic range for patients on lithium maintenance therapy. Methods: We conducted an unblinded, single-center, EHR-nested, parallel-group, superiority randomized controlled trial comparing EHR-nested reminders with usual care in adult patients receiving lithium maintenance therapy for mood disorders. The primary outcome was the achievement of therapeutically appropriate serum lithium levels between 0.4 and 1.0 mEq/L at 18 months after enrollment. The key secondary outcomes are included as follows: the number of serum lithium level monitoring except for the first and final monitoring; exacerbation of the mood disorder during the study period, defined by hospitalization, increase in lithium dose, addition of antipsychotic drugs or mood stabilizers, or addition or increase of antidepressants; adherence defined by the proportion of days covered by lithium carbonate prescription during the study period. Results: A total of 111 patients were enrolled in this study. A total of 56 patients were assigned to the reminder group, and 55 patients were assigned to the usual care group. At the follow-up, 38 (69.1%) patients in the reminder group and 33 (60.0%) patients in the usual care group achieved the primary outcome (odds ratio 2.14, 95% CI 0.82-5.58, P=.12). The median number of serum lithium monitoring was 2 in the reminder group and 0 in the usual care group (rate ratio 3.62; 95% CI 2.47-5.29, P<.001). The exacerbation of mood disorders occurred in 17 (31.5%) patients in the reminder group and in 16 (34.8%) patients in the usual care group (odds ratio 0.97, 95% CI 0.42-2.28, P=.95). Conclusions: We found insufficient evidence for an EHR-nested reminder to increase the achievement of therapeutic serum lithium concentrations. However, the number of monitoring increased with relatively simple and inexpensive intervention. The EHR-based reminders may be useful to improve quality of care for patients on lithium maintenance therapy, and they have potentials to be applied to other problems. Trial Registration: University Hospital Medical Information Network Clinical Trials Registry UMIN000033633; https://tinyurl.com/5n7wtyav %M 36947138 %R 10.2196/40595 %U https://www.jmir.org/2023/1/e40595 %U https://doi.org/10.2196/40595 %U http://www.ncbi.nlm.nih.gov/pubmed/36947138 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e35045 %T Comparison of a Daily Smartphone App and Retrospective Questionnaire Measures of Adherence to Nicotine Replacement Therapy Among Pregnant Women: Observational Study %A Emery,Joanne %A Huang,Yue %A Naughton,Felix %A Cooper,Sue %A McDaid,Lisa %A Dickinson,Anne %A Clark,Miranda %A Kinahan-Goodwin,Darren %A Thomson,Ross %A Phillips,Lucy %A Lewis,Sarah %A Coleman,Tim %+ School of Health Sciences, University of East Anglia, Norwich Research Park, Norwich, NR4 7TJ, United Kingdom, 44 1603 456161, joanne.emery@uea.ac.uk %K smoking cessation %K pregnancy %K nicotine replacement therapy %K treatment adherence measurement %K smartphone app %K questionnaires %K ecological momentary assessment %K mHealth %K mobile health %K smoking %K nicotine %D 2023 %7 7.3.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Few studies have investigated how to best measure adherence to smoking cessation medications, but continuous usage measures are recommended. Objective: In this first study of its kind, we compared methods for measuring adherence to nicotine replacement therapy (NRT) among pregnant women, investigating the completeness and validity of data collected from daily assessments using a smartphone app versus data collected from retrospective questionnaires. Methods: Women aged ≥16 years who were daily smokers and <25 weeks pregnant were offered smoking-cessation counseling and encouraged to use NRT. For 28 days after setting a quit date (QD), women were asked to report NRT use daily to a smartphone app and to questionnaires administered in person or remotely at 7 and 28 days. For both data collection methods, we provided up to £25 (~US $30) as compensation for the time taken providing research data. Data completeness and NRT use reported to the app and in questionnaires were compared. For each method, we also correlated mean daily nicotine doses reported within 7 days of the QD with Day 7 saliva cotinine concentrations. Results: Of the 438 women assessed for eligibility, 40 participated and 35 accepted NRT. More participants (31/35) submitted NRT usage data to the app by Day 28 (median 25, IQR 11 days) than completed the Day 28 questionnaire (24/35) or either of the two questionnaires (27/35). Data submitted to the app showed a lower reported duration of NRT use compared to that indicated in the questionnaire (median for app 24 days, IQR 10.25; median for questionnaire 28 days, IQR 4.75; P=.007), and there appeared to be specific cases of overreporting to the questionnaire. Mean daily nicotine doses between the QD and Day 7 were lower when calculated using app data (median for app 40 mg, IQR 52.1; median for questionnaire 40 mg, IQR 63.1; P=.001), and some large outliers were evident for the questionnaire. Mean daily nicotine doses, adjusted for cigarettes smoked, were not associated with cotinine concentrations for either method (app rs=0.184, P=.55; questionnaire rs=0.031, P=.92), but the small sample size meant that the analysis was likely underpowered. Conclusions: Daily assessment of NRT use via a smartphone app facilitated more complete data (a higher response rate) than questionnaires, and reporting rates over 28 days were encouraging among pregnant women. App data had better face validity; retrospective questionnaires appeared to overestimate NRT use for some participants. %M 36881452 %R 10.2196/35045 %U https://formative.jmir.org/2023/1/e35045 %U https://doi.org/10.2196/35045 %U http://www.ncbi.nlm.nih.gov/pubmed/36881452 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e34958 %T An Augmented Reality Technology to Provide Demonstrative Inhaler Technique Education for Patients With Asthma: Interview Study Among Patients, Health Professionals, and Key Community Stakeholders %A O'Connor,Antonia %A Sharrad,Kelsey %A King,Charmaine %A Carson-Chahhoud,Kristin %+ Translational Medicine and Technology Group, Australian Centre for Precision Health, University of South Australia, GPO Box 2471, Adelaide, 5001, Australia, 61 83020453, kristin.carson-chahhoud@unisa.edu.au %K augmented reality %K asthma %K disease management %K smartphone %K inhaler technique %K mobile phone %D 2023 %7 2.3.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Many people with asthma use incorrect inhaler technique, resulting in suboptimal disease management and increased health service use. Novel ways of delivering appropriate instructions are needed. Objective: This study explored stakeholder perspectives on the potential use of augmented reality (AR) technology to improve asthma inhaler technique education. Methods: On the basis of existing evidence and resources, an information poster displaying the images of 22 asthma inhaler devices was developed. Using AR technology via a free smartphone app, the poster launched video demonstrations of correct inhaler technique for each device. In total, 21 semistructured, one‐on‐one interviews with health professionals, people with asthma, and key community stakeholders were conducted, and data were analyzed thematically using the Triandis model of interpersonal behavior. Results: A total of 21 participants were recruited into the study, and data saturation was achieved. People with asthma were confident with inhaler technique (mean score 9.17, SD 1.33, out of 10). However, health professionals and key community stakeholders identified that this perception was misguided (mean 7.25, SD 1.39, and mean 4.5, SD 0.71, for health professionals and key community stakeholders, respectively) and facilitates persistent incorrect inhaler use and suboptimal disease management. Delivering inhaler technique education using AR was favored by all participants (21/21, 100%), particularly around ease of use, with the ability to visually display inhaler techniques for each device. There was a strongly held belief that the technology has the capacity for improving inhaler technique across all participant groups (mean 9.25, SD 0.89, for participants; mean 9.83, SD 0.41, for health professionals; and mean 9.5, SD 0.71, for key community stakeholders). However, all participants (21/21, 100%) identified some barriers, particularly regarding access and appropriateness of AR for older people. Conclusions: AR technology may be a novel means to address poor inhaler technique among certain cohorts of patients with asthma and serve as a prompt for health professionals to initiate review of inhaler devices. A randomized controlled trial design is needed to evaluate the efficacy of this technology for use in the clinical care setting. %M 36862496 %R 10.2196/34958 %U https://formative.jmir.org/2023/1/e34958 %U https://doi.org/10.2196/34958 %U http://www.ncbi.nlm.nih.gov/pubmed/36862496 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e43019 %T Development of an mHealth App to Support the Prevention of Sexually Transmitted Infections Among Black Men Who Have Sex With Men Engaged in Pre-exposure Prophylaxis Care in New Orleans, Louisiana: Qualitative User-Centered Design Study %A Clement,Meredith Edwards %A Lovett,Aish %A Caldwell,Sylvia %A Beckford,Jeremy %A Hilgart,Michelle %A Corneli,Amy %A Flickinger,Tabor %A Dillingham,Rebecca %A Ingersoll,Karen %+ Division of Infectious Diseases, Louisiana State University Health Sciences Center- New Orleans, 1542 Tulane Ave, Suite 331C, New Orleans, LA, 701120000, United States, 1 5045685204, mclem5@lsuhsc.edu %K pre-exposure prophylaxis %K HIV %K mobile apps %K mobile phone %D 2023 %7 27.2.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Sexual health disparities exist for Black men who have sex with men (BMSM) in New Orleans, Louisiana. Rates of sexually transmitted infections (STIs) are high for both BMSM and those taking HIV pre-exposure prophylaxis (PrEP). Objective: In this study, we introduced an existing PrEP adherence app to new potential users—BMSM engaged in PrEP care in New Orleans—to guide app adaptation with STI prevention features and tailoring for the local context. Methods: Using a user-centered design, we conducted 4 focus group discussions (FGDs), with interim app adaptations from December 2020 to March 2021. During the FGDs, a video of the app, app website, and mock-ups were shown to participants. We asked about facilitators of and barriers to STI prevention in general, current app use, impressions of the existing app, new app features to potentially facilitate STI prevention, and how the app should be tailored for BMSM. We used applied qualitative thematic analysis to identify themes and needs of the population. Results: Overall, 4 FGDs were conducted with 24 BMSM taking PrEP. We grouped themes into 4 categories: STI prevention, current app use and preferences, preexisting features and impressions of the prep’d app, and new features and modifications for BMSM. Participants noted concern about STIs and shared that anxiety about some STIs was higher than that for others; some participants shared that since the emergence of PrEP, little thought is given to STIs. However, participants desired STI prevention strategies and suggested prevention methods to implement through the app, including access to resources, educational content, and sex diaries to follow their sexual activity. When discussing app preferences, they emphasized the need for an app to offer relevant features and be easy to use and expressed that some notifications were important to keep users engaged but that they should be limited to avoid notification fatigue. Participants thought that the current app was useful and generally liked the existing features, including the ability to communicate with providers, staff, and each other through the community forum. They had suggestions for modifications for STI prevention, such as the ability to comment on sexual encounters, and for tailoring to the local context, such as depictions of iconic sights from the area. Mental health emerged as an important need to be addressed through the app during discussion of almost all features. Participants also stressed the importance of ensuring privacy and reducing stigma through the app. Conclusions: A PrEP adherence app was iteratively adapted with feedback from BMSM, resulting in a new app modified for the New Orleans context and with STI prevention features. Participants gave the app a new name, PCheck, to be more discreet. Next steps will assess PCheck use and STI prevention outcomes. %M 36848209 %R 10.2196/43019 %U https://formative.jmir.org/2023/1/e43019 %U https://doi.org/10.2196/43019 %U http://www.ncbi.nlm.nih.gov/pubmed/36848209 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e42691 %T Leveraging mHealth and Patient Supporters for African Americans' and Latinxs' Engagement in HIV Care (LEAN): Protocol for a Randomized, Controlled, Effectiveness-Implementation Trial %A Jones,Joyce %A McKenzie-White,Jane %A Saxton,Ronald %A Grieb,Suzanne M %A Nonyane,Bareng %A Graham,Cadeesha %A Cano,Anthony %A Johnson,Sheridan %A Childs,Lanisha %A Greenbaum,Adena %A Flynn,Colin %A Pearlowitz,Marcia %A Celano,Shivaun %A Chang,Larry W %A Page,Kathleen R %+ School of Medicine, Johns Hopkins, Phipps 540, 600 N Wolfe Street, Baltimore, MD, 21287, United States, 1 410 614 0936, lchang8@jhmi.edu %K mHealth %K HIV linkage to care %K HIV virologic suppression %K HIV continuum of care %K adherence %K implementation %D 2023 %7 14.2.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Despite substantial investments in ending the HIV epidemic, disparities in HIV care persist, and there is an urgent need to evaluate novel and scalable approaches to improving HIV care engagement and viral suppression in real-world settings. Objective: This paper aims to describe a study protocol for a pragmatic type II hybrid effectiveness-implementation randomized controlled trial comparing existing standard of care clinic HIV linkage, adherence, and retention (LAR) protocols to a mobile health (mHealth)–enhanced linkage, adherence, and retention (mLAR) intervention. Methods: The study will enroll 450 participants from clinics in Baltimore City. Eligibility criteria include being ≥18 years of age, having a new HIV diagnosis or being HIV-positive and out of care, or being HIV-positive and deemed by clinic staff as someone who could benefit from linkage and retention services. Participants randomized to the intervention receive mHealth-supported patient navigation for 12 months. Participants in the control group receive the referring clinic’s standard of care patient support. The primary outcome is HIV virologic suppression at 12 months. A subset of participants will be interviewed at 12 months to learn about their HIV care experiences and, for those in the intervention arm, their experiences with the mLAR intervention. This protocol was developed in collaboration with the Baltimore City Health Department (BCHD) and the Maryland Department of Health (MDH) and with input from a community advisory board. Results: Enrollment began on February 25, 2020. As of August 11, 2022, 411 of the 450 target participants had been enrolled. Conclusions: Pragmatic implementation science trials designed with input from key stakeholders, including health departments and community members, can help evaluate the evidence for mHealth interventions to reduce HIV health disparities. Trial Registration: ClinicalTrials.gov NCT03934437; https://clinicaltrials.gov/ct2/show/NCT03934437 International Registered Report Identifier (IRRID): DERR1-10.2196/42691 %M 36787165 %R 10.2196/42691 %U https://www.researchprotocols.org/2023/1/e42691 %U https://doi.org/10.2196/42691 %U http://www.ncbi.nlm.nih.gov/pubmed/36787165 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e40504 %T Digital Health Applications to Establish a Remote Diagnosis of Orthopedic Knee Disorders: Scoping Review %A van Eijck,Sander C %A Janssen,Daan M %A van der Steen,Maria C %A Delvaux,Eugenie J L G %A Hendriks,Johannes G E %A Janssen,Rob P A %+ Department of Orthopedic Surgery & Trauma, Máxima Medical Center, De Run 4600, Veldhoven, 5504 DB, Netherlands, 31 31641941571, sandervaneijck@gmail.com %K orthopedic surgery %K eHealth %K digital health %K mobile health %K mHealth %K telemedicine %K artificial intelligence %K diagnosis %K remote patient management %K musculoskeletal system %K knee %K mobile phone %D 2023 %7 9.2.2023 %9 Review %J J Med Internet Res %G English %X Background: Knee pain is highly prevalent worldwide, and this number is expected to rise in the future. The COVID-19 outbreak, in combination with the aging population, rising health care costs, and the need to make health care more accessible worldwide, has led to an increasing demand for digital health care applications to deliver care for patients with musculoskeletal conditions. Digital health and other forms of telemedicine can add value in optimizing health care for patients and health care providers. This might reduce health care costs and make health care more accessible while maintaining a high level of quality. Although expectations are high, there is currently no overview comparing digital health applications with face-to-face contact in clinical trials to establish a primary knee diagnosis in orthopedic surgery. Objective: This study aimed to investigate the currently available digital health and telemedicine applications to establish a primary knee diagnosis in orthopedic surgery in the general population in comparison with imaging or face-to-face contact between patients and physicians. Methods: A scoping review was conducted using the PubMed and Embase databases according to the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) statement. The inclusion criteria were studies reporting methods to determine a primary knee diagnosis in orthopedic surgery using digital health or telemedicine. On April 28 and 29, 2021, searches were conducted in PubMed (MEDLINE) and Embase. Data charting was conducted using a predefined form and included details on general study information, study population, type of application, comparator, analyses, and key findings. A risk-of-bias analysis was not deemed relevant considering the scoping review design of the study. Results: After screening 5639 articles, 7 (0.12%) were included. In total, 2 categories to determine a primary diagnosis were identified: screening studies (4/7, 57%) and decision support studies (3/7, 43%). There was great heterogeneity in the included studies in algorithms used, disorders, input parameters, and outcome measurements. No more than 25 knee disorders were included in the studies. The included studies showed a relatively high sensitivity (67%-91%). The accuracy of the different studies was generally lower, with a specificity of 27% to 48% for decision support studies and 73% to 96% for screening studies. Conclusions: This scoping review shows that there are a limited number of available applications to establish a remote diagnosis of knee disorders in orthopedic surgery. To date, there is limited evidence that digital health applications can assist patients or orthopedic surgeons in establishing the primary diagnosis of knee disorders. Future research should aim to integrate multiple sources of information and a standardized study design with close collaboration among clinicians, data scientists, data managers, lawyers, and service users to create reliable and secure databases. %M 36566450 %R 10.2196/40504 %U https://www.jmir.org/2023/1/e40504 %U https://doi.org/10.2196/40504 %U http://www.ncbi.nlm.nih.gov/pubmed/36566450 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 11 %N %P e42799 %T Effectiveness of mHealth on Adherence to Antiretroviral Therapy in Patients Living With HIV: Meta-analysis of Randomized Controlled Trials %A Sun,Liang %A Qu,Mengbing %A Chen,Bing %A Li,Chuancang %A Fan,Haohao %A Zhao,Yang %+ College of Public Health, Zhengzhou University, New campus of Zhengzhou University, 100 Science Avenue, Zhengzhou, 450001, China, 86 13803845359, zhaomiemie@126.com %K HIV %K mHealth %K antiretroviral therapy %K meta-analysis %D 2023 %7 23.1.2023 %9 Review %J JMIR Mhealth Uhealth %G English %X Background: The World Health Organization recommends that all adults with HIV adhere to antiretroviral therapy (ART). Good adherence to ART is beneficial to patients and the public. Furthermore, mHealth has shown promise in improving HIV medication adherence globally. Objective: The aim of this meta-analysis is to analyze the effectiveness of mHealth on adherence to antiretroviral therapy in patients living with HIV. Methods: Randomized controlled trials (RCTs) of the association between mHealth and adherence to ART published until December 2021 were searched in electronic databases. Odds ratios (ORs), weighted mean differences, and 95% CIs were calculated. This meta-analysis was performed using the Mantel-Haenszel method or the inverse variance test. We evaluated heterogeneity with the I2 statistic. If I2 was ≤50%, heterogeneity was absent, and a fixed effect model was used. If I2 was >50%, heterogeneity was present, and a random effects model was used. Results: A total of 2163 participants in 8 studies were included in this meta-analysis. All included studies were RCTs. The random effects model was used for a meta-analysis of the effects of various intervention measures compared to routine nursing; the outcome was not statistically significant (OR 1.54, 95% CI 0.99-2.38; P=.05). In the subgroups, only short messaging service (SMS)-based interventions significantly increased adherence to ART (OR 1.76, 95% CI 1.07-2.89; P=.03). Further analysis showed that only interactive or bidirectional SMS could significantly increase ART adherence (OR 1.69, 95% CI 1.22-2.34; P=.001). After combining the difference in CD4 cell count before and after the interventions, we concluded that there was no statistical heterogeneity among the studies (I2=0%; tau2=0.37; P=.95). Conclusions: Interactive or bidirectional SMS can enhance intervention effects. However, whether mHealth can improve adherence to ART in patients with HIV needs further study. Owing to a lack of the required significant staff time, training, and ongoing supervision, there is still much more to do to apply mHealth to the clinical use of ART for patients living with HIV. Trial Registration: PROSPERO CRD42022358774; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=358774 %M 36689267 %R 10.2196/42799 %U https://mhealth.jmir.org/2023/1/e42799 %U https://doi.org/10.2196/42799 %U http://www.ncbi.nlm.nih.gov/pubmed/36689267 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 12 %P e41735 %T Two-way Automated Text Messaging Support From Community Pharmacies for Medication Taking in Multiple Long-term Conditions: Human-Centered Design With Nominal Group Technique Development Study %A Donovan,Gemma %A Hall,Nicola %A Smith,Felicity %A Ling,Jonathan %A Wilkes,Scott %+ Generated Health, Mercury House, 117 Waterloo Road, London, SE1 8UL, United Kingdom, 44 345 5050120, gemma.donovan@pshealthgroup.com %K medication adherence %K text messaging %K human-centered design %K complex interventions %K community pharmacy %D 2022 %7 21.12.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: Reviews of digital communication technologies suggest that they can be effective in supporting medication use; however, their use alongside nondigital components is unclear. We also explored the delivery of a digital communication intervention in a relatively novel setting of community pharmacies and how such an intervention might be delivered to patients with multiple long-term conditions. This meant that despite the large number of intervention examples available in the literature, design questions remained, which we wanted to explore with key stakeholders. Examples of how to involve stakeholders in the design of complex health care interventions are lacking; however, human-centered design (HCD) has been suggested as a potential approach. Objective: This study aimed to design a new community pharmacy text messaging intervention to support medication use for multiple long-term conditions, with patient and health care professional stakeholders in primary care. Methods: HCD was used to map the intervention “journey” and identify design questions to explore with patients and health care professionals. Six prototypes were developed to communicate the intervention concept, and a modified version of the Nominal Group Technique was used to gather feedback. Nominal group meetings generated qualitative data using questions about the aspects that participants liked for each prototype and any suggested changes. The discussion was analyzed using a framework approach to transform feedback into statements. These statements were then ranked using a web-based questionnaire to establish a consensus about what elements of the design were valued by stakeholders and what changes to the design were most important. Results: A total of 30 participants provided feedback on the intervention design concept over 5 nominal group meetings (21 health care professionals and 9 patients) with a 57% (17/30) response rate to the ranking questionnaire. Furthermore, 51 proposed changes in the intervention were generated from the framework analysis. Of these 51 changes, 27 (53%) were incorporated into the next design stage, focusing on changes that were ranked highest. These included suggestions for how text message content might be tailored, patient information materials, and the structure for pharmacist consultation. All aspects that the participants liked were retained in the future design and provided evidence that the proposed intervention concept had good acceptability. Conclusions: HCD incorporating the Nominal Group Technique is an appropriate and successful approach for obtaining feedback from key stakeholders as part of an iterative design process. This was particularly helpful for our intervention, which combined digital and nondigital components for delivery in the novel setting of a community pharmacy. This approach enabled the collection and prioritization of useful multiperspective feedback to inform further development and testing of our intervention. This model has the potential to minimize research waste by gathering feedback early in the complex intervention design process. %M 36542458 %R 10.2196/41735 %U https://formative.jmir.org/2022/12/e41735 %U https://doi.org/10.2196/41735 %U http://www.ncbi.nlm.nih.gov/pubmed/36542458 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 12 %P e42941 %T Patient Trust in Physicians Matters—Understanding the Role of a Mobile Patient Education System and Patient-Physician Communication in Improving Patient Adherence Behavior: Field Study %A Wu,Dezhi %A Lowry,Paul Benjamin %A Zhang,Dongsong %A Tao,Youyou %+ Department of Integrated Information Technology, University of South Carolina, 550 Assembly Street, Columbia, SC, 29298, United States, 1 8037774691, dezhiwu@cec.sc.edu %K mobile health %K mHealth %K trust %K patient adherence %K mobile patient education system %K MPES %K patient-physician communication %K theory of planned behavior %K TPB %K patient-centered care %K mobile phone %D 2022 %7 20.12.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: The ultimate goal of any prescribed medical therapy is to achieve desired outcomes of patient care. However, patient nonadherence has long been a major problem detrimental to patient health, and thus is a concern for all health care providers. Moreover, nonadherence is extremely costly for global medical systems because of unnecessary complications and expenses. Traditional patient education programs often serve as an intervention tool to increase patients’ self-care awareness, disease knowledge, and motivation to change patient behaviors for better adherence. Patient trust in physicians, patient-physician relationships, and quality of communication have also been identified as critical factors influencing patient adherence. However, little is known about how mobile patient education technologies help foster patient adherence. Objective: This study aimed to empirically investigate whether and how a mobile patient education system (MPES) juxtaposed with patient trust can increase patient adherence to prescribed medical therapies. Methods: This study was conducted based on a field survey of 125 patients in multiple states in the United States who have used an innovative mobile health care system for their health care education and information seeking. Partial least squares techniques were used to analyze the collected data. Results: The results revealed that patient-physician communication and the use of an MPES significantly increase patients’ trust in their physicians. Furthermore, patient trust has a prominent effect on patient attitude toward treatment adherence, which in turn influences patients’ behavioral intention and actual adherence behavior. Based on the theory of planned behavior, the results also indicated that behavioral intention, response efficacy, and self-efficacy positively influenced patients’ actual treatment adherence behavior, whereas descriptive norms and subjective norms do not play a role in this process. Conclusions: Our study is one of the first that examines the relationship between patients who actively use an MPES and their trust in their physicians. This study contributes to this context by enriching the trust literature, addressing the call to identify key patient-centered technology determinants of trust, advancing the understanding of patient adherence mechanisms, adding a new explanation of the influence of education mechanisms delivered via mobile devices on patient adherence, and confirming that the theory of planned behavior holds in this patient adherence context. %M 36538351 %R 10.2196/42941 %U https://www.jmir.org/2022/12/e42941 %U https://doi.org/10.2196/42941 %U http://www.ncbi.nlm.nih.gov/pubmed/36538351 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 11 %N 12 %P e40382 %T A Novel Remote Patient and Medication Monitoring Solution to Improve Adherence and Persistence With Inflammatory Bowel Disease Therapy (ASSIST Study): Protocol for a Randomized Controlled Trial %A Axelrad,Jordan %A Long,Millie %A Horst,Sara %A Afzali,Anita %A Sapir,Tamar %A Fajardo,Kristina %A De Felice,Kara %A Sandler,Robert %A Cross,Raymond %+ Division of Gastroenterology, Department of Medicine, NYU Grossman School of Medicine, Inflammatory Bowel Disease Center at NYU Langone Health, 305 East 33rd Street, New York, NY, 10016, United States, 1 (212) 263 5290, Jordan.Axelrad@nyulangone.org %K remote therapy monitoring %K connected health %K patient engagement %K Crohn disease %K ulcerative colitis %K inflammatory bowel disease %K mobile phone %D 2022 %7 15.12.2022 %9 Protocol %J JMIR Res Protoc %G English %X Background: Inflammatory bowel diseases (IBDs) are chronic inflammatory conditions of the gastrointestinal tract. Although adherence to IBD therapies is associated with improved clinical outcomes, overall adherence is poor. Consequently, there is a critical need to develop interventions that monitor adherence in real time and identify reasons for nonadherence to support clinical teams in initiating effective interventions. Recently, electronic- and web-based platforms have been developed to monitor adherence and guide interventions. A novel remote therapy monitoring (RTM) technology, the Tappt digital health system, has been developed to monitor real-time medication adherence patterns through smart label technologies, capture patient-reported outcomes and barriers to care, and process patient data through algorithms that trigger personalized digital and human touch points between clinical visits. Such a digital health solution enables care teams to proactively identify and mitigate nonadherence and worsening clinical outcomes. Objective: We propose a 12-month multicenter randomized controlled trial to assess the effectiveness of the Tappt digital health system on adherence, clinical outcomes, and health care use among patients diagnosed with IBD starting a new oral or subcutaneous therapy. Methods: The digital health system intervention will provide automatic measurement of medication adherence via smart labels for pill bottles or injectors as well as a monitoring platform for providers. The system will prompt patients to complete a two-item assessment of symptoms monthly using the PRO-2 scales for UC and Crohn disease, from which increased symptoms will be alerted to providers. Participants will be randomized 2:1 to the intervention group or the control group, which will receive standard of care. All participants are required to complete questionnaires at baseline as well as at 12, 26, and 52 weeks. Assuming an adherence rate of 0.65 and 0.9 among control and intervention participants, respectively, we will need to enroll 123 participants: 82 (66.7%) in the intervention group and 41 (33.3%) controls. We will compare adherence as measured by the medication possession ratio, defined as the number of days of supply of medication obtained during the observation period out of the total number of days in the observation period, in participants using the RTM versus those receiving standard of care. We will also compare clinical outcomes and health care use in participants using the RTM versus those receiving standard of care. Results: We anticipate starting recruitment in December 2022. Conclusions: Effective medication adherence monitoring and intervention programs need to be cost-efficient, pose little or no burden to the patient, record reliable data in real time, and provide actionable insights to the health care team. We anticipate the Tappt digital health system to improve the medication possession ratio, clinical outcomes, and health care use compared with standard of care. Trial Registration: ClinicalTrials.gov NCT05316584; https://clinicaltrials.gov/ct2/show/NCT05316584 International Registered Report Identifier (IRRID): PRR1-10.2196/40382 %M 36520519 %R 10.2196/40382 %U https://www.researchprotocols.org/2022/12/e40382 %U https://doi.org/10.2196/40382 %U http://www.ncbi.nlm.nih.gov/pubmed/36520519 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 12 %P e36829 %T Perceptions and Attitudes Toward an Interactive Voice Response Tool (Call for Life Uganda) Providing Adherence Support and Health Information to HIV-Positive Ugandans: Qualitative Study %A Kajubi,Phoebe %A Parkes-Ratanshi,Rosalind %A Twimukye,Adelline %A Bwanika Naggirinya,Agnes %A Nabaggala,Maria Sarah %A Kiragga,Agnes %A Castelnuovo,Barbara %A King,Rachel %+ Infectious Diseases Institute, College of Health Sciences, Makerere University, PO Box 22418, Kampala, Uganda, 256 312 307000, phoebekajubi@yahoo.com %K mobile health %K mHealth %K mobile communication technologies %K people living with HIV %K antiretroviral therapy %K quality of life %K Uganda %D 2022 %7 6.12.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: The continuing decline in AIDS-related deaths in the African region is largely driven by the steady scale-up of antiretroviral therapy. However, there are challenges to retaining people living with HIV on treatment. Call for Life Uganda (CFLU) is an interactive voice response tool using simple analogue phones. CFLU supports patients with daily pill reminders, preappointment reminders, symptom reporting and management, and weekly health promotion tips. Mobile health tools are being increasingly used in resource-limited settings but are often adopted without rigorous evaluation. Objective: This qualitative study conducted at 12 months after enrollment assessed patients’ experiences, perceptions, and attitudes regarding CLFU. Methods: We conducted a qualitative substudy within an open-label randomized controlled trial titled “Improving outcomes in HIV patients using mobile phone based interactive software support.” Data were collected through 6 focus group discussions with participants sampled based on proportion of calls responded to—<25%, between 25% and 50%, and >50%—conducted at the Infectious Diseases Institute, Mulago, and the Kasangati Health Centre IV. NVivo (version 11; QSR International) was used in the management of the data and in the coding of the emerging themes. The data were then analyzed using content thematic analysis. Results: There was consensus across all groups that they had more positive than negative experiences with the CFLU system. Participants who responded to >50% of the calls reported more frequent use of the specific elements of the CFLU tool and, consequently, experienced more benefits from the system than those who responded to calls less frequently. Irrespective of calls responded to, participants identified pill reminders as the most important aspect in improved quality of life, followed by health promotion tips. The most common challenge faced was difficulty with the secret personal identification number. Conclusions: Findings showed participants’ appreciation, high willingness, and interest in the intervention, CFLU, that demonstrated great perceived potential to improve their access to health care; adherence to treatment; health awareness; and, consequently, quality of life. Trial Registration: ClinicalTrials.gov NCT02953080; https://clinicaltrials.gov/ct2/show/NCT02953080 %M 36472904 %R 10.2196/36829 %U https://formative.jmir.org/2022/12/e36829 %U https://doi.org/10.2196/36829 %U http://www.ncbi.nlm.nih.gov/pubmed/36472904 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 12 %P e39489 %T The Development of a Novel mHealth Tool for Obstructive Sleep Apnea: Tracking Continuous Positive Airway Pressure Adherence as a Percentage of Time in Bed %A Pfammatter,Angela Fidler %A Hughes,Bonnie Olivia %A Tucker,Becky %A Whitmore,Harry %A Spring,Bonnie %A Tasali,Esra %+ Department of Preventive Medicine, Feinberg School of Medicine, Northwestern University, 633 Clark St, Evanston, IL, 60208, United States, 1 847 491 3741, angela@northwestern.edu %K obstructive sleep apnea %K continuous positive airway pressure %K CPAP adherence %K weight loss %K lifestyle %D 2022 %7 5.12.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: Continuous positive airway pressure (CPAP) is the mainstay obstructive sleep apnea (OSA) treatment; however, poor adherence to CPAP is common. Current guidelines specify 4 hours of CPAP use per night as a target to define adequate treatment adherence. However, effective OSA treatment requires CPAP use during the entire time spent in bed to optimally treat respiratory events and prevent adverse health effects associated with the time spent sleeping without wearing a CPAP device. Nightly sleep patterns vary considerably, making it necessary to measure CPAP adherence relative to the time spent in bed. Weight loss is an important goal for patients with OSA. Tools are required to address these clinical challenges in patients with OSA. Objective: This study aimed to develop a mobile health tool that combined weight loss features with novel CPAP adherence tracking (ie, percentage of CPAP wear time relative to objectively assessed time spent in bed) for patients with OSA. Methods: We used an iterative, user-centered process to design a new CPAP adherence tracking module that integrated with an existing weight loss app. A total of 37 patients with OSA aged 20 to 65 years were recruited. In phase 1, patients with OSA who were receiving CPAP treatment (n=7) tested the weight loss app to track nutrition, activity, and weight for 10 days. Participants completed a usability and acceptability survey. In phase 2, patients with OSA who were receiving CPAP treatment (n=21) completed a web-based survey about their interpretations and preferences for wireframes of the CPAP tracking module. In phase 3, patients with recently diagnosed OSA who were CPAP naive (n=9) were prescribed a CPAP device (ResMed AirSense10 AutoSet) and tested the integrated app for 3 to 4 weeks. Participants completed a usability survey and provided feedback. Results: During phase 1, participants found the app to be mostly easy to use, except for some difficulty searching for specific foods. All participants found the connected devices (Fitbit activity tracker and Fitbit Aria scale) easy to use and helpful. During phase 2, participants correctly interpreted CPAP adherence success, expressed as percentage of wear time relative to time spent in bed, and preferred seeing a clearly stated percentage goal (“Goal: 100%”). In phase 3, participants found the integrated app easy to use and requested push notification reminders to wear CPAP before bedtime and to sync Fitbit in the morning. Conclusions: We developed a mobile health tool that integrated a new CPAP adherence tracking module into an existing weight loss app. Novel features included addressing OSA-obesity comorbidity, CPAP adherence tracking via percentage of CPAP wear time relative to objectively assessed time spent in bed, and push notifications to foster adherence. Future research on the effectiveness of this tool in improving OSA treatment adherence is warranted. %M 36469406 %R 10.2196/39489 %U https://www.jmir.org/2022/12/e39489 %U https://doi.org/10.2196/39489 %U http://www.ncbi.nlm.nih.gov/pubmed/36469406 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 9 %N 12 %P e39047 %T Use of an Ingestible, Sensor-Based Digital Adherence System to Strengthen the Therapeutic Relationship in Serious Mental Illness %A Richey,Anabel G %A Kovacs,Ildiko %A Browne,Sara %+ Department of Medicine, University of California, San Diego, 9452 Medical Center Dr, La jolla, CA, 92037, United States, 1 858 822 6563, shbrowne@health.ucsd.edu %K patient-physician relationship %K ingestible sensor %K mental health %K serious mental illness %K antipsychotic %K medication adherence %K digital adherence %K therapy %K digital intervention %K digital mental health %D 2022 %7 2.12.2022 %9 Viewpoint %J JMIR Ment Health %G English %X Serious mental illness is a chronic condition that requires long-term pharmacological treatment. Adherence to oral antipsychotic medication has specific nuances that affects patients and physicians alike. For patients with serious mental illness, nonadherence increases their risk of hospitalization and relapse. Nonadherence is a formidable barrier for physicians in accurately assessing medication efficacy and helping patients achieve their fullest potential. A digital adherence system approved by the Food and Drug Administration can provide near–real time aripiprazole ingestion information. The system records ingestions through an embedded ingestible sensor in oral aripiprazole, which sends a transient local signal to a patch worn on the patient’s torso that is then stored on a paired smartphone app. With patient permission, these data can be viewed remotely by their physician, along with a patient’s mood, activity, and time spent resting. Such data are able to do the following: reveal broad patterns of medication adherence behavior to the patient as well as their physician; help physicians and patients understand and create more realistic expectations for adherence; promote discussion of treatment options; and minimize therapeutic appointment time devoted to determining actual adherence, thereby maximizing the time available to address each patient’s distinctive reasons for their adherence pattern. Crucially, extra time created during appointments can be used to strengthen the therapeutic relationship, which may translate into both improvements in adherence and patient attitude toward their medication. Future investigations are needed to examine how this technology impacts the development of training and best practice guidelines for its use. Otherwise, the potential benefits of this technology may be lost, or worse, inadequate and inappropriate use may harm the therapeutic relationship. %M 36459392 %R 10.2196/39047 %U https://mental.jmir.org/2022/12/e39047 %U https://doi.org/10.2196/39047 %U http://www.ncbi.nlm.nih.gov/pubmed/36459392 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 11 %P e26925 %T Patients’ and Health Care Providers’ Perceptions on mHealth Use After High-Altitude Climate Therapy for Severe Asthma: Mixed Methods Study %A Khusial,Rishi %A van Koppen,Sophia %A Honkoop,Persijn %A Rijssenbeek-Nouwens,Lucia %A Fieten,Karin Berthine %A Keij,Sascha %A Drijver-Messelink,Marieke %A Sont,Jacob %+ Department of Biomedical Data Sciences, Section Medical Decision Making, Leiden University Medical Center, Albinusdreef 2, Leiden, 2300 RC, Netherlands, 31 7152 64574, r.j.khusial@lumc.nl %K eHealth %K mobile health %K mHealth %K asthma %K self-management %K home monitoring %K mobile phone %D 2022 %7 22.11.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: Asthma is a common chronic disease with various clinical presentations. Although most patients are able to reach good asthma control, some patients are not able to reach sufficient asthma control following the regular treatment guidelines and could be referred to high-altitude climate therapy (HACT). HACT includes environmental trigger avoidance in the alpine climate with multidisciplinary clinical treatment. Patients with severe and difficult-to-control asthma, who are unable to reach asthma control at sea level, can follow a 12-week lung rehabilitation program at 1600 m above sea level. Mobile health (mHealth) tools can be used to enhance self-management in these patients when they return home. For an mHealth system to be effective, it must meet the expectations of the end users. Objective: In this Davos@home study, we explored the attitudes toward mHealth aimed at supporting the self-management of patients with severe, difficult-to-control asthma who underwent HACT and asthma health care providers. Methods: In the first stage, interviews with referrers to HACT and focus groups with patients with asthma who participated in or completed HACT were conducted. The data were then analyzed thematically. On the basis of these results, a questionnaire was developed. In the second stage of the study, this questionnaire, combined with the Asthma Control Questionnaire and the Individual Innovativeness Questionnaire, was provided to patients who completed HACT. Results: In total, 11 interviews and 3 focus groups (n=18, age 47.6, SD 12.1 years, Asthma Control Questionnaire score 2.6, SD 1.0) were conducted. A total of 3 themes were identified: potential goals, useful measurements, and perceived barriers and facilitators. The questionnaire developed in stage 2 included items based on these results. The most agreed-upon goal among the 52 patients who completed the questionnaire was to increase their asthma control (45/52, 86% of the patients). Conclusions: Different patients reported that they would benefit the most from different functionalities. Therefore, it is important to tailor functionalities to individual (treatment) goals. When developing an mHealth intervention, it is important to allow personalization to avoid overwhelming the users. %M 36413384 %R 10.2196/26925 %U https://formative.jmir.org/2022/11/e26925 %U https://doi.org/10.2196/26925 %U http://www.ncbi.nlm.nih.gov/pubmed/36413384 %0 Journal Article %@ 2563-3570 %I JMIR Publications %V 3 %N 1 %P e36766 %T Monitoring Risk Factors and Improving Adherence to Therapy in Patients With Chronic Kidney Disease (Smit-CKD Project): Pilot Observational Study %A Vilasi,Antonio %A Panuccio,Vincenzo Antonio %A Morante,Salvatore %A Villa,Antonino %A Versace,Maria Carmela %A Mezzatesta,Sabrina %A Mercuri,Sergio %A Inguanta,Rosalinda %A Aiello,Giuseppe %A Cutrupi,Demetrio %A Puglisi,Rossella %A Capria,Salvatore %A Li Vigni,Maurizio %A Tripepi,Giovanni %A Torino,Claudia %+ Institute of Clinical Physiology, National Research Council, via Vallone Petrara, snc, Reggio Calabria, 89124, Italy, 39 09 55393252, ctorino@ifc.cnr.it %K SMIT-CKD %K mHealth %K eHealth %K CKD %K therapy adherence %K risk factor %K kidney %K adherence %K integrated system %K health app %K monitoring %K cardiology %K cardiac %K renal %K chronic kidney disease %K cardiovascular %K mobile health %K mobile app %D 2022 %7 15.11.2022 %9 Original Paper %J JMIR Bioinform Biotech %G English %X Background: Chronic kidney disease is a major public health issue, with about 13% of the general adult population and 30% of the elderly affected. Patients in the last stage of this disease have an almost uniquely high risk of death and cardiovascular events, with reduced adherence to therapy representing an additional risk factor for cardiovascular morbidity and mortality. Considering the increased penetration of mobile phones, a mobile app could educate patients to autonomously monitor cardiorenal risk factors. Objective: With this background in mind, we developed an integrated system of a server and app with the aim of improving self-monitoring of cardiovascular and renal risk factors and adherence to therapy. Methods: The software infrastructure for both the Smit-CKD server and Smit-CKD app was developed using standard web-oriented development methodologies preferring open source tools when available. To make the Smit-CKD app suitable for Android and iOS, platforms that allow the development of a multiplatform app starting from a single source code were used. The integrated system was field tested with the help of 22 participants. User satisfaction and adherence to therapy were measured by questionnaires specifically designed for this study; regular use of the app was measured using the daily reports available on the platform. Results: The Smit-CKD app allows the monitoring of cardiorenal risk factors, such as blood pressure, weight, and blood glucose. Collected data are transmitted in real time to the referring general practitioner. In addition, special reminders improve adherence to the medication regimen. Via the Smit-CKD server, general practitioners can monitor the clinical status of their patients and their adherence to therapy. During the test phase, 73% (16/22) of subjects entered all the required data regularly and sent feedback on drug intake. After 6 months of use, the percentage of regular intake of medications rose from 64% (14/22) to 82% (18/22). Analysis of the evaluation questionnaires showed that both the app and server components were well accepted by the users. Conclusions: Our study demonstrated that a simple mobile app, created to self-monitor modifiable cardiorenal risk factors and adherence to therapy, is well tolerated by patients affected by chronic kidney disease. Further studies are required to clarify if the use of this integrated system will have long-term effects on therapy adherence and if self-monitoring of risk factors will improve clinical outcomes in this population. %R 10.2196/36766 %U https://bioinform.jmir.org/2022/1/e36766 %U https://doi.org/10.2196/36766 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 11 %P e42376 %T Remotely Assessing Mechanisms of Behavioral Change in Community Substance Use Disorder Treatment to Facilitate Measurement-Informed Care: Pilot Longitudinal Questionnaire Study %A Hallgren,Kevin A %+ Department of Psychiatry and Behavioral Sciences, University of Washington, University of Washington Medical Center, Box 356560, 1959 NE Pacific Street, Seattle, WA, 98195, United States, 1 206 616 2906, khallgre@uw.edu %K addiction %K clinical pilot %K measurement-based care %K mechanisms of change %K mobile health %K mHealth %K mobile phone %D 2022 %7 7.11.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: Research shows that improvements in coping strategies, abstinence self-efficacy, craving, and depression are potential mechanisms of behavioral change (MOBC) in treatments for substance use disorders (SUDs). However, little is known about how these insights regarding MOBC can be applied to SUD treatment settings. One way to facilitate MOBC-informed care in frontline settings could be to measure and monitor changes in MOBC throughout treatment using brief, frequent questionnaires that patients complete by using mobile technologies (eg, smartphones). The results derived from these questionnaires could potentially be used for clinical monitoring (ie, measurement-based care) to better understand whether individual patients are experiencing treatment-related improvements on key clinical targets. Objective: This study evaluated whether brief, weekly MOBC questionnaires completed by patients remotely can potentially provide clinically meaningful information about changes in MOBC in the context of real-world, community-based SUD treatment. Methods: A total of 30 patients (14/30, 47% female; 13/30, 43% racial or ethnic minority) in a community SUD treatment clinic participated in a pilot study where they were invited to complete brief, weekly questionnaires that assessed various MOBC, including coping strategies, abstinence self-efficacy, craving, depression, and therapeutic alliance. Questionnaires were typically completed remotely via smartphone for up to 6 months; 618 questionnaires were completed in total. Participants also completed longer, psychometrically validated measures of the same MOBC at baseline and 6-month research appointments. Statistical analyses tested whether brief, weekly, remotely completed MOBC questionnaires exhibited characteristics that would be desirable for real-world longitudinal clinical monitoring, including a tendency to detect within-person changes in MOBC over time; cross-sectional and longitudinal associations with longer, psychometrically validated measures completed at research appointments; and similar patterns of associations with 6-month percentage of days abstinent as longer, psychometrically validated MOBC measures completed at research appointments. Results: The results of this study indicated that the brief, weekly, remotely completed MOBC measures exhibited characteristics that are desirable for clinical monitoring, including a tendency to vary longitudinally (within patients over time) more often than measures of alcohol and drug consumption, generally having medium to large cross-sectional and longitudinal correlations with longer psychometrically validated measures of MOBC completed at research appointments, and generally having similar patterns of association with 6-month percentage of days abstinent from alcohol and drugs as longer psychometrically validated MOBC measures completed at research appointments. Conclusions: The results of this pilot study provide initial evidence that incorporating brief, weekly, and remotely completed MOBC questionnaires into community SUD treatment may be a viable approach for facilitating MOBC-informed care. Such questionnaires can potentially support measurement-based care by providing meaningful information about within-patient changes in clinical domains that are often directly targeted in SUD treatments and predict long-term substance use outcomes. %M 36342773 %R 10.2196/42376 %U https://formative.jmir.org/2022/11/e42376 %U https://doi.org/10.2196/42376 %U http://www.ncbi.nlm.nih.gov/pubmed/36342773 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 10 %N 11 %P e25879 %T Digital Coaching Using Smart Inhaler Technology to Improve Asthma Management in Patients With Asthma in Italy: Community-Based Study %A Rumi,Gabriele %A Canonica,G Walter %A Foster,Juliet M %A Chavannes,Niels H %A Valenti,Giuseppe %A Contiguglia,Rosario %A Rapsomaniki,Eleni %A Kocks,Janwillem W H %A De Brasi,Dario %A Braido,Fulvio %+ Dipartimento di Scienze Mediche e Chirurgiche, Fondazione Policlinico Universitario A Gemelli IRCCS, Università Cattolica del Sacro Cuore – Medicina Interna, Presidio Columbus – COVID Team, Via Giuseppe Moscati 31, Rome, 00168, Italy, 39 06 30155896, gabriele.rumi@policlinicogemelli.it %K asthma control %K asthma management %K connected devices %K digital health %K eHealth %K inhalers %K maintenance and reliever therapy %K mobile phone %D 2022 %7 2.11.2022 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Reliance on short-acting β-2 agonists and nonadherence to maintenance medication are associated with poor clinical outcomes in asthma. Digital health solutions could support optimal medication use and therefore disease control in patients with asthma; however, their use in community settings has not been determined. Objective: The primary objective of this study is to investigate community implementation of the Turbu+ program designed to support asthma self-management, including adherence to budesonide and formoterol (Symbicort) Turbuhaler, a combination inhaler for both maintenance therapy or maintenance and reliever therapy. The secondary objective is to provide health care professionals with insights into how patients were using their medication in real life. Methods: Patients with physician-diagnosed asthma were prescribed budesonide and formoterol as maintenance therapy, at a dose of either 1 inhalation twice daily (1-BID) or 2 inhalations twice daily (2-BID), or as maintenance and reliever therapy (1-BID and reliever or 2-BID and reliever in a single inhaler), and they received training on Turbu+ in secondary care centers across Italy. An electronic device attached to the patients’ inhaler for ≥90 days (data cutoff) securely uploaded medication use data to a smartphone app and provided reminders, visualized medication use, and motivational nudge messages. Average medication adherence was defined as the proportion of daily maintenance inhalations taken as prescribed (number of recorded maintenance actuations per day or maintenance inhalations prescribed per day) averaged over the monitoring period. The proportion of adherent days was defined as the proportion of days when all prescribed maintenance inhalations were taken on a given day. The Wilcoxon test was used to compare the proportion of adherent days between patients in the maintenance regimen and patients in the maintenance and reliever regimen of a given dose. Results: In 661 patients, the mean (SD) number of days monitored was 217.2 (SD 109.0) days. The average medication adherence (maintenance doses taken/doses prescribed) was 70.2% (108,040/153,820) overall and was similar across the groups (1-BID: 6332/9520, 66.5%; 1‑BID and reliever: 43,578/61,360, 71.0%; 2-BID: 10,088/14,960, 67.4%; 2-BID and reliever: 48,042/67,980, 70.7%). The proportion of adherent days (prescribed maintenance doses/doses taken in a given day) was 56.6% (31,812/56,175) overall and was higher with maintenance and reliever therapy (1-BID and reliever vs 1-BID: 18,413/30,680, 60.0% vs 2510/4760, 52.7%; P<.001; 2-BID and reliever vs 2-BID: 8995/16,995, 52.9% vs 1894/3740, 50.6%; P=.02). Rates of discontinuation from the Turbu+ program were significantly lower with maintenance and reliever therapy compared with maintenance therapy alone (P=.01). Conclusions: Overall, the high medication adherence observed during the study might be attributed to the electronic monitoring and feedback mechanism provided by the Turbu+ program. %M 36322120 %R 10.2196/25879 %U https://mhealth.jmir.org/2022/11/e25879 %U https://doi.org/10.2196/25879 %U http://www.ncbi.nlm.nih.gov/pubmed/36322120 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 9 %N 4 %P e38048 %T The Virtual Inclusive Digital Health Intervention Design to Promote Health Equity (iDesign) Framework for Atrial Fibrillation: Co-design and Development Study %A Isakadze,Nino %A Molello,Nancy %A MacFarlane,Zane %A Gao,Yumin %A Spaulding,Erin M %A Commodore Mensah,Yvonne %A Marvel,Francoise A %A Khoury,Shireen %A Marine,Joseph E %A Michos,Erin D %A Spragg,David %A Berger,Ronald D %A Calkins,Hugh %A Cooper,Lisa A %A Martin,Seth S %+ Ciccarone Center for the Prevention of Cardiovascular Disease, Division of Cardiology, Department of Medicine, Johns Hopkins University School of Medicine, 600 N Wolfe St/Halsted 500, Baltimore, MD, 21287, United States, 1 410 955 5999, nisakad1@jh.edu %K atrial fibrillation %K digital health intervention %K human-centered design %K health equity %K smartphone %K mobile application %K cardiac %K cardiology %K virtual meeting %K virtual health %K medication adherence %K health equity %D 2022 %7 31.10.2022 %9 Original Paper %J JMIR Hum Factors %G English %X Background: Smartphone ownership and mobile app use are steadily increasing in individuals of diverse racial and ethnic backgrounds living in the United States. Growing adoption of technology creates a perfect opportunity for digital health interventions to increase access to health care. To successfully implement digital health interventions and engage users, intervention development should be guided by user input, which is best achieved by the process of co-design. Digital health interventions co-designed with the active engagement of users have the potential to increase the uptake of guideline recommendations, which can reduce morbidity and mortality and advance health equity. Objective: We aimed to co-design a digital health intervention for patients with atrial fibrillation, the most common cardiac arrhythmia, with patient, caregiver, and clinician feedback and to describe our approach to human-centered design for building digital health interventions. Methods: We conducted virtual meetings with patients with atrial fibrillation (n=8), their caregivers, and clinicians (n=8). We used the following 7 steps in our co-design process: step 1, a virtual meeting focused on defining challenges and empathizing with problems that are faced in daily life by individuals with atrial fibrillation and clinicians; step 2, a virtual meeting focused on ideation and brainstorming the top challenges identified during the first meeting; step 3, individualized onboarding of patients with an existing minimally viable version of the atrial fibrillation app; step 4, virtual prototyping of the top 3 ideas generated during ideation; step 5, further ranking by the study investigators and engineers of the ideas that were generated during ideation but were not chosen as top-3 solutions to be prototyped in step 4; step 6, ongoing engineering work to incorporate top-priority features in the app; and step 7, obtaining further feedback from patients and testing the atrial fibrillation digital health intervention in a pilot clinical study. Results: The top challenges identified by patients and caregivers included addressing risk factor modification, medication adherence, and guidance during atrial fibrillation episodes. Challenges identified by clinicians were complementary and included patient education, addressing modifiable atrial fibrillation risk factors, and remote atrial fibrillation episode management. Patients brainstormed more than 30 ideas to address the top challenges, and the clinicians generated more than 20 ideas. Ranking of the ideas informed several novel or modified features aligned with the Theory of Health Behavior Change, features that were geared toward risk factor modification; patient education; rhythm, symptom, and trigger correlation for remote atrial fibrillation management; and social support. Conclusions: We co-designed an atrial fibrillation digital health intervention in partnership with patients, caregivers, and clinicians by virtually engaging in collaborative creation through the design process. We summarize our experience and describe a flexible approach to human-centered design for digital health intervention development that can guide innovative clinical investigators. %M 36315217 %R 10.2196/38048 %U https://humanfactors.jmir.org/2022/4/e38048 %U https://doi.org/10.2196/38048 %U http://www.ncbi.nlm.nih.gov/pubmed/36315217 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 11 %N 10 %P e42216 %T Incentives and Reminders to Improve Long-term Medication Adherence (INMIND): Protocol for a Pilot Randomized Controlled Trial %A Stecher,Chad %A Ghai,Ishita %A Lunkuse,Lillian %A Wabukala,Peter %A Odiit,Mary %A Nakanwagi,Agnes %A Linnemayr,Sebastian %+ College of Health Solutions, Arizona State University, 500 N 3rd Street, Phoenix, AZ, 85004, United States, 1 6024960957, chad.stecher@asu.edu %K medication adherence %K HIV %K antiretroviral therapy %K habit formation %K routines %K behavioral economics %D 2022 %7 31.10.2022 %9 Protocol %J JMIR Res Protoc %G English %X Background: Nonadherence to antiretroviral therapy (ART) among people living with HIV is a crucial barrier to attaining viral suppression globally. Existing behavioral interventions have successfully increased ART adherence, but typically show only short-term impact that dissipates after the interventions are withdrawn. Objective: This study aims to test the feasibility, acceptability, and preliminary efficacy of a novel intervention that uses SMS text messages and conditional incentives to support ART initiators in establishing pill-taking habits. Methods: A sample of 150 participants aged ≥18 years who have initiated ART in the preceding 3 months will be recruited from Mildmay Uganda in Kampala, Uganda. All (150/150, 100%) participants will be educated on the anchoring strategy and will choose an existing routine to pair with their daily ART adherence from a set of 3 suggested routines: getting dressed in the morning, eating breakfast, or eating dinner. Then, participants will be randomized to receive either usual care (control group: 50/150, 33.3%) or 1 of the 2 interventions delivered over 3 months: daily SMS text message reminders to follow their chosen anchoring plan (messages group; treatment group 1: 50/150, 33.3%) or daily SMS text messages and incentives conditional on taking their ART medication around the time of their chosen anchor (incentives group; treatment group 2: 50/150, 33.3%). Long-term ART adherence will be evaluated for 6 months after the intervention, and survey assessments will be conducted at baseline, 3 months, and 9 months. Outcomes include feasibility and acceptability measures and intervention efficacy outcomes defined by electronically measured mean medication adherence during the intervention and during the 6 months after the intervention, along with a measure of routine ART adherence based on taking medications around the time of participants’ anchor during the intervention and during the 6 months after intervention. Results: As of February 18, 2022, recruitment was completed. A total of 150 participants were recruited, and data collection is expected to end in December of 2022. Final results are expected to be submitted for publication by April 2023. Conclusions: This study is the first to use behavioral economics–based interventions in combination with the anchoring strategy to improve long-term ART adherence among treatment initiators. We hypothesize that the combination of SMS text message reminders and incentives will increase participants’ use of their anchoring strategy, and thus medication adherence will be better maintained after the intervention ends in our intervention groups relative to the control group that uses only the anchoring strategy. Results of this pilot study will help to refine this combined intervention approach for testing at scale and broaden our understanding of the habit formation process. Trial Registration: ClinicalTrials.gov NCT05131165; https://clinicaltrials.gov/ct2/show/NCT05131165 International Registered Report Identifier (IRRID): DERR1-10.2196/42216 %M 36315224 %R 10.2196/42216 %U https://www.researchprotocols.org/2022/10/e42216 %U https://doi.org/10.2196/42216 %U http://www.ncbi.nlm.nih.gov/pubmed/36315224 %0 Journal Article %@ 2561-9128 %I JMIR Publications %V 5 %N 1 %P e38690 %T Outcomes With a Mobile Digital Health Platform for Patients Undergoing Spine Surgery: Retrospective Analysis %A Venkatraman,Vishal %A Kirsch,Elayna P %A Luo,Emily %A Kunte,Sameer %A Ponder,Madison %A Gellad,Ziad F %A Liu,Beiyu %A Lee,Hui-Jie %A Jung,Sin-Ho %A Haglund,Michael M %A Lad,Shivanand P %+ Department of Neurosurgery, Duke University Medical Center, 200 Trent Drive, Blue Zone, Durham, NC, 27710, United States, 1 919 681 1973, nandan.lad@duke.edu %K digital health %K spine surgery %K surgical outcomes %K mobile health %K mobile application %K surgery %K postoperative %K mobile health %K mobile app %K mHealth %K recovery %D 2022 %7 26.10.2022 %9 Original Paper %J JMIR Perioper Med %G English %X Background: Digital health solutions have been shown to enhance outcomes for individuals with chronic medical illnesses, but few have been validated for surgical patients. The digital health platform ManageMySurgery (MMS) has been validated for spine surgery as a feasible method for patients along their surgical journey through in-app education and completion of patient-reported outcomes surveys. Objective: The aim of this study is to determine the rates of 90-day emergency room (ER) visits, readmissions, and complications in patients undergoing spine surgery using MMS compared to patients using traditional perioperative care alone. Methods: Patients undergoing spine surgery at a US-based academic hospital were invited to use MMS perioperatively between December 2017 and September 2021. All patients received standard perioperative care and were classified as MMS users if they logged into the app. Demographic information and 90-day outcomes were acquired via electronic health record review. The odds ratios of having 90-day ER visits, readmissions, mild complications, and severe complications between the MMS and non-MMS groups were estimated using logistic regression models. Results: A total of 1015 patients were invited, with 679 using MMS. MMS users and nonusers had similar demographics: the average ages were 57.9 (SD 12.5) years and 61.5 (SD 12.7) years, 54.1% (367/679) and 47.3% (159/336) were male, and 90.1% (612/679) and 88.7% (298/336) had commercial or Medicare insurance, respectively. Cervical fusions (559/1015, 55.07%) and single-approach lumbar fusions (231/1015, 22.76%) were the most common procedures for all patients. MMS users had a lower 90-day readmission rate (55/679, 8.1%) than did nonusers (30/336, 8.9%). Mild complications (MMS: 56/679, 8.3%; non-MMS: 32/336, 9.5%) and severe complications (MMS: 66/679, 9.7%; non-MMS: 43/336, 12.8%) were also lower in MMS users. MMS users had a lower 90-day ER visit rate (MMS: 62/679, 9.1%; non-MMS: 45/336, 13.4%). After adjustments were made for age and sex, the odds of having 90-day ER visits for MMS users were 32% lower than those for nonusers, but this difference was not statistically significant (odds ratio 0.68, 95% CI 0.45-1.02; P=.06). Conclusions: This is one of the first studies to show differences in acute outcomes for people undergoing spine surgery who use a digital health app. This study found a correlation between MMS use and fewer postsurgical ER visits in a large group of spine surgery patients. A planned randomized controlled trial will provide additional evidence of whether this digital health tool can be used as an intervention to improve patient outcomes. %M 36287589 %R 10.2196/38690 %U https://periop.jmir.org/2022/1/e38690 %U https://doi.org/10.2196/38690 %U http://www.ncbi.nlm.nih.gov/pubmed/36287589 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 10 %P e38501 %T The Impact of a Theory-Based mHealth Intervention on Disease Knowledge, Self-efficacy, and Exercise Adherence Among Ankylosing Spondylitis Patients: Randomized Controlled Trial %A Song,Yuqing %A Reifsnider,Elizabeth %A Chen,Yanling %A Wang,Ying %A Chen,Hong %+ West China School of Nursing, West China Hospital, Sichuan University, No 37 Guoxue Xiang, Wuhou District, Chengdu, 610041, China, 86 189 8060 1733, 1366109878@qq.com %K rheumatic disease %K health belief model %K mobile health %K patient education %K WeChat %D 2022 %7 20.10.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: Patient education is recommended as an integral part of disease management in ankylosing spondylitis (AS), a chronic rheumatic disease that predominantly affects young males and requires long-term disease management. Convenient and cost-effective approaches to deliver patient education are required to these patients. Objective: This study aimed to examine the effects of a theory-based educational intervention delivered through a social networking app, WeChat, on disease knowledge, self-efficacy, exercise adherence, and health outcomes in Chinese AS patients. Methods: This study was a single-blind randomized controlled trial conducted in a tertiary hospital in Chengdu, China. Eligible participants were randomly allocated to the intervention or control group. Participants in the control group received standard care. The intervention group received the health belief model (HBM)-based educational intervention, consisting of 4 individual educational sessions and educational information sharing through WeChat, the predominant social networking app in China. The primary outcomes were disease knowledge, self-efficacy, and exercise adherence. The secondary outcomes were disease activity and physical function. Data were collected at baseline and at the end of the intervention (12th week). Chi-square test, t test, Mann-Whitney U tests were used to examine the effects of educational intervention. Results: This study included 118 patients with AS. The majority of participants were male (93/118, 78.8%). Around half of them were married (56/118, 47.5%), never smoked (70/118, 59.3%), and had college educational level or above (62/118, 52.5%). At posttest, participants in the intervention group had higher disease knowledge (all P<.001) and self-efficacy (P<.001), and a larger proportion of participants in the intervention group adhered to regular exercise routines than those in the control group (P=.003). The within-group analyses for the intervention group showed increases in all scores of disease knowledge (all P<.001) and self-efficacy score (P<.001), but only correct answer score (P=.04) and general knowledge score (P=.002) of disease knowledge in the control group improved. The within-group analysis for the control group found a decline of physical function (P=.002) but no significant change in disease activity (P>.05). The within-group analysis for the intervention group showed no significant change in disease activity or physical function (P>.05). At posttest, no statistically significant difference was found on disease activity or physical function between the intervention and control groups (P>.05). Conclusions: The HBM-based educational intervention through WeChat can effectively improve patient disease knowledge, self-efficacy, and exercise adherence. WeChat is feasible and effective to deliver patient education for patients with chronic diseases such as AS. This mHealth intervention can be integrated into routine rheumatology care. Trial Registration: Chinese Clinical Trial Registry ChiCTR-IPR-16009293; https://tinyurl.com/swxt8xk7 %M 36264605 %R 10.2196/38501 %U https://www.jmir.org/2022/10/e38501 %U https://doi.org/10.2196/38501 %U http://www.ncbi.nlm.nih.gov/pubmed/36264605 %0 Journal Article %@ 2371-4379 %I JMIR Publications %V 7 %N 3 %P e35039 %T Association Between Mobile Health App Engagement and Weight Loss and Glycemic Control in Adults With Type 2 Diabetes and Prediabetes (D’LITE Study): Prospective Cohort Study %A Lim,Su Lin %A Tay,Melissa Hui Juan %A Ong,Kai Wen %A Johal,Jolyn %A Yap,Qai Ven %A Chan,Yiong Huak %A Yeo,Genevieve Kai Ning %A Khoo,Chin Meng %A Yaxley,Alison %+ Department of Dietetics, National University Hospital, 5 Lower Kent Ridge Road, Singapore, 119074, Singapore, 65 67724580, su_lin_lim@nuhs.edu.sg %K engagement %K diabetes %K prediabetes %K mobile health %K mHealth %K mobile apps %K weight loss %K glycemic control %K glycated hemoglobin %K HbA1c change %K mobile phone %D 2022 %7 30.9.2022 %9 Original Paper %J JMIR Diabetes %G English %X Background: Mobile health apps are increasingly used as early intervention to support behavior change for diabetes prevention and control, with the overarching goal of lowering the overall disease burden. Objective: This prospective cohort study conducted in Singapore aimed to investigate app engagement features and their association with weight loss and improved glycemic control among adults with diabetes and prediabetes from the intervention arm of the Diabetes Lifestyle Intervention using Technology Empowerment randomized controlled trial. Methods: Diabetes and prediabetes participants (N=171) with a median age of 52 years, BMI of 29.3 kg/m2, and glycated hemoglobin (HbA1c) level of 6.5% and who were being assigned the Nutritionist Buddy Diabetes app were included. Body weight and HbA1c were measured at baseline, 3 months, and 6 months. A total of 476,300 data points on daily app engagement were tracked via the backend dashboard and developer’s report. The app engagement data were analyzed by quartiles and weekly means expressed in days per week. Linear mixed model analysis was used to determine the associations between the app engagements with percentage weight and HbA1c change. Results: The median overall app engagement rate was maintained above 90% at 6 months. Participants who were actively engaged in ≥5 app features were associated with the greatest overall weight reduction of 10.6% from baseline (mean difference −6, 95% CI −8.9 to −3.2; P<.001) at 6 months. Adhering to the carbohydrate limit of >5.9 days per week and choosing healthier food options for >4.3 days per week had the most impact, eliciting weight loss of 9.1% (mean difference −5.2, 95% CI −8.2 to −2.2; P=.001) and 8.8% (mean difference −4.2, 95% CI −7.1 to −1.3; P=.005), respectively. Among the participants with diabetes, those who had a complete meal log for >5.1 days per week or kept within their carbohydrate limit for >5.9 days per week each achieved greater HbA1c reductions of 1.2% (SD 1.3%; SD 1.5%), as compared with 0.2% (SD 1%; SD 0.6%). in the reference groups who used the features <1.1 or ≤2.5 days per week, respectively. Conclusions: Higher app engagement led to greater weight loss and HbA1c reduction among adults with overweight or obesity with type 2 diabetes or prediabetes. Trial Registration: Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12617001112358; https://anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12617001112358 %M 36178718 %R 10.2196/35039 %U https://diabetes.jmir.org/2022/3/e35039 %U https://doi.org/10.2196/35039 %U http://www.ncbi.nlm.nih.gov/pubmed/36178718 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 10 %N 9 %P e37868 %T Using the Positive Peers Mobile App to Improve Clinical Outcomes for Young People With HIV: Prospective Observational Cohort Comparison %A Step,Mary M %A McMillen Smith,Jennifer %A Lewis,Steven A %A Avery,Ann K %+ College of Public Health, Kent State University, Lowry Hall, 305b, 750 Hilltop Drive, Kent, OH, 44242, United States, 1 330 672 2630, mstep@kent.edu %K mobile health %K mHealth %K HIV %K Positive Peers %K retention in care %K re-engagement in care %K viral suppression %D 2022 %7 28.9.2022 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Disparities in HIV outcomes persist among racial, gender, and sexual minorities in the United States. Younger people face a greater risk of contracting HIV, often living without knowledge of their HIV status for long periods. The Positive Peers App (PPA) is a multifunctional HIV support tool designed to improve HIV-related clinical outcomes for young people with HIV. The app was designed according to the specifications of an in-care young adult HIV community in Northeast Ohio. Data provided in this study provide preliminary evidence of the usefulness of PPA as a relevant tool for engaging this clinical patient population in care and facilitating viral suppression. Objective: In this study, we aimed to describe variations in PPA use and examine the associations between use and HIV clinical outcomes between self-selected user and nonuser cohorts in the same clinical population. Methods: The PPA was offered free of charge to persons with HIV, aged 13 to 34 years of age, diagnosed with HIV within the last 12 months, out of care for 6 months during the last 24 months, or not virally suppressed (HIV viral load >200 copies/mL) in the prior 24 months. Baseline and 6- and 12-month surveys were administered via an audio computer-assisted self-interviewing system to all participants. The app’s user activity was tracked natively by the app and stored in a secure server. Participant demographic and HIV care data were extracted from clinical records within 12 months before the start of the study and across the duration of the study period. HIV care outcomes of PPA users (n=114) were compared with those of nonusers (n=145) at the end of the study period (n=259). Results: The analysis showed that younger PPA users (aged 13-24 years) were more likely to obtain HIV laboratories (adjusted odds ratio 2.85, 95% CI 1.03-7.90) and achieve sustained viral suppression than nonusers (adjusted odds ratio 4.2, 95% CI 1.2-13.9). Conclusions: The PPA appears to help younger users sustain HIV suppression. The app offers an important tool for addressing this critical population. The PPA remains in the field and is currently being adopted by other localities to facilitate their efforts to end the HIV epidemic. Although our reported observational results require additional validation and stringent ongoing surveillance, the results represent our best efforts in a pilot study to provide a measure of efficacy for the PPA. Next steps include a large-scale evaluation of the PPA acceptability and effectiveness. Given the building evidence of user reports and outcomes, the freely available PPA could be a helpful tool for achieving Ending the HIV Epidemic goals. %M 36170001 %R 10.2196/37868 %U https://mhealth.jmir.org/2022/9/e37868 %U https://doi.org/10.2196/37868 %U http://www.ncbi.nlm.nih.gov/pubmed/36170001 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 10 %N 9 %P e33247 %T mHealth Apps Using Behavior Change Techniques to Self-report Data: Systematic Review %A Aguiar,Maria %A Trujillo,Maria %A Chaves,Deisy %A Álvarez,Roberto %A Epelde,Gorka %+ Vicomtech Foundation, Basque Research and Technology Alliance, Paseo Mikeletegi 57, Donostia-San Sebastián, 20009, Spain, 34 943 30 92 30, maria.aguiar@correounivalle.edu.co %K mobile health %K mHealth %K behavior change techniques %K adherence %K app %K mobile health interventions %K behavior %D 2022 %7 9.9.2022 %9 Review %J JMIR Mhealth Uhealth %G English %X Background: The popularization of mobile health (mHealth) apps for public health or medical care purposes has transformed human life substantially, improving lifestyle behaviors and chronic condition management. Objective: This review aimed to identify behavior change techniques (BCTs) commonly used in mHealth, assess their effectiveness based on the evidence reported in interventions and reviews to highlight the most appropriate techniques to design an optimal strategy to improve adherence to data reporting, and provide recommendations for future interventions and research. Methods: We performed a systematic review of studies published between 2010 and 2021 in relevant scientific databases to identify and analyze mHealth interventions using BCTs that evaluated their effectiveness in terms of user adherence. Search terms included a mix of general (eg, data, information, and adherence), computer science (eg, mHealth and BCTs), and medicine (eg, personalized medicine) terms. Results: This systematic review included 24 studies and revealed that the most frequently used BCTs in the studies were feedback and monitoring (n=20), goals and planning (n=14), associations (n=14), shaping knowledge (n=12), and personalization (n=7). However, we found mixed effectiveness of the techniques in mHealth outcomes, having more effective than ineffective outcomes in the evaluation of apps implementing techniques from the feedback and monitoring, goals and planning, associations, and personalization categories, but we could not infer causality with the results and suggest that there is still a need to improve the use of these and many common BCTs for better outcomes. Conclusions: Personalization, associations, and goals and planning techniques were the most used BCTs in effective trials regarding adherence to mHealth apps. However, they are not necessarily the most effective since there are studies that use these techniques and do not report significant results in the proposed objectives; there is a notable overlap of BCTs within implemented app components, suggesting a need to better understand best practices for applying (a combination of) such techniques and to obtain details on the specific BCTs used in mHealth interventions. Future research should focus on studies with longer follow-up periods to determine the effectiveness of mHealth interventions on behavior change to overcome the limited evidence in the current literature, which has mostly small-sized and single-arm experiments with a short follow-up period. %M 36083606 %R 10.2196/33247 %U https://mhealth.jmir.org/2022/9/e33247 %U https://doi.org/10.2196/33247 %U http://www.ncbi.nlm.nih.gov/pubmed/36083606 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 8 %P e37163 %T Delivering an mHealth Adherence Support Intervention for Patients With HIV: Mixed Methods Process Evaluation of the Philippines Connect for Life Study %A O'Connor,Cara %A Leyritana,Katerina %A Doyle,Aoife M %A Birdthistle,Isolde %A Lewis,James J %A Gill,Randeep %A Salvaña,Edsel Maurice %+ Faculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, Keppel Street, London, WC1E 7HT, United Kingdom, 44 791336248, caraoc@gmail.com %K mobile health %K mHealth %K adherence %K HIV %K antiretroviral therapy %K process evaluation %K Philippines %K men who have sex with men %K MSM %K mobile phone %D 2022 %7 12.8.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: The Philippines HIV epidemic is one of the fastest growing epidemics globally, and infections among men who have sex with men are increasing at an alarming rate. Connect for Life Philippines is a mobile health (mHealth) intervention that supports antiretroviral therapy (ART) adherence in this key population through individualized voice calls and SMS text messages. Objective: The objective of this process evaluation is to assess the intervention reach, dose delivered and received, fidelity, and acceptability and to describe contextual factors affecting the implementation of an mHealth adherence support intervention for patients on ART in a clinic in Metro Manila, Philippines. Methods: A mixed methods process evaluation approach was used in an observational cohort study. Quantitative data sources for the process evaluation were call and SMS text message logs obtained from the mHealth platform and questionnaires collected at 12-, 24-, and 48-week study visits. Qualitative data were collected from process reports and through a series of focus group discussions conducted with a subset of participants during the intervention development phase, after an initial 8-week pilot phase, and at the end of the study. Results: The 462 study participants received 31,095 interactive voice calls and 8234 SMS text messages during the study. Owing to technical issues, intervention fidelity was low, with only 22.1% (102/462) of the participants receiving reminders via voice calls and others (360/462, 77.9%) receiving only SMS text messages during the intervention. After 48 weeks in the study, 63.5% (293/462) of the participants reported that they would be quite likely or very likely to recommend the program to a friend, and 53.8% (249/462) of the participants reported that they benefited quite a bit or very much from the intervention. Participants who were on ART for <6 months at the beginning of the study and those who received the daily or weekly pill reminders were more likely to report that they benefited from the intervention (P=.02 and P=.01, respectively). Conclusions: The Connect for Life intervention had high participant satisfaction and acceptability, especially among those who received high dose of the intervention. However, poor reliability of local telecommunication networks had a large impact on the intervention’s usability, fidelity, and dose received. %M 35969425 %R 10.2196/37163 %U https://formative.jmir.org/2022/8/e37163 %U https://doi.org/10.2196/37163 %U http://www.ncbi.nlm.nih.gov/pubmed/35969425 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 8 %P e37936 %T Effect of a Reminder System on Pre-exposure Prophylaxis Adherence in Men Who Have Sex With Men: Prospective Cohort Study Based on WeChat Intervention %A Lin,Bing %A Liu,Jiaxiu %A He,Wei %A Pan,Haiying %A Ma,Yingjie %A Zhong,Xiaoni %+ School of Public Health and Management, Chongqing Medical University, No.1 Medical College Road, Yuzhong District, Chongqing, 400042, China, 86 13308368059, zhongxiaoni@cqmu.edu.cn %K pre-exposure prophylaxis (PrEP) %K adherence %K reminder system %K men who have sex with men (MSM) %K WeChat %K oral PrEP %K HIV prevention %K MSM %K reminder %K message %D 2022 %7 11.8.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: The efficacy of pre-exposure prophylaxis (PrEP) is highly dependent on adherence, and one of the main reasons for poor adherence is forgetfulness. Therefore, it is important to explore how to remind users to take their medicine on time. Objective: This study aims to explore the effect of a reminder system on PrEP adherence in men who have sex with men (MSM) to improve adherence. The main function of the reminder system based on the WeChat social media app is to send daily messages to PrEP users reminding them to take their medicine. Methods: An open-label, multicenter, prospective cohort study of PrEP in HIV-negative MSM was conducted from November 2019 to June 2021. Study participants who met the criteria were randomly divided into 2 groups: no-reminder group and reminder group. Both groups received daily oral PrEP with follow-up every 3 months. Adherence was measured on the basis of self-report and was defined as the percentage of medications taken on time. Participants in the reminder group scanned a WeChat QR code and received a reminder message every day. Participants in the no-reminder group took daily oral medicines without reminders. The longitudinal trajectories of adherence for both groups were displayed to compare the variability in adherence at each time point. The association between the changes in adherence (no change, improvement, decline) at each time point and the use of the reminder system was analyzed by multinomial logistic regression models to further explore the effectiveness of the system. Results: A total of 716 MSM were included in the analysis, that is, 372 MSM in the no-reminder group and 344 MSM in the reminder group. Adherence in the no-reminder group fluctuated between 0.75 and 0.80 and that in the reminder group gradually increased over time from 0.76 to 0.88. Adherence at each time point was not statistically different between the 2 groups. Further analysis showed that an improvement in adherence in the early stage was associated with the use of the reminder system (odds ratio [OR] 1.65, 95% CI 1.01-2.70; P=.04). An improvement in average adherence compared to initial adherence was positively associated with the use of the reminder system (OR 1.82, 95% CI 1.10-3.01; P=.02). Conclusions: The effect of the reminder system on PrEP adherence in MSM was more significant in the early stage, which is related to the increased motivation of users and the development of medicine-taking habits. The reminder system is potentially effective for early-stage medicine management, encouraging users to develop healthy medicine-taking habits and to increase their adherence. Trial Registration: Chinese Clinical Trial ChiCTR190026414; http://www.chictr.org.cn/showproj.aspx?proj=35077 %M 35969436 %R 10.2196/37936 %U https://www.jmir.org/2022/8/e37936 %U https://doi.org/10.2196/37936 %U http://www.ncbi.nlm.nih.gov/pubmed/35969436 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 8 %P e38247 %T Programmatic Adoption and Implementation of Video-Observed Therapy in Minnesota: Prospective Observational Cohort Study %A Bachina,Preetham %A Lippincott,Christopher Kirk %A Perry,Allison %A Munk,Elizabeth %A Maltas,Gina %A Bohr,Rebecca %A Rock,Robert Bryan %A Shah,Maunank %+ Division of Infectious Diseases, Johns Hopkins School of Medicine, CRB-II, 1M-10, 1550 Orleans St, Baltimore, MD, 21287, United States, 1 4432870401, mshah28@jhmi.edu %K video directly observed therapy %K vDOT %K mobile health %K mHealth %K tuberculosis %K medication adherence %K telemedicine %K treatment %K telehealth %K observed therapy %K COVID-19 %K primary outcome %K treatment adherence %K technology adoption %K virtual health %D 2022 %7 5.8.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: In-person directly observed therapy (DOT) is standard of care for tuberculosis (TB) treatment adherence monitoring in the US, with increasing use of video-DOT (vDOT). In Minneapolis, vDOT became available in 2019. Objective: In this paper, we aimed to evaluate the use and effectiveness of vDOT in a program setting, including comparison of verified adherence among those receiving vDOT and in-person DOT. We also sought to understand the impact of COVID-19 on TB treatment adherence and technology adoption. Methods: We abstracted routinely collected data on individuals receiving therapy for TB in Minneapolis, MN, between September 2019 and June 2021. Our primary outcomes were to assess vDOT use and treatment adherence, defined as the proportion of prescribed doses (7 days per week) verified by observation (in person versus video-DOT), and to compare individuals receiving therapy in the pre–COVID-19 (before March 2020), and post–COVID-19 (after March 2020) periods; within the post–COVID-19 period, we evaluated early COVID-19 (March-August 2020), and intra–COVID-19 (after August 2020) periods. Results: Among 49 patients with TB (mean age 41, SD 19; n=27, 55% female and n=47, 96% non–US born), 18 (36.7%) received treatment during the post–COVID-19 period. Overall, verified adherence (proportion of observed doses) was significantly higher when using vDOT (mean 81%, SD 17.4) compared to in-person DOT (mean 54.5%, SD 10.9; P=.001). The adoption of vDOT increased significantly from 35% (11/31) of patients with TB in the pre–COVID-19 period to 67% (12/18) in the post–COVID-19 period (P=.04). Consequently, overall verified (ie, observed) adherence among all patients with TB in the clinic improved across the study periods (56%, 67%, and 79%, P=.001 for the pre–, early, and intra–COVID-19 periods, respectively). Conclusions: vDOT use increased after the COVID-19 period, was more effective than in-person DOT at verifying ingestion of prescribed treatment, and led to overall increased verified adherence in the clinic despite the onset of the COVID-19 pandemic. %M 35834671 %R 10.2196/38247 %U https://formative.jmir.org/2022/8/e38247 %U https://doi.org/10.2196/38247 %U http://www.ncbi.nlm.nih.gov/pubmed/35834671 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 11 %N 7 %P e39098 %T An mHealth App to Promote Adherence to Immunosuppressant Medication and Track Symptoms in Children After Hematopoietic Stem Cell Transplant: Protocol for a Mixed Methods Usability Study %A Skeens,Micah %A Sezgin,Emre %A Stevens,Jack %A Landier,Wendy %A Pai,Ahna %A Gerhardt,Cynthia %+ Center for Biobehavioral Health, Abigail Wexner Research Institute, Nationwide Children's Hospital, North East Office Building, 3rd floor, 700 Children's Drive, Columbus, OH, 43205, United States, 1 6147228958, micah.skeens@nationwidechildrens.org %K medication adherence %K digital health %K mHealth %K pediatrics %K app %K bone marrow transplant %K adherence %K usability %K feasibility %K caregivers %K children %K hematopoietic stem cell transplant %K HSCT %D 2022 %7 21.7.2022 %9 Protocol %J JMIR Res Protoc %G English %X Background: In the United States, poor adherence accounts for up to 70% of all medication-related hospital admissions, resulting in $100 billion in health care costs annually. In pediatrics, adherence is largely dependent on caregivers. In a high-risk hematopoietic stem cell transplant (HSCT) population, caregivers are isolated with their child due to infection risk and must manage challenging treatment regimens at home, often with limited time and support. Complex behavioral interventions, typically employed to address adherence, are difficult to deliver and manage in the context of these daily tasks. The most successful adherence interventions, and thus improved clinical outcomes, have included mobile health (mHealth) reminder approaches and a direct measure of adherence. Objective: This is a 3-phase project, with this protocol describing phase 2, to determine the usability and feasibility of an mHealth app (BMT4me) designed to promote adherence to immunosuppressant medication and to track symptoms among children who received HSCT. Methods: This study uses an iterative convergent mixed methods design to develop and assess the usability and feasibility of an adherence digital health intervention. We will recruit 15 caregivers of pediatric patients receiving HSCT to complete user testing. Qualitative and quantitative data will be integrated to enhance and expand upon study findings. Results: Enrollment began in September 2021 and is ongoing. A total of 7 caregivers have enrolled. We anticipate completion by fall 2022. We anticipate high usability scores and a better understanding of unique features within the app that are needed for HSCT families post transplant. To date, usability scores among enrolled participants are greater than 70%. Feedback from qualitative interviews is being used to further adapt the app by adding specific weekly logs, call provider options, and voice to text. Conclusions: This protocol describes a mixed methods usability and feasibility study to develop and implement a smartphone app for caregivers of children receiving HSCT. The app was designed to improve immunosuppressant adherence and to track symptoms in the acute phase post discharge. Study findings will inform further refinement of the app and the feasibility of a pilot randomized controlled trial examining efficacy on clinical outcomes. Trial Registration: ClinicalTrials.gov NCT04976933; https://clinicaltrials.gov/ct2/show/NCT04976933 International Registered Report Identifier (IRRID): DERR1-10.2196/39098 %M 35862184 %R 10.2196/39098 %U https://www.researchprotocols.org/2022/7/e39098 %U https://doi.org/10.2196/39098 %U http://www.ncbi.nlm.nih.gov/pubmed/35862184 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 11 %N 7 %P e38796 %T Tuberculosis Treatment Compliance Under Smartphone-Based Video-Observed Therapy Versus Community-Based Directly Observed Therapy: Protocol for a Cluster Randomized Controlled Trial %A Kumwichar,Ponlagrit %A Chongsuvivatwong,Virasakdi %A Prappre,Tagoon %+ Epidemiology Department, Faculty of Medicine, Prince of Songkla University, 15 Kanjanavanich Rd, Kho Hong, Hat Yai District, 90110, Thailand, 66 74451165, cvirasak@medicine.psu.ac.th %K VOT %K VDOT %K video-enhanced therapy %K tuberculosis %K health care system %K observed therapy %K video-observed therapy %K treatment compliance %K lung disease %K randomized trial %K digital health %K telehealth %K telemedicine %D 2022 %7 8.7.2022 %9 Protocol %J JMIR Res Protoc %G English %X Background: The health care system in Thailand has struggled to cope with the COVID-19 pandemic, resulting in decreased administration of community-based directly observed therapy (DOT) for tuberculosis (TB). As an alternative to failed DOT, video-observed therapy (VOT) or the Thai asynchronous VOT system, “TH VOT,” was devised. We developed a protocol for a study to test the superiority of VOT over DOT in ensuring treatment compliance. Objective: We aim to compare the mean cumulative compliance days of TB patients and their observers under the VOT program with that of individuals under the DOT program during the intensive phase of TB treatment. Methods: A cluster randomized controlled trial of pulmonary TB patients and their observers will be conducted over a 2-month period. This study will be conducted in the Hat Yai and Meuang Songkhla districts of Songkhla Province, Southern Thailand. A total of 38 observers working at 38 primary care units (PCUs) will be randomized equally into VOT and DOT groups. The TH VOT system will be implemented in 19 PCUs in the VOT group while the other 19 PCUs will continue with the traditional DOT program. Approximately 1-5 TB patients will be under observation, depending on the PCU jurisdiction in which the patients reside. The inclusion criteria for TB patients will be as follows: patients diagnosed with newly active pulmonary TB with a positive acid-fast bacilli sputum smear, aged >18 years, own a smartphone, and are able to use the LINE (Line Corporation) app. The exclusion criteria will be patients with a condition that requires the intervention of a specialist, rifampicin resistance according to a cartridge-based nucleic acid amplification test (GeneXpert MTB/RIF), unable to continue the treatment, and/or alcohol dependence. After the 2-month observation period, all sessions and follow-up clinical outcomes recorded will be retrieved. An intention-to-treat analysis will be performed to assess the compliance of both patients undergoing drug administration and their observers. Results: The Human Research Ethics Committee, Faculty of Medicine, Prince of Songkla University approved the trial on February 19, 2021 (approval number 64-03618-9). The trial was funded in May 2021. The recruitment period will be from January 2022 to July 2022. The observation is scheduled to end by September 2022. Conclusions: If the VOT shows superiority in observational compliance among patients and observers, the existing DOT policy will be replaced with VOT. Trial Registration: Thai Clinical Trials Registry TCTR20210624002; https://www.thaiclinicaltrials.org/show/TCTR20210624002 International Registered Report Identifier (IRRID): DERR1-10.2196/38796 %M 35802403 %R 10.2196/38796 %U https://www.researchprotocols.org/2022/7/e38796 %U https://doi.org/10.2196/38796 %U http://www.ncbi.nlm.nih.gov/pubmed/35802403 %0 Journal Article %@ 2371-4379 %I JMIR Publications %V 7 %N 2 %P e33264 %T Smartphone Apps for Diabetes Medication Adherence: Systematic Review %A Islam,Sheikh Mohammed Shariful %A Mishra,Vinaytosh %A Siddiqui,Muhammad Umer %A Moses,Jeban Chandir %A Adibi,Sasan %A Nguyen,Lemai %A Wickramasinghe,Nilmini %+ Institute for Physical Activity and Nutrition, School of Exercise and Nutrition Sciences, Faculty of Health, Deakin University, 221 Burwood Highway, Burwood, Melbourne, 3125, Australia, 61 0392468393, shariful@deakin.edu.au %K smartphones %K digital health %K diabetes %K medication adherence %K applications %K apps %K mHealth %K mobile health %K task-technology fit %D 2022 %7 21.6.2022 %9 Review %J JMIR Diabetes %G English %X Background: Diabetes is one of the leading noncommunicable chronic diseases globally. In people with diabetes, blood glucose levels need to be monitored regularly and managed adequately through healthy lifestyles and medications. However, various factors contribute to poor medication adherence. Smartphone apps can improve medication adherence in people with diabetes, but it is not clear which app features are most beneficial. Objective: This study aims to systematically review and evaluate high-quality apps for diabetes medication adherence, which are freely available to the public in Android and Apple app stores and present the technical features of the apps. Methods: We systematically searched Apple App Store and Google Play for apps that assist in diabetes medication adherence, using predefined selection criteria. We assessed apps using the Mobile App Rating Scale (MARS) and calculated the mean app-specific score (MASS) by taking the average of app-specific scores on 6 dimensions, namely, awareness, knowledge, attitudes, intention to change, help-seeking, and behavior change rated on a 5-point scale (1=strongly disagree and 5=strongly agree). We used the mean of the app’s performance on these 6 dimensions to calculate the MASS. Apps that achieved a total MASS mean quality score greater than 4 out of 5 were considered to be of high quality in our study. We formulated a task-technology fit matrix to evaluate the apps for diabetes medication adherence. Results: We identified 8 high-quality apps (MASS score≥4) and presented the findings under 3 main categories: characteristics of the included apps, app features, and diabetes medication adherence. Our framework to evaluate smartphone apps in promoting diabetes medication adherence considered physiological factors influencing diabetes and app features. On evaluation, we observed that 25% of the apps promoted high adherence and another 25% of the apps promoted moderate adherence. Finally, we found that 50% of the apps provided low adherence to diabetes medication. Conclusions: Our findings show that almost half of the high-quality apps publicly available for free did not achieve high to moderate medication adherence. Our framework could have positive implications for the future design and development of apps for patients with diabetes. Additionally, apps need to be evaluated using a standardized framework, and only those promoting higher medication adherence should be prescribed for better health outcomes. %M 35727613 %R 10.2196/33264 %U https://diabetes.jmir.org/2022/2/e33264 %U https://doi.org/10.2196/33264 %U http://www.ncbi.nlm.nih.gov/pubmed/35727613 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 10 %N 6 %P e31491 %T Validation Parameters of Patient-Generated Data for Digitally Recorded Allergic Rhinitis Symptom and Medication Scores in the @IT.2020 Project: Exploratory Study %A Dramburg,Stephanie %A Perna,Serena %A Di Fraia,Marco %A Tripodi,Salvatore %A Arasi,Stefania %A Castelli,Sveva %A Villalta,Danilo %A Buzzulini,Francesca %A Sfika,Ifigenia %A Villella,Valeria %A Potapova,Ekaterina %A Brighetti,Maria Antonia %A Travaglini,Alessandro %A Verardo,Pierluigi %A Pelosi,Simone %A Matricardi,Paolo Maria %+ Department of Pediatric Respiratory Medicine, Immunology and Critical Care Medicine, Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Augustenburgerplatz, 1, Berlin, 13353, Germany, 49 30 450 566 406, paolo.matricardi@charite.de %K allergic rhinitis %K symptom scores %K patient-generated data %K patient-reported outcomes %K mHealth %K mobile health %K health applications %K allergies %K allergy monitor %K digital health %K medication scores %D 2022 %7 3.6.2022 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Mobile health technologies enable allergists to monitor disease trends by collecting daily patient-reported outcomes of allergic rhinitis. To this end, patients with allergies are usually required to enter their symptoms and medication repetitively over long time periods, which may present a risk to data completeness and quality in the case of insufficient effort reporting. Completeness of patient’s recording is easily measured. In contrast, the intrinsic quality and accuracy of the data entered by the patients are more elusive. Objective: The aim of this study was to explore the association of adherence to digital symptom recording with a predefined set of parameters of the patient-generated symptom and medication scores and to identify parameters that may serve as proxy measure of the quality and reliability of the information recorded by the patient. Methods: The @IT.2020 project investigates the diagnostic synergy of mobile health and molecular allergology in patients with seasonal allergic rhinitis. In its pilot phase, 101 children with seasonal allergic rhinitis were recruited in Rome and instructed to record their symptoms, medication intake, and general conditions daily via a mobile app (AllergyMonitor) during the relevant pollen season. We measured adherence to daily recording as the percentage of days with data recording in the observation period. We examined the patient’s trajectories of 3 disease indices (Rhinoconjunctivitis Total Symptom Score [RTSS], Combined Symptom and Medication Score [CSMS], and Visual Analogue Scale [VAS]) as putative proxies of data quality with the following 4 parameters: (1) intravariation index, (2) percentage of zero values, (3) coefficient of variation, and (4) percentage of changes in trend. Lastly, we examined the relationship between adherence to recording and each of the 4 proxy measures. Results: Adherence to recording ranged from 20% (11/56) to 100% (56/56), with 64.4% (65/101) and 35.6% (36/101) of the patients’ values above (highly adherent patients) or below (low adherent patients) the threshold of 80%, respectively. The percentage of zero values, the coefficient of variation, and the intravariation index did not significantly change with the adherence to recording. By contrast, the proportion of changes in trend was significantly higher among highly adherent patients, independently from the analyzed score (RTSS, CSMS, and VAS). Conclusions: The percentage of changes in the trend of RTSS, CSMS, and VAS is a valuable candidate to validate the quality and accuracy of the data recorded by patients with allergic rhinitis during the pollen season. The performance of this parameter must be further investigated in real-life conditions before it can be recommended for routine use in apps and electronic diaries devoted to the management of patients with allergic rhinitis. %M 35657659 %R 10.2196/31491 %U https://mhealth.jmir.org/2022/6/e31491 %U https://doi.org/10.2196/31491 %U http://www.ncbi.nlm.nih.gov/pubmed/35657659 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 5 %P e34906 %T An In-Home Medication Dispensing System to Support Medication Adherence for Patients With Chronic Conditions in the Community Setting: Prospective Observational Pilot Study %A Patel,Tejal %A Ivo,Jessica %A Pitre,Teresa %A Faisal,Sadaf %A Antunes,Kristen %A Oda,Kasumi %+ School of Pharmacy, University of Waterloo, 10 Victoria Street S, Kitchener, ON, N2G 1C5, Canada, 1 519 888 4567 ext 21337, t5patel@uwaterloo.ca %K smart %K medication adherence %K usability %K geriatric %K in-home %K community %K chronic diseases %K medication dispensing %K eHealth %K platform %K self management %K support tool %K chronic disease %K caregiver %K usability %K satisfaction %D 2022 %7 19.5.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: Innovative digital technology systems that support and monitor real-time medication intake are now available commercially; however, there is limited knowledge of the use of such technology in patients’ homes. One such smart medication dispenser, spencer, provides alerts to patients to take their medications and allows for tracking and reporting real-time medication adherence data. Objective: The objectives of this study were to examine the use of a smart medication dispenser as a medication adherence and self-management support tool for community dwelling adults over a 6-month period, in addition to usability, usefulness, satisfaction, and impact on caregiver support. Methods: This prospective, observational study invited community-dwelling adults aged 45 years and older taking at least one chronic medication and their caregivers to use this smart medication dispenser for their medication administration for 6 months. Adherence was defined as a dose intake within 2 hours post scheduled time. Real-time adherence data were collected using the smart medication dispenser and the AdhereNet platform. Usability, usefulness, and satisfaction were measured using the System Usability Scale and the Usefulness, Satisfaction, and Ease of Use questionnaire, respectively. Caregiver burden was measured on a visual analog scale at baseline and at the end of the 6-month study period. Results: A total of 58 participants were recruited, of which 55% (32/58) were female with a mean age of 66.36 (SD 11.28; range 48-90) years. Eleven caregiver participants were recruited, of whom 91% (10/11) were female. The average monthly adherence over 6 months was 98% (SD 3.1%; range 76.5%-100%). The average System Usability score was 85.74 (n=47; SD 12.7; range 47.5-100). Of the 46 participants who provided data, 44 (96%) rated the product as easy, 43 (93%) as simple to use, and 43 (93%) were satisfied with the product. Caregiver burden prior to and following smart medication dispenser use for 6 months was found to be statistically significantly different (P<.001; CI 2.11-5.98). Conclusions: Smart medication adherence products such as spencer, when connected and clinically monitored, can be a useful solution for medication management and have the potential to improve caregiver burden. %M 35587371 %R 10.2196/34906 %U https://formative.jmir.org/2022/5/e34906 %U https://doi.org/10.2196/34906 %U http://www.ncbi.nlm.nih.gov/pubmed/35587371 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 11 %N 5 %P e36845 %T A Skills-Based HIV Serostatus Disclosure Intervention for Sexual Minority Men in South Africa: Protocol for Intervention Adaptation and a Pilot Randomized Controlled Trial %A Daniels,Joseph %A Peters,Remco P H %A Medina-Marino,Andrew %A Bongo,Cikizwa %A Stephenson,Rob %+ Edson College of Nursing and Health Innovation, Arizona State University, 550 N 3rd St, Phoenix, AZ, 85004, United States, 1 602 496 2644, daniels.joseph@gmail.com %K gay %K bisexual %K men who have sex with men %K HIV intervention adaptation %K videoconference delivery %K HIV %K public health %K mobile phone %D 2022 %7 16.5.2022 %9 Protocol %J JMIR Res Protoc %G English %X Background: Gay, bisexual, and other men who have sex with men (GBMSM) living with HIV have low antiretroviral treatment adherence in South Africa due to limited skills in managing disclosure and prevention behaviors with sexual and romantic partners. As a result, there is a high HIV transmission risk within HIV-discordant partnerships, but an existing intervention may address these outcomes, if adapted effectively. Healthy Relationships (HR) is a behavioral intervention that was originally delivered in groups and in person over 5 sessions to develop coping skills for managing HIV-related stress and sexually risky situations, enhance decision-making skills for HIV disclosure to partners, and establish and maintain safer sex practices with partners. HR effectively improves prevention behaviors but has yet to be tailored to a non-US context. Objective: We aim to adapt HR into a new culturally grounded intervention entitled Speaking Out & Allying Relationships for GBMSM and then assess its feasibility in Eastern Cape, South Africa. Methods: The study will have 2 aims. For aim 1—adaptation—we will use a human-centered design approach. Initial intervention tailoring will involve integrating Undetectable=Untransmittable and pre-exposure prophylaxis education, developing intervention content for a videoconference format, and designing role-plays and movies for skill building based on preliminary data. Afterward, interviews and surveys will be administered to GBMSM to assess intervention preferences, and a focus group will be conducted with health care providers and information technology experts to assess the intervention’s design. Finally, a usability test will be performed to determine functionality and content understanding. Participants will be GBMSM living with HIV (n=15) who are in a relationship and health care providers and information technology (n=7) experts working in HIV care and programming with this population. For aim 2, we will examine the feasibility of the adapted intervention by using a pilot randomized control design. There will be 60 individuals per arm. Feasibility surveys and interviews will be conducted with the intervention arm, and behavioral and biomedical assessments for relationship and treatment adherence outcomes will be collected for both arms. All participants will be GBMSM living with HIV who are in a relationship with an HIV-negative or unknown status partner. Results: Intervention adaptation began in August 2021. Initial tailoring and the refining of GBMSM intervention preferences were completed in December 2021. Usability and feasibility assessments are due to be completed by March 2022 and February 2024, respectively. Conclusions: GBMSM need efficacious interventions that tackle partnership dynamics, HIV prevention, and treatment outcomes for antiretroviral treatment adherence and viral suppression in South Africa. Harnessing everyday technology use for social networking (eg, videoconferences), Undetectable=Untransmittable education, and pre-exposure prophylaxis to update an existing intervention for South African GBMSM has the potential to strengthen relationship communication about HIV treatment and prevention and, in turn, improve outcomes. International Registered Report Identifier (IRRID): DERR1-10.2196/36845 %M 35576574 %R 10.2196/36845 %U https://www.researchprotocols.org/2022/5/e36845 %U https://doi.org/10.2196/36845 %U http://www.ncbi.nlm.nih.gov/pubmed/35576574 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 5 %P e37124 %T The Acceptability of Adherence Support via Mobile Phones for Antituberculosis Treatment in South India: Exploratory Study %A Jose,Nisha K %A Vaz,Clint %A Chai,Peter R %A Rodrigues,Rashmi %+ Non Communicable Diseases Division, Indian Council of Medical Research, Ansari Nagar, New Delhi, 110029, India, 91 9717660464, cathnisha@gmail.com %K adherence %K tuberculosis %K antitubercular therapy %K mHealth %K mobile health %K digital health %K South India %K technology acceptance %K health intervention %D 2022 %7 13.5.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: India has the greatest burden of tuberculosis (TB). However, over 15% of the people on antitubercular therapy (ATT) in India are nonadherent. Several adherence monitoring techniques deployed in India to enhance ATT adherence have had modest effects. Increased adoption of mobile phones and other technologies pose potential solutions to measuring and intervening in ATT adherence. Several technology-based interventions around ATT adherence have been demonstrated in other countries. Objective: The objective of our study was to understand the acceptance of mobile phone adherence supports for ATT using self-administered quantitative measures among patients with TB in South India. Methods: This exploratory study was conducted at a TB treatment center (TTC) at a tertiary care center in Thrissur District, Kerala, India. We recruited 100 patients with TB on ATT using convenience sampling after obtaining written informed consent. Trained study staff administered the questionnaire in Malayalam, commonly spoken in Kerala, India. We used frequency, mean, median, and SD or IQR to describe the data. Results: Of the 100 participants diagnosed with TB on ATT, 90% used mobile phones routinely, and 84% owned a mobile phone. Ninety-five percent of participants knew how to use the calling function, while 65% of them did not know how to use the SMS function on their mobile phone. Overall, 89% of the participants did not consider mobile phone–based ATT adherence interventions an intrusion in their privacy, and 93% did not fear stigma if the adherence reminder was received by someone else. Most (95%) of the study participants preferred mobile phone reminders instead of directly observed treatment, short-course. Voice calls (n=80, 80%) were the more preferred reminder modality than SMS reminders (n=5, 5%). Conclusions: Mobile phones are likely an acceptable platform to deliver ATT adherence interventions among individuals with TB in South India. Preference of voice call reminders may inform the architecture of future adherence interventions surrounding ATT in South India. %M 35560021 %R 10.2196/37124 %U https://formative.jmir.org/2022/5/e37124 %U https://doi.org/10.2196/37124 %U http://www.ncbi.nlm.nih.gov/pubmed/35560021 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 5 %P e36114 %T Multimodal Chronic Pain Therapy for Adults via Smartphone: Randomized Controlled Clinical Trial %A Morcillo-Muñoz,Yolanda %A Sánchez-Guarnido,Antonio José %A Calzón-Fernández,Silvia %A Baena-Parejo,Isabel %+ Primary Care, Andalusian Health Service, Plaza de la Mujer s/n, District Campo de Gibraltar, Algeciras, 11207, Spain, 34 670946860, ymmcadiz1969@gmail.com %K chronic pain %K eHealth %K multimodal intervention %K catastrophizing %K self-management %K mHealth %K mobile phone %K randomized controlled trials %D 2022 %7 11.5.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: Combination therapies delivered remotely via the internet or mobile devices are increasingly being used to improve and promote the self-management of chronic conditions. However, little is known regarding the long-term effects of these interventions. Objective: The aim of this study is to evaluate the effectiveness of a multimodal intervention program that measures associated variables such as catastrophizing, pain acceptance, and quality of life using a mobile device in people with chronic pain in an outpatient setting. Methods: A randomized controlled clinical trial was performed using parallel treatment groups. A total of 209 patients with chronic musculoskeletal pain were randomly assigned to one of the two study arms. The intervention group received a standard web-based psychosocial therapy-type program of activities through a smartphone for 6 weeks. The control group only had access to the Find out more section of the app, which contained audiovisual material for pain management based on a self-help approach. The primary outcome was catastrophizing measured using the Pain Catastrophizing Scale (PCS). Secondary outcomes were pain acceptance measured using the Chronic Pain Acceptance Questionnaire and health-related quality of life measured using the EuroQol Visual Analogue Scale. Assessments were conducted at baseline (T1), after treatment (T2), and at the 3-month follow-up (T3). The variations between the different phases were assessed using the percentage change rescaled with log base 2. The Cohen d was calculated based on the results of the linear mixed model. The investigators of the study who evaluated the results were not involved in patient recruitment and were blinded to the group assignment. Results: Positive effects were found in the intervention group (T2–T1) in catastrophizing between the baseline and posttreatment phases (P<.001) and in helplessness (−0.72 vs 0.1; P=.002), rumination (−1.59 vs −0.53; P<.001), acceptance (0.38 vs 0.05; P=.001), and quality of life (0.43 vs −0.01; P=.002), although no significant changes were found for magnification (0.2 vs 0.77; P=.14) and satisfaction with health (0.25 vs −0.27; P=.13). Three months after treatment, significant differences were observed in the intervention group for the outcome variable of catastrophizing (PCS; −0.59 vs 0.2; P=.006) and the PCS subscales of helplessness (−0.65 vs 0.01; P=.07), rumination (1.23 vs −0.59; P=.04), and magnification (0.1 vs 0.86; P=.02). Conclusions: The results of our study suggest that app-based mobile multidimensional treatments for adults with chronic pain improve catastrophizing, quality of life, and psychological flexibility immediately after treatment and that the effects are maintained for the primary outcome of catastrophizing for at least 3 months following treatment. Moreover, they promote self-management and can be used to complement face-to-face pain treatments. Trial Registration: ClinicalTrials.gov NCT04509154; https://clinicaltrials.gov/ct2/show/NCT04509154 %M 35373 %R 10.2196/36114 %U https://www.jmir.org/2022/5/e36114 %U https://doi.org/10.2196/36114 %U http://www.ncbi.nlm.nih.gov/pubmed/35373 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 11 %N 5 %P e37946 %T Asthma and Technology in Emerging African American Adults (The ATHENA Project): Protocol for a Trial Using the Multiphase Optimization Strategy Framework %A Baptist,Alan %A Gibson-Scipio,Wanda %A Carcone,April Idalski %A Ghosh,Samiran %A Jacques-Tiura,Angela J %A Hall,Amy %A MacDonell,Karen Kolmodin %+ Department of Family Medicine and Public Health Sciences, School of Medicine, Wayne State University, iBio 6135 Woodward Ave, Detroit, MI, 48202, United States, 1 3135776996, karen.macdonell@wayne.edu %K African American emerging adults %K asthma management %K mHealth %K mobile health %K motivational interviewing %K asthma control %K physical activity %D 2022 %7 10.5.2022 %9 Protocol %J JMIR Res Protoc %G English %X Background: Asthma causes substantial morbidity and mortality in the United States, particularly among African American emerging adults (AAEAs; aged 18-30 years), but very few asthma programs have targeted this population. Interventions that provide education and address underlying motivation for managing asthma may be the most effective. However, intensive face-to-face interventions are often difficult to implement in this population. Objective: The purpose of this study is to develop an effective mobile asthma management intervention to improve control among AAEAs. Methods: We will assess the ability of multiple technologic components to assist and improve traditional asthma education. The first component is the Motivational Enhancement System for asthma management. It is a mobile 4-session intervention using supported self-regulation and motivational interviewing. Personalized content is based on each participant’s activity level, daily experiences, and goals. The second component is supportive accountability. It is administered by asthma nurses using targeted mobile support (Skype/voice calls) to provide education, promote self-efficacy, and overcome barriers through a motivational interviewing–based framework. The third component is SMS text messaging. It provides reminders for asthma education, medication adherence, and physical activity. The fourth component is physical activity tracking. It uses wearable technology to help meet user-defined physical activity goals. Using a multiphase optimization strategy (MOST) framework, we will test intervention components and combinations of components to identify the most effective mobile intervention. The MOST framework is an innovative, and cost- and time-effective framework that uses engineering principles to produce effective behavioral interventions. We will conduct a component selection experiment using a factorial research design to build an intervention that has been optimized for maximum efficacy, using a clinically significant improvement in asthma. Participants (N=180) will be randomized to 1 of 6 intervention arms. Participants will be recruited from multiple sites of the American Lung Association-Airway Clinical Research Centers network and ambulatory care clinics at the Detroit Medical Center. Data collections will occur at baseline, and 3, 6, and 12 months. Results: At study completion, we will have an empirically supported optimized mobile asthma management intervention to improve asthma control for AAEAs. We hypothesize that postintervention (3, 6, and 12 months), participants with uncontrolled asthma will show a clinically significant improvement in asthma control. We also hypothesize that improvements in asthma management behaviors (including physical activity), quality of life, symptoms, adherence, and exacerbation (secondary outcomes) will be observed. Conclusions: AAEAs are disproportionately impacted by asthma, but have been underrepresented in research. Mobile asthma management interventions may help improve asthma control and allow people to live healthier lives. During this project, we will use an innovative strategy to develop an optimized mobile asthma management intervention using the most effective combination of nurse-delivered asthma education, a smartphone app, and text messaging. International Registered Report Identifier (IRRID): PRR1-10.2196/37946 %M 35536642 %R 10.2196/37946 %U https://www.researchprotocols.org/2022/5/e37946 %U https://doi.org/10.2196/37946 %U http://www.ncbi.nlm.nih.gov/pubmed/35536642 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 4 %P e30058 %T Effects of Using a Text Message Intervention on Psychological Constructs and the Association Between Changes to Psychological Constructs and Medication Adherence in People With Type 2 Diabetes: Results From a Randomized Controlled Feasibility Study %A Bartlett,Yvonne Kiera %A Farmer,Andrew %A Newhouse,Nikki %A Miles,Lisa %A Kenning,Cassandra %A French,David P %+ Manchester Centre for Health Psychology, School of Health Sciences, University of Manchester, Coupland 1 Building, Oxford Road, Manchester, M13 9PL, United Kingdom, 44 161 3065436, kiera.bartlett.uom@gmail.com %K medication adherence %K type 2 diabetes mellitus %K behavior change techniques %K text messaging %K feasibility studies %K diabetes %K medication %K digital health %D 2022 %7 29.4.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: Poor adherence to oral medications is common in people with type 2 diabetes and can lead to an increased chance of health complications. Text messages may provide an effective delivery method for an intervention; however, thus far, the majority of these interventions do not specify either a theoretical basis or propose specific mechanisms of action. This makes it hard to determine how and whether an intervention is having an effect. The text messages included in the current intervention have been developed to deliver specific behavior change techniques. These techniques are the “active ingredients” of the intervention and were selected to target psychological constructs identified as predictors of medication adherence. Objective: There are 2 aims of this study: (1) to assess whether a text message intervention with specified behavior change techniques can change the constructs that predict medication adherence behaviors in people with type 2 diabetes and (2) to assess whether changes to psychological constructs are associated with changes in self-reported medication adherence. Methods: We conducted a randomized controlled, 6-month feasibility trial. Adults prescribed oral medication for type 2 diabetes (N=209) were recruited from general practice and randomized to either receive a text message–based intervention or care as usual. Data were analyzed with repeated measures analysis of covariance and Spearman rho correlation coefficients. Results: For 8 of the 14 constructs that were measured, a significant time-by-condition interaction was found: necessity beliefs, intention, maintenance self-efficacy, recovery self-efficacy, action control, prompts and cues, social support, and satisfaction with experienced consequences all increased in the intervention group compared to the control group. Changes in action self-efficacy, intention, automaticity, maintenance self-efficacy, and satisfaction with experienced consequences were positively associated with changes in self-reported medication adherence. Conclusions: A relatively low-cost, scalable, text message–only intervention targeting medication adherence using behavior change techniques can influence psychological constructs that predict adherence. Not only do these constructs predict self-reported medication adherence, but changes in these constructs are correlated with changes in self-reported medication adherence. These findings support the promise of text message–based interventions for medication adherence in this population and suggest likely mechanisms of action. Trial Registration: ISRCTN Registry ISRCTN13404264; https://www.isrctn.com/ISRCTN13404264 %M 35486430 %R 10.2196/30058 %U https://formative.jmir.org/2022/4/e30058 %U https://doi.org/10.2196/30058 %U http://www.ncbi.nlm.nih.gov/pubmed/35486430 %0 Journal Article %@ 2561-7605 %I JMIR Publications %V 5 %N 2 %P e32169 %T Benefits of, Barriers to, and Needs for an Artificial Intelligence–Powered Medication Information Voice Chatbot for Older Adults: Interview Study With Geriatrics Experts %A Gudala,Meghana %A Ross,Mary Ellen Trail %A Mogalla,Sunitha %A Lyons,Mandi %A Ramaswamy,Padmavathy %A Roberts,Kirk %+ School of Biomedical Informatics, University of Texas Health Science Center at Houston, 7000 Fannin St #600, Houston, TX, 77030, United States, 1 713 500 3653, Kirk.Roberts@uth.tmc.edu %K medication information %K chatbot %K older adults %K technology capabilities %K mobile phone %D 2022 %7 28.4.2022 %9 Original Paper %J JMIR Aging %G English %X Background: One of the most complicated medical needs of older adults is managing their complex medication regimens. However, the use of technology to aid older adults in this endeavor is impeded by the fact that their technological capabilities are lower than those of much of the rest of the population. What is needed to help manage medications is a technology that seamlessly integrates within their comfort levels, such as artificial intelligence agents. Objective: This study aimed to assess the benefits, barriers, and information needs that can be provided by an artificial intelligence–powered medication information voice chatbot for older adults. Methods: A total of 8 semistructured interviews were conducted with geriatrics experts. All interviews were audio-recorded and transcribed. Each interview was coded by 2 investigators (2 among ML, PR, METR, and KR) using a semiopen coding method for qualitative analysis, and reconciliation was performed by a third investigator. All codes were organized into the benefit/nonbenefit, barrier/nonbarrier, and need categories. Iterative recoding and member checking were performed until convergence was reached for all interviews. Results: The greatest benefits of a medication information voice-based chatbot would be helping to overcome the vision and dexterity hurdles experienced by most older adults, as it uses voice-based technology. It also helps to increase older adults’ medication knowledge and adherence and supports their overall health. The main barriers were technology familiarity and cost, especially in lower socioeconomic older adults, as well as security and privacy concerns. It was noted however that technology familiarity was not an insurmountable barrier for older adults aged 65 to 75 years, who mostly owned smartphones, whereas older adults aged >75 years may have never been major users of technology in the first place. The most important needs were to be usable, to help patients with reminders, and to provide information on medication side effects and use instructions. Conclusions: Our needs analysis results derived from expert interviews clarify that a voice-based chatbot could be beneficial in improving adherence and overall health if it is built to serve the many medication information needs of older adults, such as reminders and instructions. However, the chatbot must be usable and affordable for its widespread use. %M 35482367 %R 10.2196/32169 %U https://aging.jmir.org/2022/2/e32169 %U https://doi.org/10.2196/32169 %U http://www.ncbi.nlm.nih.gov/pubmed/35482367 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 10 %N 4 %P e25561 %T A Mobile Phone App to Support Adherence to Daily HIV Pre-exposure Prophylaxis Engagement Among Young Men Who Have Sex With Men and Transgender Women Aged 15 to 19 Years in Thailand: Pilot Randomized Controlled Trial %A Kawichai,Surinda %A Songtaweesin,Wipaporn Natalie %A Wongharn,Prissana %A Phanuphak,Nittaya %A Cressey,Tim R %A Moonwong,Juthamanee %A Vasinonta,Anuchit %A Saisaengjan,Chutima %A Chinbunchorn,Tanat %A Puthanakit,Thanyawee %+ Center of Excellence in Transgender Health, Chulalongkorn University, King Chulalongkorn Memorial Hospital, 1873 Rama 4 Rd, Patumwan, Bangkok, 10330, Thailand, 66 22564930, wipaporn.n@chula.ac.th %K mHealth %K PrEP adherence %K adolescents %K men who have sex with men %K transgender women %K mobile phone %D 2022 %7 21.4.2022 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Widespread smartphone use provides opportunities for mobile health HIV prevention strategies among at-risk populations. Objective: This study aims to investigate engagement in a theory-based (information–motivation–behavioral skills model) mobile phone app developed to support HIV pre-exposure prophylaxis (PrEP) adherence among Thai young men who have sex with men (YMSM) and young transgender women (YTGW) in Bangkok, Thailand. Methods: A randomized controlled trial was conducted among HIV-negative YMSM and YTGW aged 15-19 years initiating daily oral PrEP. Participants were randomized to receive either youth-friendly PrEP services (YFS) for 6 months, including monthly contact with site staff (clinic visits or telephone follow-up) and staff consultation access, or YFS plus use of a PrEP adherence support app (YFS+APP). The target population focus group discussion findings and the information–motivation–behavioral skills model informed app development. App features were based on the 3Rs—risk assessment of self-HIV acquisition risk, reminders to take PrEP, and rewards as redeemable points. Dried blood spots quantifying of tenofovir diphosphate were collected at months 3 and 6 to assess PrEP adherence. Tenofovir diphosphate ≥350-699 fmol/punch was classified as fair adherence and ≥700 fmol/punch as good adherence. Data analysis on app use paradata and exit interviews were conducted on the YFS+APP arm after 6 months of follow-up. Results: Between March 2018 and June 2019, 200 participants with a median age of 18 (IQR 17-19) years were enrolled. Overall, 74% (148/200) were YMSM; 87% (87/100) of participants who received YFS+APP logged in to the app and performed weekly HIV acquisition risk assessments (log-in and risk assessment [LRA]). The median duration between the first and last log-in was 3.5 (IQR 1.6-5.6) months, with a median frequency of 6 LRAs (IQR 2-10). Moreover, 22% (22/100) of the participants in the YFS+APP arm were frequent users (LRA≥10) during the 6-month follow-up period. YMSM were 9.3 (95% CI 1.2-74.3) times more likely to be frequent app users than YTGW (P=.04). Frequent app users had higher proportions (12%-16%) of PrEP adherence at both months 3 and 6 compared with infrequent users (LRA<10) and the YFS arm, although this did not reach statistical significance. Of the 100 participants in the YFS+APP arm, 23 (23%) were interviewed. The risk assessment function is perceived as the most useful app feature. Further aesthetic adaptations and a more comprehensive rewards system were suggested by the interviewees. Conclusions: Higher rates of PrEP adherence among frequent app users were observed; however, this was not statistically significant. A short app use duration of 3 months suggests that they may be useful in establishing habits in taking daily PrEP, but not long-term adherence. Further studies on the specific mechanisms of mobile phone apps that influence health behaviors are needed. Trial Registration: ClinicalTrials.gov NCT03778892; https://clinicaltrials.gov/ct2/show/NCT03778892 %M 35451976 %R 10.2196/25561 %U https://mhealth.jmir.org/2022/4/e25561 %U https://doi.org/10.2196/25561 %U http://www.ncbi.nlm.nih.gov/pubmed/35451976 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 11 %N 4 %P e32702 %T Problems and Barriers Related to the Use of Digital Health Applications: Protocol for a Scoping Review %A Giebel,Godwin Denk %A Speckemeier,Christian %A Abels,Carina %A Börchers,Kirstin %A Wasem,Jürgen %A Blase,Nikola %A Neusser,Silke %+ Institute for Healthcare Management and Research, University of Duisburg-Essen, Thea-Leymann-Str. 9, Essen, 45127, Germany, 49 02011833180, godwin.giebel@medman.uni-due.de %K digital health application %K DHA %K mHealth, problems, barriers, scoping review %K mobile health %K health insurance %K electronic database %K health database %K mHealth app %D 2022 %7 21.4.2022 %9 Protocol %J JMIR Res Protoc %G English %X Background: The use of mobile health (mHealth) apps is increasing rapidly worldwide. More and more institutions and organizations develop regulations and guidelines to enable an evidence-based and safe use. In Germany, mHealth apps fulfilling predefined criteria (Digitale Gesundheitsanwendungen [DiGA]) can be prescribed and are reimbursable by the German statutory health insurance scheme. Due to the increasing distribution of DiGA, problems and barriers should receive special attention. Objective: This study aims to identify the relevant problems and barriers related to the use of mHealth apps fulfilling the criteria of DiGA. Methods: This scoping review will follow published methodological frameworks and the PRISMA-Scr (Preferred Reporting Items for Systematic Reviews and Meta-analyses Extension for Scoping Reviews) criteria. Electronic databases (MEDLINE, EMBASE, PsycINFO, and JMIR), reference lists of relevant articles, and grey literature sources will be searched. Two reviewers will assess the eligibility of the articles by a two-stage (title and abstract as well as full text) screening process. Only problems and barriers related to mHealth apps fulfilling the criteria of DiGA are included for this research. The identified studies will be categorized and analyzed with MAXQDA. Results: This scoping review gives an overview of the available evidence and identifies research gaps regarding problems and barriers related to DiGA. The results are planned to be submitted to an indexed, peer-reviewed journal in the first quarter of 2022. Conclusions: This is the first review to identify the problems and barriers related to the use of mHealth apps fulfilling the German definition of DiGA. Nevertheless, the findings can be applied to other contexts and health care systems as well. International Registered Report Identifier (IRRID): DERR1-10.2196/32702 %M 35451979 %R 10.2196/32702 %U https://www.researchprotocols.org/2022/4/e32702 %U https://doi.org/10.2196/32702 %U http://www.ncbi.nlm.nih.gov/pubmed/35451979 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 10 %N 4 %P e33628 %T Residual Effect of Texting to Promote Medication Adherence for Villagers with Schizophrenia in China: 18-Month Follow-up Survey After the Randomized Controlled Trial Discontinuation %A Cai,Yiyuan %A Gong,Wenjie %A He,Wenjun %A He,Hua %A Hughes,James P %A Simoni,Jane %A Xiao,Shuiyuan %A Gloyd,Stephen %A Lin,Meijuan %A Deng,Xinlei %A Liang,Zichao %A Dai,Bofeng %A Liao,Jing %A Hao,Yuantao %A Xu,Dong Roman %+ Center for World Health Organization (WHO) Studies and Department of Health Management, School of Health Management of Southern Medical University, 1023 South Shatai Road, Guangzhou, 510515, China, 86 02061647194, romanxu@i.smu.edu.cn %K medication adherence %K mobile texting %K lay health worker %K resource-poor community %K primary health care %K quality of care %K mHealth %K schizophrenia %K maintenance %K residual effect %K mental health %K patient outcomes %D 2022 %7 19.4.2022 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Reducing the treatment gap for mental health in low- and middle-income countries is a high priority. Even with treatment, adherence to antipsychotics is rather low. Our integrated intervention package significantly improved medication adherence within 6 months for villagers with schizophrenia in resource-poor communities in rural China. However, considering the resource constraint, we need to test whether the effect of those behavior-shaping interventions may be maintained even after the suspension of the intervention. Objective: The aim of this study is to explore the primary outcome of adherence and other outcomes at an 18-month follow-up after the intervention had been suspended. Methods: In a 6-month randomized trial, 277 villagers with schizophrenia were randomized to receive either a government community mental health program (686 Program) or the 686 Program plus Lay health supporters, e-platform, award, and integration (LEAN), which included health supporters for medication or care supervision, e-platform access for sending mobile SMS text messaging reminders and education message, a token gift for positive behavior changes (eg, continuing taking medicine), and integrating the e-platform with the existing 686 Program. After the 6-month intervention, both groups received only the 686 Program for 18 months (phase 2). Outcomes at both phases included antipsychotic medication adherence, functioning, symptoms, number of rehospitalization, suicide, and violent behaviors. The adherence and functioning were assessed at the home visit by trained assessors. We calculated the adherence in the past 30 days by counting the percentage of dosages taken from November to December 2018 by unannounced home-based pill counts. The functioning was assessed using the World Health Organization Disability Assessment Schedule 2.0. The symptoms were evaluated using the Clinical Global Impression–Schizophrenia during their visits to the 686 Program psychiatrists. Other outcomes were routinely collected in the 686 Program system. We used intention-to-treat analysis, and missing data were dealt with using multiple imputation. The generalized estimating equation model was used to assess program effects on adherence, functioning, and symptoms. Results: In phase 1, antipsychotic adherence and rehospitalization incidence improved significantly. However, in phase 2, the difference of the mean of antipsychotic adherence (adjusted mean difference 0.05, 95% CI −0.06 to 0.16; P=.41; Cohen d effect size=0.11) and rehospitalization incidence (relative risk 0.65, 95% CI 0.32-1.33; P=.24; number needed to treat 21.83, 95% CI 8.30-34.69) was no longer statistically significant, and there was no improvement in other outcomes in either phase (P≥.05). Conclusions: The simple community-based LEAN intervention could not continually improve adherence and reduce the rehospitalization of people with schizophrenia. Our study inclined to suggest that prompts for medication may be necessary to maintain medication adherence for people with schizophrenia, although we cannot definitively exclude other alternative interpretations. %M 35438649 %R 10.2196/33628 %U https://mhealth.jmir.org/2022/4/e33628 %U https://doi.org/10.2196/33628 %U http://www.ncbi.nlm.nih.gov/pubmed/35438649 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 10 %N 3 %P e31040 %T Comparing Reminders Sent via SMS Text Messaging and Email for Improving Adherence to an Electronic Health Program: Randomized Controlled Trial %A Kulhánek,Adam %A Lukavska,Katerina %A Gabrhelík,Roman %A Novák,Daniel %A Burda,Václav %A Prokop,Jindřich %A Holter,Marianne T S %A Brendryen,Håvar %+ Department of Addictology, General University Hospital in Prague, Apolinářská 4, Prague, 12000, Czech Republic, 420 224 968 273, katerina.lukavska@lf1.cuni.cz %K eHealth %K randomized controlled trial %K adherence %K reminders %K SMS text messaging %K email %K smoking cessation %K text message %D 2022 %7 18.3.2022 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: eHealth interventions can help people change behavior (eg, quit smoking). Reminders sent via SMS text messaging or email may improve the adherence to web-based programs and increase the probability of successful behavior change; however, it is unclear whether their efficiency is affected by the modality of the communication channel. Objective: A 2-armed randomized control trial was conducted to compare the effect of providing reminders via SMS text messaging versus email on the adherence to an eHealth program for smoking cessation and on the probability to initiate a quit attempt. Methods: Smokers were recruited via an internet-based advertisement. A total of 591 participants who diverted from intended use of the program (ie, failed to log on to a session) were automatically randomized to the experimental (SMS text messaging reminder, n=304) or the active comparator (email reminder, n=287) group. Results: Unexpectedly, we found that the mode of reminder delivery did not significantly affect either the adherence, namely the number of completed program sessions, with the SMS text messaging reminder group showing a mean of 4.30 (SD 3.24) and the email reminder group showing a mean of 4.36 (SD 3.27) (t586=0.197, P=.84, and Cohen d=0.016), or the outcome, namely the quit smoking attempt rate (34.2% in the SMS text messaging group vs 31.7% in the email group; χ21=0.4, P=.52). Secondary analyses showed that age, gender, and education had significant effects on program adherence and education on the outcome. Moreover, we found a significant interaction effect between the mode of reminder delivery and gender on program adherence, suggesting that the effectiveness of SMS text message reminders might be different for females and males. However, this particular finding should be treated with care as it was based on post hoc subgroup analysis. Conclusions: This study indicates that the modality of user reminders to log on increased neither the program adherence nor the probability of quitting smoking. This suggests that program developers may save costs using emails instead of SMS text messaging reminders. Trial Registration: ClinicalTrials.gov NCT03276767; https://clinicaltrials.gov/ct2/show/ NCT03276767 %M 35302945 %R 10.2196/31040 %U https://mhealth.jmir.org/2022/3/e31040 %U https://doi.org/10.2196/31040 %U http://www.ncbi.nlm.nih.gov/pubmed/35302945 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 3 %P e27588 %T Effectiveness, Cost-effectiveness, and Cost-Utility of a Digital Smoking Cessation Intervention for Cancer Survivors: Health Economic Evaluation and Outcomes of a Pragmatic Randomized Controlled Trial %A Mujcic,Ajla %A Blankers,Matthijs %A Boon,Brigitte %A Verdonck-de Leeuw,Irma M %A Smit,Filip %A van Laar,Margriet %A Engels,Rutger %+ Erasmus School of Social and Behavioural Sciences, Erasmus University, Burgemeester Oudlaan 50, Rotterdam, 3062PA, Netherlands, 31 30 29 59 256, amujcic@trimbos.nl %K smoking cessation %K cancer survivors %K effectiveness %K cost-effectiveness %K eHealth %D 2022 %7 17.3.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: Smoking cessation (SC) interventions may contribute to better treatment outcomes and the general well-being of cancer survivors. Objective: This study aims to evaluate the effectiveness, cost-effectiveness, and cost-utility of a digital interactive SC intervention compared with a noninteractive web-based information brochure for cancer survivors. Methods: A health economic evaluation alongside a pragmatic 2-arm parallel-group randomized controlled trial was conducted with follow-ups at 3, 6, and 12 months. The study was conducted in the Netherlands over the internet from November 2016 to September 2019. The participants were Dutch adult smoking cancer survivors with the intention to quit smoking. In total, 165 participants were included and analyzed: 83 (50.3%) in the MyCourse group and 82 (49.7%) in the control group. In the intervention group, participants had access to a newly developed, digital, minimally guided SC intervention (MyCourse-Quit Smoking). Control group participants received a noninteractive web-based information brochure on SC. Both groups received unrestricted access to usual care. The primary outcome was self-reported 7-day smoking abstinence at the 6-month follow-up. Secondary outcomes were quality-adjusted life years gained, number of cigarettes smoked, nicotine dependence, and treatment satisfaction. For the health economic evaluation, intervention costs, health care costs, and costs stemming from productivity losses were assessed over a 12-month horizon. Results: At the 6-month follow-up, the quit rates were 28% (23/83) and 26% (21/82) in the MyCourse and control groups, respectively (odds ratio 0.47, 95% CI 0.03-7.86; P=.60). In both groups, nicotine dependence scores were reduced at 12 months, and the number of smoked cigarettes was reduced by approximately half. The number of cigarettes decreased more over time, and the MyCourse group demonstrated a significantly greater reduction at the 12-month follow-up (incidence rate ratio 0.87; 95% CI 0.76-1.00; P=.04). Intervention costs were estimated at US $193 per participant for the MyCourse group and US $74 for the control group. The mean per-participant societal costs were US $25,329 (SD US $29,137) and US $21,836 (SD US $25,792), respectively. In the cost-utility analysis, MyCourse was not preferred over the control group from a societal perspective. With smoking behavior as the outcome, the MyCourse group led to marginally better results per reduced pack-year against higher societal costs, with a mean incremental cost-effectiveness ratio of US $52,067 (95% CI US $32,515-US $81,346). Conclusions: At 6 months, there was no evidence of a differential effect on cessation rates; in both groups, approximately a quarter of the cancer survivors quit smoking and their number of cigarettes smoked was reduced by half. At 12 months, the MyCourse intervention led to a greater reduction in the number of smoked cigarettes, albeit at higher costs than for the control group. No evidence was found for a differential effect on quality-adjusted life years. Trial Registration: The Netherlands Trial Register NTR6011; https://www.trialregister.nl/trial/5434 International Registered Report Identifier (IRRID): RR2-10.1186/s12885-018-4206-z %M 35297777 %R 10.2196/27588 %U https://www.jmir.org/2022/3/e27588 %U https://doi.org/10.2196/27588 %U http://www.ncbi.nlm.nih.gov/pubmed/35297777 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 3 %P e31972 %T Ascertaining Medication Use and Patient-Reported Outcomes via an App and Exploring Gamification in Patients With Multiple Sclerosis Treated With Interferon β-1b: Observational Study %A Limmroth,Volker %A Bayer-Gersmann,Kirsten %A Mueller,Christian %A Schürks,Markus %+ Bayer Vital GmbH, Medical Affairs, Neurology, Immunology & Ophthalmology, Leverkusen, 51368, Germany, 49 214 30 51455, markus.schuerks@bayer.com %K digital observational study %K BETACONNECT %K app %K interferon β-1b %K multiple sclerosis %K medication adherence %K medication compliance %K medication persistence %K health-related quality of life %K gamification %K mobile phone %D 2022 %7 14.3.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: The BETACONNECT autoinjector and myBETAapp app were designed to support patients with multiple sclerosis receiving interferon β-1b and are an ideal platform for digital observational studies. A recent pilot study in Germany demonstrated the feasibility of using the app to recruit patients, obtain informed consent, and evaluate medication-taking behavior over 6 months. Objective: This study aims to describe medication-taking behavior for 1 year in patients with multiple sclerosis receiving interferon β-1b based on data collected from the app and to provide information on patient-reported outcomes (PROs). The optional use of the cognitive training tool PEAK (Peak, formerly Brainbow Ltd) is included to test the feasibility of gamification in this setting. Methods: A prospective and retrospective, exploratory, digital, observational cohort study was conducted among users of the app in Germany. Invitations to participate were sent to patients’ apps between February and May 2019. Participants provided electronic informed consent. Injection-related data from consenting patients’ devices were collected prospectively for 1 year following the consent date and retrospectively for ≤1 year from the first day of use (if historical data were available). Participants also completed three electronic PRO instruments every 3 months: the EuroQol 5-Dimension, 5-Level questionnaire (EQ-5D-5L); the Treatment Satisfaction Questionnaire for Medication (TSQM; version II); and a questionnaire on satisfaction with treatment support (on a server accessed via an emailed hyperlink). All patients were offered optional access to the professional version of PEAK. Results: Of 1778 registered app accounts (May 2019), 79 patients (4.44%) provided informed consent; 62 (3.49%) were eligible for inclusion in the prospective analysis, of whom, 60 (97%) also had retrospective data. The mean age of the 62 participants was 43.2 (SD 11.5) years and 41 (66%) were women. Compliance over the 1-year prospective observational period (primary end point) was high (median 98.9%, IQR 94.3%-100%) and similar among men and women. Persistence and adherence (coprimary end points) decreased from 85% (53/62) and 74% (46/62), respectively, at 6 months to 76% (47/62) and 65% (40/62), respectively, at 12 months; both were higher in men than in women. A retrospective analysis showed similar patterns. The PRO questionnaires were answered by 79% (49/62) of the participants at baseline and 50% (31/62) of them at month 12. Women had more severe problems in some EQ-5D-5L dimensions (mobility, usual activities, and pain/discomfort) and lower median convenience scores on the TSQM (version II) than men. At month 12, 84% (26/31) of the patients were satisfied or very satisfied with the app. PEAK was used by 67% (14/21) of men and 49% (20/41) of women. Conclusions: This study showed high compliance and decreasing persistence and adherence over 1 year and demonstrated the feasibility of including remotely completed electronic PRO instruments in digital observational studies. %M 35285806 %R 10.2196/31972 %U https://formative.jmir.org/2022/3/e31972 %U https://doi.org/10.2196/31972 %U http://www.ncbi.nlm.nih.gov/pubmed/35285806 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 10 %N 3 %P e35157 %T Technologies for Medication Adherence Monitoring and Technology Assessment Criteria: Narrative Review %A Mason,Madilyn %A Cho,Youmin %A Rayo,Jessica %A Gong,Yang %A Harris,Marcelline %A Jiang,Yun %+ School of Nursing, University of Michigan, 400 North Ingalls, Ann Arbor, MI, 48109, United States, 1 734 763 3705, jiangyu@umich.edu %K medication adherence %K technology assessment %K remote sensing technology %K telemedicine %D 2022 %7 10.3.2022 %9 Review %J JMIR Mhealth Uhealth %G English %X Background: Accurate measurement and monitoring of patient medication adherence is a global challenge because of the absence of gold standard methods for adherence measurement. Recent attention has been directed toward the adoption of technologies for medication adherence monitoring, as they provide the opportunity for continuous tracking of individual medication adherence behavior. However, current medication adherence monitoring technologies vary according to their technical features and data capture methods, leading to differences in their respective advantages and limitations. Overall, appropriate criteria to guide the assessment of medication adherence monitoring technologies for optimal adoption and use are lacking. Objective: This study aims to provide a narrative review of current medication adherence monitoring technologies and propose a set of technology assessment criteria to support technology development and adoption. Methods: A literature search was conducted on PubMed, Scopus, CINAHL, and ProQuest Technology Collection (2010-present) using the combination of keywords medication adherence, measurement technology, and monitoring technology. The selection focused on studies related to medication adherence monitoring technology and its development and use. The technological features, data capture methods, and potential advantages and limitations of the identified technology applications were extracted. Methods for using data for adherence monitoring were also identified. Common recurring elements were synthesized as potential technology assessment criteria. Results: Of the 3865 articles retrieved, 98 (2.54%) were included in the final review, which reported a variety of technology applications for monitoring medication adherence, including electronic pill bottles or boxes, ingestible sensors, electronic medication management systems, blister pack technology, patient self-report technology, video-based technology, and motion sensor technology. Technical features varied by technology type, with common expectations for using these technologies to accurately monitor medication adherence and increase adoption in patients’ daily lives owing to their unobtrusiveness and convenience of use. Most technologies were able to provide real-time monitoring of medication-taking behaviors but relied on proxy measures of medication adherence. Successful implementation of these technologies in clinical settings has rarely been reported. In all, 28 technology assessment criteria were identified and organized into the following five categories: development information, technology features, adherence to data collection and management, feasibility and implementation, and acceptability and usability. Conclusions: This narrative review summarizes the technical features, data capture methods, and various advantages and limitations of medication adherence monitoring technology reported in the literature and the proposed criteria for assessing medication adherence monitoring technologies. This collection of assessment criteria can be a useful tool to guide the development and selection of relevant technologies, facilitating the optimal adoption and effective use of technology to improve medication adherence outcomes. Future studies are needed to further validate the medication adherence monitoring technology assessment criteria and construct an appropriate technology assessment framework. %M 35266873 %R 10.2196/35157 %U https://mhealth.jmir.org/2022/3/e35157 %U https://doi.org/10.2196/35157 %U http://www.ncbi.nlm.nih.gov/pubmed/35266873 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 3 %P e27202 %T An mHealth Intervention to Improve Medication Adherence and Health Outcomes Among Patients With Coronary Heart Disease: Randomized Controlled Trial %A Ni,Zhao %A Wu,Bei %A Yang,Qing %A Yan,Lijing L %A Liu,Changqing %A Shaw,Ryan J %+ School of Medicine, Yale University, 135 College Street, New Haven, CT, 06510, United States, 1 646 617 2232, zhao.ni@yale.edu %K mHealth %K medication adherence %K coronary disease %K blood pressure %K China %K randomized controlled trial %D 2022 %7 9.3.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: The treatment of many chronic illnesses involves long-term pharmaceutical therapy, but it is an ongoing challenge to find effective ways to improve medication adherence to promote good health outcomes. Cardioprotective medications can prevent the enlargement of harmful clots, cardiovascular symptoms, and poor therapeutic outcomes, such as uncontrolled high blood pressure and hyperlipidemia, for patients with coronary heart disease. Poor adherence to cardioprotective medications, however, has been reported as a global health concern among patients with coronary heart disease, and it is particularly a concern in China. Objective: This study aimed to evaluate the efficacy of a mobile health (mHealth) intervention using 2 mobile apps to improve medication adherence and health outcomes. Methods: A randomized, placebo-controlled, 2-arm parallel study was conducted in a major university-affiliated medical center located in Chengdu, China. Participants were recruited by flyers and health care provider referrals. Each participant was observed for 90 days, including a 60-day period of mHealth intervention and a 30-day period of nonintervention follow-up. The study coordinator used WeChat and Message Express to send educational materials and reminders to take medication, respectively. Participants used WeChat to receive both the educational materials and reminders. Participants in the control group only received educational materials. This study received ethics approval from the Duke Health Institutional Review Board (Pro00073395) on May 5, 2018, and was approved by West China Hospital (20170331180037). Recruitment began on May 20, 2018. The pilot phase of this study was registered on June 8, 2016, and the current, larger-scale study was retrospectively registered on January 11, 2021 (ClinicalTrials.gov). Results: We recruited 230 patients with coronary heart disease. Of these patients, 196 completed the baseline survey and received the intervention. The majority of participants were married (181/196, 92.4%), male (157/196, 80.1%), and lived in urban China (161/196, 82.1%). Participants’ average age was 61 years, and half were retired (103/191, 53.9%). More than half the participants (121/196, 61.7%) were prescribed at least 5 medications. The mean decrease in medication nonadherence score was statistically significant at both 60 days (t179=2.04, P=.04) and 90 days (t155=3.48, P<.001). Systolic blood pressure and diastolic blood pressure decreased in the experimental group but increased in the control group. The mean decrease in diastolic blood pressure was statistically significant at both 60 days (t160=2.07, P=.04) and 90 days (t164=2.21, P=.03). The mean decrease in systolic blood pressure was significantly different in the groups at 90 days (t165=3.12, P=.002). Conclusions: The proposed mHealth intervention can improve medication adherence and health outcomes, including systolic blood pressure and diastolic blood pressure. Trial Registration: ClinicalTrials.gov NCT02793830; https://clinicaltrials.gov/ct2/show/NCT02793830 and ClinicalTrials.gov NCT04703439; https://clinicaltrials.gov/ct2/show/NCT04703439 %M 35262490 %R 10.2196/27202 %U https://www.jmir.org/2022/3/e27202 %U https://doi.org/10.2196/27202 %U http://www.ncbi.nlm.nih.gov/pubmed/35262490 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 11 %N 3 %P e28332 %T mHealth Intervention to Improve Treatment Outcomes Among People With HIV Who Use Cocaine: Protocol for a Pilot Randomized Controlled Trial %A Ranjit,Yerina S %A Krishnan,Archana %A Ghosh,Debarchana %A Cravero,Claire %A Zhou,Xin %A Altice,Frederick L %+ Department of Communication, University of Missouri, 108 Switzler Hall, Columbia, MO, 65211, United States, 1 573 822 0881, ranjity@missouri.edu %K smart pillbox %K smartphone %K mHealth intervention %K people with HIV %K cocaine use %K antiretroviral therapy %K description of feasibility and acceptability %K mobile phone %D 2022 %7 7.3.2022 %9 Protocol %J JMIR Res Protoc %G English %X Background: Antiretroviral therapy is effective in reducing HIV-related morbidity, mortality, and transmission among people with HIV. However, adherence and persistence to antiretroviral therapy are crucial for successful HIV treatment outcomes. People with HIV who use cocaine have poor access to HIV services and lower retention in care. Objective: The primary goal of this paper is to provide a detailed description of a mobile health intervention. This study is designed to improve medication adherence among people with HIV who use cocaine. A secondary goal is to list the important challenges and adaptations incorporated in the study design. Methods: This study, titled Project SMART, used a wireless technology–based intervention, including cellular-enabled electronic pillboxes called TowerView Health and smartphones, to provide reminders and feedback on adherence behavior. The intervention design was based on the theoretical frameworks provided by the self-determination theory and the Motivation Technology Model. The 12-week pilot randomized controlled trial with four arms provided three types of feedback: automated feedback, automated+clinician feedback, and automated feedback+social network feedback. Results: The study was funded by the National Institute of Drug Abuse (R21DA039842) on August 1, 2016. The institutional review board for the study was approved by Yale University on March 21, 2017. Data collection lasted from June 2017 to January 2020. The final enrollment was 71 participants, of whom 57 (80%) completed the study. The data are currently undergoing analysis, and the manuscript is being developed for publication in early 2022. Conclusions: Implementing complex mobile health interventions for high-risk and marginalized populations with multicomponent interventions poses certain challenges, such as finding companies with adequate technology for clients and financial stability and minimizing the research-related burden for the study population. Conducting feasibility studies is important to recognize these challenges and the opportunity to address these challenges with solutions while keeping the design of a randomized controlled trial as true as possible. Trial Registration: Clinicaltrials.gov NCT04418076; https://clinicaltrials.gov/ct2/show/NCT04418076 International Registered Report Identifier (IRRID): DERR1-10.2196/28332 %M 35254270 %R 10.2196/28332 %U https://www.researchprotocols.org/2022/3/e28332 %U https://doi.org/10.2196/28332 %U http://www.ncbi.nlm.nih.gov/pubmed/35254270 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 10 %N 3 %P e29415 %T mHealth Interventions for Self-management of Hypertension: Framework and Systematic Review on Engagement, Interactivity, and Tailoring %A Cao,Weidan %A Milks,M Wesley %A Liu,Xiaofu %A Gregory,Megan E %A Addison,Daniel %A Zhang,Ping %A Li,Lang %+ Department of Biomedical Informatics, The Ohio State University, 250 Lincoln Tower, 1800 Cannon Drive, Columbus, OH, 43210, United States, 1 614 292 4778, lang.li@osumc.edu %K mHealth %K mobile app %K digital behavior change %K interventions %K systematic review %K hypertension %K engagement %K interactivity %K tailoring %K mobile phone %D 2022 %7 2.3.2022 %9 Review %J JMIR Mhealth Uhealth %G English %X Background: Engagement is essential for the effectiveness of digital behavior change interventions. Existing systematic reviews examining hypertension self-management interventions via mobile apps have primarily focused on intervention efficacy and app usability. Engagement in the prevention or management of hypertension is largely unknown. Objective: This systematic review explores the definition and role of engagement in hypertension-focused mobile health (mHealth) interventions, as well as how determinants of engagement (ie, tailoring and interactivity) have been implemented. Methods: A systematic review of mobile app interventions for hypertension self-management targeting adults, published from 2013 to 2020, was conducted. A total of 21 studies were included in this systematic review. Results: The engagement was defined or operationalized as a microlevel concept, operationalized as interaction with the interventions (ie, frequency of engagement, time or duration of engagement with the program, and intensity of engagement). For all 3 studies that tested the relationship, increased engagement was associated with better biomedical outcomes (eg, blood pressure change). Interactivity was limited in digital behavior change interventions, as only 7 studies provided 2-way communication between users and a health care professional, and 9 studies provided 1-way communication in possible critical conditions; that is, when abnormal blood pressure values were recorded, users or health care professionals were notified. The tailoring of interventions varied at different aspects, from the tailoring of intervention content (including goals, patient education, advice and feedback from health professionals, reminders, and motivational messages) to the tailoring of intervention dose and communication mode. Tailoring was carried out in a number of ways, considering patient characteristics such as goals, preferences, disease characteristics (eg, hypertension stage and medication list), disease self-management experience levels, medication adherence rate, and values and beliefs. Conclusions: Available studies support the importance of engagement in intervention effectiveness as well as the essential roles of patient factors in tailoring, interactivity, and engagement. A patient-centered engagement framework for hypertension self-management using mHealth technology is proposed here, with the intent of facilitating intervention design and disease self-management using mHealth technology. %M 35234655 %R 10.2196/29415 %U https://mhealth.jmir.org/2022/3/e29415 %U https://doi.org/10.2196/29415 %U http://www.ncbi.nlm.nih.gov/pubmed/35234655 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 2 %P e33062 %T Digital Health Technologies to Improve Medication Adherence and Treatment Outcomes in Patients With Tuberculosis: Systematic Review of Randomized Controlled Trials %A Ridho,Abdurahman %A Alfian,Sofa D %A van Boven,Job F M %A Levita,Jutti %A Yalcin,Esin Aki %A Le,Ly %A Alffenaar,Jan-Willem %A Hak,Eelko %A Abdulah,Rizky %A Pradipta,Ivan S %+ Department of Pharmacology and Clinical Pharmacy, Faculty of Pharmacy, Universitas Padjadjaran, Jl. Raya Bandung-Sumedang Km. 21, Jatinangor, Sumedang, 45363, Indonesia, 62 842 888888 ext 3510, ivanpradipta@unpad.ac.id %K tuberculosis %K intervention %K eHealth %K medication adherence technology %K nonadherence %K digital health %K systematic review %K treatment outcomes %D 2022 %7 23.2.2022 %9 Review %J J Med Internet Res %G English %X Background: Nonadherence to medication in tuberculosis (TB) hampers optimal treatment outcomes. Digital health technology (DHT) seems to be a promising approach to managing problems of nonadherence to medication and improving treatment outcomes. Objective: This paper systematically reviews the effect of DHT in improving medication adherence and treatment outcomes in patients with TB. Methods: A literature search in PubMed and Cochrane databases was conducted. Randomized controlled trials (RCTs) that analyzed the effect of DHT interventions on medication adherence outcomes (treatment completion, treatment adherence, missed doses, and noncompleted rate) and treatment outcomes (cure rate and smear conversion) were included. Adult patients with either active or latent TB infection were included. The Jadad score was used for evaluating the study quality. The PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guideline was followed to report study findings. Results: In all, 16 RCTs were selected from 552 studies found, and 6 types of DHT interventions for TB were identified: 3 RCTs examined video directly observed therapy (VDOT), 1 examined video-observed therapy (VOT), 1 examined an ingestible sensor, 1 examined phone call reminders, 2 examined medication monitor boxes, and 8 examined SMS text message reminders. The outcomes used were treatment adherence, including treatment completion, treatment adherence, missed dose, and noncompleted rate, as well as clinical outcomes, including cure rate and smear conversion. In treatment completion, 4 RCTs (VDOT, VOT, ingestible sensor, SMS reminder) found significant effects, with odds ratios and relative risks (RRs) ranging from 1.10 to 7.69. Treatment adherence was increased in 1 study by SMS reminders (RR 1.05; 95% CI 1.04-1.06), and missed dose was reduced in 1 study by a medication monitor box (mean ratio 0.58; 95% CI 0.42-0.79). In contrast, 3 RCTs of VDOT and 3 RCTs of SMS reminders did not find significant effects for treatment completion. Moreover, no improvement was found in treatment adherence in 1 RCT of VDOT, missed dose in 1 RCT of SMS reminder, and noncompleted rate in 1 RCT of a monitor box, and 2 RCTs of SMS reminders. For clinical outcomes such as cure rate, 2 RCTs reported that phone calls (RR 1.30; 95% CI 1.07-1.59) and SMS reminders (OR 2.47; 95% CI 1.13-5.43) significantly affected cure rates. However, 3 RCTs found that SMS reminders did not have a significant impact on cure rate or smear conversion. Conclusions: It was found that DHT interventions can be a promising approach. However, the interventions exhibited variable effects regarding effect direction and the extent of improving TB medication adherence and clinical outcomes. Developing DHT interventions with personalized feedback is required to have a consistent and beneficial effect on medication adherence and outcomes among patients with TB. %M 35195534 %R 10.2196/33062 %U https://www.jmir.org/2022/2/e33062 %U https://doi.org/10.2196/33062 %U http://www.ncbi.nlm.nih.gov/pubmed/35195534 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 10 %N 2 %P e30671 %T The Use of Gamification and Incentives in Mobile Health Apps to Improve Medication Adherence: Scoping Review %A Tran,Steven %A Smith,Lorraine %A El-Den,Sarira %A Carter,Stephen %+ School of Pharmacy, Faculty of Medicine and Health, University of Sydney, Camperdown, Sydney, 2006, Australia, 61 93512222, steventran@hotmail.com.au %K gamification %K incentives %K mobile application %K mHealth %K medication adherence %K mobile phone %D 2022 %7 21.2.2022 %9 Review %J JMIR Mhealth Uhealth %G English %X Background: Emerging health care strategies addressing medication adherence include the use of direct-to-patient incentives or elements adapted from computer games. However, there is currently no published evidence synthesis on the use of gamification or financial incentives in mobile apps to improve medication adherence. Objective: The aim of this scoping review is to synthesize and appraise the literature pertaining to the use of mobile apps containing gamification or financial incentives for medication adherence. There were two objectives: to explore the reported effectiveness of these features and to describe and appraise the design and development process, including patient involvement. Methods: The following databases were searched for relevant articles published in English from database inception to September 24, 2020: Embase, MEDLINE, PsycINFO, CINAHL, and Web of Science. The framework by Arksey and O’Malley and the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) checklist guided this scoping review. Using a systematic screening process, studies were included if incentives or game features were used within mobile apps to specifically address medication adherence. An appraisal using risk of bias tools was also applied to their respective study design. Results: A total of 11 studies from the initial 691 retrieved articles were included in this review. Across the studies, gamification alone (9/11, 82%) was used more than financial incentives (1/11, 9%) alone or a combination of the two (1/11, 9%). The studies generally reported improved or sustained optimal medication adherence outcomes; however, there was significant heterogeneity in the patient population, methodology such as outcome measures, and reporting of these studies. There was considerable variability in the development process and evaluation of the apps, with authors opting for either the waterfall or agile methodology. App development was often guided by a theory, but across the reviewed studies, there were no common theories used. Patient involvement was not commonly evident in predevelopment phases but were generally reserved for evaluations of feasibility, acceptance, and effectiveness. Patient perspectives on gamified app features indicated a potential to motivate positive health behaviors such as medication adherence along with critical themes of repetitiveness and irrelevance of certain features. The appraisal indicated a low risk of bias in most studies, although concerns were identified in potential confounding. Conclusions: To effectively address medication adherence via gamified and incentivized mobile apps, an evidence-based co-design approach and agile methodology should be used. This review indicates some adoption of an agile approach in app development; however, patient involvement is lacking in earlier stages. Further research in a generalized cohort of patients living with chronic conditions would facilitate the identification of barriers, potential opportunities, and the justification for the use of gamification and financial incentives in mobile apps for medication adherence. %M 35188475 %R 10.2196/30671 %U https://mhealth.jmir.org/2022/2/e30671 %U https://doi.org/10.2196/30671 %U http://www.ncbi.nlm.nih.gov/pubmed/35188475 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 2 %P e25597 %T Acceptability of and Willingness to Take Digital Pills by Patients, the Public, and Health Care Professionals: Qualitative Content Analysis of a Large Online Survey %A Chevance,Astrid %A Fortel,Axel %A Jouannin,Adeline %A Denis,Faustine %A Mamzer,Marie-France %A Ravaud,Philippe %A Sidorkiewicz,Stephanie %+ Center for Research in Epidemiology and Statistics, Université de Paris-French National Institute for Health and Medical Research, 1, place du pravis de Notre Dame, Paris, 75004, France, 33 142348987, astrid.chevance@gmail.com %K acceptability %K health technology assessment %K clinical effectiveness research %K ethics %K digital pill %K digital health %K digital therapeutics %K ingestible sensor %K adherence %D 2022 %7 18.2.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: Digital pills are pills combined with a sensor, which sends a signal to a patch connected to a smartphone when the pills are ingested. Health care professionals can access patient data from digital pills online via their own interface, thus allowing them to check whether a patient took the drug. Digital pills were developed for the stated goal of improving treatment adherence. The US Food and Drug Administration approved the first digital pills in November 2017, but the manufacturer withdrew its application to the European Medicines Agency in July 2020 because of insufficient evaluation. Objective: As recommended for the evaluation of health technologies, this study assesses the prospective acceptability of and willingness to take digital pills among patients, the public, and health care professionals. Methods: Participants were patients who were receiving long-term treatment for a chronic condition, public participants (both groups recruited from a representative sample), and health care professionals. Participants answered 5 open-ended questions regarding the acceptability of digital pills and 1 close-ended question regarding the willingness to take digital pills, which were developed in a preliminary qualitative study. We explored the 5 theoretical dimensions of acceptability by performing an abductive qualitative content analysis of all free-text responses. We assessed data saturation with mathematical models. We fitted a multivariate logistic regression model to identify the sociodemographic and health characteristics associated with the willingness to take digital pills. Results: Between January 29, 2020, and April 18, 2020, 767 patients, 1238 public participants, and 246 health care professionals provided 11,451 free-text responses. We identified 98 codes related to the acceptability of digital pills: 29 codes on perceived clinical effectiveness (eg, sensor safety cited by 66/2251 participants, 29.5%), 6 on perceived burden (eg, increased doctors’ workload, 164/2251 participants, 7.3%), 25 on perceived ethicality (eg, policing, 345/2251 participants, 15.3%), 30 codes on perceived opportunity (eg, exclusively negative perception, 690/2251 participants, 30.7%), and 8 on affective attitude (eg, anger, 541/2251, 24%). Overall, 271/767 (35.3%) patients, 376/1238 (30.4%) public participants, and 39/246 (15.8%) health care professionals reported willingness to take digital pills. This willingness was associated with male sex (odds ratio 1.98, 95% CI 1.62-2.43) and current use of a connected device to record health settings (with a dose–response relationship). Conclusions: The prospective acceptability of and willingness to take digital pills were limited by clinical and ethical concerns both at the individual and societal level. Our results suggest that digital pills should not be considered a mere change in the form of drug administration but a complex intervention requiring specific evaluation before extended use in clinical routine practice as well as an ethical and legal framework to ensure safe and ethical collection and use of health data through a patient-centered approach. %M 35179509 %R 10.2196/25597 %U https://www.jmir.org/2022/2/e25597 %U https://doi.org/10.2196/25597 %U http://www.ncbi.nlm.nih.gov/pubmed/35179509 %0 Journal Article %@ 2291-9279 %I JMIR Publications %V 10 %N 1 %P e31570 %T A Serious Puzzle Game to Enhance Adherence to Antirheumatic Drugs in Patients With Rheumatoid Arthritis: Systematic Development Using Intervention Mapping %A Pouls,Bart PH %A Bekker,Charlotte L %A van Dulmen,Sandra %A Vriezekolk,Johanna E %A van den Bemt,Bart JF %+ Department of Rheumatology Research, Sint Maartenskliniek, Hengstdal 3, Nijmegen, 6574NA, Netherlands, 31 612502678, b.pouls@maartenskliniek.nl %K medication adherence %K serious game %K eHealth %K rheumatoid arthritis %K intervention mapping %K intervention development %D 2022 %7 18.2.2022 %9 Original Paper %J JMIR Serious Games %G English %X Background: Patients’ implicit attitudes toward medication need and concerns may influence their adherence. Targeting these implicit attitudes by combining game-entertainment with medication-related triggers might improve medication adherence in patients with rheumatoid arthritis (RA). Objective: The aim of this study was to describe the systematic development of a serious game to enhance adherence to antirheumatic drugs by using intervention mapping. Methods: A serious game was developed using the intervention mapping framework guided by a multidisciplinary expert group, which proceeded along 6 steps: (1) exploring the problem by assessing the relationship between medication adherence and implicit attitudes, (2) defining change objectives, (3) selecting evidence-based behavior change techniques that focused on adjusting implicit attitudes, (4) designing the intervention, (5) guaranteeing implementation by focusing on intrinsic motivation, and (6) planning a scientific evaluation. Results: Based on the problem assessment and guided by the Dual-Attitude Model, implicit negative and illness-related attitudes of patients with RA were defined as the main target for the intervention. Consequently, the change objective was “after the intervention, participants have a more positive attitude toward antirheumatic drugs.” Attention bias modification, evaluative conditioning, and goal priming were the techniques chosen to implicitly target medication needs. These techniques were redesigned into medication-related triggers and built in the serious puzzle game. Thirty-seven patients with RA tested the game at several stages. Intrinsic motivation was led by the self-determination theory and addressed the 3 needs, that is, competence, autonomy, and relatedness. The intervention will be evaluated in a randomized clinical trial that assesses the effect of playing the serious game on antirheumatic drug adherence. Conclusions: We systematically developed a serious game app to enhance adherence to antirheumatic drugs among patients with RA by using the intervention mapping framework. This paper could serve as a guideline for other health care providers when developing similar interventions. %M 35179510 %R 10.2196/31570 %U https://games.jmir.org/2022/1/e31570 %U https://doi.org/10.2196/31570 %U http://www.ncbi.nlm.nih.gov/pubmed/35179510 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 2 %P e33603 %T Consistency With and Disengagement From Self-monitoring of Weight, Dietary Intake, and Physical Activity in a Technology-Based Weight Loss Program: Exploratory Study %A Carpenter,Chelsea A %A Eastman,Abraham %A Ross,Kathryn M %+ Department of Clinical and Health Psychology, College of Public Health and Health Professions, University of Florida, PO Box 100165, Gainesville, FL, 32610, United States, 1 (352) 294 8433, kmross@phhp.ufl.edu %K self-monitoring %K adherence %K weight loss %K digital tools %K mobile phone %D 2022 %7 18.2.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: Digital self-monitoring tools offer promise to improve adherence to self-monitoring of weight and weight-related behaviors; however, less is known regarding the patterns of participant consistency and disengagement with these tools. Objective: This study characterizes the consistency of use and time to disengagement with digital self-monitoring tools during a 6-month weight loss intervention and investigates whether the provision of phone-based intervention improved self-monitoring adherence. Methods: Participants were 54 adults with overweight or obesity (mean age 49.6 years, SD 12.4 years; mean BMI 32.6 kg/m2, SD 3.2 kg/m2) enrolled in a pilot trial assessing the impact of self-monitoring technology (Fitbit Zip, Aria scale, and smartphone app), with and without additional interventionist contact, on weight loss. All participants received weight loss education and were asked to self-monitor weight, dietary intake, and physical activity daily throughout the 6-month program. Consistency was defined as the number of weeks that participants adhered to self-monitoring recommendations (7 out of 7 days). Disengagement was defined as the first of 2 consecutive weeks that the 7-day self-monitoring adherence goal was not met. Wilcoxon signed-rank tests were used to examine differences in consistency and disengagement by behavioral targets. t tests (2-tailed) and Cox proportional hazards models were used to examine whether providing additional interventionist contact would lead to significant improvements in consistency and time to disengagement from self-monitoring tools, respectively. Linear regressions were used to examine associations between consistency, time to disengagement, and weight loss. Results: Participants consistently self-monitored physical activity for more weeks (mean 17.4 weeks, SD 8.5 weeks) than weight (mean 11.1 weeks, SD 8.5 weeks) or dietary intake (mean 10.8 weeks, SD 8.7 weeks; P<.05). Similarly, participants had a significantly longer time to disengagement from self-monitoring of physical activity (median 19.5 weeks) than weight (4 weeks) or dietary intake (10 weeks; P<.001). Participants randomized to receive additional interventionist contact had significantly greater consistency and longer time to disengagement for self-monitoring of dietary intake compared with participants who did not (P=.006); however, there were no statistically significant differences between groups for self-monitoring of weight or physical activity (P=.24 and P=.25, respectively). Greater consistency and longer time to disengagement were associated with greater weight loss for self-monitoring of weight and dietary intake (P<.001 and P=.004, respectively) but not for physical activity (P=.57). Conclusions: Results demonstrated that self-monitoring adherence differed by behavioral target, with greater consistency and longer time to disengagement associated with lower-burden tools (ie, self-monitoring of physical activity). Consistent with supportive accountability theory, additional interventionist contact improved consistency and lengthened time to disengagement from self-monitoring of dietary intake. Given the observed associations between consistency, disengagement, and weight loss outcomes, it is important to identify additional methods of increasing consistency and engagement with digital self-monitoring tools. %M 35179513 %R 10.2196/33603 %U https://formative.jmir.org/2022/2/e33603 %U https://doi.org/10.2196/33603 %U http://www.ncbi.nlm.nih.gov/pubmed/35179513 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 2 %P e32946 %T Posthospitalization Follow-Up of Patients With Heart Failure Using eHealth Solutions: Restricted Systematic Review %A Morken,Ingvild Margreta %A Storm,Marianne %A Søreide,Jon Arne %A Urstad,Kristin Hjorthaug %A Karlsen,Bjørg %A Husebø,Anne Marie Lunde %+ Department of Public Health, University of Stavanger, Prof Olav Hanssens vei 10, Stavanger, 4021, Norway, 47 99262805, anne.m.husebo@uis.no %K adherence %K eHealth %K heart failure %K posthospitalization follow-up %K patient outcome %K review %D 2022 %7 15.2.2022 %9 Review %J J Med Internet Res %G English %X Background: Heart failure (HF) is a clinical syndrome with high incidence rates, a substantial symptom and treatment burden, and a significant risk of readmission within 30 days after hospitalization. The COVID-19 pandemic has revealed the significance of using eHealth interventions to follow up on the care needs of patients with HF to support self-care, increase quality of life (QoL), and reduce readmission rates during the transition between hospital and home. Objective: The aims of this review are to summarize research on the content and delivery modes of HF posthospitalization eHealth interventions, explore patient adherence to the interventions, and examine the effects on the patient outcomes of self-care, QoL, and readmissions. Methods: A restricted systematic review study design was used. Literature searches and reviews followed the (PRISMA-S) Preferred Reporting Items for Systematic Reviews and Meta-Analyses literature search extension checklist, and the CINAHL, MEDLINE, Embase, and Cochrane Library databases were searched for studies published between 2015 and 2020. The review process involved 3 groups of researchers working in pairs. The Mixed Methods Appraisal Tool was used to assess the included studies’ methodological quality. A thematic analysis method was used to analyze data extracted from the studies. Results: A total of 18 studies were examined in this review. The studies were published between 2015 and 2019, with 56% (10/18) of them published in the United States. Of the 18 studies, 16 (89%) were randomized controlled trials, and 14 (78%) recruited patients upon hospital discharge to eHealth interventions lasting from 14 days to 12 months. The studies involved structured telephone calls, interactive voice response, and telemonitoring and included elements of patient education, counseling, social and emotional support, and self-monitoring of symptoms and vital signs. Of the 18 studies, 11 (61%) provided information on patient adherence, and the adherence levels were 72%-99%. When used for posthospitalization follow-up of patients with HF, eHealth interventions can positively affect QoL, whereas its impact is less evident for self-care and readmissions. Conclusions: This review suggests that patients with HF should receive prompt follow-up after hospitalization and eHealth interventions have the potential to improve these patients’ QoL. Patient adherence in eHealth follow-up trials shows promise for successful future interventions and adherence research. Further studies are warranted to examine the effects of eHealth interventions on self-care and readmissions among patients with HF. %M 35166680 %R 10.2196/32946 %U https://www.jmir.org/2022/2/e32946 %U https://doi.org/10.2196/32946 %U http://www.ncbi.nlm.nih.gov/pubmed/35166680 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 2 %P e29393 %T Home-Based Spirometry Telemonitoring After Allogeneic Hematopoietic Cell Transplantation: Mixed Methods Evaluation of Acceptability and Usability %A Sheshadri,Ajay %A Makhnoon,Sukh %A Alousi,Amin M %A Bashoura,Lara %A Andrade,Rene %A Miller,Christopher J %A Stolar,Karen R %A Arain,Muhammad Hasan %A Noor,Laila %A Balagani,Amulya %A Jain,Akash %A Blanco,David %A Ortiz,Abel %A Taylor,Michael S %A Stenzler,Alex %A Mehta,Rohtesh %A Popat,Uday R %A Hosing,Chitra %A Ost,David E %A Champlin,Richard E %A Dickey,Burton F %A Peterson,Susan K %+ Department of Pulmonary Medicine, The University of Texas MD Anderson Cancer Center, 1400 Pressler Unit 1462, Houston, TX, 77030, United States, 1 7135631987, asheshadri@mdanderson.org %K allogeneic hematopoietic cell transplantation %K home-based spirometry %K acceptability %K usability %K mixed methods evaluation %K patient perspectives %K spirometry %K feasibility %K mHealth %K home-based %K remote care %K respirology %K pulmonary medicine %K mobile phone %D 2022 %7 7.2.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: Home-based spirometry (HS) allows for the early detection of lung complications in recipients of an allogeneic hematopoietic cell transplant (AHCT). Although the usability and acceptability of HS are critical for adherence, patient-reported outcomes of HS use remain poorly understood in this setting. Objective: The aim of this study is to design a longitudinal, mixed methods study to understand the usability and acceptability of HS among recipients of AHCT. Methods: Study participants performed HS using a Bluetooth-capable spirometer that transmitted spirometry data to the study team in real time. In addition, participants completed usability questionnaires and in-depth interviews and reported their experiences with HS. Analysis of interview data was guided by the constructs of performance expectancy, effort expectancy, and social influence from the Unified Theory of Acceptance and Use of Technology model. Results: Recipients of AHCT found HS to be highly acceptable despite modest technological barriers. On average, participants believed that the HS was helpful in managing symptoms related to AHCT (scores ranging from 2.22 to 2.68 on a scale of 0-4) and for early detection of health-related problems (score range: 2.88-3.12). Participants viewed HS favorably and were generally supportive of continued use. No significant barriers to implementation were identified from the patient’s perspective. Age and gender were not associated with the patient perception of HS. Conclusions: Study participants found HS acceptable and easy to use. Some modifiable technical barriers to performing HS were identified; however, wider implementation of pulmonary screening is feasible from the patient’s perspective. %M 35129455 %R 10.2196/29393 %U https://formative.jmir.org/2022/2/e29393 %U https://doi.org/10.2196/29393 %U http://www.ncbi.nlm.nih.gov/pubmed/35129455 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 2 %P e30811 %T Interactive Mobile Phone HIV Adherence Support for Men Who Have Sex With Men in the Philippines Connect for Life Study: Mixed Methods Approach to Intervention Development and Pilot Testing %A O'Connor,Cara %A Leyritana,Katerina %A Doyle,Aoife M %A Lewis,James J %A Gill,Randeep %A Salvaña,Edsel Maurice %+ Faculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, Keppel Street, London, WC1E 7HT, United Kingdom, 44 791336248, caraoc@gmail.com %K mHealth %K adherence %K HIV %K antiretroviral therapy %K intervention development %K mobile phone %D 2022 %7 3.2.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: The HIV epidemic in the Philippines is one of the fastest growing epidemics globally, and infections among men who have sex with men are rising at an alarming rate. The World Health Organization recommends the use of mobile health (mHealth) technologies to engage patients in care and ensure high levels of adherence to antiretroviral therapy (ART). Existing mHealth interventions can be adapted and tailored to the context and population served. Objective: This study aims to create a locally tailored intervention using a mobile phone platform to support treatment adherence for HIV patients on ART in the Philippines. Methods: A mixed methods approach guided by the Behavior Change Wheel framework was used to adapt an existing mHealth adherence support platform for the local setting and target population. A literature review, retrospective clinical record review, and focus group discussions with patients were conducted to understand the drivers of ART adherence and tailor the intervention accordingly. The resulting intervention was pilot-tested for 8 weeks, followed by focus group discussions with patients who received the intervention to assess the acceptability of the design. Results: Key issues contributing to nonadherence included side effects, lack of behavioral skills for pill taking, social support, mental health, and substance use. Patients identified mHealth as an acceptable mode of intervention delivery and wanted mHealth services to be highly personalizable. The study team, clinicians, and software developers integrated these findings into the intervention, which included a menu of services as follows: pill reminders, health tips, adherence feedback, appointment reminders, and symptom reporting. During the pilot phase, technical issues in the interactive voice response system (IVRS) were identified and addressed. Patients who participated in the pilot phase expressed a preference for SMS text messaging over the IVRS. Patients responded positively to the appointment reminders and health tips, whereas patient feedback on daily and weekly pill reminders and adherence feedback was mixed. Conclusions: The mobile phone–based SMS text messaging and IVRS intervention was acceptable to men who have sex with men in Manila, the Philippines, and qualitative analysis suggested that the intervention helped promote ART adherence and appointment attendance. %M 35113030 %R 10.2196/30811 %U https://formative.jmir.org/2022/2/e30811 %U https://doi.org/10.2196/30811 %U http://www.ncbi.nlm.nih.gov/pubmed/35113030 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 10 %N 1 %P e32626 %T Adherence to Growth Hormone Treatment Using a Connected Device in Latin America: Real-World Exploratory Descriptive Analysis Study %A Assefi,Aria %A van Dommelen,Paula %A Arnaud,Lilian %A Otero,Carlos %A Fernandez-Luque,Luis %A Koledova,Ekaterina %A Calliari,Luis Eduardo %+ Fertility and Endocrinology, Merck SA (an affiliate of Merck KGaA, Darmstadt, Germany), Edificio Panamericana Plaza, Tronador, Buenos Aires, 4890, Argentina, 54 9 11 2275146, aria.assefi@merckgroup.com %K adherence %K connected device %K growth %K growth disorders %K growth hormone %K electronic injection device %K real-world data %K disorder %K therapy %K treatment %K children %K outcome %D 2022 %7 20.1.2022 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Recombinant human growth hormone (rhGH) therapy is an effective treatment for children with growth disorders. However, poor outcomes are often associated with suboptimal adherence to treatment. Objective: The easypod connected injection device records and transmits injection settings and dose data from patients receiving rhGH. In this study, we evaluated adherence to rhGH treatment, and associated growth outcomes, in Latin American patients. Methods: Adherence and growth data from patients aged 2-18 years from 12 Latin American countries were analyzed. Adherence data were available for 6207 patients with 2,449,879 injections, and growth data were available for 497 patients with 2232 measurements. Adherence was categorized, based on milligrams of rhGH injected versus milligrams of rhGH prescribed, as high (≥85%), intermediate (>56%-<85%), or low (≤56%). Transmission frequency was categorized as high (≥1 per 3 months) or low (<1 per 3 months). Chi-square tests were applied to study the effect of pubertal status at treatment start and sex on high adherence, and to test differences in frequency transmission between the three adherence levels. Multilevel linear regression techniques were applied to study the effect of adherence on observed change in height standard deviation score (∆HSDS). Results: Overall, 68% (4213/6207), 25% (n=1574), and 7% (n=420) of patients had high, intermediate, and low adherence, respectively. Pubertal status at treatment start and sex did not have a significant effect on high adherence. Significant differences were found in the proportion of patients with high transmission frequency between high (2018/3404, 59%), intermediate (608/1331, 46%), and low (123/351, 35%) adherence groups (P<.001). Adherence level had a significant effect on ∆HSDS (P=.006). Mean catch-up growth between 0-24 months was +0.65 SD overall (+0.52 SD in patients with low/intermediate monthly adherence and +0.69 SD in patients with high monthly adherence). This difference translated into 1.1 cm greater catch-up growth with high adherence. Conclusions: The data extracted from the easypod Connect ecosystem showed high adherence to rhGH treatment in Latin American patients, with positive growth outcomes, indicating the importance of connected device solutions for rhGH treatment in patients with growth disorders. %M 35049518 %R 10.2196/32626 %U https://mhealth.jmir.org/2022/1/e32626 %U https://doi.org/10.2196/32626 %U http://www.ncbi.nlm.nih.gov/pubmed/35049518 %0 Journal Article %@ 2561-1011 %I JMIR Publications %V 6 %N 1 %P e24174 %T The Impact of a Mobile App on Participation in Cardiac Rehabilitation and Understanding Barriers to Success: Comparative Cohort Study %A Rivers,John T %A Smith,Carla %A Smith,Ian %A Cameron,James %+ Queensland Cardiovascular Group, St Andrew's Specialist Centre, 457 Wickham Terrace, Brisbane, 4004, Australia, 61 438601941, johnr@qcg.com.au %K cardiac rehabilitation %K digital health %K smartphone app %K Cardihab %K participation rates %K rehabilitation %K cardiology %K heart %K app %K barrier %D 2022 %7 17.1.2022 %9 Original Paper %J JMIR Cardio %G English %X Background: Poor patient uptake of cardiac rehabilitation (CR) remains a challenge for multiple reasons including geographic, time, cultural, cost, and psychological constraints. Objective: We evaluated the impact on CR participation rates associated with the addition of the option of mobile app–based CR (Cardihab) for patients declining conventional CR. Methods: A total of 204 consecutive patients were offered CR following angioplasty; of these, 99 were in cohort 1 (offered conventional CR only) and 105 were in cohort 2 (app-based CR offered to those declining conventional CR). Patients in each cohort were followed throughout a 6-week CR program and participation rates were compared for both groups. Patients in cohort 2 declining both forms of CR were interviewed to assess reasons for nonparticipation. Results: CR participation improved from 21% (95% CI 14%-30%) to 63% (95% CI 53%-71%) with the addition of the app (P<.001). Approximately 25% (9/39) of the group declining the app-based program identified technology issues as the reason for nonparticipation. The remainder declined both CR programs or were ineligible due to frailty or comorbidities. Conclusions: Providing patients with the additional option of an app-based CR program substantially improved CR participation. Technology and psychological barriers can limit CR participation. Further innovation in CR delivery systems is required to improve uptake. %M 35037891 %R 10.2196/24174 %U https://cardio.jmir.org/2022/1/e24174 %U https://doi.org/10.2196/24174 %U http://www.ncbi.nlm.nih.gov/pubmed/35037891 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 11 %N 1 %P e34885 %T A Technology-Based Intervention Among Young Men Who Have Sex With Men and Nonbinary People (The Conectad@s Project): Protocol for A Vanguard Mixed Methods Study %A Torres,Thiago Silva %A Jalil,Emilia Moreira %A Coelho,Lara Esteves %A Bezerra,Daniel Rodrigues Barros %A Jalil,Cristina Moreira %A Hoagland,Brenda %A Cardoso,Sandra Wagner %A Arayasirikul,Sean %A Veloso,Valdilea Gonçalves %A Wilson,Erin C %A McFarland,Willi %A Grinsztejn,Beatriz %+ Instituto Nacional de Infectologia Evandro Chagas, Fundação Oswaldo Cruz, Av Brasil 4365 Manguinhos, Rio de Janeiro, 21040360, Brazil, 55 2138659623, thiago.torres@ini.fiocruz.br %K sexual and gender minorities %K young MSM %K Brazil %K HIV prevention %K technology-based adherence intervention %K HIV %D 2022 %7 13.1.2022 %9 Protocol %J JMIR Res Protoc %G English %X Background: In many parts of the world, including Brazil, uptake for biomedical interventions has been insufficient to reverse the HIV epidemic among key populations at high risk for HIV, including men who have sex with men. Young MSM (YMSM), particularly Black YMSM, have high HIV incidence, low viral suppression, and low preexposure prophylaxis (PrEP) uptake and adherence. Therefore, novel approaches to increase the HIV biomedical interventions uptake by YMSM are urgently needed. Objective: We describe the Conectad@s Project, which aims to: (1) estimate the prevalence and incidence of HIV and other sexually transmitted infections, the onset of sexual risk behavior, and barriers to biomedical interventions among YMSM aged 18 to 24 years in Rio de Janeiro, Brazil; and (2) conduct a technology-based adherence intervention study to promote a rapid linkage of YMSM to HIV care or prevention, and support and sustain adherence. Methods: A cross-sectional survey will be conducted with 400 YMSM recruited using respondent-driven sampling (RDS) adapted for social media-based sampling, preceded by a formative phase. HIV and sexually transmitted infections testing will be conducted, including early HIV infection biomarker detection. Behavioral, partnership, network, and structural measures will be collected through structured questionnaires. All individuals recruited for the survey will have access to HIV risk assessment, antiretroviral therapy (ART), PrEP, prevention counseling, and a technology-based adherence intervention. Those who accept the adherence intervention will receive weekly text messages via a social networking app (WhatsApp) for 24 weeks, with follow-up data collected over 48 weeks. Results: The Conectad@s project has been approved by our local institutional review board (#CAAE 26086719.0.0000.4262) in accordance with all applicable regulations. Questionnaires for the RDS survey and intervention were developed and tested in 2020, formative interviews were conducted in January and February 2021 to guide the development of the RDS, and enrollment is planned to begin in early 2022. Conclusions: The Conectad@s Project is a vanguard study that, for the first time, will apply digital RDS to sample and recruit YMSM in Brazil and rapidly connect them to ART, PrEP, or prevention counseling through a technology-based adherence intervention. RDS will allow us to estimate HIV prevalence among YMSM and measure HIV infection biomarkers in the context of the onset of risky behavior. The data will lay the groundwork to adapt and implement HIV prevention strategies, identify barriers to the earliest HIV infection diagnosis, immediate ART or PrEP initiation, and detect new clusters of HIV transmission. International Registered Report Identifier (IRRID): DERR1-10.2196/34885 %M 35023848 %R 10.2196/34885 %U https://www.researchprotocols.org/2022/1/e34885 %U https://doi.org/10.2196/34885 %U http://www.ncbi.nlm.nih.gov/pubmed/35023848 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 10 %N 1 %P e27192 %T Effect of an Integrative Mobile Health Intervention in Patients With Hypertension and Diabetes: Crossover Study %A Oh,Sang Woo %A Kim,Kyoung-Kon %A Kim,Sung Soo %A Park,Su Kyung %A Park,Sangshin %+ Department of Family Medicine, Dongguk University Ilsan Hospital, Dongguk University College of Medicine, 27, Dongguk-ro, Ilsandong-gu, Goyang-si, Gyeonggi-do, 10326, Republic of Korea, 82 31 961 7490, osw6021@naver.com %K diabetes mellitus type 2 %K obesity %K hypertension %K mHealth %K mobile phone %D 2022 %7 11.1.2022 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Obesity, hypertension, and type 2 diabetes mellitus (T2DM) are worldwide epidemics that inflict burdens on both public health and health care costs. Self-management plays an important role in the proper management of these 3 chronic diseases, and in this context, mobile health (mHealth) can be a cost-effective self-management tool. Objective: The aim of this pilot study is to evaluate the effects of an integrative mHealth approach for obesity, hypertension, and T2DM on body fat, blood pressure, and blood glucose levels and demonstrate the clinical outcomes. The participants were patients aged 40 to 70 years who were treated for T2DM (hemoglobin A1c [HbA1c] above 6.0%) without insulin or hypertension and obesity, controlled with pharmacotherapy. Methods: This pilot study was performed using a controlled, randomized, 3-month, 2-period crossover design. A total of 37 participants were recruited from 2 university hospitals in South Korea. Integrative mHealth comprised 4 parts: self-measuring home devices for monitoring blood glucose and blood pressure; 2 smartphone apps, where one gathered lifestyle data, giving them feedback with health information, and the other provided drug information and reminders of the medication schedule; unmanned kiosks for official measurement of blood pressure and body composition; and web-based access to participants’ health information. Results: Data from the 32 participants were analyzed. Their mean HbA1c level was 7.5% (SD 0.8, ranging from 6.1% to 9.4%). Approximately 38% (12/32) of the participants had hypertension. BMIs of all participants except 1 were >23 kg/m2. The input rates of food intake and exercise to the smartphone app were very low (24.9% and 5.3%, respectively). On the contrary, the input rate of medicine intake was high (84.0%). Moreover, there was no significant difference in the input rate of taking medicine irrespective of whether the mHealth period was before or after the conventional treatment period (80.3% and 87.3%, respectively; P=.06). Among the 3 input functions of food intake, exercise, and medicine intake in smartphone apps, the input of medicine intake was a more helpful, easier to use, and better-designed function than the others. There were no significant differences in changes in body weight (−0.519 kg vs 0 kg), BMI (−0.133 kg/m2 vs −0.167 kg/m2), body composition (body fat −0.255% vs 0.172%), blood pressure (systolic −0.226 mm Hg vs −2.839 mm Hg), and HbA1c (−0.269% vs –0.009%) between the integrative mHealth and conventional treatment groups. However, in proportion to the elevation in the input rate of taking medicine, body fat mass (P=.04) and HbA1c (P=.03) were lower in the integrative mHealth group. Conclusions: Although smartphone apps can influence body fat and blood glucose levels, they have failed to show clinical improvement. A higher input rate of taking medicine was related to significantly lower body fat mass and HbA1c levels. %M 35014961 %R 10.2196/27192 %U https://mhealth.jmir.org/2022/1/e27192 %U https://doi.org/10.2196/27192 %U http://www.ncbi.nlm.nih.gov/pubmed/35014961 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 10 %N 1 %P e30807 %T A Smartphone App to Improve Oral Anticoagulation Adherence in Patients With Atrial Fibrillation: Prospective Observational Study %A Senoo,Keitaro %A Miki,Tomonori %A Ohkura,Takashi %A Iwakoshi,Hibiki %A Nishimura,Tetsuro %A Shiraishi,Hirokazu %A Teramukai,Satoshi %A Matoba,Satoaki %+ Department of Cardiac Arrhythmia Research and Innovation, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto-shi, Kamigyo-ku Kajii-cho 465, Kawaramachi-Hirokoji, Kyoto, 602-8566, Japan, 81 8031117168, swcqg251@yahoo.co.jp %K atrial fibrillation %K smartphone app %K anticoagulants %K drug adherence %K education %K patient involvement %D 2022 %7 7.1.2022 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Poor adherence to oral anticoagulation in elderly patients with atrial fibrillation (AF) has been shown to negatively impact health care costs, morbidity, and mortality. Although various methods such as automated reminders, counseling, telephone support, and patient education have been effective in improving medication adherence, the burden on health care providers has been considerable. Recently, an attempt has been made to improve medication adherence without burdening health care providers by using smartphone apps; however, the use of the app for elderly patients with AF is still limited. Objective: The purpose of this study was to determine whether the newly developed smartphone app for patients with AF (the Smart AF), which integrates education, automatic reminder, and patient engagement strategies with a simple user interface, can improve medication adherence in elderly patients with AF. Methods: Patient enrollment was carried out by obtaining informed consent from patients with AF attending Kyoto Prefectural University of Medicine hospital between May 2019 and September 2020. Follow-up was planned at 1, 3, and 6 months after enrollment, and questionnaire reminders were automatically sent to patient apps at designated follow-up time points. A questionnaire-based survey of medication adherence was performed electronically using the self-reported 8-item Morisky Medication Adherence Scale (MMAS-8) as the survey tool. Results: A total of 136 patients with AF were enrolled in this study. During the follow-up period, 112 (82%) patients underwent follow-up at 1 month, 107 (79%) at 3 months, and 96 (71%) at 6 months. The mean age of the enrolled patients was 64.3 years (SD 9.6), and male participants accounted for 79.4% (108/136) of the study population. The mean CHADS2 (congestive heart failure, hypertension, age, diabetes, previous stroke, or transient ischemic attack) score was 1.2, with hypertension being the most common comorbidity. At the time of enrollment, 126 (93%) and 10 (7%) patients were taking direct oral anticoagulants and warfarin, respectively. For medication adherence as measured according to the MMAS-8, MMAS scores at 1 month, 3 months, and 6 months were significantly improved compared with baseline MMAS scores (all P values less than .01). The overall improvement in medication adherence achieved by the 6-month intervention was as follows: 77.8% (14/18) of the patients in the high adherence group (score=8) at baseline remained in the same state, 45.3% (24/53) of the patients in the medium adherence group (score=6 to <8) at baseline moved to the high adherence group, and 72% (18/25) of the patients in the low adherence group (score <6) moved to either the medium or high adherence group. Conclusions: The Smart AF app improved medication adherence among elderly patients with AF. In the realm of medication management, an approach using a mobile health technology that emphasizes education, automatic reminder, and patient engagement may be helpful. %M 34894626 %R 10.2196/30807 %U https://mhealth.jmir.org/2022/1/e30807 %U https://doi.org/10.2196/30807 %U http://www.ncbi.nlm.nih.gov/pubmed/34894626 %0 Journal Article %@ 2561-9128 %I JMIR Publications %V 4 %N 2 %P e31852 %T An Innovative App (ExoDont) for Postoperative Care of Patients After Tooth Extraction: Prototype Development and Testing Study %A Krishna,Meenakshi %A Sybil,Deborah %A Shrivastava,Priyanshu Kumar %A Premchandani,Shubhangi %A Kumar,Himanshu %A Kumar,Pintu %+ Faculty of Dentistry, Jamia Millia Islamia, Maulana Mohammad Ali Jauhar Marg, Jamia Nagar, New Delhi, 110025, India, 91 8340593862, priyanshushri25@gmail.com %K ExoDont %K Android app %K teledentistry %K mHealth %K tooth extraction %K postoperative %K dentistry %K dentist %K teeth %K dental surgery %K oral surgery %D 2021 %7 31.12.2021 %9 Original Paper %J JMIR Perioper Med %G English %X Background: The postoperative period is crucial for the initiation of healing and prevention of complications after any surgical procedure. Due to factors such as poor compliance, comprehension, and retention of instructions, and other unaccounted factors, the objectives of postoperative care are not always achieved. Therefore, an Android-based mobile health app (ExoDont) was developed to ensure a smooth postoperative period for patients after a dental extraction. The ExoDont app delivers reminders for postoperative instructions and drug intake at defined intervals, thus fostering self-reliance among patients in taking their prescribed dose of medication. Objective: The aim of this study is to design, develop, and validate ExoDont, an innovative app for improved adherence to postoperative instructions after tooth extraction. Methods: A postoperative treatment protocol was developed by a team of oral and maxillofacial surgeons and general dentists, following which the clinical and technological requirements of the app were determined along with the software engineers, graphic designers, and applications architect in the team. ExoDont was developed to provide timely reminders for medication and postoperative care. The app was field tested and validated using the User Version of the Mobile Application Rating Scale. Results: The ExoDont software design was divided into a 3-level architecture comprising a user interface application, logical layer, and database layer. The software architecture consists of an Android-based ExoDont app for patients and a web version of the admin panel. The testing and validation of the ExoDont app revealed that Perceived Impact received the highest mean score of all rated components (mean 4.6, SD 0.5), while Engagement received the lowest mean score (mean 3.5, SD 0.8). Conclusions: The testing and validation of the app support its usability and functionality, as well as its impact on users. The ExoDont app has been designed, keeping the welfare of patients in view, in a user-friendly manner that will help patients adhere to the prescribed drug regimen and ensure easy and efficient dissemination of postoperative instructions. It could play an instrumental role in fostering compliance among patients and significantly decrease the complication rate following dental extractions. %M 34982720 %R 10.2196/31852 %U https://periop.jmir.org/2021/2/e31852 %U https://doi.org/10.2196/31852 %U http://www.ncbi.nlm.nih.gov/pubmed/34982720 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 5 %N 12 %P e31890 %T Detection of Clenbuterol-Induced Changes in Heart Rate Using At-Home Recorded Smartwatch Data: Randomized Controlled Trial %A Elzinga,Willem O %A Prins,Samantha %A Borghans,Laura G J M %A Gal,Pim %A Vargas,Gabriel A %A Groeneveld,Geert J %A Doll,Robert J %+ Centre for Human Drug Research, Zernikedreef 8, Leiden, 2333CL, Netherlands, 31 715246400, rjdoll@chdr.nl %K photoplethysmography %K smartwatch %K wearable %K at-home %K heart rate %K RCT %K wearable device %K digital health %K cardiovascular %K cardiology %K sensors %K heart rate sensor %K smart technology %D 2021 %7 30.12.2021 %9 Original Paper %J JMIR Form Res %G English %X Background: Although electrocardiography is the gold standard for heart rate (HR) recording in clinical trials, the increasing availability of smartwatch-based HR monitors opens up possibilities for drug development studies. Smartwatches allow for inexpensive, unobtrusive, and continuous HR estimation for potential detection of treatment effects outside the clinic, during daily life. Objective: The aim of this study is to evaluate the repeatability and sensitivity of smartwatch-based HR estimates collected during a randomized clinical trial. Methods: The data were collected as part of a multiple-dose, investigator-blinded, randomized, placebo-controlled, parallel-group study of 12 patients with Parkinson disease. After a 6-day baseline period, 4 and 8 patients were treated for 7 days with an ascending dose of placebo and clenbuterol, respectively. Throughout the study, the smartwatch provided HR and sleep state estimates. The HR estimates were quantified as the 2.5th, 50th, and 97.5th percentiles within awake and asleep segments. Linear mixed models were used to calculate the following: (1) the intraclass correlation coefficient (ICC) of estimated sleep durations, (2) the ICC and minimum detectable effect (MDE) of the HR estimates, and (3) the effect sizes of the HR estimates. Results: Sleep duration was moderately repeatable (ICC=0.64) and was not significantly affected by study day (P=.83), clenbuterol (P=.43), and study day by clenbuterol (P=.73). Clenbuterol-induced changes were detected in the asleep HR as of the first night (+3.79 beats per minute [bpm], P=.04) and in the awake HR as of the third day (+8.79 bpm, P=.001). The median HR while asleep had the highest repeatability (ICC=0.70). The MDE (N=12) was found to be smaller when patients were asleep (6.8 bpm to 11.7 bpm) than while awake (10.7 bpm to 22.1 bpm). Overall, the effect sizes for clenbuterol-induced changes were higher while asleep (0.49 to 2.75) than while awake (0.08 to 1.94). Conclusions: We demonstrated the feasibility of using smartwatch-based HR estimates to detect clenbuterol-induced changes during clinical trials. The asleep HR estimates were most repeatable and sensitive to treatment effects. We conclude that smartwatch-based HR estimates obtained during daily living in a clinical trial can be used to detect and track treatment effects. Trial Registration: Netherlands Trials Register NL8002; https://www.trialregister.nl/trial/8002 %M 34967757 %R 10.2196/31890 %U https://formative.jmir.org/2021/12/e31890 %U https://doi.org/10.2196/31890 %U http://www.ncbi.nlm.nih.gov/pubmed/34967757 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 9 %N 12 %P e26356 %T Personalized Reminders for Immunization Using Short Messaging Systems to Improve Human Papillomavirus Vaccination Series Completion: Parallel-Group Randomized Trial %A Wynn,Chelsea S %A Catallozzi,Marina %A Kolff,Chelsea A %A Holleran,Stephen %A Meyer,Dodi %A Ramakrishnan,Rajasekhar %A Stockwell,Melissa S %+ Division of Child and Adolescent Health, Department of Pediatrics, Columbia University Irving Medical Center, 622 W 168th St, VC 417, New York, NY, 10032, United States, 1 212 342 5732, mss2112@cumc.columbia.edu %K text messaging %K mobile reminders %K human papillomavirus %K adolescent %K text reminders %K vaccine completion %K vaccine decision-making %K vaccine education %K transtheoretical model %K mobile phone %K smartphone %K mHealth %K mobile health %K minority health %D 2021 %7 27.12.2021 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Completion rates among adolescents who initiate the human papillomavirus (HPV) vaccine 3-dose series are low. SMS text message vaccine reminders are effective, but less is known about the best types for HPV series completion or the ability to assess and target vaccine decision-making stage. Objective: The aim of this study is to compare the effectiveness of HPV vaccine series completion in minority adolescents who received precision and educational versus conventional SMS text message reminders. Methods: Enrolled parents of adolescents aged 9-17 years who received the first HPV vaccine dose at 1 of the 4 academic-affiliated community health clinics in New York City were randomized 1:1 to 1 of the 2 parallel, unblinded arms: precision SMS text messages (which included stage-targeted educational information, next dose due date, and site-specific walk-in hours) or conventional SMS text messages without educational information. Randomization was stratified according to gender, age, and language. The primary outcome was series completion within 12 months. In post hoc analysis, enrollees were compared with concurrent nonenrollees and historical controls. Results: Overall, 956 parents were enrolled in the study. The precision (475 families) and conventional (481 families) SMS text message arms had similarly high series completion rates (344/475, 72.4% vs 364/481, 75.7%). A total of 42 days after the first dose, two-thirds of families, not initially in the preparation stage, moved to preparation or vaccinated stage. Those in either SMS text message arm had significantly higher completion rates than nonenrollees (708/1503, 47.1% vs 679/1503, 45.17%; P<.001). Even after removing those needing only 2 HPV doses, adolescents receiving any SMS text messages had higher completion rates than historical controls (337/2823, 11.93% vs 981/2823, 34.75%; P<.001). A population-wide effect was seen from 2014 to 2016, above historical trends. Conclusions: SMS text message reminders led to timely HPV vaccine series completion in a low-income, urban, minority study population and also led to population-wide effects. Educational information did not provide an added benefit to this population. Trial Registration: ClinicalTrials.gov NCT02236273; https://clinicaltrials.gov/ct2/show/NCT02236273 %M 34958306 %R 10.2196/26356 %U https://mhealth.jmir.org/2021/12/e26356 %U https://doi.org/10.2196/26356 %U http://www.ncbi.nlm.nih.gov/pubmed/34958306 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 12 %P e22672 %T A Digital Platform to Support Self-management of Multiple Chronic Conditions (ProACT): Findings in Relation to Engagement During a One-Year Proof-of-Concept Trial %A Doyle,Julie %A Murphy,Emma %A Gavin,Shane %A Pascale,Alessandra %A Deparis,Stéphane %A Tommasi,Pierpaolo %A Smith,Suzanne %A Hannigan,Caoimhe %A Sillevis Smitt,Myriam %A van Leeuwen,Cora %A Lastra,Julia %A Galvin,Mary %A McAleer,Patricia %A Tompkins,Lorraine %A Jacobs,An %A M Marques,Marta %A Medina Maestro,Jaime %A Boyle,Gordon %A Dinsmore,John %+ NetwellCASALA, Dundalk Institute of Technology, Dublin Road, Dundalk, A91 K584, Ireland, 353 429370497, julie.doyle@dkit.ie %K digital health %K aging %K multimorbidity %K chronic disease %K self-management %K integrated care %K longitudinal study %K engagement %K usability %K mobile phone %D 2021 %7 15.12.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Populations globally are ageing, resulting in higher incidence rates of chronic diseases. Digital health platforms, designed to support those with chronic conditions to self-manage at home, offer a promising solution to help people monitor their conditions and lifestyle, maintain good health, and reduce unscheduled clinical visits. However, despite high prevalence rates of multimorbidity or multiple chronic conditions, most platforms tend to focus on a single disease. A further challenge is that despite the importance of users actively engaging with such systems, little research has explored engagement. Objective: The objectives of this study are to design and develop a digital health platform, ProACT, for facilitating older adults self-managing multimorbidity, with support from their care network, and evaluate end user engagement and experiences with this platform through a 12-month trial. Methods: The ProACT digital health platform is presented in this paper. The platform was evaluated in a year-long proof-of-concept action research trial with 120 older persons with multimorbidity in Ireland and Belgium. Alongside the technology, participants had access to a clinical triage service responding to symptom alerts and a technical helpdesk. Interactions with the platform during the trial were logged to determine engagement. Semistructured interviews were conducted with participants and analyzed using inductive thematic analysis, whereas usability and user burden were examined using validated questionnaires. Results: This paper presents the ProACT platform and its components, along with findings on engagement with the platform and its usability. Of the 120 participants who participated, 24 (20%) withdrew before the end of the study, whereas 3 (2.5%) died. The remaining 93 participants actively used the platform until the end of the trial, on average, taking 2 or 3 health readings daily over the course of the trial in Ireland and Belgium, respectively. The participants reported ProACT to be usable and of low burden. Findings from interviews revealed that participants experienced multiple benefits as a result of using ProACT, including improved self-management, health, and well-being and support from the triage service. For those who withdrew, barriers to engagement were poor health and frustration when technology, in particular sensing devices, did not work as expected. Conclusions: This is the first study to present findings from a longitudinal study of older adults using digital health technology to self-manage multimorbidity. Our findings show that older adults sustained engagement with the technology and found it usable. Potential reasons for these results include a strong focus on user-centered design and engagement throughout the project lifecycle, resulting in a platform that meets user needs, as well as the integration of behavior change techniques and personal analytics into the platform. The provision of triage and technical support services alongside the platform during the trial were also important facilitators of engagement. International Registered Report Identifier (IRRID): RR2-10.2196/22125 %M 34914612 %R 10.2196/22672 %U https://www.jmir.org/2021/12/e22672 %U https://doi.org/10.2196/22672 %U http://www.ncbi.nlm.nih.gov/pubmed/34914612 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 12 %P e22125 %T A Digital Health Platform for Integrated and Proactive Patient-Centered Multimorbidity Self-management and Care (ProACT): Protocol for an Action Research Proof-of-Concept Trial %A Dinsmore,John %A Hannigan,Caoimhe %A Smith,Suzanne %A Murphy,Emma %A Kuiper,Janneke M L %A O'Byrne,Emma %A Galvin,Mary %A Jacobs,An %A Sillevis Smitt,Myriam %A van Leeuwen,Cora %A McAleer,Patricia %A Tompkins,Lorraine %A Brady,Anne-Marie %A McCarron,Mary %A Doyle,Julie %+ Trinity Centre for Practice and Healthcare Innovation, School of Nursing and Midwifery, Trinity College Dublin, GAS Building, 24 D'Olier Street, Dublin, D02 T283, Ireland, 353 18964155 ext 4155, dinsmorj@tcd.ie %K multimorbidity %K digital health %K chronic disease %K self-management %K older adults %K integrated care %K behaviour change %K mobile phone %K smart phone %K smart device %D 2021 %7 15.12.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: Multimorbidity is defined as the presence of two or more chronic diseases and associated comorbidities. There is a need to improve best practices around the provision of well-coordinated, person-centered care for persons with multimorbidities. Present health systems across the European Union (EU) focus on supporting a single-disease framework of care; the primary challenge is to create a patient-centric, integrated care ecosystem to understand and manage multimorbidity. ProACT is a large-scale project funded by the European Commission under the Horizon 2020 programme, that involved the design, development, and evaluation of a digital health platform to improve and advance home-based integrated care, and supported self-management, for older adults (aged ≥65 years) living with multimorbidity. Objective: This paper describes the trial implementation protocol of a proof-of-concept digital health platform (ProACT) in 2 EU member states (Ireland and Belgium) to support older persons with multimorbidities self-managing at home, supported by their care network (CN). Methods: Research was conducted across 2 EU member states, Ireland and Belgium. A 12-month action research trial design, divided into 3 evaluation cycles and lasting 3 months each, with a reflective redesign and development phase of 1 month after cycles 1 and 2 was conducted. Participants were 120 (60/120, 50% in Ireland and 60/120, 50% in Belgium) older persons with multimorbidities diagnosed with two or more of the following chronic conditions: diabetes, chronic obstructive pulmonary disease, chronic heart failure, and cardiovascular diseases. With permission from persons with multimorbidities, members of their CN were invited to participate in the study. Persons with multimorbidities were provided with ProACT technologies (tablet, devices, or sensors) to support them in self-managing their conditions. CN members also received access to an app to remotely support their persons with multimorbidity. Qualitative and quantitative feedback and evaluation data from persons with multimorbidity and CN participants were collected across four time points: baseline (T1), at the end of each 3-month action research cycle (T2 and T3), and in a final posttrial interview (T4). Thematic analysis was used to analyze the qualitative interview data. Quantitative data were analyzed via platform use statistics (to assess engagement) and standardized questionnaires (using descriptive and inferential statistics). This study is approved by the ethics committees of Ireland and Belgium. Results: The trial implementation phase for this 44-month (2016-2019) funded study was April 2018 to June 2019. The trial outcomes are at various stages of publication since 2021. Conclusions: ProACT aims to co-design and develop a digital intervention with persons with multimorbidities and their CN, incorporating clinical guidelines with the state of the art in human-computer interaction, behavioral science, health psychology, and data analytic methods to deliver a digital health platform to advance self-management of multimorbidity at home, as part of a proactive, integrated model of supported person-centered care. International Registered Report Identifier (IRRID): RR1-10.2196/22125 %M 34914613 %R 10.2196/22125 %U https://www.researchprotocols.org/2021/12/e22125 %U https://doi.org/10.2196/22125 %U http://www.ncbi.nlm.nih.gov/pubmed/34914613 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 8 %N 4 %P e29197 %T A Mobile App to Support Self-management of Chronic Kidney Disease: Development Study %A Markossian,Talar W %A Boyda,Jason %A Taylor,Jennifer %A Etingen,Bella %A Modave,François %A Price,Ron %A Kramer,Holly J %+ Department of Public Health Sciences, Parkinson School of Health Sciences and Public Health, Loyola University Chicago, 2160 S First Avenue, Maywood, IL, 60153, United States, 1 7083279027, tmarkossian@luc.edu %K chronic kidney disease %K mobile app %K self-management %K mHealth %K mobile apps %K digital health %K kidney disease %K smartphone %D 2021 %7 15.12.2021 %9 Original Paper %J JMIR Hum Factors %G English %X Background: Chronic kidney disease (CKD) is a common and costly condition that is usually accompanied by multiple comorbidities including type 2 diabetes, hypertension, and obesity. Proper management of CKD can delay or prevent kidney failure and help mitigate cardiovascular disease risk, which increases as kidney function declines. Smart device apps hold potential to enhance patient self-management of chronic conditions including CKD. Objective: The objective of this study was to develop a mobile app to facilitate self-management of nondialysis-dependent CKD. Methods: Our stakeholder team included 4 patients with stage 3-4 nondialysis-dependent CKD; a kidney transplant recipient; a caretaker; CKD care providers (pharmacists, a nurse, primary care physicians, a nephrologist, and a cardiologist); 2 health services and CKD researchers; a researcher in biomedical informatics, nutrition, and obesity; a system developer; and 2 programmers. Focus groups and in-person interviews with the patients and providers were conducted using a focus group and interview guide based on existing literature on CKD self-management and the mobile app quality criteria from the Mobile App Rating Scale. Qualitative analytic methods including the constant comparative method were used to analyze the focus group and interview data. Results: Patients and providers identified and discussed a list of requirements and preferences regarding the content, features, and technical aspects of the mobile app, which are unique for CKD self-management. Requirements and preferences centered along themes of communication between patients and caregivers, partnership in care, self-care activities, adherence to treatment regimens, and self-care self-efficacy. These identified themes informed the features and content of our mobile app. The mobile app user can enter health data including blood pressure, weight, and blood glucose levels. Symptoms and their severity can also be entered, and users are prompted to contact a physician as indicated by the symptom and its severity. Next, mobile app users can select biweekly goals from a set of predetermined goals with the option to enter customized goals. The user can also keep a list of medications and track medication use. Our app includes feedback mechanisms where in-range values for health data are depicted in green and out-of-range values are depicted in red. We ensured that data entered by patients could be downloaded into a user-friendly report, which could be emailed or uploaded to an electronic health record. The mobile app also includes a mechanism that allows either group or individualized video chat meetings with a provider to facilitate either group support, education, or even virtual clinic visits. The CKD app also includes educational material on CKD and its symptoms. Conclusions: Patients with CKD and CKD care providers believe that a mobile app can enhance CKD self-management by facilitating patient-provider communication and enabling self-care activities including treatment adherence. %M 34914614 %R 10.2196/29197 %U https://humanfactors.jmir.org/2021/4/e29197 %U https://doi.org/10.2196/29197 %U http://www.ncbi.nlm.nih.gov/pubmed/34914614 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 5 %N 12 %P e17839 %T The Effect of an Automated Mobile Patient Engagement Application on Emergency Department Revisits: Prospective Observational Study %A Chatterjee,Pothik %A Beck,Adam M %A Brager,Jenna Ashley Levenson %A Durand,Daniel J %A D'Adamo,Christopher R %+ Innovation and Research Department, LifeBridge Health, 2401 W. Belvedere Ave, Baltimore, MD, 21215, United States, 1 410 601 1083, pchatter@lifebridgehealth.org %K patient engagement %K value-based care %K digital health %K mobile app %K automation %K readmission %K revisit %K emergency department %D 2021 %7 13.12.2021 %9 Original Paper %J JMIR Form Res %G English %X Background: Revisits within 30 days to an emergency department (ED), observation care unit, or inpatient setting following patient discharge continue to be a challenge, especially in urban settings. In addition to the consequences for the patient, these revisits have a negative impact on a health system’s finances in a value-based care or global budget environment. LifeBridge Health, a community health system in Maryland, United States, implemented an automated mobile patient engagement application as part of our enterprise-wide digital health strategy to improve patient engagement and reduce revisits to the ED. Objective: The aim of this paper was to evaluate the effectiveness of a customized automated digital patient engagement application (GetWell Loop) to reduce 30-day revisits after home discharge from an ED. Methods: The LifeBridge Health Innovation Department and ED staff from 2 participating health system hospitals collaborated with GetWellNetwork to customize their patient engagement application with automated check-in questions and other on-demand resources (eg, streaming content explaining aspects of self-care during COVID-19). An application link was emailed to adult patients discharged home from the ED. A study of ED visits for patients treated for general medicine and cardiology conditions between August 1, 2018, and July 31, 2019, was conducted using CRISP (Chesapeake Regional Information System for our Patients), Maryland’s state-designated health information exchange. We also used data within GetWell Loop (GetWellNetwork) to track patient activation and engagement. The primary outcome was the number of ED patients who experienced a 30-day revisit and who did or did not activate their GetWell Loop account. Secondary outcomes included the overall activation rate and the rate of engagement as measured by the number of logins, alerts, and comments generated by patients through the application. Bivariate analysis comparing outcomes among patients who activated the GetWell Loop application to patients who did not was conducted using the Fisher exact test. Multivariate logistic regression modeling with elastic net regularization was also performed to account for potential confounders and potential collinearity of covariates. Results: During this 1-year study, 1062 (27.4%) of 3866 of all emergency patients treated for general medicine or cardiology conditions, who received an invite to use the digital application, activated their account. The patients discharged from the ED, who were treated for general medicine conditions (n=2087) and who activated their GetWell Loop account, experienced a 30-day revisit rate of 17.3% (n=101) compared with 24.6% (n=369) for those who did not activate their account (P<.001). Of the patients treated for cardiology conditions (n=1779), 12.8% (n=61) of those who activated their GetWell account experienced a 30-day revisit compared with 17.7% (n=231) of those who did not activate their account (P=.01). The significance of these findings persisted after adjustment for confounding variables including age, race, sex, and payor in logistic regression modeling (adjusted odds ratio 0.75, 95% CI 0.62-0.92; P=.006). Conclusions: Our results suggest that a significant percentage of patients are willing to utilize a digital application following ED discharge to better engage in their own care, and that usage of such digital applications may significantly reduce 30-day revisit rates. LifeBridge Health’s experience demonstrates that health care systems can leverage automated mobile apps to improve patient engagement and successfully impact clinical outcomes at scale. %M 34898451 %R 10.2196/17839 %U https://formative.jmir.org/2021/12/e17839 %U https://doi.org/10.2196/17839 %U http://www.ncbi.nlm.nih.gov/pubmed/34898451 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 12 %P e22557 %T Comparing the Effects of Gamification and Teach-Back Training Methods on Adherence to a Therapeutic Regimen in Patients After Coronary Artery Bypass Graft Surgery: Randomized Clinical Trial %A Ghorbani,Banafsheh %A Jackson,Alun C %A Noorchenarboo,Mohammad %A Mandegar,Mohammad H %A Sharifi,Farshad %A Mirmoghtadaie,Zohrehsadat %A Bahramnezhad,Fatemeh %+ School of Nursing & Midwifery, Nursing and Midwifery Care Research Center, Spiritual Health Group, Research Center of Quran, Hadith and Medicine, Tehran University of Medical Sciences, Nosrat St., Tohid Sq., Tehran, 141973317, Iran, 98 2166914368, bahramnezhad@sina.tums.ac.ir %K teach back %K gamification %K treatment regimen %K coronary artery bypass graft %K patient training %D 2021 %7 10.12.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Patients undergoing coronary artery bypass graft surgery (CABGS) may fail to adhere to their treatment regimen for many reasons. Among these, one of the most important reasons for nonadherence is the inadequate training of such patients or training using inappropriate methods. Objective: This study aimed to compare the effect of gamification and teach-back training methods on adherence to a therapeutic regimen in patients after CABGS. Methods: This randomized clinical trial was conducted on 123 patients undergoing CABGS in Tehran, Iran, in 2019. Training was provided to the teach-back group individually. In the gamification group, an app developed for the purpose was installed on each patient’s smartphone, with training given via this device. The control group received usual care, or routine training. Adherence to the therapeutic regimen was assessed using a questionnaire on adherence to a therapeutic regimen (physical activity and dietary regimen) and an adherence scale as a pretest and a 1-month posttest. Results: One-way analysis of variance (ANOVA) for comparing the mean scores of teach-back and gamification training methods showed that the mean normalized scores for the dietary regimen (P<.001, F=71.80), movement regimen (P<.001, F=124.53), and medication regimen (P<.001, F=9.66) before and after intervention were significantly different between the teach-back, gamification, and control groups. In addition, the results of the Dunnett test showed that the teach-back and gamification groups were significantly different from the control group in all three treatment regimen methods. There was no statistically significant difference in adherence to the therapeutic regimen between the teach-back and control groups. Conclusions: Based on the results of this study, the use of teach-back and gamification training approaches may be suggested for patients after CABGS to facilitate adherence to the therapeutic regimen. Trial Registration: Iranian Registry of Clinical Trials IRCT20111203008286N8; https://en.irct.ir/trial/41507 %M 34890346 %R 10.2196/22557 %U https://www.jmir.org/2021/12/e22557 %U https://doi.org/10.2196/22557 %U http://www.ncbi.nlm.nih.gov/pubmed/34890346 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 9 %N 12 %P e25129 %T Behavioral Theories and Motivational Features Underlying eHealth Interventions for Adolescent Antiretroviral Adherence: Systematic Review %A Bezabih,Alemitu Mequanint %A Gerling,Kathrin %A Abebe,Workeabeba %A Abeele,Vero Vanden %+ Department of Computer Science, e-Media Research Lab, Katholieke Universiteit Leuven, Andreas Vesaliusstraat 13, Leuven, 3000, Belgium, 32 0485949954, alem.bezabih@kuleuven.be %K HIV %K adolescents %K ART adherence %K eHealth %K health theories %K behavior change techniques %K motivational design principles %D 2021 %7 10.12.2021 %9 Review %J JMIR Mhealth Uhealth %G English %X Background: eHealth systems provide new opportunities for the delivery of antiretroviral therapy (ART) adherence interventions for adolescents. They may be more effective if grounded in health behavior theories and behavior change techniques (BCTs). Prior reviews have examined the effectiveness, feasibility, and acceptability of these eHealth systems. However, studies have not systematically explored the use of health behavior theories and BCTs in the design of these applications. Objective: The purpose of this review was to explore whether health behavior theories and BCTs were considered to ground designs of eHealth systems supporting adolescents’ (10-24 years) ART adherence. More specifically, we examined which specific theories and BCTs were applied, and how these BCTs were implemented as design features. Additionally, we investigated the quality and effect of eHealth systems. Methods: A systematic search was performed on IEEE Xplore, ACM, ScienceDirect, PubMed, Scopus, and Web of Science databases from 2000 to 2020. Theory use and BCTs were coded using the Theory Coding Scheme and the Behavior Change Technique Taxonomy version 1 (BCTTv1), respectively. Design features were identified using the lenses of motivational design for mobile health (mHealth). The number of BCTs and design features for each eHealth system and their prevalence across all systems were assessed. Results: This review identified 16 eHealth systems aiming to support ART adherence among adolescents. System types include SMS text message reminders (n=6), phone call reminders (n=3), combined SMS text message and phone call reminders (n=1), electronic adherence monitoring devices (n=3), smartphone apps (n=1), smartphone serious games (n=1), gamified smartphone apps (n=1), leveraging existing social media (n=2), web-based applications (n=1), videoconferencing (n=1), and desktop applications (n=1). Nine were grounded in theory, of which 3 used theories extensively. The impact of adolescent developmental changes on ART adherence was not made explicit. A total of 42 different BCTs and 24 motivational design features were used across systems. Ten systems reported positive effects on 1 or more outcomes; however, of these ten systems, only 3 reported exclusively positive effects on all the outcomes they measured. As much as 6 out of 16 reported purely no effect in all the outcomes measured. Conclusions: Basic applications (SMS text messaging and phone calls) were most frequent, although more advanced systems such as mobile apps and games are also emerging. This review indicated gaps in the use of theory and BCTs, and particularly the impact of developmental changes on ART adherence was not adequately considered. Together with adopting a developmental orientation, future eHealth systems should effectively leverage health theories and consider developing more advanced systems that open the door to using BCTs more comprehensively. Overall, the impact of eHealth systems on adolescent ART adherence and its mediators is promising, but conclusive evidence on effect still needs to be provided. %M 34890353 %R 10.2196/25129 %U https://mhealth.jmir.org/2021/12/e25129 %U https://doi.org/10.2196/25129 %U http://www.ncbi.nlm.nih.gov/pubmed/34890353 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 5 %N 12 %P e30762 %T Tracking Lower Urinary Tract Symptoms and Tamsulosin Side Effects Among Older Men Using a Mobile App (PERSONAL): Feasibility and Usability Study %A Lee,Austin W %A Kenfield,Stacey A %A Wang,Elizabeth Y %A Enriquez,Anthony %A Oni-Orisan,Akinyemi %A Steinman,Michael A %A Sim,Ida %A Breyer,Benjamin N %A Bauer,Scott R %+ Department of Urology, University of California, San Francisco, 550 16th Street, Box 1695, San Francisco, CA, 94158, United States, 1 415 221 4810 ext 24322, Scott.Bauer@ucsf.edu %K LUTS %K tamsulosin %K mobile %K app %K mobile phone %D 2021 %7 10.12.2021 %9 Original Paper %J JMIR Form Res %G English %X Background: Continuous α1a-blockade is the first-line treatment for lower urinary tract symptoms (LUTS) among older men with suspected benign prostatic hyperplasia. Variable efficacy and safety for individual men necessitate a more personalized, data-driven approach to prescribing and deprescribing tamsulosin for LUTS in older men. Objective: We aim to evaluate the feasibility and usability of the PERSONAL (Placebo–Controlled, Randomized, Patient-Selected Outcomes, N-of-1 Trials) mobile app for tracking daily LUTS severity and medication side effects among older men receiving chronic tamsulosin therapy. Methods: We recruited patients from the University of California, San Francisco health care system to participate in a 2-week pilot study. The primary objectives were to assess recruitment feasibility, study completion rates, frequency of symptom tracking, duration of tracking sessions, and app usability rankings measured using a follow-up survey. As secondary outcomes, we evaluated whether daily symptom tracking led to changes in LUTS severity, perceptions of tamsulosin, overall quality of life, medication adherence between baseline and follow-up surveys, and perceived app utility. Results: We enrolled 19 men within 23 days, and 100% (19/19) of the participants completed the study. Each participant selected a unique combination of symptoms to track and recorded data in the PERSONAL app, with a median daily completion rate of 79% (11/14 days). The median duration of the app session was 44 (IQR 33) seconds. On a scale of 1 (strongly disagree) to 5 (strongly agree), the participants reported that the PERSONAL app was easy to use (mean 4.3, SD 1.0), that others could learn to use it quickly (mean 4.2, SD 0.9), and that they felt confident using the app (mean 4.4, SD 0.8). LUTS severity, quality of life, and medication adherence remained unchanged after the 2-week study period. Fewer men were satisfied with tamsulosin after using the app (14/19, 74% vs 17/19, 89% at baseline), although the perceived benefit from tamsulosin remained unchanged (18/19, 95% at baseline and at follow-up). In total, 58% (11/19) of the participants agreed that the PERSONAL app could help people like them manage their urinary symptoms. Conclusions: This pilot study demonstrated the high feasibility and usability of the PERSONAL mobile app to track patient-selected urinary symptoms and medication side effects among older men taking tamsulosin to manage LUTS. We observed that daily symptom monitoring had no adverse effects on the secondary outcomes. This proof-of-concept study establishes a framework for future mobile app studies, such as digital n-of-1 trials, to collect comprehensive individual-level data for personalized LUTS management in older men. %M 34889745 %R 10.2196/30762 %U https://formative.jmir.org/2021/12/e30762 %U https://doi.org/10.2196/30762 %U http://www.ncbi.nlm.nih.gov/pubmed/34889745 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 12 %P e32842 %T An App-Based Just-in-Time Adaptive Self-management Intervention for Care Partners (CareQOL): Protocol for a Pilot Trial %A Carlozzi,Noelle E %A Choi,Sung Won %A Wu,Zhenke %A Miner,Jennifer A %A Lyden,Angela K %A Graves,Christopher %A Wang,Jitao %A Sen,Srijan %+ Department of Physical Medicine and Rehabilitation, University of Michigan, 2800 Plymouth Rd, Ann Arbor, MI, 48109, United States, 1 7347638917, carlozzi@med.umich.edu %K caregivers %K quality of life %K spinal cord injuries %K Huntington disease %K hematopoietic stem cell transplantation %K feasibility studies %K self-management %K mobile apps %K outcome assessment %K mobile phone %D 2021 %7 9.12.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: Care partners (ie, informal family caregivers) of individuals with health problems face considerable physical and emotional stress, often with a substantial negative impact on the health-related quality of life (HRQOL) of both care partners and care recipients. Given that these individuals are often overwhelmed by their caregiving responsibilities, low-burden self-management interventions are needed to support care partners to ensure better patient outcomes. Objective: The primary objective of this study is to describe an intensive data collection protocol that involves the delivery of a personalized just-in-time adaptive intervention that incorporates passive mobile sensor data feedback (sleep and activity data from a Fitbit [Fitbit LLC]) and real time self-reporting of HRQOL via a study-specific app called CareQOL (University of Michigan) to provide personalized feedback via app alerts. Methods: Participants from 3 diverse care partner groups will be enrolled (care partners of persons with spinal cord injury, care partners of persons with Huntington disease, and care partners of persons with hematopoietic cell transplantation). Participants will be randomized to either a control group, where they will wear the Fitbit and provide daily reports of HRQOL over a 3-month (ie, 90 days) period (without personalized feedback), or the just-in-time adaptive intervention group, where they will wear the Fitbit, provide daily reports of HRQOL, and receive personalized push notifications for 3 months. At the end of the study, participants will complete a feasibility and acceptability questionnaire, and metrics regarding adherence and attrition will be calculated. Results: This trial opened for recruitment in November 2020. Data collection was completed in June 2021, and the primary results are expected to be published in 2022. Conclusions: This trial will determine the feasibility and acceptability of an intensive app-based intervention in 3 distinct care partner groups: care partners for persons with a chronic condition that was caused by a traumatic event (ie, spinal cord injury); care partners for persons with a progressive, fatal neurodegenerative disease (ie, Huntington disease); and care partners for persons with episodic cancer conditions that require intense, prolonged inpatient and outpatient treatment (persons with hematopoietic cell transplantation). Trial Registration: ClinicalTrials.gov NCT04556591; https://clinicaltrials.gov/ct2/show/NCT04556591 International Registered Report Identifier (IRRID): DERR1-10.2196/32842 %M 34889775 %R 10.2196/32842 %U https://www.researchprotocols.org/2021/12/e32842 %U https://doi.org/10.2196/32842 %U http://www.ncbi.nlm.nih.gov/pubmed/34889775 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 12 %P e29563 %T Prospective Prediction of Lapses in Opioid Use Disorder: Protocol for a Personal Sensing Study %A Moshontz,Hannah %A Colmenares,Alejandra J %A Fronk,Gaylen E %A Sant'Ana,Sarah J %A Wyant,Kendra %A Wanta,Susan E %A Maus,Adam %A Gustafson Jr,David H %A Shah,Dhavan %A Curtin,John J %+ Department of Psychology, University of Wisconsin-Madison, 1202 W Johnson St, Madison, WI, 53706, United States, 1 (608) 262 1040, jjcurtin@wisc.edu %K digital therapeutics %K risk prediction %K opioid lapse %K mobile phone %D 2021 %7 7.12.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: Successful long-term recovery from opioid use disorder (OUD) requires continuous lapse risk monitoring and appropriate use and adaptation of recovery-supportive behaviors as lapse risk changes. Available treatments often fail to support long-term recovery by failing to account for the dynamic nature of long-term recovery. Objective: The aim of this protocol paper is to describe research that aims to develop a highly contextualized lapse risk prediction model that forecasts the ongoing probability of lapse. Methods: The participants will include 480 US adults in their first year of recovery from OUD. Participants will report lapses and provide data relevant to lapse risk for a year with a digital therapeutic smartphone app through both self-report and passive personal sensing methods (eg, cellular communications and geolocation). The lapse risk prediction model will be developed using contemporary rigorous machine learning methods that optimize prediction in new data. Results: The National Institute of Drug Abuse funded this project (R01DA047315) on July 18, 2019 with a funding period from August 1, 2019 to June 30, 2024. The University of Wisconsin-Madison Health Sciences Institutional Review Board approved this project on July 9, 2019. Pilot enrollment began on April 16, 2021. Full enrollment began in September 2021. Conclusions: The model that will be developed in this project could support long-term recovery from OUD—for example, by enabling just-in-time interventions within digital therapeutics. International Registered Report Identifier (IRRID): DERR1-10.2196/29563 %M 34559061 %R 10.2196/29563 %U https://www.researchprotocols.org/2021/12/e29563 %U https://doi.org/10.2196/29563 %U http://www.ncbi.nlm.nih.gov/pubmed/34559061 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 9 %N 12 %P e28242 %T Impact of a Mobile Telerehabilitation Solution on Metabolic Health Outcomes and Rehabilitation Adherence in Patients With Obesity: Randomized Controlled Trial %A Bughin,François %A Bui,Gaspard %A Ayoub,Bronia %A Blervaque,Leo %A Saey,Didier %A Avignon,Antoine %A Brun,Jean Frédéric %A Molinari,Nicolas %A Pomies,Pascal %A Mercier,Jacques %A Gouzi,Fares %A Hayot,Maurice %+ PhyMedExp, Centre Hospitalier Universitaire Montpellier, University of Montpellier, Institut national de la santé et de la recherche médicale, Centre national de la recherche scientifique, Avenue Doyen Gaston Giraud, Montpellier, 34090, France, 33 467338284, f-bughin@chu-montpellier.fr %K telerehabilitation %K mHealth %K rehabilitation %K obesity %K mobile phone %D 2021 %7 6.12.2021 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Obesity is a major public health issue. Combining exercise training, nutrition, and therapeutic education in metabolic rehabilitation (MR) is recommended for obesity management. However, evidence from randomized controlled studies is lacking. In addition, MR is associated with poor patient adherence. Mobile health devices improve access to MR components. Objective: The aim of this study is to compare the changes in body composition, anthropometric parameters, exercise capacity, and quality of life (QOL) within 12 weeks of patients in the telerehabilitation (TR) program to those of usual care patients with obesity. Methods: This was a parallel-design randomized controlled study. In total, 50 patients with obesity (BMI>30 kg/m²) were included in a TR group (TRG) or a usual care group (UCG) for 12 weeks. Patients underwent biometric impedance analyses, metabolic exercise tests, actimetry, and QOL and satisfaction questionnaires. The primary outcome was the change in fat mass at 12 weeks from baseline. Secondary outcomes were changes in body weight, metabolic parameters, exercise capacity, QOL, patients’ adhesion, and satisfaction. Results: A total of 49 patients completed the study. No significant group × time interaction was found for fat mass (TRG: mean 1.7 kg, SD 2.6 kg; UCG: mean 1.2 kg, SD 2.4 kg; P=.48). Compared with the UCG, TRG patients tended to significantly improve their waist to hip ratios (TRG: −0.01 kg, SD 0.04; UCG: +0.01 kg, SD 0.06; P=.07) and improved QOL physical impact (TRG: +21.8, SD 43.6; UCG: −1.2, SD 15.4; P=.005). Significant time effects were observed for body composition, 6-minute walk test distance, exercise metabolism, sedentary time, and QOL. Adherence (95%) and satisfaction in the TRG were good. Conclusions: In adults with obesity, the TR program was not superior to usual care for improving body composition. However, TR was able to deliver full multidisciplinary rehabilitation to patients with obesity and improve some health outcomes. Given the patients’ adherence and satisfaction, pragmatic programs should consider mobile health devices to improve access to MR. Further studies are warranted to further establish the benefits that TR has over usual care. Trial Registration: ClinicalTrials.gov NCT03396666; http://clinicaltrials.gov/ct2/show/NCT03396666 %M 34874887 %R 10.2196/28242 %U https://mhealth.jmir.org/2021/12/e28242 %U https://doi.org/10.2196/28242 %U http://www.ncbi.nlm.nih.gov/pubmed/34874887 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 12 %P e33568 %T Optimizing a Just-in-Time Adaptive Intervention to Improve Dietary Adherence in Behavioral Obesity Treatment: Protocol for a Microrandomized Trial %A Goldstein,Stephanie P %A Zhang,Fengqing %A Klasnja,Predrag %A Hoover,Adam %A Wing,Rena R %A Thomas,John Graham %+ Weight Control and Diabetes Research Center, The Miriam Hospital, 196 Richmond St., Providence, RI, 02903, United States, 1 4017939727, stephanie_goldstein@brown.edu %K obesity %K weight loss %K dietary adherence %K just-in-time adaptive intervention %K microrandomized trial %K mobile phone %D 2021 %7 6.12.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: Behavioral obesity treatment (BOT) is a gold standard approach to weight loss and reduces the risk of cardiovascular disease. However, frequent lapses from the recommended diet stymie weight loss and prevent individuals from actualizing the health benefits of BOT. There is a need for innovative treatment solutions to improve adherence to the prescribed diet in BOT. Objective: The aim of this study is to optimize a smartphone-based just-in-time adaptive intervention (JITAI) that uses daily surveys to assess triggers for dietary lapses and deliver interventions when the risk of lapse is high. A microrandomized trial design will evaluate the efficacy of any interventions (ie, theory-driven or a generic alert to risk) on the proximal outcome of lapses during BOT, compare the effects of theory-driven interventions with generic risk alerts on the proximal outcome of lapse, and examine contextual moderators of interventions. Methods: Adults with overweight or obesity and cardiovascular disease risk (n=159) will participate in a 6-month web-based BOT while using the JITAI to prevent dietary lapses. Each time the JITAI detects elevated lapse risk, the participant will be randomized to no intervention, a generic risk alert, or 1 of 4 theory-driven interventions (ie, enhanced education, building self-efficacy, fostering motivation, and improving self-regulation). The primary outcome will be the occurrence of lapse in the 2.5 hours following randomization. Contextual moderators of intervention efficacy will also be explored (eg, location and time of day). The data will inform an optimized JITAI that selects the theory-driven approach most likely to prevent lapses in a given moment. Results: The recruitment for the microrandomized trial began on April 19, 2021, and is ongoing. Conclusions: This study will optimize a JITAI for dietary lapses so that it empirically tailors the provision of evidence-based intervention to the individual and context. The finalized JITAI will be evaluated for efficacy in a future randomized controlled trial of distal health outcomes (eg, weight loss). Trial Registration: ClinicalTrials.gov NCT04784585; http://clinicaltrials.gov/ct2/show/NCT04784585 International Registered Report Identifier (IRRID): DERR1-10.2196/33568 %M 34874892 %R 10.2196/33568 %U https://www.researchprotocols.org/2021/12/e33568 %U https://doi.org/10.2196/33568 %U http://www.ncbi.nlm.nih.gov/pubmed/34874892 %0 Journal Article %@ 2369-2529 %I JMIR Publications %V 8 %N 4 %P e31213 %T Effect of a Mobile Health App on Adherence to Physical Health Treatment: Retrospective Analysis %A Greenstein,Jay %A Topp,Robert %A Etnoyer-Slaski,Jena %A Staelgraeve,Michael %A McNulty,John %+ Kaizenovate, Kaizo Clinical Research Institute, Kaizo Health, 827E Rockville Pike, Rockville, MD, 20852, United States, 1 301 251 2777, drjay@kaizo-health.com %K adherence %K self-discharge %K phone app %K physical therapy %K chiropractor %K mobile phone %D 2021 %7 2.12.2021 %9 Original Paper %J JMIR Rehabil Assist Technol %G English %X Background: Adherence to prescribed medical interventions can predict the efficacy of the treatment. In physical health clinics, not adhering to prescribed therapy can take the form of not attending a scheduled clinic visit (no-show appointment) or prematurely terminating treatment against the advice of the provider (self-discharge). A variety of interventions, including mobile phone apps, have been introduced for patients to increase their adherence to attending scheduled clinic visits. Limited research has examined the impact of a mobile phone app among patients attending chiropractic and rehabilitation clinic visits. Objective: This study aims to compare adherence to prescribed physical health treatment among patients attending a chiropractic and rehabilitation clinic who did and did not choose to adopt a phone-based app to complement their treatment. Methods: The medical records of new patients who presented for care during 2019 and 2020 at 5 community-based chiropractic and rehabilitation clinics were reviewed for the number of kept and no-show appointments and to determine whether the patient was provider-discharged or self-discharged. During this 24-month study, 36.28% (1497/4126) of patients seen in the targeted clinics had downloaded the Kanvas app on their mobile phone, whereas the remaining patients chose not to download the app (usual care group). The gamification component of the Kanvas app provided the patient with a point every time they attended their visits, which could be redeemed as an incentive. Results: During both 2019 and 2020, the Kanvas app group was provider-discharged at a greater rate than the usual care group. The Kanvas app group kept a similar number of appointments compared with the usual care group in 2019 but kept significantly more appointments than the usual care group in 2020. During 2019, both groups exhibited a similar number of no-show appointments; however, in 2020, the Kanvas app group demonstrated more no-show appointments than the usual care group. When collapsed across years and self-discharged, the Kanvas app group had a greater number of kept appointments compared with the usual care group. When provider-discharged, both groups exhibited a similar number of kept appointments. The Kanvas app group and the usual care group were similar in the number of no-show appointments when provider-discharged, and when self-discharged, the Kanvas app group had more no-show appointments compared with the usual care group. Conclusions: Patients who did or did not have access to the Kanvas app and were provider-discharged exhibited a similar number of kept appointments and no-show appointments. When patients were self-discharged and received the Kanvas app, they exhibited 3.2 more kept appointments and 0.94 more no-show appointments than the self-discharged usual care group. %M 34655468 %R 10.2196/31213 %U https://rehab.jmir.org/2021/4/e31213 %U https://doi.org/10.2196/31213 %U http://www.ncbi.nlm.nih.gov/pubmed/34655468 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 11 %P e29758 %T Using Methods From Computational Decision-making to Predict Nonadherence to Fitness Goals: Protocol for an Observational Study %A McCarthy,Marie %A Zhang,Lili %A Monacelli,Greta %A Ward,Tomas %+ Insight Centre For Data Analytics, Dublin City University, Collins Ave Ext, Whitehall, Dublin, D9, Ireland, 353 12912500, marie.mccarthy65@mail.dcu.ie %K decision-making games %K computational psychology %K fitness goals %K advanced analytics %K mobile app %K computational modeling %K fitness tracker %K mobile phone %D 2021 %7 26.11.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: Can methods from computational models of decision-making be used to build a predictive model to identify individuals most likely to be nonadherent to personal fitness goals? Such a model may have significant value in the global battle against obesity. Despite growing awareness of the impact of physical inactivity on human health, sedentary behavior is increasingly linked to premature death in the developed world. The annual impact of sedentary behavior is significant, causing an estimated 2 million deaths. From a global perspective, sedentary behavior is one of the 10 leading causes of mortality and morbidity. Annually, considerable funding and countless public health initiatives are applied to promote physical fitness, with little impact on sustained behavioral change. Predictive models developed from multimodal methodologies combining data from decision-making tasks with contextual insights and objective physical activity data could be used to identify those most likely to abandon their fitness goals. This has the potential to enable development of more targeted support to ensure that those who embark on fitness programs are successful. Objective: The aim of this study is to determine whether it is possible to use decision-making tasks such as the Iowa Gambling Task to help determine those most likely to abandon their fitness goals. Predictive models built using methods from computational models of decision-making, combining objective data from a fitness tracker with personality traits and modeling from decision-making games delivered via a mobile app, will be used to ascertain whether a predictive algorithm can identify digital personae most likely to be nonadherent to self-determined exercise goals. If it is possible to phenotype these individuals, it may be possible to tailor initiatives to support these individuals to continue exercising. Methods: This is a siteless study design based on a bring your own device model. A total of 200 healthy adults who are novice exercisers and own a Fitbit (Fitbit Inc) physical activity tracker will be recruited via social media for this study. Participants will provide consent via the study app, which they will download from the Google Play store (Alphabet Inc) or Apple App Store (Apple Inc). They will also provide consent to share their Fitbit data. Necessary demographic information concerning age and sex will be collected as part of the recruitment process. Over 12 months, the scheduled study assessments will be pushed to the subjects to complete. The Iowa Gambling Task will be administered via a web app shared via a URL. Results: Ethics approval was received from Dublin City University in December 2020. At manuscript submission, study recruitment was pending. The expected results will be published in 2022. Conclusions: It is hoped that the study results will support the development of a predictive model and the study design will inform future research approaches. Trial Registration: ClinicalTrials.gov NCT04783298; https://clinicaltrials.gov/ct2/show/NCT04783298 %M 34842557 %R 10.2196/29758 %U https://www.researchprotocols.org/2021/11/e29758 %U https://doi.org/10.2196/29758 %U http://www.ncbi.nlm.nih.gov/pubmed/34842557 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 11 %P e23359 %T Objective Measurements of Physical Activity and Sedentary Behavior Using Wearable Devices in Patients With Axial Spondyloarthritis: Protocol for a Systematic Review %A Carlin,Thomas %A Soulard,Julie %A Aubourg,Timothée %A Knitza,Johannes %A Vuillerme,Nicolas %+ AGEIS, Université Grenoble Alpes, Faculty of Medicine, La Tronche, 38706, France, 33 476637104, nicolas.vuillerme@univ-grenoble-alpes.fr %K axial spondyloarthritis %K rheumatology %K physical activity %K sedentary behavior %K objective measures %K wearable %K systematic review %D 2021 %7 25.11.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: Axial spondyloarthritis (axSpA) is a subgroup of inflammatory rheumatic diseases. Practicing regular exercise is critical to manage pain and stiffness, reduce disease activity, and improve physical functioning, spinal mobility, and cardiorespiratory function. Accordingly, monitoring physical activity and sedentary behavior in patients with axSpA is relevant for clinical outcomes and disease management. Objective: This review aims to determine which wearable devices, assessment methods, and associated metrics are commonly used to quantify physical activity or sedentary behavior in patients with axSpA. Methods: The PubMed, Physiotherapy Evidence Database (PEDro), and Cochrane electronic databases will be searched, with no limit on publication date, to identify all the studies matching the inclusion criteria. Only original English-language articles published in a peer-reviewed journal will be included. The search strategy will include a combination of keywords related to the study population, wearable devices, physical activity, and sedentary behavior. We will use the Boolean operators “AND” and “OR” to combine keywords as well as Medical Subject Headings terms. Results: Search strategy was completed in June 2020 with 23 records obtained. Data extraction and synthesis are currently ongoing. Dissemination of study results in peer-reviewed journals is expected at the end of 2021. Conclusions: This review will provide a comprehensive and detailed synthesis of published studies that examine the use of wearable devices for objective assessment of physical activity and sedentary behavior in patients with axSpA. Trial Registration: PROSPERO CRD42020182398; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=182398 International Registered Report Identifier (IRRID): PRR1-10.2196/23359 %M 34842559 %R 10.2196/23359 %U https://www.researchprotocols.org/2021/11/e23359 %U https://doi.org/10.2196/23359 %U http://www.ncbi.nlm.nih.gov/pubmed/34842559 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 5 %N 11 %P e31678 %T Digital Instruments for Reporting of Gastrointestinal Symptoms in Clinical Trials: Comparison of End-of-Day Diaries Versus the Experience Sampling Method %A Beckers,Abraham B %A Snijkers,Johanna T W %A Weerts,Zsa Zsa R M %A Vork,Lisa %A Klaassen,Tim %A Smeets,Fabienne G M %A Masclee,Ad A M %A Keszthelyi,Daniel %+ Division of Gastroenterology-Hepatology, Department of Internal Medicine, Maastricht University Medical Center, Universiteitssingel 50, Maastricht, 6229 ER, Netherlands, 31 0433881844, ab.beckers@maastrichtuniversity.nl %K irritable bowel syndrome %K functional dyspepsia %K digital diary %K experience sampling method %K smartphone app %K mobile phone application %K mHealth %K eHealth %K compliance %K patient-reported outcome measures %D 2021 %7 24.11.2021 %9 Original Paper %J JMIR Form Res %G English %X Background: Questionnaires are necessary tools for assessing symptoms of disorders of the brain-gut interaction in clinical trials. We previously reported on the excellent adherence to a smartphone app used as symptom diary in a randomized clinical trial on irritable bowel syndrome (IBS). Other sampling methods, such as the experience sampling method (ESM), are better equipped to measure symptom variability over time and provide useful information regarding possible symptom triggers, and they are free of ecological and recall bias. The high frequency of measurements, however, could limit the feasibility of ESM in clinical trials. Objective: This study aimed to compare the adherence rates of a smartphone-based end-of-day diary and ESM for symptom assessment in IBS and functional dyspepsia (FD). Methods: Data from 4 separate studies were included. Patients with IBS participated in a randomized controlled trial, which involved a smartphone end-of-day diary for a 2+8-week (pretreatment + treatment) period, and an observational study in which patients completed ESM assessments using a smartphone app for 1 week. Patients with FD participated in a randomized controlled trial, which involved a smartphone end-of-day diary for a 2+12-week (pretreatment + treatment) period, and an observational study in which patients completed ESM assessments using a smartphone app for 1 week. Adherence rates were compared between these 2 symptom sampling methods. Results: In total, 25 patients with IBS and 15 patients with FD were included. Overall adherence rates for the end-of-day diaries were significantly higher than those for ESM (IBS: 92.7% vs 69.8%, FD: 90.1% vs 61.4%, respectively). Conclusions: This study demonstrates excellent adherence rates for smartphone app–based end-of-day diaries as used in 2 separate clinical trials. Overall adherence rates for ESM were significantly lower, rendering it more suitable for intermittent sampling periods rather than continuous sampling during longer clinical trials. %M 34821561 %R 10.2196/31678 %U https://formative.jmir.org/2021/11/e31678 %U https://doi.org/10.2196/31678 %U http://www.ncbi.nlm.nih.gov/pubmed/34821561 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 11 %P e32521 %T Smartband-Based Automatic Smoking Detection and Real-time Mindfulness Intervention: Protocol for a Feasibility Trial %A Horvath,Mark %A Grutman,Aurora %A O'Malley,Stephanie S %A Gueorguieva,Ralitza %A Khan,Nashmia %A Brewer,Judson A %A Garrison,Kathleen A %+ Department of Psychiatry, Yale School of Medicine, 1 Church Street #730, New Haven, CT, 06510, United States, 1 4152608618, kathleen.garrison@yale.edu %K smartband %K smartphone %K smoking %K mindfulness %K craving %K mHealth %D 2021 %7 16.11.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: Smoking is the leading cause of preventable death in the United States. Smoking cessation interventions delivered by smartphone apps are a promising tool for helping smokers quit. However, currently available smartphone apps for smoking cessation have not exploited their unique potential advantages to aid quitting. Notably, few to no available apps use wearable technologies, most apps require users to self-report their smoking, and few to no apps deliver treatment automatically contingent upon smoking. Objective: This pilot trial tests the feasibility of using a smartband and smartphone to monitor and detect smoking and deliver brief mindfulness interventions in real time to reduce smoking. Methods: Daily smokers (N=100, ≥5 cigarettes per day) wear a smartband for 60 days to monitor and detect smoking, notify them about their smoking events in real time, and deliver real-time brief mindfulness exercises triggered by detected smoking events or targeted at predicted smoking events. Smokers set a quit date at 30 days. A three-step intervention to reduce smoking is tested. First, participants wear a smartband to monitor and detect smoking, and notify them of smoking events in real time to bring awareness to smoking and triggers for 21 days. Next, a “mindful smoking” exercise is triggered by detected smoking events to bring a clear recognition of the actual effects of smoking for 7 days. Finally, after their quit date, a “RAIN” (recognize, allow, investigate, nonidentification) exercise is delivered to predicted smoking events (based on the initial 3 weeks of tracking smoking data) to help smokers learn to work mindfully with cravings rather than smoke for 30 days. The primary outcomes are feasibility measures of treatment fidelity, adherence, and acceptability. The secondary outcomes are smoking rates at end of treatment. Results: Recruitment for this trial started in May 2021 and will continue until November 2021 or until enrollment is completed. Data monitoring and management are ongoing for enrolled participants. The final 60-day end of treatment data is anticipated in January 2022. We expect that all trial results will be available in April 2022. Conclusions: Findings will provide data and information on the feasibility of using a smartband and smartphone to monitor and detect smoking and deliver real-time brief mindfulness interventions, and whether the intervention warrants additional testing for smoking cessation. Trial Registration: ClinicalTrials.gov NCT03995225; https://clinicaltrials.gov/ct2/show/NCT03995225 International Registered Report Identifier (IRRID): DERR1-10.2196/32521 %M 34783663 %R 10.2196/32521 %U https://www.researchprotocols.org/2021/11/e32521 %U https://doi.org/10.2196/32521 %U http://www.ncbi.nlm.nih.gov/pubmed/34783663 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 8 %N 4 %P e30786 %T A Novel Digital Pill System for Medication Adherence Measurement and Reporting: Usability Validation Study %A Baumgartner,Susan L %A Buffkin Jr,D Eric %A Rukavina,Elise %A Jones,Jason %A Weiler,Elizabeth %A Carnes,Tony C %+ etectRx, Inc., 747 SW 2nd Avenue, Suite 365T, IMB 24, Gainesville, FL, 32601, United States, 1 678 602 5701, susan.baumgartner@etectrx.com %K digital pills %K digital medication %K ingestible event marker %K ingestible sensor %K human factors %K usability %K validation study %K medication adherence %K medication nonadherence %K remote patient monitoring %K mobile phone %D 2021 %7 8.11.2021 %9 Original Paper %J JMIR Hum Factors %G English %X Background: Medication nonadherence is a costly problem that is common in clinical use and clinical trials alike, with significant adverse consequences. Digital pill systems have proved to be effective and safe solutions to the challenges of nonadherence, with documented success in improving adherence and health outcomes. Objective: The aim of this human factors validation study is to evaluate a novel digital pill system, the ID-Cap System from etectRx, for usability among patient users in a simulated real-world use environment. Methods: A total of 17 patients with diverse backgrounds who regularly take oral prescription medications were recruited. After training and a period of training decay, the participants were asked to complete 12 patient-use scenarios during which errors or difficulties were logged. The participants were also interviewed about their experiences with the ID-Cap System. Results: The participants ranged in age from 27 to 74 years (mean 51 years, SD 13.8 years), and they were heterogeneous in other demographic factors as well, such as education level, handedness, and sex. In this human factors validation study, the patient users completed 97.5% (196/201) of the total use scenarios successfully; 75.1% (151/201) were completed without any failures or errors. The participants found the ID-Cap System easy to use, and they were able to accurately and proficiently record ingestion events using the device. Conclusions: The participants demonstrated the ability to safely and effectively use the ID-Cap System for its intended use. The ID-Cap System has great potential as a useful tool for encouraging medication adherence and can be easily implemented by patient users. %M 34747709 %R 10.2196/30786 %U https://humanfactors.jmir.org/2021/4/e30786 %U https://doi.org/10.2196/30786 %U http://www.ncbi.nlm.nih.gov/pubmed/34747709 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 5 %N 11 %P e25749 %T A Mobile App to Enhance Behavioral Activation Treatment for Substance Use Disorder: App Design, Use, and Integration Into Treatment in the Context of a Randomized Controlled Trial %A Paquette,Catherine E %A Rubalcava,Dillon T %A Chen,Yun %A Anand,Deepika %A Daughters,Stacey B %+ Department of Psychology and Neuroscience, University of North Carolina at Chapel Hill, 235 E. Cameron Avenue, Chapel Hill, NC, 27599-3270, United States, 1 919 962 9924, daughter@unc.edu %K substance use disorder %K smartphone app %K mHealth %K behavioral activation %K mobile phone %D 2021 %7 3.11.2021 %9 Original Paper %J JMIR Form Res %G English %X Background: Group-based formats typically used in low-resource substance use disorder (SUD) treatment settings result in little individual attention to help reinforce and guide skill use, which may contribute to poor posttreatment outcomes. Smartphone apps offer a convenient, user-friendly, and cost-effective tool that can extend the reach of effective SUD treatments. A smartphone app was developed and integrated into a group-based, brief behavioral activation (BA) treatment for SUD to increase engagement in treatment skills outside clinician-administered sessions. Objective: This study aims to describe the features of the app and its use and integration into treatment, report the participants’ self-reported feasibility and acceptability of the app, and discuss challenges and provide recommendations for future smartphone app integration into behavioral treatments for SUD. Methods: A total of 56 individuals recruited from intensive outpatient SUD treatment received a smartphone-enhanced BA treatment, the Life Enhancement Treatment for Substance Use. Self-reported weekly app use and reasons for nonuse were assessed at posttreatment and at 1- and 3-month follow-ups. In addition, 2-tailed t tests and chi-square tests compared the self-reported use of each app component and overall app use over time. Results: Participant feedback suggested that the integration of the smartphone app into the Life Enhancement Treatment for Substance Use was feasible and well accepted, and participants found the app useful for planning value-based activities outside of sessions. Self-reported app engagement decreased over the follow-up period: 72% (39/54) of participants reported using the app at posttreatment, decreasing to 69% (37/54) at the 1-month follow-up and 37% (20/54) at the 3-month follow-up. Participants reported forgetting to use the app as a primary reason for nonuse. Conclusions: This study provides support for the feasibility and acceptability of smartphone-enhanced BA treatment, offering promise for future research testing the integration of technology into SUD treatment. Design decisions may help streamline smartphone integration into treatment, for example, allowing participants to download the treatment app on their own phones or use a low-cost study smartphone (or offering both options). Long-term app engagement may be increased via built-in reminders, alerts, and in-app messages. Trial Registration: ClinicalTrials.gov NCT02707887; https://clinicaltrials.gov/ct2/show/study/NCT02707887 %M 34730535 %R 10.2196/25749 %U https://formative.jmir.org/2021/11/e25749 %U https://doi.org/10.2196/25749 %U http://www.ncbi.nlm.nih.gov/pubmed/34730535 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 9 %N 11 %P e30674 %T Analysis of Apps With a Medication List Functionality for Older Adults With Heart Failure Using the Mobile App Rating Scale and the IMS Institute for Healthcare Informatics Functionality Score: Evaluation Study %A Diaz-Skeete,Yohanca Maria %A McQuaid,David %A Akinosun,Adewale Samuel %A Ekerete,Idongesit %A Carragher,Natacha %A Carragher,Lucia %+ NetwellCASALA Advanced Research Centre, Dundalk Institute of Technology, Dublin Road, Marshes Upper, Dundalk, A91 K584, Ireland, 353 429370497 ext 2592, yohanca.diaz@dkit.ie %K mobile app %K mHealth %K medication app %K heart failure %K Mobile App Rating Scale %D 2021 %7 2.11.2021 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Managing the care of older adults with heart failure (HF) largely centers on medication management. Because of frequent medication or dosing changes, an app that supports these older adults in keeping an up-to-date list of medications could be advantageous. During the COVID-19 pandemic, HF outpatient consultations are taking place virtually or by telephone. An app with the capability to share a patient’s medication list with health care professionals before consultation could support clinical efficiency, for example, by reducing consultation time. However, the influence of apps on maintaining an up-to-date medication history for older adults with HF in Ireland remains largely unexplored. Objective: The aims of this review are twofold: to review apps with a medication list functionality and to assess the quality of the apps included in the review using the Mobile App Rating Scale (MARS) and the IMS Institute for Healthcare Informatics functionality scale. Methods: A systematic search of apps was conducted in June 2019 using the Google Play Store and iTunes App Store. The MARS was used independently by 4 researchers to assess the quality of the apps using an Android phone and an iPad. Apps were also evaluated using the IMS Institute for Healthcare Informatics functionality score. Results: Google Play and iTunes App store searches identified 483 potential apps (292 from Google Play and 191 from iTunes App stores). A total of 6 apps (3 across both stores) met the inclusion criteria. Of the 6 apps, 4 achieved an acceptable MARS score (3/5). The Medisafe app had the highest overall MARS score (4/5), and the Medication List & Medical Records app had the lowest overall score (2.5/5). On average, the apps had 8 functions based on the IMS functionality criteria (range 5-11). A total of 2 apps achieved the maximum score for number of features (11 features) according to the IMS Institute for Healthcare Informatics functionality score, and 2 scored the lowest (5 features). Peer-reviewed publications were identified for 3 of the apps. Conclusions: The quality of current apps with medication list functionality varies according to their technical aspects. Most of the apps reviewed have an acceptable MARS objective quality (ie, the overall quality of an app). However, subjective quality (ie, satisfaction with the apps) was poor. Only 3 apps are based on scientific evidence and have been tested previously. A total of 2 apps featured all the IMS Institute for Healthcare Informatics functionalities, and half did not provide clear instructions on how to enter medication data, did not display vital parameter data in an easy-to-understand format, and did not guide users on how or when to take their medication. %M 34726613 %R 10.2196/30674 %U https://mhealth.jmir.org/2021/11/e30674 %U https://doi.org/10.2196/30674 %U http://www.ncbi.nlm.nih.gov/pubmed/34726613 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 9 %N 10 %P e32548 %T The Effect of a WeChat-Based Tertiary A-Level Hospital Intervention on Medication Adherence and Risk Factor Control in Patients With Stable Coronary Artery Disease: Multicenter Prospective Study %A Shi,Boqun %A Liu,Xi %A Dong,Qiuting %A Yang,Yuxiu %A Cai,Zhongxing %A Wang,Haoyu %A Yin,Dong %A Wang,Hongjian %A Dou,Kefei %A Song,Weihua %+ Cardiometabolic Medicine Center, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, No 167 North Lishi Road, Xicheng District, Beijing, 100037, China, 86 1088396863, songweihua@fuwai.com %K WeChat %K telemedicine %K coronary artery disease %K medication adherence %K mobile phone %D 2021 %7 27.10.2021 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: In China, ischemic heart disease is the main cause of mortality. Having cardiac rehabilitation and a secondary prevention program in place is a class IA recommendation for individuals with coronary artery disease. WeChat-based interventions seem to be feasible and efficient for the follow-up and management of chronic diseases. Objective: This study aims to evaluate the effectiveness of a tertiary A-level hospital, WeChat-based telemedicine intervention in comparison with conventional community hospital follow-up on medication adherence and risk factor control in individuals with stable coronary artery disease. Methods: In this multicenter prospective study, 1424 patients with stable coronary artery disease in Beijing, China, were consecutively enrolled between September 2018 and September 2019 from the Fuwai Hospital and 4 community hospitals. At 1-, 3-, 6-, and 12-month follow-up, participants received healthy lifestyle recommendations and medication advice. Subsequently, the control group attended an offline outpatient clinic at 4 separate community hospitals. The intervention group had follow-up visits through WeChat-based telemedicine management. The main end point was medication adherence, which was defined as participant compliance in taking all 4 cardioprotective medications that would improve the patient’s outcome (therapies included antiplatelet therapy, β-blockers, statins, and angiotensin-converting-enzyme inhibitors or angiotensin-receptor blockers). Multivariable generalized estimating equations were used to compare the primary and secondary outcomes between the 2 groups and to calculate the relative risk (RR) at 12 months. Propensity score matching and inverse probability of treatment weighting were performed as sensitivity analyses, and propensity scores were calculated using a multivariable logistic regression model. Results: At 1 year, 88% (565/642) of patients in the intervention group and 91.8% (518/564) of patients in the control group had successful follow-up data. We matched 257 pairs of patients between the intervention and control groups. There was no obvious advantage in medication adherence with the 4 cardioprotective drugs in the intervention group (172/565, 30.4%, vs 142/518, 27.4%; RR 0.99, 95% CI 0.97-1.02; P=.65). The intervention measures improved smoking cessation (44/565, 7.8%, vs 118/518, 22.8%; RR 0.48, 95% CI 0.44-0.53; P<.001) and alcohol restriction (33/565, 5.8%, vs 91/518, 17.6%; RR 0.47, 95% CI 0.42-0.54; P<.001). Conclusions: The tertiary A-level hospital, WeChat-based intervention did not improve adherence to the 4 cardioprotective medications compared with the traditional method. Tertiary A-level hospital, WeChat-based interventions have a positive effect on improving lifestyle, such as quitting drinking and smoking, in patients with stable coronary artery disease and can be tried as a supplement to community hospital follow-up. Trial Registration: ClinicalTrials.gov NCT04795505; https://clinicaltrials.gov/ct2/show/NCT04795505 %M 34569467 %R 10.2196/32548 %U https://mhealth.jmir.org/2021/10/e32548 %U https://doi.org/10.2196/32548 %U http://www.ncbi.nlm.nih.gov/pubmed/34569467 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 9 %N 10 %P e27131 %T Stakeholders’ Perceptions of Benefits of and Barriers to Using Video-Observed Treatment for Monitoring Patients With Tuberculosis in Uganda: Exploratory Qualitative Study %A Sekandi,Juliet Nabbuye %A Kasiita,Vicent %A Onuoha,Nicole Amara %A Zalwango,Sarah %A Nakkonde,Damalie %A Kaawa-Mafigiri,David %A Turinawe,Julius %A Kakaire,Robert %A Davis-Olwell,Paula %A Atuyambe,Lynn %A Buregyeya,Esther %+ Department of Epidemiology and Biostatistics, College of Public Health, University of Georgia, 100 Foster Road, Athens, GA, 30602, United States, 1 17063387993, jsekandi@uga.edu %K tuberculosis %K adherence %K mHealth %K video directly observed therapy %K Uganda %K mobile phone %D 2021 %7 27.10.2021 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Nonadherence to treatment remains a barrier to tuberculosis (TB) control. Directly observed therapy (DOT) is the standard for monitoring adherence to TB treatment worldwide, but its implementation is challenging, especially in resource-limited settings. DOT is labor-intensive and inconvenient to both patients and health care workers. Video DOT (VDOT) is a novel patient-centered alternative that uses mobile technology to observe patients taking medication remotely. However, the perceptions and acceptability of potential end users have not been evaluated in Africa. Objective: This study explores stakeholders’ acceptability of, as well as perceptions of potential benefits of and barriers to, using VDOT to inform a pilot study for monitoring patients with TB in urban Uganda. Methods: An exploratory, qualitative, cross-sectional study with an exit survey was conducted in Kampala, Uganda, from April to May 2018. We conducted 5 focus group discussions, each comprising 6 participants. Groups included patients with TB (n=2 groups; male and female), health care providers (n=1), caregivers (n=1), and community DOT volunteer workers (n=1). The questions that captured perceived benefits and barriers were guided by domains adopted from the Technology Acceptance Model. These included perceived usefulness, ease of use, and intent to use technology. Eligible participants were aged ≥18 years and provided written informed consent. For patients with TB, we included only those who had completed at least 2 months of treatment to minimize the likelihood of infection. A purposive sample of patients, caregivers, health care providers, and community DOT workers was recruited at 4 TB clinics in Kampala. Trained interviewers conducted unstructured interviews that were audio-recorded, transcribed, and analyzed using inductive content analysis to generate emerging themes. Results: The average age of participants was 34.5 (SD 10.7) years. VDOT was acceptable to most participants on a scale of 1 to 10. Of the participants, 70% (21/30) perceived it as highly acceptable, with scores ≥8, whereas 30% (9/30) scored between 5 and 7. Emergent themes on perceived benefits of VDOT were facilitation of easy adherence monitoring, timely follow-up on missed doses, patient-provider communication, and saving time and money because of minimal travel to meet in person. Perceived barriers included limited technology usability skills, inadequate cellular connectivity, internet access, availability of electricity, cost of the smartphone, and use of the internet. Some female patients raised concerns about the disruption of their domestic work routines to record videos. The impact of VDOT on privacy and confidentiality emerged as both a perceived benefit and barrier. Conclusions: VDOT was acceptable and perceived as beneficial by most study participants, despite potential technical and cost barriers. Mixed perceptions emerged about the impact of VDOT on privacy and confidentiality. Future efforts should focus on training users, ensuring adequate technical infrastructure, assuring privacy, and performing comparative cost analyses in the local context. %M 34704961 %R 10.2196/27131 %U https://mhealth.jmir.org/2021/10/e27131 %U https://doi.org/10.2196/27131 %U http://www.ncbi.nlm.nih.gov/pubmed/34704961 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 10 %P e32789 %T Understanding Adolescent and Young Adult 6-Mercaptopurine Adherence and mHealth Engagement During Cancer Treatment: Protocol for Ecological Momentary Assessment %A Psihogios,Alexandra M %A Rabbi,Mashfiqui %A Ahmed,Annisa %A McKelvey,Elise R %A Li,Yimei %A Laurenceau,Jean-Philippe %A Hunger,Stephen P %A Fleisher,Linda %A Pai,Ahna LH %A Schwartz,Lisa A %A Murphy,Susan A %A Barakat,Lamia P %+ Children's Hospital of Philadelphia, University of Pennsylvania, Abramson Pediatric Research Center, Room 1429C, 3615 Civic Center Blvd, Philadelphia, PA, 19104, United States, 1 267 314 0164, psihogiosa@email.chop.edu %K mHealth %K ecological momentary assessment %K adolescents %K young adults %K oncology %K cancer %K self-management %K mobile phone %D 2021 %7 22.10.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: Adolescents and young adults (AYAs) with cancer demonstrate suboptimal oral chemotherapy adherence, increasing their risk of cancer relapse. It is unclear how everyday time-varying contextual factors (eg, mood) affect their adherence, stalling the development of personalized mobile health (mHealth) interventions. Poor engagement is also a challenge across mHealth trials; an effective adherence intervention must be engaging to promote uptake. Objective: This protocol aims to determine the temporal associations between daily contextual factors and 6-mercaptopurine (6-MP) adherence and explore the proximal impact of various engagement strategies on ecological momentary assessment survey completion. Methods: At the Children’s Hospital of Philadelphia, AYAs with acute lymphoblastic leukemia or lymphoma who are prescribed prolonged maintenance chemotherapy that includes daily oral 6-MP are eligible, along with their matched caregivers. Participants will use an ecological momentary assessment app called ADAPTS (Adherence Assessments and Personalized Timely Support)—a version of an open-source app that was modified for AYAs with cancer through a user-centered process—and complete surveys in bursts over 6 months. Theory-informed engagement strategies will be microrandomized to estimate the causal effects on proximal survey completion. Results: With funding from the National Cancer Institute and institutional review board approval, of the proposed 30 AYA-caregiver dyads, 60% (18/30) have been enrolled; of the 18 enrolled, 15 (83%) have completed the study so far. Conclusions: This protocol represents an important first step toward prescreening tailoring variables and engagement components for a just-in-time adaptive intervention designed to promote both 6-MP adherence and mHealth engagement. International Registered Report Identifier (IRRID): DERR1-10.2196/32789 %M 34677129 %R 10.2196/32789 %U https://www.researchprotocols.org/2021/10/e32789 %U https://doi.org/10.2196/32789 %U http://www.ncbi.nlm.nih.gov/pubmed/34677129 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 5 %N 9 %P e26361 %T Voice Assistant Reminders and the Latency of Scheduled Medication Use in Older Adults With Pain: Descriptive Feasibility Study %A Shade,Marcia %A Rector,Kyle %A Kupzyk,Kevin %+ College of Nursing, University of Nebraska Medical Center, 985330 Nebraska Medical Center, Omaha, NE, 68198, United States, 1 4025596641, marcia.shade@unmc.edu %K adherence %K pain medications %K older adults %K reminders %K mHealth %K voice assistants %D 2021 %7 28.9.2021 %9 Original Paper %J JMIR Form Res %G English %X Background: Pain is difficult to manage in older adults. It has been recommended that pain management in older adults should include both nonpharmacologic and pharmacologic strategies. Unfortunately, nonadherence to pain medication is more prevalent than nonadherence to any other chronic disease treatment. Technology-based reminders have some benefit for medication adherence, but adherence behavior outcomes have mostly been verified by self-reports. Objective: We aimed to describe objective medication adherence and the latency of medication use after a voice assistant reminder prompted participants to take pain medications for chronic pain. Methods: A total of 15 older adults created a voice assistant reminder for taking scheduled pain medications. A subsample of 5 participants were randomly selected to participate in a feasibility study, in which a medication event monitoring system for pain medications was used to validate medication adherence as a health outcome. Data on the subsample’s self-assessed pain intensity, pain interference, concerns and necessity beliefs about pain medications, self-confidence in managing pain, and medication implementation adherence were analyzed. Results: In the 5 participants who used the medication event monitoring system, the overall latency between voice assistant reminder deployment and the medication event (ie, medication bottle cap opening) was 55 minutes. The absolute latency (before or after the reminder) varied among the participants. The shortest average time taken to open the cap after the reminder was 17 minutes, and the longest was 4.5 hours. Of the 168 voice assistant reminders for scheduled pain medications, 25 (14.6%) resulted in the opening of MEMS caps within 5 minutes of the reminder, and 107 (63.7%) resulted in the opening of MEMS caps within 30 minutes of the reminder. Conclusions: Voice assistant reminders may help cue patients to take scheduled medications, but the timing of medication use may vary. The timing of medication use may influence treatment effectiveness. Tracking the absolute latency time of medication use may be a helpful method for assessing medication adherence. Medication event monitoring may provide additional insight into medication implementation adherence during the implementation of mobile health interventions. %M 34581677 %R 10.2196/26361 %U https://formative.jmir.org/2021/9/e26361 %U https://doi.org/10.2196/26361 %U http://www.ncbi.nlm.nih.gov/pubmed/34581677 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 9 %P e25922 %T Facilitator Contact, Discussion Boards, and Virtual Badges as Adherence Enhancements to a Web-Based, Self-guided, Positive Psychological Intervention for Depression: Randomized Controlled Trial %A Moskowitz,Judith Tedlie %A Addington,Elizabeth L %A Shiu,Eva %A Bassett,Sarah M %A Schuette,Stephanie %A Kwok,Ian %A Freedman,Melanie E %A Leykin,Yan %A Saslow,Laura R %A Cohn,Michael A %A Cheung,Elaine O %+ Department of Medical Social Sciences, Osher Center for Integrative Medicine, Northwestern University Feinberg School of Medicine, 625 N Michigan Ave, Suite 2700, Chicago, IL, 60611, United States, 1 3125037712, judith.moskowitz@northwestern.edu %K mHealth %K adherence %K depression %K discussion board %K gamification %K positive psychological intervention %K mobile phone %D 2021 %7 22.9.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Adherence to self-guided interventions tends to be very low, especially in people with depression. Prior studies have demonstrated that enhancements may increase adherence, but little is known about the efficacy of various enhancements in comparison to, or in combination with, one another. Objective: The aim of our study is to test whether 3 enhancements—facilitator contact (FC), an online discussion board, and virtual badges (VB)—alone, or in combination, improve adherence to a self-guided, web-based intervention for depression. We also examined whether age, gender, race, ethnicity, comfort with technology, or baseline depression predicted adherence or moderated the effects that each enhancement had on adherence. Methods: Participants were recruited through web-based sources and, after completing at least 4 out of 7 daily emotion reports, were sequentially assigned to 1 of 9 conditions—the intervention alone; the intervention plus 1, 2, or all 3 enhancements; or an emotion reporting control condition. The intervention was a positive psychological program consisting of 8 skills that specifically targeted positive emotions, and it was delivered over 5 weeks in a self-guided, web-based format. We operationalized adherence as the number of skills accessed. Results: A total of 602 participants were enrolled in this study. Participants accessed, on average, 5.61 (SD 2.76) of 8 skills. The total number of enhancements participants received (0-3) did not predict the number of skills accessed. Participants who were assigned to the VB+FC condition accessed significantly more skills than those in the intervention only conditions. Furthermore, participants in arms that received the combination of both the VB and FC enhancements (VB+FC and VB+FC+online discussion board) accessed a greater number of skills relative to the number of skills accessed by participants who received either VB or FC without the other. Moderation analyses revealed that the receipt of VB (vs no VB) predicted higher adherence among participants with moderately severe depression at baseline. Conclusions: The results suggested that the VB+FC combination significantly increased the number of skills accessed in a self-guided, web-based intervention for elevated depression. We have provided suggestions for refinements to these enhancements, which may further improve adherence. Trial Registration: ClinicalTrials.gov NCT02861755; http://clinicaltrials.gov/ct2/show/NCT02861755 %M 34550076 %R 10.2196/25922 %U https://www.jmir.org/2021/9/e25922 %U https://doi.org/10.2196/25922 %U http://www.ncbi.nlm.nih.gov/pubmed/34550076 %0 Journal Article %@ 2561-6722 %I JMIR Publications %V 4 %N 3 %P e27999 %T Digital Technologies for Monitoring and Improving Treatment Adherence in Children and Adolescents With Asthma: Scoping Review of Randomized Controlled Trials %A Milne-Ives,Madison %A Lam,Ching %A Meinert,Edward %+ Centre for Health Technology, University of Plymouth, 6 Kirkby Place, Room 2, Plymouth, PL4 6DT, United Kingdom, 44 1752600600, edward.meinert@plymouth.ac.uk %K asthma %K disease management %K child %K adolescent %K telemedicine %D 2021 %7 17.9.2021 %9 Review %J JMIR Pediatr Parent %G English %X Background: Inadequate pediatric asthma care has resulted in potentially avoidable unplanned hospital admissions and morbidity. A wide variety of digital technologies have been developed to monitor and support treatment adherence in children and adolescents with asthma. However, existing reviews need to be updated and expanded to provide an overview of the current state of research on these technologies and how they are being integrated into existing health care services and care pathways. Objective: This study aims to provide an overview of the current research landscape and knowledge gaps regarding the use of digital technologies to support the care of children and adolescents with asthma. Methods: This study was structured according to the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) and Population, Intervention, Comparator, Outcome, and Study frameworks. Five databases (PubMed, the Cochrane Central Register of Controlled Trials, Web of Science, Embase, and PsycINFO) were systematically searched for studies published in English from 2014 onward. Two reviewers independently screened the references and selected studies for inclusion based on the eligibility criteria. Data were systematically extracted per research question, which were synthesized in a descriptive analysis. Results: A wide variety of study characteristics, including the number and age of participants, study duration, and type of digital intervention, were identified. There was mixed evidence for the effectiveness of the interventions. Of the 10 studies that evaluated treatment adherence, 7 (70%) found improvements, but the evidence was inconsistent for asthma control (6/9, 67% of studies reported improvement or maintenance, but only 1 was significantly different between groups) and health outcome variables (5/9, 56% of studies found no evidence of effectiveness). The 6 studies that examined patient perceptions and assessments of acceptability and usability generally had positive findings. Conclusions: A wide range of digital interventions are being developed and evaluated to support the monitoring and treatment adherence of children and adolescents with asthma. Meta-analyses are inhibited by the use of samples with a variety of overlapping age ranges; a theoretical framework for evaluating specific age groups would aid comparison between studies. Most studies found significant evidence for improved adherence to treatment or medications, but there was mixed evidence of the impact of the digital interventions on asthma control and other health outcomes. There are gaps in the literature relating to cost-effectiveness and integration with existing clinical care pathways. This study will be necessary to determine which digital interventions for children and young people with asthma are worth supporting and adopting in the clinical care pathways. %M 34533463 %R 10.2196/27999 %U https://pediatrics.jmir.org/2021/3/e27999 %U https://doi.org/10.2196/27999 %U http://www.ncbi.nlm.nih.gov/pubmed/34533463 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 9 %P e27576 %T A Smartphone-Based App to Improve Adjuvant Treatment Adherence to Multidisciplinary Decisions in Patients With Early-Stage Breast Cancer: Observational Study %A Yu,Jing %A Wu,Jiayi %A Huang,Ou %A Chen,Xiaosong %A Shen,Kunwei %+ Department of General Surgery, Comprehensive Breast Health Center, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, 197 Ruijin Er Road, Shanghai, 200025, China, 86 13564497086, chenxiaosong0156@hotmail.com %K breast cancer %K adherence %K multidisciplinary treatment %K adjuvant treatment %K smartphone-based app %K mobile phone %D 2021 %7 16.9.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Multidisciplinary treatment (MDT) and adjuvant therapy are associated with improved survival rates in breast cancer. However, nonadherence to MDT decisions is common in patients. We developed a smartphone-based app that can facilitate the full-course management of patients after surgery. Objective: This study aims to investigate the influence factors of treatment nonadherence and to determine whether this smartphone-based app can improve the compliance rate with MDTs. Methods: Patients who had received a diagnosis of invasive breast cancer and had undergone MDT between March 2013 and May 2019 were included. Patients were classified into 3 groups: Pre-App cohort (November 2017, before the launch of the app); App nonused, cohort (after November 2017 but not using the app); and App used cohort (after November 2017 and using the app). Univariate and multivariate analyses were performed to identify the factors related to MDT adherence. Compliance with specific adjuvant treatments, including chemotherapy, radiotherapy, endocrine therapy, and targeted therapy, was also evaluated. Results: A total of 4475 patients were included, with Pre-App, App nonused, and App used cohorts comprising 2966 (66.28%), 861 (19.24%), and 648 (14.48%) patients, respectively. Overall, 15.53% (695/4475) patients did not receive MDT recommendations; the noncompliance rate ranged from 27.4% (75/273) in 2013 to 8.8% (44/500) in 2019. Multivariate analysis demonstrated that app use was independently associated with adherence to adjuvant treatment. Compared with the patients in the Pre-App cohort, patients in the App used cohort were less likely to deviate from MDT recommendations (odds ratio [OR] 0.61, 95% CI 0.43-0.87; P=.007); no significant difference was found in the App nonused cohort (P=.77). Moreover, app use decreased the noncompliance rate for adjuvant chemotherapy (OR 0.41, 95% CI 0.27-0.65; P<.001) and radiotherapy (OR 0.49, 95% CI 0.25-0.96; P=.04), but not for anti-HER2 therapy (P=.76) or endocrine therapy (P=.39). Conclusions: This smartphone-based app can increase MDT adherence in patients undergoing adjuvant therapy; this was more obvious for adjuvant chemotherapy and radiotherapy. %M 34528890 %R 10.2196/27576 %U https://www.jmir.org/2021/9/e27576 %U https://doi.org/10.2196/27576 %U http://www.ncbi.nlm.nih.gov/pubmed/34528890 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 9 %N 9 %P e23916 %T An mHealth-Based Intervention for Adolescents With Type 1 Diabetes and Their Parents: Pilot Feasibility and Efficacy Single-Arm Study %A Holtz,Bree %A Mitchell,Katharine M %A Holmstrom,Amanda J %A Cotten,Shelia R %A Dunneback,Julie K %A Jimenez-Vega,Jose %A Ellis,Deborah A %A Wood,Michael A %+ Department of Advertising and Public Relations, Michigan State University, 404 Wilson Road, Room 309, East Lansing, MI, 48824, United States, 1 5178844537, bholtz@msu.edu %K mobile health (mHealth) %K adolescents %K type 1 diabetes %K mobile phone %K parent-adolescent %K chronic disease %K feasibility %K diabetes management %D 2021 %7 14.9.2021 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Type 1 diabetes (T1D) affects more than 165,000 individuals younger than 20 years in the United States of America. The transition from parent management to parent-child team management, with the child taking on increased levels of self-care, can be stressful and is associated with a deterioration in self-management behaviors. Therefore, a mobile app intervention, MyT1DHero, was designed to facilitate diabetes-specific positive parent-adolescent communication and improve diabetes-related outcomes. The MyT1DHero intervention links an adolescent with T1D and their parent through 2 separate app interfaces and is designed to promote positive communication regarding T1D management. Objective: The aim of this pilot study was to determine (1) the initial efficacy of the MyT1DHero intervention in improving diabetes outcomes in adolescents, specifically the hemoglobin A1c (HbA1c) levels, diabetes care adherence, and quality of life, and (2) the adolescents’ overall satisfaction with this intervention. Methods: This pilot study included 30 adolescent-parent pairs who used the MyT1DHero app in a 12-week single-arm clinical trial. Participants were recruited from the local pediatric endocrinology subspecialty clinic via snowball sampling. HbA1c levels, diabetes care adherence, quality of life, family conflict, and satisfaction levels were measured and analyzed using paired sample two-sided t tests and linear regression analyses. Results: The final analysis included 25 families. The mean age of the adolescents was 12.28 (SD 1.62) years. Half of the participants (13/25) reported a diabetes diagnosis of less than 5 years. After 12 weeks of the intervention, diabetes care adherence significantly improved (before the study: mean 3.87 [SD 0.59]; after the study: mean 4.19 [SD 0.65]; t21=–2.52, P=.02, d=0.52) as did quality of life (before the study: mean 4.02 [SD 0.84]; after the study: mean 4.27 [SD 0.73]; t24=2.48, P=.01, d=0.32). HbA1c levels (before the study: mean 8.94 [SD 1.46]; after the study: mean 8.87 [SD 1.29]; t24=0.67, P=.51, d=0.04) and family conflict (before the study: mean 2.45 [SD 0.55]; after the study: mean 2.61 [SD 0.45]; t23=0.55, P=.14, d=0.32) changed in the hypothesized direction, but the change was not significant. However, higher use of the mobile app was associated with more improvement in HbA1c levels (F1,20=9.74, P<.005; R2=0.33). Overall, the adolescents were satisfied with the app intervention. Conclusions: In a 12-week pilot study of the mobile app intervention designed to facilitate parent-adolescent communication for improving diabetes outcomes, significant benefits were demonstrated in self-care adherence and quality of life. A randomized controlled trial with a longer intervention is needed to replicate these findings and to determine the stability of the intervention effects. Trial Registration: ClinicalTrials.gov NCT03436628; https://clinicaltrials.gov/ct2/show/NCT03436628 %M 34519670 %R 10.2196/23916 %U https://mhealth.jmir.org/2021/9/e23916 %U https://doi.org/10.2196/23916 %U http://www.ncbi.nlm.nih.gov/pubmed/34519670 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 9 %P e27162 %T Effectiveness of a Dyadic Buddy App for Smoking Cessation: Randomized Controlled Trial %A Schwaninger,Philipp %A Berli,Corina %A Scholz,Urte %A Lüscher,Janina %+ Applied Social and Health Psychology, Department of Psychology, University of Zurich, Binzmühlestrasse 14/14, Zurich, 8050, Switzerland, 41 44 635 72 25, philipp.schwaninger@psychologie.uzh.ch %K mHealth %K smartphone app %K smoking cessation %K buddy %K social support %K mobile phone %D 2021 %7 9.9.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Tobacco smoking is one of the biggest public health threats. Smartphone apps offer new promising opportunities for supporting smoking cessation in real time. This randomized controlled trial investigated the effectiveness of an app that encourages individuals to quit smoking with the help of a social network member (buddy) in daily life. Objective: The objective of this study is to test the effectiveness of the SmokeFree buddy app compared with a control group with self-reported smoking abstinence and carbon monoxide (CO)–verified smoking abstinence as primary outcomes and self-reports of smoked cigarettes per day (CPD) as a secondary outcome. Methods: A total of 162 adults who smoked participated in this single-blind, two-arm, parallel-group, intensive longitudinal randomized controlled trial. Around a self-set quit date (ie, 7 days before the self-set quit date and 20 days after) and 6 months later, participants of the intervention and control groups reported on daily smoking abstinence and CPD in end-of-day diaries. Daily smoking abstinence was verified via daily exhaled CO assessments. This assessment was administered via an app displaying results of exhaled CO, thus addressing self-monitoring in both groups. In addition, participants in the intervention group used the SmokeFree buddy app, a multicomponent app that facilitates social support from a buddy of choice. Results: A significant reduction in CPD from baseline to the 6-month follow-up was observed among participants in both groups. Multilevel analyses revealed no significant intervention effect on self-reported and CO-verified daily smoking abstinence at the quit date and 3 weeks later. However, CPD was lower at the quit date and 3 weeks later in the intervention group than in the control group. No significant differences between groups were found for any outcome measures 6 months after the quit date. Overall, low app engagement and low perceived usefulness were observed. Conclusions: Despite some encouraging short-term findings on the amount of smoking, the SmokeFree buddy app did not have beneficial effects on smoking abstinence over and above the self-monitoring control condition. Future studies should examine whether and what support processes can be effectively stimulated and how app use can be improved to better achieve this goal. Trial Registration: ISRCTN Registry 11154315; https://www.isrctn.com/ISRCTN11154315 International Registered Report Identifier (IRRID): RR2-10.1186/s12889-019-7723-z %M 34499045 %R 10.2196/27162 %U https://www.jmir.org/2021/9/e27162 %U https://doi.org/10.2196/27162 %U http://www.ncbi.nlm.nih.gov/pubmed/34499045 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 9 %P e29018 %T Adherence to Telemonitoring Therapy for Medicaid Patients With Hypertension: Case Study %A Park,Sulki %A Kum,Hye-Chung %A Morrisey,Michael A %A Zheng,Qi %A Lawley,Mark A %+ Department of Health Policy and Management, Texas A&M University, 212 Adriance Lab Rd, College Station, TX, 77843, United States, 1 979 436 9439, kum@tamu.edu %K telemedicine %K hypertension %K Medicaid %K blood pressure %K pulse %K telemonitoring %K mobile phone %D 2021 %7 6.9.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Almost 50% of the adults in the United States have hypertension. Although clinical trials indicate that home blood pressure monitoring can be effective in managing hypertension, the reported results might not materialize in practice because of patient adherence problems. Objective: The aims of this study are to characterize the adherence of Medicaid patients with hypertension to daily telemonitoring, identify the impacts of adherence reminder calls, and investigate associations with blood pressure control. Methods: This study targeted Medicaid patients with hypertension from the state of Texas. A total of 180 days of blood pressure and pulse data in 2016-2018 from a telemonitoring company were analyzed for mean transmission rate and mean blood pressure change. The first 30 days of data were excluded because of startup effects. The protocols required the patients to transmit readings by a specified time daily. Patients not transmitting their readings received an adherence reminder call to troubleshoot problems and encourage transmission. The patients were classified into adherent and nonadherent cohorts; adherent patients were those who transmitted data on at least 80% of the days. Results: The mean patient age was 73.2 (SD 11.7) years. Of the 823 patients, 536 (65.1%) were women, and 660 (80.2%) were urban residents. The adherent cohort (475/823, 57.7%) had mean transmission rates of 74.9% before the adherence reminder call and 91.3% after the call, whereas the nonadherent cohort (348/823, 42.3%) had mean transmission rates of 39% and 58% before and after the call, respectively. From month 1 to month 5, the transmission rates dropped by 1.9% and 10.2% for the adherent and nonadherent cohorts, respectively. The systolic and diastolic blood pressure values improved by an average of 2.2 and 0.7 mm Hg (P<.001 and P=.004), respectively, for the adherent cohort during the study period, whereas only the systolic blood pressure value improved by an average of 1.6 mm Hg (P=.02) for the nonadherent cohort. Conclusions: Although we found that patients can achieve high levels of adherence, many experience adherence problems. Although adherence reminder calls help, they may not be sufficient. Telemonitoring lowered blood pressure, as has been observed in clinical trials. Furthermore, blood pressure control was positively associated with adherence. %M 34486977 %R 10.2196/29018 %U https://www.jmir.org/2021/9/e29018 %U https://doi.org/10.2196/29018 %U http://www.ncbi.nlm.nih.gov/pubmed/34486977 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 5 %N 9 %P e28784 %T A Smartphone App to Support Adherence to Inhaled Corticosteroids in Young Adults With Asthma: Multi-Methods Feasibility Study %A Murphy,Jane %A McSharry,Jenny %A Hynes,Lisa %A Molloy,Gerard J %+ School of Psychology, National University of Ireland, Galway, University Rd, Galway, H91 TK33, Ireland, 353 91 524411, j.murphy51@nuigalway.ie %K asthma %K young adult %K medication adherence %K self-management %K mobile applications %K mHealth %K intervention %K usability %K acceptability %K feasibility %K multi-methods %K mobile phone %D 2021 %7 1.9.2021 %9 Original Paper %J JMIR Form Res %G English %X Background: Young adults with asthma often report low adherence to inhaled corticosteroids (ICS), leading to uncontrolled symptoms and poor disease outcomes. Technology-enabled digital supports such as mobile health (mHealth) asthma smartphone apps have the potential to support adherence to ICS and asthma self-management. There is a need for feasibility studies to determine the usability, acceptability, and feasibility of these interventions. In addition, it is essential to determine the feasibility of recruiting and retaining young adults to plan future efficacy and effectiveness trials and therefore, establish evidence-based asthma apps. Objective: This study aimed to determine (1) the feasibility of recruiting and retaining young adults to a trial and (2) the usability, acceptability, and feasibility of using the AsthmaMD app to support adherence to ICS in a population of young adults living with asthma. Methods: A multi-methods feasibility study was conducted. Young adults aged 18-30 years with asthma and current prescription for ICS were eligible and invited to take part through a university circular email, social media, and general practice sites. Participation involved completing a baseline self-report questionnaire, downloading and using the AsthmaMD app for 2 weeks, and completing the follow-up assessment, including self-report and open-ended questions about participants’ experience of using the app. Primary outcomes included participant recruitment and retention and the usability, acceptability, and feasibility of using AsthmaMD. Quantitative self-report data were analyzed using descriptive statistics, and qualitative open-ended data were analyzed using inductive reflexive thematic analysis. Results: A total of 122 young adults (females, n=101, 82.8%) with a mean age of 24.4 (SD 3.8) years were recruited and they completed baseline measures. Of the 122 young adults, 59 (48.4%) completed the study. The AsthmaMD app received a mean score of 63.1/100 (SD 20.1) on the System Usability Scale (ie, a standardized measure of usability for technology-based apps), and an overall user satisfaction score of 5.8/10 (SD 2.2). Of the 59 participants who completed the study, 49 (83%) participants used the app ≥1 day per week. Two main themes were identified in the qualitative analysis of user experiences: (1) learning how to use the app to suit the individual and (2) benefits and relevance of using the app. Conclusions: The findings from this study indicate that it is feasible to recruit and retain young adults to examine efficacy and effectiveness in a future trial and that young adults living with asthma may find AsthmaMD to be usable, acceptable, and feasible to support adherence to ICS. Our findings also identified opportunities to further optimize the usability of AsthmaMD and similar apps. Based on our findings, we recommend providing more accessible information on how to use the app and replacing medical terminology with simplified language within the app to improve usability. Trial Registration: ISRCTN Registry ISRCTN11295269; https://www.isrctn.com/ISRCTN11295269 %M 34468325 %R 10.2196/28784 %U https://formative.jmir.org/2021/9/e28784 %U https://doi.org/10.2196/28784 %U http://www.ncbi.nlm.nih.gov/pubmed/34468325 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 5 %N 8 %P e26861 %T A Mobile Health App (WYZ) for Engagement in Care and Antiretroviral Therapy Adherence Among Youth and Young Adults Living With HIV: Single-Arm Pilot Intervention Study %A Saberi,Parya %A Lisha,Nadra E %A Erguera,Xavier A %A Hudes,Estie Sid %A Johnson,Mallory O %A Ruel,Theodore %A Neilands,Torsten B %+ Department of Medicine, University of California, San Francisco, 550 16th street, San Francisco, CA, 94143, United States, 1 415 502 1000 ext 17171, Parya.Saberi@ucsf.edu %K youth living with HIV %K mobile health %K mobile app %K engagement in care %K antiretroviral therapy adherence %K pilot %D 2021 %7 31.8.2021 %9 Original Paper %J JMIR Form Res %G English %X Background: Youth are globally recognized as being vulnerable to HIV. Younger age has been correlated with worse health outcomes. Mobile health (mHealth) interventions have the potential to interact with youth where they are, using a device they already access. Objective: Using predefined benchmarks, we sought to evaluate the feasibility and acceptability of WYZ, an mHealth app, for improved engagement in care and antiretroviral therapy (ART) adherence among youth and young adults living with HIV. WYZ was designed and developed with input from youth and young adults living with HIV using a human-centered design approach and was based on the information, motivation, and behavioral skills framework to address common barriers to care and ART adherence among youth and young adults living with HIV. Methods: We recruited youth and young adults living with HIV (18-29 years old) from the San Francisco Bay Area to take part in a 6-month pilot trial. Their participation included completing baseline and exit surveys, and participating in seven phone check-ins about their use of WYZ. Results: Youth and young adults living with HIV (N=79) reported high levels of feasibility and acceptability with WYZ use. We met predefined benchmarks for recruitment (79/84, 94%), mean logins per week (5.3), tracking ART adherence (5442/9393, 57.9%), posting chat topics per week (4.8), and app crashes reported per week (0.24). The ease of app download, install, and setup, and comfort with security, privacy, and anonymity were highly rated (all over 91%). Additionally, participants reported high satisfaction for a research project that was remotely conducted. Participants used the app for shorter timeframes compared to the predefined benchmark. Conclusions: We noted high feasibility and acceptability with WYZ. Further research to examine the efficacy of WYZ will enable youth and young adults living with HIV and their providers to make informed decisions when using, recommending, and prescribing the app for improved engagement in HIV care and ART adherence. Trial Registration: ClinicalTrials.gov NCT03587857; https://clinicaltrials.gov/ct2/show/NCT03587857 %M 34463622 %R 10.2196/26861 %U https://formative.jmir.org/2021/8/e26861 %U https://doi.org/10.2196/26861 %U http://www.ncbi.nlm.nih.gov/pubmed/34463622 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 8 %P e29061 %T Digital Technology Tools to Examine Patient Adherence to a Prescription-Only Omega-3 Polyunsaturated Fatty Acid Therapy To Mitigate Cardiovascular Risk: Protocol for a Prospective Observational Study and Preliminary Demographic Analysis %A Arutyunov,Gregory P %A Arutyunov,Alexander G %A Ageev,Fail T %A Fofanova,Tatiana V %+ Pirogov Russian National Research Medical University, Department of Internal Medicine, Ostrovityanova Street, Moscow, 117997, Russian Federation, 7 9103281989, arut@ossn.ru %K omega-3-acid ethyl esters %K myocardial infarction %K hypertriglyceridemia %K adherence %K compliance %K persistence %K mHealth %K eHealth %K patient-reported outcomes %D 2021 %7 30.8.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: Sustained adherence and persistence with prescription medications is considered essential to achieve maximal treatment benefit for patients with major chronic, noncommunicable diseases such as hyperlipidemia and lipid-associated cardiovascular disease. It is widely documented, however, that many patients with these conditions have poor long-term adherence to their treatments. The population of Russia is affected by poor adherence in the same ways as populations elsewhere and continues to have high rates of cardiovascular disease. Objective: The purpose of this study was to examine patient adherence to a prescription-only preparation of highly purified omega-3 polyunsaturated fatty acids (1.2 to 1 eicosapentaenoic acid to docosahexaenoic ratio, 90% purity) in a large sample of patients at risk for cardiovascular diseases using digital technology to monitor patient behavior and as an outreach facility for patient education and engagement. Methods: We conducted a 6-month prospective observational study (DIAPAsOn) at >100 centers in the Russian Federation. A bespoke electronic data capture and patient engagement system were developed with a well-established Russian technology supplier that enables information obtained during clinic visits to be supplemented by remote patient self-reporting. Other aspects of the program included raising patients' awareness about their condition via educational materials available in personal patient accounts in the electronic system. Results: From an initial cohort of 3000 patients, a safety population of 2572 patients (age: mean 60 years) with an equal proportion of men and women has been characterized. There was widespread concomitant cardiovascular pathology and commensurate use of multiple classes of cardiovascular medication, notably lipid-modifying and antihypertensive drugs. The program was completed by 1975 patients, of whom 780 were prescribed highly purified omega-3 polyunsaturated fatty acid supplements for secondary prevention after myocardial infarction and 1195 were prescribed highly purified omega-3 polyunsaturated fatty acid supplements for hypertriglyceridemia. Data collection and analysis have been completed. Conclusions: DIAPAsOn will provide insights into patient adherence with prescription-grade omega-3 polyunsaturated fatty acid therapy and perspectives on the role of mobile technology in monitoring and encouraging adherence to therapy. %M 34459746 %R 10.2196/29061 %U https://www.researchprotocols.org/2021/8/e29061 %U https://doi.org/10.2196/29061 %U http://www.ncbi.nlm.nih.gov/pubmed/34459746 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 9 %N 8 %P e28104 %T Supporting Women Undergoing IVF Treatment With Timely Patient Information Through an App: Randomized Controlled Trial %A Timmers,Thomas %A Keijsers,Manouk %A Kremer,Jan A M %A Janssen,Loes %A Smeenk,Jesper %+ IQ healthcare, Radboud Institute for Health Sciences, Radboud University Medical Center, Geert Grooteplein Zuid 10, Nijmegen, 6525 GA, Netherlands, 31 24 3615305, thomas@interactivestudios.nl %K patient education %K fertilization in vitro %K mobile health %K health literacy %K gynecology %D 2021 %7 27.8.2021 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Since the introduction of assisted reproductive technologies in 1978, over 2 million in vitro fertilization (IVF) babies have been born worldwide. Patients play a vital role in the success of this treatment. They are required to take fertility medication (hormone injections) to activate the ovaries to produce a sufficient number of oocytes. Later, they need to take medication to increase the chance of the embryo surviving inside the uterus. Patients are educated during an intake consultation at the start of the treatment to minimize the emotional burden and reduce noncompliance. The consultation lasts about 30 to 45 minutes and covers all essential subjects. Even though ample time and energy is spent on patient education, patients still feel anxious, unknowledgeable, and unsupported. As such, electronic health utilizing a smartphone or tablet app can offer additional support, as it allows health care professionals to provide their patients with the correct information at the right time by using push notifications. Objective: This randomized controlled trial aimed to evaluate the capacity of an app to support IVF patients throughout the different phases of their treatment and assess its effectiveness. The study's primary outcome was to determine the patients’ level of satisfaction with the information provided. The secondary outcomes included their level of knowledge, ability to administer the medication, overall experienced quality of the treatment, health care consumption, and app usage. Methods: This study was performed at a specialized fertility clinic of the nonacademic teaching hospital Elisabeth-TweeSteden Ziekenhuis in Tilburg, the Netherlands. Patients who were scheduled for IVF or intracytoplasmic sperm injection treatments between April 2018 and August 2019 were invited to participate in a physician-blinded, randomized controlled trial. Results: In total, 54 patients participated (intervention group: n=29). Patients in the intervention group demonstrated a higher level of satisfaction on a 0 to 10 scale (mean 8.43, SD 1.03 vs mean 7.70, SD 0.66; P=.004). In addition, they were more knowledgeable about the different elements of the treatment on a 7 to 35 scale (mean 27.29, SD 2.94 vs mean 23.05, SD 2.76; P<.001). However, the difference disappeared over time. There were no differences between the two patient groups on the other outcomes. In total, 25 patients in the intervention group used the app 1425 times, an average of 57 times per patient. Conclusions: Our study demonstrates that, in comparison with standard patient education, using an app to provide patients with timely information increases their level of satisfaction. Furthermore, using the app leads to a higher level of knowledge about the steps and procedures of IVF treatment. Finally, the app’s usage statistics demonstrate patients’ informational needs and their willingness to use an electronic health application as part of their treatment. Trial Registration: Netherlands Trial Register (NTR) 6959; https://www.trialregister.nl/trial/6959 %M 34448725 %R 10.2196/28104 %U https://mhealth.jmir.org/2021/8/e28104 %U https://doi.org/10.2196/28104 %U http://www.ncbi.nlm.nih.gov/pubmed/34448725 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 5 %N 8 %P e28163 %T Evaluation and Refinement of a Bank of SMS Text Messages to Promote Behavior Change Adherence Following a Diabetes Prevention Program: Survey Study %A MacPherson,Megan %A Cranston,Kaela %A Johnston,Cara %A Locke,Sean %A Jung,Mary E %+ School of Health and Exercise Sciences, Faculty of Health and Social Development, University of British Columbia, 1147 Research Road, Kelowna, BC, V1V 1V7, Canada, 1 250 807 9670, mary.jung@ubc.ca %K text messaging %K prediabetic state %K telemedicine %K telecommunications %K exercise %K diet %K preventive medicine %K mHealth %K intervention development %K behavior change %K mobile phone %D 2021 %7 27.8.2021 %9 Original Paper %J JMIR Form Res %G English %X Background: SMS text messaging is a low-cost and far-reaching modality that can be used to augment existing diabetes prevention programs and improve long-term diet and exercise behavior change adherence. To date, little research has been published regarding the process of SMS text message content development. Understanding how interventions are developed is necessary to evaluate their evidence base and to guide the implementation of effective and scalable mobile health interventions in public health initiatives and in future research. Objective: This study aims to describe the development and refinement of a bank of SMS text messages targeting diet and exercise behavior change to be implemented following a diabetes prevention program. Methods: A bank of 124 theory-based SMS text messages was developed using the Behaviour Change Wheel and linked to active intervention components (behavior change techniques [BCTs]). The Behaviour Change Wheel is a theory-based framework that provides structure to intervention development and can guide the use of evidence-based practices in behavior change interventions. Once the messages were written, 18 individuals who either participated in a diabetes prevention program or were a diabetes prevention coach evaluated the messages on their clarity, utility, and relevance via survey using a 5-point Likert scale. Messages were refined according to participant feedback and recoded to obtain an accurate representation of BCTs in the final bank. Results: 76/124 (61.3%) messages were edited, 4/124 (3.2%) were added, and 8/124 (6.5%) were removed based on participant scores and feedback. Of the edited messages, 43/76 (57%) received minor word choice and grammar alterations while retaining their original BCT code; the remaining 43% (33/76, plus the 4 newly written messages) were recoded by a reviewer trained in BCT identification. Conclusions: This study outlines the process used to develop and refine a bank of SMS text messages to be implemented following a diabetes prevention program. This resulted in a bank of 120 theory-based, user-informed SMS text messages that were overall deemed clear, useful, and relevant by both individuals who will be receiving and delivering them. This formative development process can be used as a blueprint in future SMS text messaging development to ensure that message content is representative of the evidence base and is also grounded in theory and evaluated by key knowledge users. %M 34448713 %R 10.2196/28163 %U https://formative.jmir.org/2021/8/e28163 %U https://doi.org/10.2196/28163 %U http://www.ncbi.nlm.nih.gov/pubmed/34448713 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 9 %N 8 %P e24555 %T Effect of Physician-Pharmacist Participation in the Management of Ambulatory Cancer Pain Through a Digital Health Platform: Randomized Controlled Trial %A Zhang,Lu %A McLeod,Howard L %A Liu,Ke-Ke %A Liu,Wen-Hui %A Huang,Hang-Xing %A Huang,Ya-Min %A Sun,Shu-Sen %A Chen,Xiao-Ping %A Chen,Yao %A Liu,Fang-Zhou %A Xiao,Jian %+ Department of Pharmacy, Xiangya Hospital, Central South University, Room 404, No. 87 Xiangya Road, Kaifu District, Changsha, 410008, China, 86 13973168895, admanoas@163.com %K cancer pain %K self-management %K ambulatory setting %K digital health %K physician-pharmacist %D 2021 %7 16.8.2021 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Self-management of ambulatory cancer pain is full of challenges. Motivated by the need for better pain management, we developed a WeChat-supported platform, Medication Housekeeper (MediHK), to enhance communication, optimize outcomes, and promote self-management in the home setting. Objective: We conducted a randomized controlled trial to assess whether the joint physician-pharmacist team through MediHK would provide better self-management of ambulatory patients with cancer pain. Methods: Patients were randomly assigned to either an intervention group or control group. During the 4-week study period, the pharmacist would send 24-hour pain diaries daily, adverse drug reaction (ADR) forms every 3 days, and the Brief Pain Inventory form every 15 days to patients in the intervention group via MediHK. If a patient needed a change in drug/dosage or treatment of an ADR after the comprehensive review, the pharmacist would propose pharmacological interventions to the attending physician, who was then responsible for prescribing or adjusting pain medications. If no adjustments were needed, the pharmacist provided appropriate targeted education based on knowledge deficits. Patients in the control group received conventional care and did not receive reminders to fill out the forms. However, if the control group patients filled out a form via MediHK, the pain management team would review and respond in the same way as for the intervention group. The primary outcomes included pain intensity and pain interference in daily life. Secondary outcomes included patient-reported outcome measures, medication adherence, ADRs, and rehospitalization rates. Results: A total of 100 patients were included, with 51 (51%) in the intervention group and 49 (49%) in the control group. The worst pain scores, least pain scores, and average pain scores in the intervention group and the control group were statistically different, with median values of 4 (IQR 3-7) vs 7 (IQR 6-8; P=.001), 1 (IQR 0-2) vs 2 (IQR 1-3; P=.02), and 2 (IQR 2-4) vs 4 (IQR 3-5; P=.001), respectively, at the end of the study. The pain interference on patients' general activity, mood, relationships with others, and interests was reduced, but the difference was not statistically significant compared with the control group (Ps=.10-.76). The medication adherence rate increased from 43% to 63% in the intervention group, compared with an increase of 33% to 51% in the control group (P<.001). The overall number of ADRs increased at 4 weeks, and more ADRs were monitored in the intervention group (P=.003). Rehospitalization rates were similar between the 2 groups. Conclusions: The joint physician-pharmacist team operating through MediHK improved pain management. This study supports the feasibility of integrating the internet into the self-management of cancer pain. Trial Registration: Chinese Clinical Trial Registry ChiCTR1900023075; https://www.chictr.org.cn/showproj.aspx?proj=36901 %M 34398796 %R 10.2196/24555 %U https://mhealth.jmir.org/2021/8/e24555 %U https://doi.org/10.2196/24555 %U http://www.ncbi.nlm.nih.gov/pubmed/34398796 %0 Journal Article %@ 2561-1011 %I JMIR Publications %V 5 %N 2 %P e23464 %T A Patient Decision Aid for Anticoagulation Therapy in Patients With Nonvalvular Atrial Fibrillation: Development and Pilot Study %A de Castro,Kim Paul %A Chiu,Harold Henrison %A De Leon-Yao,Ronna Cheska %A Almelor-Sembrana,Lorraine %A Dans,Antonio Miguel %+ Department of Medicine, Philippine General Hospital, University of the Philippines, Taft Avenue, Manila, Philippines, 63 9989563472, kimpauldecastro@gmail.com %K shared decision-making %K patient decision aid %K atrial fibrillation %K anticoagulation %K stroke prevention %K mHealth %K mobile health %D 2021 %7 12.8.2021 %9 Original Paper %J JMIR Cardio %G English %X Background: Atrial fibrillation (AF) is one of the most common predisposing factors for ischemic stroke worldwide. Because of this, patients with AF are prescribed anticoagulant medications to decrease the risk. The availability of different options for oral anticoagulation makes it difficult for some patients to decide a preferred choice of medication. Clinical guidelines often recommend enhancing the decision-making process of patients by increasing their involvement in health decisions. In particular, the use of patient decision aids (PDAs) in patients with AF was associated with increased knowledge and increased likelihood of making a choice. However, the majority of available PDAs are from Western countries. Objective: We aimed to develop and pilot test a PDA to help patients with nonvalvular AF choose an oral anticoagulant for stroke prevention in the local setting. Outcomes were (1) reduction in patient decisional conflict, (2) improvement in patient knowledge, and (3) patient and physician acceptability. Methods: We followed the International Patient Decision Aid Standards (IPDAS) to develop a mobile app–based PDA for anticoagulation therapy in patients with nonvalvular AF. Focus group discussions identified decisional needs, which were subsequently incorporated into the PDA to compare choices for anticoagulation. Based on recommendations, the prototype PDA was rendered by at least 30 patients and 30 physicians. Decisional conflict and patient knowledge were tested before and after the PDA was implemented. Patient acceptability and physician acceptability were measured after each encounter. Results: Anticoagulant options were compared by the PDA using three factors that were identified (impact on stroke and bleeding risk, and price). The comparisons were presented as tables and graphs. The prototype PDA was rendered by 30 doctors and 37 patients for pilot testing. The mean duration of the encounters was 15 minutes. The decisional conflict score reduced by 35 points (100-point scale; P<.001). The AF knowledge score improved from 10 to 15 (P<.001). The PDA was acceptable for both patients and doctors. Conclusions: Our study showed that an app-based PDA for anticoagulation therapy in patients with nonvalvular AF (1) reduced patient decisional conflict, (2) improved patient knowledge, and (3) was acceptable to patients and physicians. A PDA is potentially acceptable and useful in our setting. A randomized controlled trial is warranted to test its effectiveness compared to usual care. PDAs for other conditions should also be developed. %M 34385138 %R 10.2196/23464 %U https://cardio.jmir.org/2021/2/e23464 %U https://doi.org/10.2196/23464 %U http://www.ncbi.nlm.nih.gov/pubmed/34385138 %0 Journal Article %@ 2291-9694 %I JMIR Publications %V 9 %N 7 %P e26000 %T Effects of Background Colors, Flashes, and Exposure Values on the Accuracy of a Smartphone-Based Pill Recognition System Using a Deep Convolutional Neural Network: Deep Learning and Experimental Approach %A Cha,KyeongMin %A Woo,Hyun-Ki %A Park,Dohyun %A Chang,Dong Kyung %A Kang,Mira %+ Department of Digital Health, Samsung Advanced Institute of Health Sciences & Technology, Sungkyunkwan University, 81 Irwon-ro, Gangnam-gu, Seoul, 06351, Republic of Korea, 82 01099336838, kang.mirad@gmail.com %K pill recognition %K deep neural network %K image processing %K color space %K color difference %K pharmaceutical %K imaging %K photography %K neural network %K mobile phone %D 2021 %7 28.7.2021 %9 Original Paper %J JMIR Med Inform %G English %X Background: Pill image recognition systems are difficult to develop due to differences in pill color, which are influenced by external factors such as the illumination from and the presence of a flash. Objective: In this study, the differences in color between reference images and real-world images were measured to determine the accuracy of a pill recognition system under 12 real-world conditions (ie, different background colors, the presence and absence of a flash, and different exposure values [EVs]). Methods: We analyzed 19 medications with different features (ie, different colors, shapes, and dosages). The average color difference was calculated based on the color distance between a reference image and a real-world image. Results: For images with black backgrounds, as the EV decreased, the top-1 and top-5 accuracies increased independently of the presence of a flash. The top-5 accuracy for images with black backgrounds increased from 26.8% to 72.6% when the flash was on and increased from 29.5% to 76.8% when the flash was off as the EV decreased. However, the top-5 accuracy increased from 62.1% to 78.4% for images with white backgrounds when the flash was on. The best top-1 accuracy was 51.1% (white background; flash on; EV of +2.0). The best top-5 accuracy was 78.4% (white background; flash on; EV of 0). Conclusions: The accuracy generally increased as the color difference decreased, except for images with black backgrounds and an EV of −2.0. This study revealed that background colors, the presence of a flash, and EVs in real-world conditions are important factors that affect the performance of a pill recognition model. %M 34319239 %R 10.2196/26000 %U https://medinform.jmir.org/2021/7/e26000 %U https://doi.org/10.2196/26000 %U http://www.ncbi.nlm.nih.gov/pubmed/34319239 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 9 %N 7 %P e25548 %T Efficacy and Safety of Text Messages Targeting Adherence to Cardiovascular Medications in Secondary Prevention: TXT2HEART Colombia Randomized Controlled Trial %A Bermon,Anderson %A Uribe,Ana Fernanda %A Pérez-Rivero,Paula Fernanda %A Prieto-Merino,David %A Saaibi,Jose Federico %A Silva,Federico Arturo %A Canon,Diana Ivonne %A Castillo-Gonzalez,Karol Melissa %A Cáceres-Rivera,Diana Isabel %A Guio,Elizabeth %A Meneses-Castillo,Karen Janneth %A Castillo-Meza,Alberto %A Atkins,Louise %A Horne,Robert %A Murray,Elizabeth %A Serrano,Norma Cecilia %A Free,Caroline %A Casas,Juan Pablo %A Perel,Pablo %+ Research Center, Fundación Cardiovascular de Colombia, Calle 155A #23-58, Floridablanca, 681001, Colombia, 57 3002053041, andebermon@gmail.com %K randomized controlled trial %K Colombia %K text messaging %K cardiovascular disease %K secondary prevention %D 2021 %7 28.7.2021 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Atherosclerotic cardiovascular disease (ASCVD) is the leading cause of mortality worldwide, with a prevalence of approximately 100 million patients. There is evidence that antiplatelet agents and antihypertensive medications could reduce the risk of new vascular events in this population; however, treatment adherence is very low. An SMS text messaging intervention was recently developed based on behavior change techniques to increase adherence to pharmacological treatment among patients with a history of ASCVD. Objective: This study aims to evaluate the efficacy and safety of an SMS text messaging intervention to improve adherence to cardiovascular medications in patients with ASCVD. Methods: A randomized controlled clinical trial for patients with a prior diagnosis of cardiovascular events, such as acute myocardial infarction, unstable angina, cerebrovascular disease, or peripheral artery disease, in one center in Colombia was conducted. Patients randomized to the intervention arm were assigned to receive SMS text messages daily for the first 4 weeks, 5 SMS text messages on week 5, 3 SMS text messages each in weeks 6 and 7, and 1 SMS text message weekly from week 8 until week 52. In contrast, patients in the control arm received a monthly SMS text message reminding them of the next study appointment and the importance of the study, requesting information about changes in their phone number, and thanking them for participating in the study. The primary endpoint was the change in low-density lipoprotein cholesterol (LDL-C) levels, whereas the secondary endpoints were the changes in thromboxane B2 levels, heart rate, systolic and diastolic blood pressure, medication adherence, cardiac and noncardiac mortality, and hospitalization. Linear regression analyses and bivariate tests were performed. Results: Of the 930 randomized patients, 805 (86.5%) completed follow-up and were analyzed for the primary endpoint. There was no evidence that the intervention changed the primary outcome (LDL-C levels; P=.41) or any of the secondary outcomes evaluated (all P>.05). There was also no evidence that the intervention was associated with adverse events. Conclusions: In this study, there was no evidence that a behavior modification intervention delivered by SMS text messaging improved LDL-C levels, blood pressure levels, or adherence at 12 months. More research is needed to evaluate whether different SMS text messaging strategies, including personalized messages and different timings, are effective; future studies should include mixed methods to better understand why, for whom, and in which context (eg, health system or social environment) SMS text messaging interventions work (or not) to improve adherence in patients with ASCVD. Trial Registration: ClinicalTrials.gov NCT03098186; https://clinicaltrials.gov/ct2/show/NCT03098186 International Registered Report Identifier (IRRID): RR2-10.1136/bmjopen-2018-028017 %M 34319247 %R 10.2196/25548 %U https://mhealth.jmir.org/2021/7/e25548 %U https://doi.org/10.2196/25548 %U http://www.ncbi.nlm.nih.gov/pubmed/34319247 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 7 %P e29475 %T Effectiveness of eHealth Interventions in Improving Medication Adherence for Patients With Chronic Obstructive Pulmonary Disease or Asthma: Systematic Review %A Schulte,Mieke H J %A Aardoom,Jiska J %A Loheide-Niesmann,Lisa %A Verstraete,Leonie L L %A Ossebaard,Hans C %A Riper,Heleen %+ Department of Clinical, Neuro- and Developmental Psychology, Vrije Universiteit, Medical Faculty, Van der Boechorststraat 7, Amsterdam, 1081 BT, Netherlands, 31 20 59 82619, h.riper@vu.nl %K chronic obstructive pulmonary disease %K asthma %K medication adherence %K exercise adherence %K treatment adherence %K eHealth %K systematic review %K COPD %K adherence %K exercise %K treatment %K review %D 2021 %7 27.7.2021 %9 Review %J J Med Internet Res %G English %X Background: Poor treatment adherence in patients with chronic obstructive pulmonary disease (COPD) or asthma is a global public health concern with severe consequences in terms of patient health and societal costs. A potentially promising tool for addressing poor compliance is eHealth. Objective: This review investigates the effects of eHealth interventions on medication adherence in patients with COPD or asthma. Methods: A systematic literature search was conducted in the databases of Cochrane Library, PsycINFO, PubMed, and Embase for studies with publication dates between January 1, 2000, and October 29, 2020. We selected randomized controlled trials targeting adult patients with COPD or asthma, which evaluated the effectiveness of an eHealth intervention on medication adherence. The risk of bias in the included studies was examined using the Cochrane Collaboration’s risk of bias tool. The results were narratively reviewed. Results: In total, six studies focusing on COPD and seven focusing on asthma were analyzed. Interventions were mostly internet-based or telephone-based, and could entail telemonitoring of symptoms and medication adherence, education, counseling, consultations, and self-support modules. Control groups mostly comprised usual care conditions, whereas a small number of studies used a face-to-face intervention or waiting list as the control condition. For COPD, the majority of eHealth interventions were investigated as an add-on to usual care (5/6 studies), whereas for asthma the majority of interventions were investigated as a standalone intervention (5/7 studies). Regarding eHealth interventions targeting medication adherence for COPD, two studies reported nonsignificant effects, one study found a significant effect in comparison to usual care, and three reported mixed results. Of the seven studies that investigated eHealth interventions targeting medication adherence in asthma, three studies found significant effects, two reported nonsignificant effects, and two reported mixed effects. Conclusions: The mixed results on the effectiveness of eHealth interventions in improving treatment adherence for asthma and COPD are presumably related to the type, context, and intensity of the interventions, as well as to differences in the operationalization and measurement of adherence outcomes. Much remains to be learned about the potential of eHealth to optimize treatment adherence in COPD and asthma. %M 34313593 %R 10.2196/29475 %U https://www.jmir.org/2021/7/e29475 %U https://doi.org/10.2196/29475 %U http://www.ncbi.nlm.nih.gov/pubmed/34313593 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 5 %N 7 %P e29463 %T Development of a Video-Observed Therapy System to Improve Monitoring of Tuberculosis Treatment in Thailand: Mixed-Methods Study %A Kumwichar,Ponlagrit %A Chongsuvivatwong,Virasakdi %A Prappre,Tagoon %+ Epidemiology Unit, Faculty of Medicine, Prince of Songkla University, Kanjanavanich Rd, Kho Hong, Hat Yai District, Songkhla, 90110, Thailand, 66 74451165, cvirasak@medicine.psu.ac.th %K app %K mixed-methods analysis %K remote monitoring %K therapy %K tuberculosis %K user experience %K video directly observed therapy %K video-enhanced therapy %K video-observed therapy %D 2021 %7 27.7.2021 %9 Original Paper %J JMIR Form Res %G English %X Background: Directly observed therapy programs for monitoring tuberculosis (TB) treatment in Thailand are unsustainable, especially during the COVID-19 pandemic. The current video-observed therapy (VOT) system, the Thai VOT (TH VOT), was developed to replace the directly observed therapy program. Objective: This study aimed to describe the VOT system design and identify the potential for system improvements. Methods: This pilot study was conducted in Na Yong district, a small district in Trang province, south of Thailand. The TH VOT system consists of a smartphone app for patients, a secured web-based platform for staff, items used, and standard operating procedures. There were three groups of users: observers who were TB staff, healthy volunteers as simulated patients, and patients with active TB. All participants were trained to follow the standard operating procedures. After 2-week usage, VOT session records were analyzed to measure the compliance of the patients and observers. The User Experience Questionnaire was used to lead the participant users to focus on 6 standard dimensions of usability, and was supplemented with an in-depth interview to identify potential system improvements from users’ experience. Results: Only 2 of 16 patients with currently active TB had a usable smartphone. Sixty of 70 drug-taking sessions among 2 patients and 3 simulated patients in 2 weeks were recorded and uploaded. Only 37 sessions were inspected by the observers within 24 hours. All participants needed a proper notification system. An audit system was also requested. Conclusions: Before upscaling, the cost of smartphone lending, audit management, and notification systems should be elucidated. %M 34313602 %R 10.2196/29463 %U https://formative.jmir.org/2021/7/e29463 %U https://doi.org/10.2196/29463 %U http://www.ncbi.nlm.nih.gov/pubmed/34313602 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 5 %N 7 %P e25796 %T Development of Automated Reinforcement Management System (ARMS): Protocol for a Phase I Feasibility and Usability Study %A Miguel,Andre %A Smith,Crystal %A Perea,Nicole %A Johnson,Kim %A McDonell,Michael %A McPherson,Sterling %+ Elson S Floyd College of Medicine, Washington State University, 665 N Riverpoint Blvd, Office 406, Spokane, WA, 99202, United States, 1 5096866896, andre.miguel@wsu.edu %K alcohol use disorder %K contingency management %K ecological momentary assessment %K treatment %D 2021 %7 19.7.2021 %9 Protocol %J JMIR Form Res %G English %X Background: Alcohol use is directly related to over 3 million deaths worldwide every year. Contingency management is a cost-effective treatment for substance use disorders; however, few studies have examined its efficacy for alcohol use disorder. Recent technological advances have enabled the combined use of mobile apps and low-cost electronic breathalyzer devices to remotely monitor alcohol use. Leveraging this type of technology, our study group has recently developed an integrated contingency management system that would enable community treatment programs to remotely deliver contingency management to anyone who owns a smartphone. Objective: In this paper, we present a full description of our integrated contingency management system, Automated Reinforcement Management System (ARMS), and describe a protocol that will evaluate its feasibility and usability. Methods: Initially, 6 clinicians will participate in a 1-hour focus group where the study staff will navigate through ARMS as it would be used by clinicians and patients. Clinicians will provide feedback on the intervention in general, which will be used to modify ARMS to make it more user friendly, time saving, and relevant to treatment. A second focus group will summarize the changes made following the initial clinician feedback and will provide additional input regarding the potential utilization of ARMS. Thereafter, the clinicians’ acceptability of ARMS will be evaluated using the System Usability Scale. Following the clinicians’ assessments of ARMS and final modifications, the system will be evaluated in terms of feasibility and patient usability by using an A-B-A within-subject experimental design wherein 20 treatment-seeking individuals with alcohol use disorder will be recruited. The two A phases (control conditions) will each last 2 weeks, and the B phase (contingency management condition) will last 4 weeks. During all phases, participants will be asked to use the ARMS app to submit three breathalyzer samples per day (at 10 AM, 2 PM, and 8 PM). Participants will be prompted by the ARMS app at these predetermined times to record and submit their breathalyzer samples. During the A phases, participants will earn vouchers for every breathalyzer sample submitted, independent of their sample results. During the B phase, vouchers will be provided contingent upon the submission of alcohol-negative breathalyzer samples (breath alcohol content = 0.00). At the end of the A-B-A experiment trial, patients’ usability of the ARMS app will be evaluated using the System Usability Scale. Feasibility will be measured based on whether the ARMS app helped significantly increase alcohol abstinence. Results: Recruitment for this study began in January 2021 and is expected to be completed by December 2021. Conclusions: This study will provide the baseline capability for the implementation of a remotely monitored contingency management platform. If successful, ARMS has the potential to provide effective treatment for alcohol use disorders to individuals living in remote rural areas. %M 34279238 %R 10.2196/25796 %U https://formative.jmir.org/2021/7/e25796 %U https://doi.org/10.2196/25796 %U http://www.ncbi.nlm.nih.gov/pubmed/34279238 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 5 %N 7 %P e27327 %T Medication Adherence Reminder System for Virtual Home Assistants: Mixed Methods Evaluation Study %A Corbett,Cynthia F %A Combs,Elizabeth M %A Chandarana,Peyton S %A Stringfellow,Isabel %A Worthy,Karen %A Nguyen,Thien %A Wright,Pamela J %A O'Kane,Jason M %+ College of Nursing, University of South Carolina, 1601 Greene St, Columbia, SC, 29208, United States, 1 8035766275, corbett@sc.edu %K medication adherence %K medication %K virtual home assistants %K virtual assistant %K public health %K health care costs %K Echo device %K device usability %K digital health %K mobile phone %D 2021 %7 13.7.2021 %9 Original Paper %J JMIR Form Res %G English %X Background: Medication nonadherence is a global public health challenge that results in suboptimal health outcomes and increases health care costs. Forgetting to take medicines is one of the most common reasons for unintentional medication nonadherence. Research findings indicate that voice-activated virtual home assistants, such as Amazon Echo and Google Home devices, may be useful in promoting medication adherence. Objective: This study aims to create a medication adherence app (skill), MedBuddy, for Amazon Echo devices and measure the use, usability, and usefulness of this medication-taking reminder skill. Methods: A single-group, mixed methods, cohort feasibility study was conducted with women who took oral contraceptives (N=25). Participants were undergraduate students (age: mean 21.8 years, SD 6.2) at an urban university in the Southeast United States. Participants were given an Amazon Echo Dot with MedBuddy—a new medication reminder skill for Echo devices created by our team—attached to their study account, which they used for 60 days. Participants self-reported their baseline and poststudy medication adherence. MedBuddy use was objectively evaluated by tracking participants’ interactions with MedBuddy through Amazon Alexa. The usability and usefulness of MedBuddy were evaluated through a poststudy interview in which participants responded to both quantitative and qualitative questions. Results: Participants’ interactions with MedBuddy, as tracked through Amazon Alexa, only occurred on half of the study days (mean 50.97, SD 29.5). At study end, participants reported missing their medication less in the past 1 and 6 months compared with baseline (χ21=0.9 and χ21=0.4, respectively; McNemar test: P<.001 for both). However, there was no significant difference in participants’ reported adherence to consistently taking medication within the same 2-hour time frame every day in the past 1 or 6 months at the end of the study compared with baseline (χ21=3.5 and χ21=0.4, respectively; McNemar test: P=.63 and P=.07, respectively). Overall feedback about usability was positive, and participants provided constructive feedback about the skill’s features that could be improved. Participants’ evaluation of MedBuddy’s usefulness was overwhelmingly positive—most (15/23, 65%) said that they would continue using MedBuddy as a medication reminder if provided with the opportunity and that they would recommend it to others. MedBuddy features that participants enjoyed were an external prompt separate from their phone, the ability to hear the reminder prompt from a separate room, multiple reminders, and verbal responses to prompts. Conclusions: The findings of this feasibility study indicate that the MedBuddy medication reminder skill may be useful in promoting medication adherence. However, the skill could benefit from further usability enhancements. %M 34255669 %R 10.2196/27327 %U https://formative.jmir.org/2021/7/e27327 %U https://doi.org/10.2196/27327 %U http://www.ncbi.nlm.nih.gov/pubmed/34255669 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 6 %P e25522 %T A Comprehensive 6A Framework for Improving Patient Self-Management of Hypertension Using mHealth Services: Qualitative Thematic Analysis %A Song,Ting %A Liu,Fang %A Deng,Ning %A Qian,Siyu %A Cui,Tingru %A Guan,Yingping %A Arnolda,Leonard %A Zhang,Zhenyu %A Yu,Ping %+ Centre for Digital Transformation, School of Computing and Information Technology, Faculty of Engineering and Information Sciences, University of Wollongong, Northfields Avenue, Wollongong, 2522, Australia, 61 2 4221 5412, ping@uow.edu.au %K patient experience %K mHealth %K mobile phone %K mobile app %K intervention %K self-management %K high blood pressure %K chronic disease management %K qualitative research %D 2021 %7 21.6.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Hypertension affects over 15% of the world’s population and is a significant global public health and socioeconomic challenge. Mobile health (mHealth) services have been increasingly introduced to support hypertensive patients to improve their self-management behaviors, such as adherence to pharmacotherapy and lifestyle modifications. Objective: This study aims to explore patients’ perceptions of mHealth services and the mechanisms by which the services support them to self-manage their hypertension. Methods: A semistructured, in-depth interview study was conducted with 22 outpatients of the General Hospital of Ningxia Medical University from March to May 2019. In 2015, the hospital introduced an mHealth service to support community-dwelling outpatients with self-management of hypertension. Content analysis was conducted by following a grounded theory approach for inductive thematic extraction. Constant comparison and categorization classified the first-level codes with similar meanings into higher-level themes. Results: The patient-perceived mechanisms by which the mHealth service supported their self-management of hypertension were summarized as 6A: access, assessment, assistance, awareness, ability, and activation. With the portability of mobile phones and digitization of information, the mHealth service provided outpatients with easy access to assess their vital signs and self-management behaviors. The assessment results gave the patients real-time awareness of their health conditions and self-management performance, which activated their self-management behaviors. The mHealth service also gave outpatients access to assistance, which included health education and self-management reminders. Both types of assistance could also be activated by abnormal assessment results, that is, uncontrolled or deteriorating blood pressure values, discomfort symptoms, or not using the service for a long period. With its scalable use to handle any possible information and services, the mHealth service provided outpatients with educational materials to learn at their own pace. This led to an improvement in self-management awareness and ability, again activating their self-management behaviors. The patients would like to see further improvements in the service to provide more useful, personalized information and reliable services. Conclusions: The mHealth service extended the traditional hypertension care model beyond the hospital and clinician’s office. It provided outpatients with easy access to otherwise inaccessible hypertension management services. This led to process improvement for outpatients to access health assessment and health care assistance and improved their awareness and self-management ability, which activated their hypertension self-management behaviors. Future studies can apply the 6A framework to guide the design, implementation, and evaluation of mHealth services for outpatients to self-manage chronic conditions. %M 34152272 %R 10.2196/25522 %U https://www.jmir.org/2021/6/e25522 %U https://doi.org/10.2196/25522 %U http://www.ncbi.nlm.nih.gov/pubmed/34152272 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 6 %P e28094 %T Mobile Tuberculosis Treatment Support Tools to Increase Treatment Success in Patients with Tuberculosis in Argentina: Protocol for a Randomized Controlled Trial %A Iribarren,Sarah %A Milligan,Hannah %A Goodwin,Kyle %A Aguilar Vidrio,Omar Alfonso %A Chirico,Cristina %A Telles,Hugo %A Morelli,Daniela %A Lutz,Barry %A Sprecher,Jennifer %A Rubinstein,Fernando %+ Biobehavioral Nursing and Health Informatics, University of Washington, 1959 NE Pacific Street, HSB, Box 357266, Seattle, WA, 98195, United States, 1 2065435211, sjiribar@uw.edu %K tuberculosis %K disease management %K infectious disease %K mHealth %K digital health %K direct drug metabolite test %K mobile phone %D 2021 %7 21.6.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: Tuberculosis (TB) is an urgent global health threat and the world’s deadliest infectious disease despite being largely curable. A critical challenge is to ensure that patients adhere to the full course of treatment to prevent the continued spread of the disease and development of drug-resistant disease. Mobile health interventions hold promise to provide the required adherence support to improve TB treatment outcomes. Objective: This study aims to evaluate the effectiveness of the TB treatment support tools (TB-TSTs) intervention on treatment outcomes (success and default) and to assess patient and provider perceptions of the facilitators and barriers to TB-TSTs implementation. Methods: The TB-TSTs study is an open-label, randomized controlled trial with 2 parallel groups in which 400 adult patients newly diagnosed with TB will be randomly assigned to receive usual care or usual care plus TB-TSTs. Participants will be recruited on a rolling basis from 4 clinical sites in Argentina. The intervention consists of a smartphone progressive web app, a treatment supporter (eg, TB nurse, physician, or social worker), and a direct adherence test strip engineered for home use. Intervention group participants will report treatment progress and interact with a treatment supporter using the app and metabolite urine test strip. The primary outcome will be treatment success. Secondary outcomes will include treatment default rates, self-reported adherence, technology use, and usability. We will assess patients’ and providers’ perceptions of barriers to implementation and synthesize lessons learned. We hypothesize that the TB-TSTs intervention will be more effective because it allows patients and TB supporters to monitor and address issues in real time and provide tailored support. We will share the results with stakeholders and policy makers. Results: Enrollment began in November 2020, with a delayed start due to the COVID-19 pandemic, and complete enrollment is expected by approximately July 2022. Data collection and follow-up are expected to be completed 6 months after the last patient is enrolled. Results from the analyses based on the primary end points are expected to be submitted for publication within a year of data collection completion. Conclusions: To our knowledge, this randomized controlled trial will be the first study to evaluate a patient-centered remote treatment support strategy using a mobile tool and a home-based direct drug metabolite test. The results will provide robust scientific evidence on the effectiveness, implementation, and adoption of mobile health tools. The findings have broader implications not only for TB adherence but also more generally for chronic disease management and will improve our understanding of how to support patients facing challenging treatment regimens. Trial Registration: ClinicalTrials.gov NCT04221789; https://clinicaltrials.gov/ct2/show/NCT04221789. International Registered Report Identifier (IRRID): DERR1-10.2196/28094 %M 34152281 %R 10.2196/28094 %U https://www.researchprotocols.org/2021/6/e28094 %U https://doi.org/10.2196/28094 %U http://www.ncbi.nlm.nih.gov/pubmed/34152281 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 6 %P e24510 %T Directly Observed Therapy to Measure Adherence to Tuberculosis Medication in Observational Research: Protocol for a Prospective Cohort Study %A Ragan,Elizabeth J %A Gill,Christopher J %A Banos,Matthew %A Bouton,Tara C %A Rooney,Jennifer %A Horsburgh,Charles R %A Warren,Robin M %A Myers,Bronwyn %A Jacobson,Karen R %+ Section of Infectious Diseases, Boston Medical Center, 801 Massachusetts Avenue, Boston, MA, 02118, United States, 1 617 414 5213, kjacobso@bu.edu %K tuberculosis %K directly observed therapy %K treatment adherence and compliance %K medication adherence %K mobile applications %D 2021 %7 16.6.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: A major challenge for prospective, clinical tuberculosis (TB) research is accurately defining a metric for measuring medication adherence. Objective: We aimed to design a method to capture directly observed therapy (DOT) via mobile health carried out by community workers. The program was created specifically to measure TB medication adherence for a prospective TB cohort in Western Cape Province, South Africa. Methods: Community workers collect daily adherence data on mobile smartphones. Participant-level adherence, program-level adherence, and program function are systematically monitored to assess DOT program implementation. A data dashboard allows for regular visualization of indicators. Numerous design elements aim to prevent or limit data falsification and ensure study data integrity. Results: The cohort study is ongoing and data collection is in progress. Enrollment began on May 16, 2017, and as of January 12, 2021, a total of 236 participants were enrolled. Adherence data will be used to analyze the study’s primary aims and to investigate adherence as a primary outcome. Conclusions: The DOT program includes a mobile health application for data collection as well as a monitoring framework and dashboard. This approach has potential to be adapted for other settings to improve the capture of medication adherence in clinical TB research. Trial Registration: Clinicaltrials.gov NCT02840877; https://clinicaltrials.gov/ct2/show/NCT02840877 %M 34132642 %R 10.2196/24510 %U https://www.researchprotocols.org/2021/6/e24510 %U https://doi.org/10.2196/24510 %U http://www.ncbi.nlm.nih.gov/pubmed/34132642 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 9 %N 6 %P e17418 %T Acceptability of a Mobile Phone Support Tool (Call for Life Uganda) for Promoting Adherence to Antiretroviral Therapy Among Young Adults in a Randomized Controlled Trial: Exploratory Qualitative Study %A Twimukye,Adelline %A Bwanika Naggirinya,Agnes %A Parkes-Ratanshi,Rosalind %A Kasirye,Ronnie %A Kiragga,Agnes %A Castelnuovo,Barbara %A Wasswa,Jacob %A Nabaggala,Maria Sarah %A Katabira,Elly %A Lamorde,Mohammed %A King,Rachel Lisa %+ Infectious Diseases Institute, College of Health Sciences, Makerere University, P.O. Box 22418, University Hall Lane, Kampala, 10218, Uganda, 256 256 312 307000, anaggirinya@idi.co.ug %K HIV %K mHealth %K young adults %K adherence %K qualitative %K Uganda %D 2021 %7 14.6.2021 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Adherence to treatment is critical for successful treatment outcomes. Although factors influencing antiretroviral therapy (ART) adherence vary, young adults are less likely to adhere owing to psychosocial issues such as stigma, ART-related side effects, and a lack of access to treatment. The Call for Life Uganda (CFLU) mobile health (mHealth) tool is a mobile phone–based technology that provides text messages or interactive voice response functionalities through a web interface and offers 4 modules of support. Objective: This study aims to describe the acceptability and feasibility of a mobile phone support tool to promote adherence to ART among young adults in a randomized controlled trial. Methods: An exploratory qualitative design with a phenomenological approach at 2 study sites was used. A total of 17 purposively selected young adults with HIV infection who had used the mHealth tool CFLU from 2 clinics were included. In total, 11 in-depth interviews and 1 focus group discussion were conducted to examine the following topics: experience with the CFLU tool (benefits and challenges), components of the tool, the efficiency of the system (level of comfort, ease, or difficulty in using the system), how CFLU resolved adherence challenges, and suggestions to improve CFLU. Participants belonged to 4 categories of interest: young adults on ART for the prevention of mother-to-child transmission, young adults switching to or on the second-line ART, positive partners in an HIV-discordant relationship, and young adults initiating the first-line ART. All young adults had 12 months of daily experience using the tool. Data were analyzed using NVivo version 11 software (QSR International Limited) based on a thematic approach. Results: The CFLU mHealth tool was perceived as an acceptable intervention; young adults reported improvement in medication adherence, strengthened clinician-patient relationships, and increased health knowledge from health tips. Appointment reminders and symptom reporting were singled out as beneficial and helped to address the problems of forgetfulness and stigma-related issues. HIV-related stigma was reported by a few young people. Participants requested extra support for scaling up CFLU to make it more youth friendly. Improving the tool to reduce technical issues, including network outages and a period of software failure, was suggested. They suggested that in addition to digital solutions, other support, including the promotion of peer support meetings and the establishment of a designated space and staff members for youth, was also important. Conclusions: This mHealth tool was an acceptable and feasible strategy for improving ART adherence and retention among young adults in resource-limited settings. Trial Registration: ClinicalTrials.gov NCT02953080; https://clinicaltrials.gov/ct2/show/NCT02953080 %M 34121665 %R 10.2196/17418 %U https://mhealth.jmir.org/2021/6/e17418 %U https://doi.org/10.2196/17418 %U http://www.ncbi.nlm.nih.gov/pubmed/34121665 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 6 %P e25958 %T Preferences for mHealth Technology and Text Messaging Communication in Patients With Type 2 Diabetes: Qualitative Interview Study %A Lauffenburger,Julie C %A Barlev,Renee A %A Sears,Ellen S %A Keller,Punam A %A McDonnell,Marie E %A Yom-Tov,Elad %A Fontanet,Constance P %A Hanken,Kaitlin %A Haff,Nancy %A Choudhry,Niteesh K %+ Brigham and Women's Hospital, Harvard Medical School, 1620 Tremont Street, Suite 3030, Boston, MA, 02120, United States, 1 6175258865, jlauffenburger@bwh.harvard.edu %K diabetes %K technology %K mobile health %K medication adherence %K mobile phone %D 2021 %7 11.6.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Individuals with diabetes need regular support to help them manage their diabetes on their own, ideally delivered via mechanisms that they already use, such as their mobile phones. One reason for the modest effectiveness of prior technology-based interventions may be that the patient perspective has been insufficiently incorporated. Objective: This study aims to understand patients’ preferences for mobile health (mHealth) technology and how that technology can be integrated into patients’ routines, especially with regard to medication use. Methods: We conducted semistructured qualitative individual interviews with patients with type 2 diabetes from an urban health care system to elicit and explore their perspectives on diabetes medication–taking behaviors, daily patterns of using mobile technology, use of mHealth technology for diabetes care, acceptability of text messages to support medication adherence, and preferred framing of information within text messages to support diabetes care. The interviews were digitally recorded and transcribed. The data were analyzed using codes developed by the study team to generate themes, with representative quotations selected as illustrations. Results: We conducted interviews with 20 participants, of whom 12 (60%) were female and 9 (45%) were White; in addition, the participants’ mean glycated hemoglobin A1c control was 7.8 (SD 1.1). Overall, 5 key themes were identified: patients try to incorporate cues into their routines to help them with consistent medication taking; many patients leverage some form of technology as a cue to support adherence to medication taking and diabetes self-management behaviors; patients value simplicity and integration of technology solutions used for diabetes care, managing medications, and communicating with health care providers; some patients express reluctance to rely on mobile technology for these diabetes care behaviors; and patients believe they prefer positively framed communication, but communication preferences are highly individualized. Conclusions: The participants expressed some hesitation about using mobile technology in supporting diabetes self-management but have largely incorporated it or are open to incorporating it as a cue to make medication taking more automatic and less burdensome. When using technology to support diabetes self-management, participants exhibited individualized preferences, but overall, they preferred simple and positively framed communication. mHealth interventions may be improved by focusing on integrating them easily into daily routines and increasing the customization of content. %M 34114964 %R 10.2196/25958 %U https://www.jmir.org/2021/6/e25958 %U https://doi.org/10.2196/25958 %U http://www.ncbi.nlm.nih.gov/pubmed/34114964 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 6 %P e23294 %T Acceptability of the Medication Event Reminder Monitor for Promoting Adherence to Multidrug-Resistant Tuberculosis Therapy in Two Indian Cities: Qualitative Study of Patients and Health Care Providers %A Thomas,Beena E %A Kumar,J Vignesh %A Periyasamy,Murugesan %A Khandewale,Amit Subhash %A Hephzibah Mercy,J %A Raj,E Michael %A Kokila,S %A Walgude,Apurva Shashikant %A Gaurkhede,Gunjan Rahul %A Kumbhar,Jagannath Dattatraya %A Ovung,Senthanro %A Paul,Mariyamma %A Rajkumar,B Sathyan %A Subbaraman,Ramnath %+ Department of Public Health and Community Medicine, Tufts University School of Medicine, 136 Harrison Ave, MV237, Boston, MA, 02111, United States, 1 6176360985, ramnath.subbaraman@tufts.edu %K tuberculosis %K drug-resistant %K medication adherence %K mHealth %K digital adherence technologies %K India %D 2021 %7 10.6.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Patients with multidrug-resistant tuberculosis (MDR-TB) face challenges adhering to medications, given that treatment is prolonged and has a high rate of adverse effects. The Medication Event Reminder Monitor (MERM) is a digital pillbox that provides pill-taking reminders and facilitates the remote monitoring of medication adherence. Objective: This study aims to assess the MERM’s acceptability to patients and health care providers (HCPs) during pilot implementation in India’s public sector MDR-TB program. Methods: From October 2017 to September 2018, we conducted qualitative interviews with patients who were undergoing MDR-TB therapy and were being monitored with the MERM and HCPs in the government program in Chennai and Mumbai. Interview transcripts were independently coded by 2 researchers and analyzed to identify the emergent themes. We organized findings by using the Unified Theory of Acceptance and Use of Technology (UTAUT), which outlines 4 constructs that predict technology acceptance—performance expectancy, effort expectancy, social influence, and facilitating conditions. Results: We interviewed 65 patients with MDR-TB and 10 HCPs. In patient interviews, greater acceptance of the MERM was related to perceptions that the audible and visual reminders improved medication adherence and that remote monitoring reduced the frequency of clinic visits (performance expectancy), that the device’s organization and labeling of medications made it easier to take them correctly (effort expectancy), that the device facilitated positive family involvement in the patient’s care (social influences), and that remote monitoring made patients feel more cared for by the health system (facilitating conditions). Lower patient acceptance was related to problems with the durability of the MERM’s cardboard construction and difficulties with portability and storage because of its large size (effort expectancy), concerns regarding stigma and the disclosure of patients’ MDR-TB diagnoses (social influences), and the incorrect understanding of the MERM because of suboptimal counseling (facilitating conditions). In their interviews, HCPs reported that MERM implementation resulted in fewer in-person interactions with patients and thus allowed HCPs to dedicate more time to other tasks, which improved job satisfaction. Conclusions: Several features of the MERM support its acceptability among patients with MDR-TB and HCPs, and some barriers to patient use could be addressed by improving the design of the device. However, some barriers, such as disease-related stigma, are more difficult to modify and may limit use of the MERM among some patients with MDR-TB. Further research is needed to assess the accuracy of MERM for measuring adherence, its effectiveness for improving treatment outcomes, and patients’ sustained use of the device in larger scale implementation. %M 34110300 %R 10.2196/23294 %U https://www.jmir.org/2021/6/e23294 %U https://doi.org/10.2196/23294 %U http://www.ncbi.nlm.nih.gov/pubmed/34110300 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 6 %P e27496 %T Wireless Home Blood Pressure Monitoring System With Automatic Outcome-Based Feedback and Financial Incentives to Improve Blood Pressure in People With Hypertension: Protocol for a Randomized Controlled Trial %A Bilger,Marcel %A Koong,Agnes Ying Leng %A Phoon,Ian Kwong Yun %A Tan,Ngiap Chuan %A Bahadin,Juliana %A Bairavi,Joann %A Batcagan-Abueg,Ada Portia M %A Finkelstein,Eric A %+ Health Economics and Policy, Vienna University of Economics and Business, Welthandelsplatz 1, Building D4, Room: Third Floor / D4.3.280, Vienna, Austria, 1020, Austria, 43 1 31336 5861, marcel.bilger@wu.ac.at %K telemedicine %K home blood pressure monitoring %K behavior change %K hypertension %K financial incentive %K medication adherence %K remote titration %D 2021 %7 9.6.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: Hypertension is prevalent in Singapore and is a major risk factor for cardiovascular morbidity and mortality and increased health care costs. Strategies to lower blood pressure include lifestyle modifications and home blood pressure monitoring. Nonetheless, adherence to home blood pressure monitoring remains low. This protocol details an algorithm for remote management of primary care patients with hypertension. Objective: The objective of this study was to determine whether wireless home blood pressure monitoring with or without financial incentives is more effective at reducing systolic blood pressure than nonwireless home blood pressure monitoring (usual care). Methods: This study was designed as a randomized controlled open-label superiority study. A sample size of 224 was required to detect differences of 10 mmHg in average systolic blood pressure. Participants were to be randomized, in the ratio of 2:3:3, into 1 of 3 parallel study arms :(1) usual care, (2) wireless home blood pressure monitoring, and (3) wireless home blood pressure monitoring with financial incentives. The primary outcome was the mean change in systolic blood pressure at month 6. The secondary outcomes were the mean reduction in diastolic blood pressure, cost of financial incentives, time taken for the intervention, adherence to home blood pressure monitoring, effectiveness of the framing of financial incentives in decreasing nonadherence to blood pressure self-monitoring and the adherence to antihypertensive medication at month 6. Results: This study was approved by SingHealth Centralised Institutional Review Board and registered. Between January 24, 2018 and July 10, 2018, 42 participants (18.75% of the required sample size) were enrolled, and 33 participants completed the month 6 assessment by January 31, 2019. Conclusions: Due to unforeseen events, the study was stopped prematurely; therefore, no results are available. Depending on the blood pressure information received from the patients, the algorithm can trigger immediate blood pressure advice (eg, Accident and Emergency department visit advice for extremely high blood pressure), weekly feedback on blood pressure monitoring, medication titration, or skipping of routine follow-ups. The inclusion of financial incentives framed as health capital provides a novel idea on how to promote adherence to remote monitoring, and ultimately, improve chronic disease management. Trial Registration: ClinicalTrials.gov NCT 03368417; https://clinicaltrials.gov/ct2/show/NCT03368417 International Registered Report Identifier (IRRID): DERR1-10.2196/27496 %M 34106085 %R 10.2196/27496 %U https://www.researchprotocols.org/2021/6/e27496 %U https://doi.org/10.2196/27496 %U http://www.ncbi.nlm.nih.gov/pubmed/34106085 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 9 %N 6 %P e20330 %T mHealth Interventions for Treatment Adherence and Outcomes of Care for Cardiometabolic Disease Among Adults Living With HIV: Systematic Review %A Odukoya,Oluwakemi Ololade %A Ohazurike,Chidumga %A Akanbi,Maxwell %A O'Dwyer,Linda C %A Isikekpei,Brenda %A Kuteyi,Ewemade %A Ameh,Idaomeh O %A Osadiaye,Olanlesi %A Adebayo,Khadijat %A Usinoma,Adewunmi %A Adewole,Ajoke %A Odunukwe,Nkiruka %A Okuyemi,Kola %A Kengne,Andre Pascal %+ Department of Community Health and Primary Care, College of Medicine, University of Lagos, #16 Ishaga Road, Idi-Araba, Lagos, PMB 12003, Nigeria, 234 8023200770, drolukemiodukoya@yahoo.com %K mHealth %K HIV %K cardiometabolic disease %K text messaging %K mobile %K systematic review %K telephone calls %K wearable devices %K smartphones %K desktop %K web-based %K mobile apps %D 2021 %7 9.6.2021 %9 Review %J JMIR Mhealth Uhealth %G English %X Background: The success of antiretroviral therapy has led to an increase in life expectancy and an associated rise in the risk of cardiometabolic diseases (CMDs) among people living with HIV. Objective: Our aim was to conduct a systematic review to synthesize the existing literature on the patterns of use and effects of mobile health (mHealth) interventions for improving treatment adherence and outcomes of care for CMD among people living with HIV. Methods: A systematic search of multiple databases, including PubMed-MEDLINE, Embase, CINAHL, Scopus, Web of Science, African Journals online, ClinicalTrials.gov, and the World Health Organization Global Index Medicus of peer-reviewed articles, was conducted with no date or language restrictions. Unpublished reports on mHealth interventions for treatment adherence and outcomes of care for CMD among adults living with HIV were also included in this review. Studies were included if they had at least 1 component that used an mHealth intervention to address treatment adherence or 1 or more of the stated outcomes of care for CMD among people living with HIV. Results: Our search strategy yielded 1148 unique records. In total, 10 articles met the inclusion criteria and were included in this review. Of the 10 studies, only 4 had published results. The categories of mHealth interventions ranged from short messaging, telephone calls, and wearable devices to smartphone and desktop web-based mobile apps. Across the different categories of interventions, there were no clear patterns in terms of consistency in the use of a particular intervention, as most studies (9/10, 90%) assessed a combination of mHealth interventions. Short messaging and telephone calls were however the most common interventions. Half of the studies (5/10, 50%) reported on outcomes that were indirectly linked to CMD, and none of them provided reliable evidence for evaluating the effectiveness of mHealth interventions for treatment adherence and outcomes of care for CMD among people living with HIV. Conclusions: Due to the limited number of studies and the heterogeneity of interventions and outcome measures in the studies, no definitive conclusions could be drawn on the patterns of use and effects of mHealth interventions for treatment adherence and outcomes of care for CMD among people living with HIV. We therefore recommend that future trials should focus on standardized outcomes for CMD. We also suggest that future studies should consider having a longer follow-up period in order to determine the long-term effects of mHealth interventions on CMD outcomes for people living with HIV. Trial Registration: PROSPERO International Prospective Register of Systematic Reviews CRD42018086940; https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42018086940 %M 34106075 %R 10.2196/20330 %U https://mhealth.jmir.org/2021/6/e20330 %U https://doi.org/10.2196/20330 %U http://www.ncbi.nlm.nih.gov/pubmed/34106075 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 9 %N 6 %P e24952 %T An Intervention to Improve Medication Adherence in People With Heart Disease (Text4HeartII): Randomized Controlled Trial %A Maddison,Ralph %A Jiang,Yannan %A Stewart,Ralph %A Scott,Tony %A Kerr,Andrew %A Whittaker,Robyn %A Benatar,Jocelyn %A Rolleston,Anna %A Estabrooks,Paul %A Dale,Leila %+ Institute for Physical Activity and Nutrition, Deakin University, 221 Burwood Highway, Burwood, 3125, Australia, 61 3 924 46218, ralph.maddison@deakin.edu.au %K cardiovascular disease %K self-management %K text messaging %K risk factors %D 2021 %7 9.6.2021 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Mobile health technologies have the potential to improve the reach and delivery of interventions for promoting long-term secondary prevention of coronary heart disease. Objective: This study aims to determine the effectiveness of an SMS text messaging intervention (Text4HeartII) for improving adherence to medication and lifestyle changes over and above usual care in people with coronary heart disease at 24 and 52 weeks. Methods: A two-arm, parallel, randomized controlled trial was conducted in New Zealand. Participants with a recent acute coronary syndrome were randomized to receive usual cardiac services alone (control, n=153) or a 24-week SMS text message program for supporting self-management plus usual cardiac services (n=153). The primary outcome was adherence to medication at 24 weeks, defined as a medication possession ratio of 80% or more for aspirin, statin, and antihypertensive therapy. Secondary outcomes included medication possession ratio at 52 weeks, self-reported medication adherence, adherence to healthy lifestyle behaviors, and health-related quality of life at 24 and 52 weeks. Results: Participants were predominantly male (113/306, 80.3%) and European New Zealanders (210/306, 68.6%), with a mean age of 61 years (SD 11 years). Groups were comparable at baseline. National hospitalization and pharmacy dispensing records were available for all participants; 92% (282/306, 92.1%) of participants completed a 24-week questionnaire and 95.1% (291/306) of participants completed a 52-week questionnaire. Adherence with 3 medication classes were lower in the intervention group than in the control group (87/153, 56.8% vs 105/153, 68.6%, odds ratio 0.60, 95% CI 0.38-0.96; P=.03) and 52 weeks (104/153, 67.9% vs 83/153, 54.2%; odds ratio 0.56, 95% CI 0.35-0.89; P=.01). Self-reported medication adherence scores showed the same trend at 52 weeks (mean difference 0.3; 95% CI 0.01-0.59; P=.04). Moreover, self-reported adherence to health-related behaviors was similar between groups. Conclusions: Text4HeartII did not improve dispensed medication or adherence to a favorable lifestyle over and above usual care. This finding contrasts with previous studies and highlights that the benefits of text interventions may depend on the context in which they are used. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12616000422426; http://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=370398. International Registered Report Identifier (IRRID): RR2-10.1186/s13063-018-2468-z %M 34106081 %R 10.2196/24952 %U https://mhealth.jmir.org/2021/6/e24952 %U https://doi.org/10.2196/24952 %U http://www.ncbi.nlm.nih.gov/pubmed/34106081 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 9 %N 6 %P e19941 %T Motivating Adherence to Exercise Plans Through a Personalized Mobile Health App: Enhanced Action Design Research Approach %A Sun,Ruo-Ting %A Han,Wencui %A Chang,Hsin-Lu %A Shaw,Michael J %+ Department of Management Information Systems, National Chengchi University, 64, Sec 2, Chinan Rd,, Taipei, 116, Taiwan, 886 2 29393091 ext 81214, hlchang@nccu.edu.tw %K adherence %K mobile health %K motivation %K personality %K MBTI %K action design research %K mobile phone %D 2021 %7 2.6.2021 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Physical inactivity is a global issue that affects people’s health and productivity. With the advancement of mobile technologies, many apps have been developed to facilitate health self-management. However, few studies have examined the effectiveness of these mobile health (mHealth) apps in motivating exercise adherence. Objective: This study aims to demonstrate the enhanced action design research (ADR) process and improve the design of mHealth apps for exercise self-management. Specifically, we investigate whether sending motivational messages improves adherence to exercise plans, whether the motivational effect is affected by personality, the impact of message type and repetition, and the process of involving a field experiment in the design process and learning new design principles from the results. Methods: This formative research was conducted by proposing an enhanced ADR process. We incorporated a field experiment into the process to iteratively refine and evaluate the design until it converges into a final mHealth app. We used the Apple ResearchKit to develop the mHealth app and promoted it via trainers at their gyms. We targeted users who used the app for at least two months. Participants were randomly assigned to 1 of the 12 groups in a 2×3×2 factorial design and remained blinded to the assigned intervention. The groups were defined based on personality type (thinking or feeling), message type (emotional, logical, or none), and repetition (none or once). Participants with different personality types received tailored and repeated messages. Finally, we used the self-reported completion rate to measure participants’ adherence level to exercise plans. By analyzing users’ usage patterns, we could verify, correct, and enhance the mHealth app design principles. Results: In total, 160 users downloaded the app, and 89 active participants remained during the 2-month period. The results suggest a significant main effect of personality type and repetition and a significant interaction effect between personality type and repetition. The adherence rate of people with feeling personality types was 18.15% higher than that of people with thinking types. Emotional messages were more effective than logical messages in motivating exercise adherence. Although people received repeated messages, they were more likely to adhere to exercise plans. With repeated reminders, the adherence rates of people with thinking personality types were significantly improved by 27.34% (P<.001). Conclusions: This study contributes to the literature on mHealth apps. By incorporating a field experiment into the ADR process, we demonstrate the benefit of combining design science and field experiments. This study also contributes to the research on mHealth apps. The principles learned from this study can be applied to improve the effectiveness of mHealth apps. The app design can be considered a foundation for the development of more advanced apps for specific diseases, such as diabetes and asthma, in future research. %M 34076580 %R 10.2196/19941 %U https://mhealth.jmir.org/2021/6/e19941 %U https://doi.org/10.2196/19941 %U http://www.ncbi.nlm.nih.gov/pubmed/34076580 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 5 %N 6 %P e17858 %T Adequate Management of Phosphorus in Patients Undergoing Hemodialysis Using a Dietary Smartphone App: Prospective Pilot Study %A Fakih El Khoury,Cosette %A Crutzen,Rik %A Schols,Jos MGA %A Halfens,Ruud JG %A Karavetian,Mirey %+ Department of Health Sciences, Zayed University, Academic city PO Box 19282, Dubai, United Arab Emirates, 971 562446865, kmirey@gmail.com %K renal diet %K mhealth %K dietary app %D 2021 %7 1.6.2021 %9 Original Paper %J JMIR Form Res %G English %X Background: The renal diet is complex and requires alterations of the diet and careful monitoring of various nutrients. Elevated serum phosphorus is common among patients undergoing hemodialysis, and it is associated with many complications. Smartphone technology could be used to support both dietitians and patients by providing a source of accessible and reliable information. Objective: The aim of this pilot is to assess the potential efficacy of an intervention using the educational and self-monitoring mobile app KELA.AE on the phosphorous management in hemodialysis patients. Results will be used to improve both the app and a planned, rigorous large-scale trial intended to assess app efficacy. Methods: This is a prospective pilot study performed at the hemodialysis unit of Al Qassimi Hospital (Emirate of Sharjah, United Arab Emirates). All patients were assessed for eligibility and, based on inclusion criteria, considered for enrollment. Participants met with a dietitian once a week and used the mobile app regularly for 2 weeks. Outcomes (knowledge, self-reported nonadherence, dietary intake, anthropometry, and biochemical data) were measured. This pilot is reported as per guidelines for nonrandomized pilot and feasibility studies and in line with the CONSORT (Consolidated Standards of Reporting Trials) 2010 checklist for reporting pilot or feasibility trials. Results: Of 26 subjects, 23 successfully completed the pilot. Patient dietary knowledge about phosphorous management improved from 51.4% (SD 13.9) to 68.1% (SD 13.3) after intervention with a large effect size (d=1.22, 95% CI 0.59 to 1.85). Dietary protein intake increased from a mean of 0.9 g/kg (SD 0.3) per day to a mean of 1.3 g/kg (SD 0.5) per day with a large effect size (d=1.07, 95% CI 0.45 to 1.69). Phosphorus to protein ratio dropped from a mean of 18.4 mg/g protein to 13.5 mg/g protein with a large effect size (d=0.83, 95% CI 0.22 to 1.43). There was no evidence of change in phosphorous intake, self-reported nonadherence, and serum phosphorus. Conclusions: The findings of this prospective pilot reveal the potential efficacy of a smartphone app as a supportive nutrition education tool for phosphorus management in patients undergoing hemodialysis. This pilot study showed that the KELA.AE app has the potential to improve knowledge and dietary choices. A rigorous randomized controlled trial should be performed to evaluate the efficacy, assessing app use of a long-term intervention. %M 34061034 %R 10.2196/17858 %U https://formative.jmir.org/2021/6/e17858 %U https://doi.org/10.2196/17858 %U http://www.ncbi.nlm.nih.gov/pubmed/34061034 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 5 %N 5 %P e22513 %T Patient-Provider Text Messaging and Video Calling Among Case-Managed Patients Living With HIV: Formative Acceptability and Feasibility Study %A Fonner,Virginia A %A Kennedy,Samuel %A Desai,Rohan %A Eichberg,Christie %A Martin,Lisa %A Meissner,Eric G %+ Division of Global and Community Health, Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, 176 Croghan Spur, Suite 104, Charleston, SC, 29407, United States, 1 8438761463, fonner@musc.edu %K HIV %K mHealth %K text messaging %K video calling %K implementation science %K mobile phone %D 2021 %7 27.5.2021 %9 Original Paper %J JMIR Form Res %G English %X Background: Patient-provider communication is critical for engaging and retaining people living with HIV in care, especially among medically case-managed patients in need of service coordination and adherence support. Expanding patient-provider communication channels to include mobile health modalities, such as text messaging and video calling, has the potential to facilitate communication and ultimately improve clinical outcomes. However, the implementation of these communication modalities in clinical settings has not been well characterized. Objective: The purpose of this study is to understand patient and provider perspectives on the acceptability of and preferences for using text messaging and video calling as a means of communication; perceived factors relevant to adoption, appropriateness, and feasibility; and organizational perspectives on implementation within an HIV clinic in South Carolina. Methods: We conducted 26 semistructured in-depth interviews among patients receiving case management services (n=12) and clinic providers (n=14) using interview guides and content analysis informed by the Proctor taxonomy of implementation outcomes and the Consolidated Framework for Implementation Research. Participants were purposefully sampled to obtain maximum variation in terms of age and gender for patients and clinic roles for providers. The data were analyzed using quantitative and qualitative content analyses. Results: Most patients (11/12, 92%) and providers (12/14, 86%) agreed that they should have the capacity to text message and/or video call each other. Although consensus was not reached, most preferred using a secure messaging app rather than standard text messaging because of the enhanced security features. Perceived benefits to adoption included the added convenience of text messaging, and potential barriers included the cost and access of smartphone-based technology for patients. From an organizational perspective, some providers were concerned that offering text messaging could lead to unreasonable expectations of instant access and increased workload. Conclusions: Patients and providers perceived text messaging and video calling as acceptable, appropriate, and feasible and felt that these expanded modes of communication could help meet patients’ needs while being safe and not excessively burdensome. Although patients and providers mostly agreed on implementation barriers and facilitators, several differences emerged. Taking both perspectives into account when using implementation frameworks is critical for expanding mobile health–based communication, especially as implementation requires active participation from providers and patients. %M 34042596 %R 10.2196/22513 %U https://formative.jmir.org/2021/5/e22513 %U https://doi.org/10.2196/22513 %U http://www.ncbi.nlm.nih.gov/pubmed/34042596 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 9 %N 5 %P e26442 %T Feasibility and Acceptability of an Asthma App to Monitor Medication Adherence: Mixed Methods Study %A Jácome,Cristina %A Almeida,Rute %A Pereira,Ana Margarida %A Amaral,Rita %A Mendes,Sandra %A Alves-Correia,Magna %A Vidal,Carmen %A López Freire,Sara %A Méndez Brea,Paula %A Araújo,Luís %A Couto,Mariana %A Antolín-Amérigo,Darío %A de la Hoz Caballer,Belén %A Barra Castro,Alicia %A Gonzalez-De-Olano,David %A Todo Bom,Ana %A Azevedo,João %A Leiria Pinto,Paula %A Pinto,Nicole %A Castro Neves,Ana %A Palhinha,Ana %A Todo Bom,Filipa %A Costa,Alberto %A Chaves Loureiro,Cláudia %A Maia Santos,Lilia %A Arrobas,Ana %A Valério,Margarida %A Cardoso,João %A Emiliano,Madalena %A Gerardo,Rita %A Cidrais Rodrigues,José Carlos %A Oliveira,Georgeta %A Carvalho,Joana %A Mendes,Ana %A Lozoya,Carlos %A Santos,Natacha %A Menezes,Fernando %A Gomes,Ricardo %A Câmara,Rita %A Rodrigues Alves,Rodrigo %A Moreira,Ana Sofia %A Bordalo,Diana %A Alves,Carlos %A Ferreira,José Alberto %A Lopes,Cristina %A Silva,Diana %A Vasconcelos,Maria João %A Teixeira,Maria Fernanda %A Ferreira-Magalhães,Manuel %A Taborda-Barata,Luís %A Cálix,Maria José %A Alves,Adelaide %A Almeida Fonseca,João %+ Center for Health Technology and Services Research, Faculty of Medicine, University of Porto, Rua Dr Plácido da Costa, Porto, 4200-450, Portugal, 351 225 513 622, cristinajacome.ft@gmail.com %K mHealth %K smartphone %K technology assessment %K medication adherence %K self-management %K gamification %K patient participation %D 2021 %7 25.5.2021 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Poor medication adherence is a major challenge in asthma, and objective assessment of inhaler adherence is needed. The InspirerMundi app aims to monitor adherence while providing a positive experience through gamification and social support. Objective: This study aimed to evaluate the feasibility and acceptability of the InspirerMundi app to monitor medication adherence in adolescents and adults with persistent asthma (treated with daily inhaled medication). Methods: A 1-month mixed method multicenter observational study was conducted in 26 secondary care centers from Portugal and Spain. During an initial face-to-face visit, physicians reported patients’ asthma therapeutic plan in a structured questionnaire. During the visits, patients were invited to use the app daily to register their asthma medication intakes. A scheduled intake was considered taken when patients registered the intake (inhaler, blister, or other drug formulation) by using the image-based medication detection tool. At 1 month, patients were interviewed by phone, and app satisfaction was assessed on a 1 (low) to 5 (high) scale. Patients were also asked to point out the most and least preferred app features and make suggestions for future app improvements. Results: A total of 107 patients (median 27 [P25-P75 14-40] years) were invited, 92.5% (99/107) installed the app, and 73.8% (79/107) completed the 1-month interview. Patients interacted with the app a median of 9 (P25-P75 1-24) days. At least one medication was registered in the app by 78% (77/99) of patients. A total of 53% (52/99) of participants registered all prescribed inhalers, and 34% (34/99) registered the complete asthma therapeutic plan. Median medication adherence was 75% (P25-P75 25%-90%) for inhalers and 82% (P25-P75 50%-94%) for other drug formulations. Patients were globally satisfied with the app, with 75% (59/79) scoring ≥4,; adherence monitoring, symptom monitoring, and gamification features being the most highly scored components; and the medication detection tool among the lowest scored. A total of 53% (42/79) of the patients stated that the app had motivated them to improve adherence to inhaled medication and 77% (61/79) would recommend the app to other patients. Patient feedback was reflected in 4 major themes: medication-related features (67/79, 85%), gamification and social network (33/79, 42%), symptom monitoring and physician communication (21/79, 27%), and other aspects (16/79, 20%). Conclusions: The InspirerMundi app was feasible and acceptable to monitor medication adherence in patients with asthma. Based on patient feedback and to increase the registering of medications, the therapeutic plan registration and medication detection tool were redesigned. Our results highlight the importance of patient participation to produce a patient-centered and engaging mHealth asthma app. %M 34032576 %R 10.2196/26442 %U https://mhealth.jmir.org/2021/5/e26442 %U https://doi.org/10.2196/26442 %U http://www.ncbi.nlm.nih.gov/pubmed/34032576 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 5 %P e24190 %T Mobile Apps to Improve Medication Adherence in Cardiovascular Disease: Systematic Review and Meta-analysis %A Al-Arkee,Shahd %A Mason,Julie %A Lane,Deirdre A %A Fabritz,Larissa %A Chua,Winnie %A Haque,M Sayeed %A Jalal,Zahraa %+ Institute of Clinical Sciences, University of Birmingham, Edgbaston, Birmingham, B15 2TT, United Kingdom, 44 0121 414 4042, s.k.k.al-arkee@pgr.bham.ac.uk %K mobile health care applications %K medication adherence %K cardiovascular disease %K systematic review %K mobile phone %D 2021 %7 25.5.2021 %9 Review %J J Med Internet Res %G English %X Background: Adherence rates of preventative medication for cardiovascular disease (CVD) have been reported as 57%, and approximately 9% of all CVD events in Europe are attributable to poor medication adherence. Mobile health technologies, particularly mobile apps, have the potential to improve medication adherence and clinical outcomes. Objective: The objective of this study is to assess the effects of mobile health care apps on medication adherence and health-related outcomes in patients with CVD. This study also evaluates apps’ functionality and usability and the involvement of health care professionals in their use. Methods: Electronic databases (MEDLINE [Ovid], PubMed Central, Cochrane Library, CINAHL Plus, PsycINFO [Ovid], Embase [Ovid], and Google Scholar) were searched for randomized controlled trials (RCTs) to investigate app-based interventions aimed at improving medication adherence in patients with CVD. RCTs published in English from inception to January 2020 were reviewed. The Cochrane risk of bias tool was used to assess the included studies. Meta-analysis was performed for clinical outcomes and medication adherence, with meta-regression analysis used to evaluate the impact of app intervention duration on medication adherence. Results: This study included 16 RCTs published within the last 6 years. In total, 12 RCTs reported medication adherence as the primary outcome, which is the most commonly self-reported adherence. The duration of the interventions ranged from 1 to 12 months, and sample sizes ranged from 24 to 412. Medication adherence rates showed statistically significant improvements in 9 RCTs when compared with the control, and meta-analysis of the 6 RCTs reporting continuous data showed a significant overall effect in favor of the app intervention (mean difference 0.90, 95% CI 0.03-1.78) with a high statistical heterogeneity (I2=93.32%). Moreover, 9 RCTs assessed clinical outcomes and reported an improvement in systolic blood pressure, diastolic blood pressure, total cholesterol, and low-density lipoprotein cholesterol levels in the intervention arm. Meta-analysis of these clinical outcomes from 6 RCTs favored app interventions, but none were significant. In the 7 trials evaluating app usability, all were found to be acceptable. There was a great variation in the app characteristics. A total of 10 RCTs involved health care professionals, mainly physicians and nurses, in the app-based interventions. The apps had mixed functionality: 2 used education, 7 delivered reminders, and 7 provided reminders in combination with educational support. Conclusions: Apps tended to increase medication adherence, but interventions varied widely in design, content, and delivery. Apps have an acceptable degree of usability; yet the app characteristics conferring usability and effectiveness are ill-defined. Future large-scale studies should focus on identifying the essential active components of successful apps. Trial Registration: PROSPERO International Prospective Register of Systematic Reviews CRD42019121385; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=121385 %M 34032583 %R 10.2196/24190 %U https://www.jmir.org/2021/5/e24190 %U https://doi.org/10.2196/24190 %U http://www.ncbi.nlm.nih.gov/pubmed/34032583 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 5 %P e18984 %T Text Messaging and Home Blood Pressure Monitoring for Patients with Uncontrolled Hypertension: Proposal for a Feasibility Pilot Randomized Controlled Trial %A Campos,Claudia L %A Jones,Deanna %A Snively,Beverly M %A Rocco,Michael %A Pedley,Carolyn %A Atwater,Sara %A Moore,Justin B %+ Department of Internal Medicine, Wake Forest School of Medicine, Medical Center Boulevard, Winston-Salem, NC, 27157, United States, 1 336713600, ccampos@wakehealth.edu %K hypertension %K home blood pressure monitoring %K telehealth %K medication adherence %K SMS %K health disparities %D 2021 %7 14.5.2021 %9 Proposal %J JMIR Res Protoc %G English %X Background: A decrease in blood pressure, even modestly (ie, 2 mmHg), lowers cardiovascular morbidity and mortality. Low patient adherence to antihypertensive medication is the most significant modifiable patient-related barrier to achieving controlled blood pressure. Preliminary studies have shown that SMS text messaging and home blood pressure monitoring (HBPM) can be effective in promoting medication adherence and blood pressure control. The best strategy to engage with older patients of low socioeconomic status who are low adopters of technology and disproportionally affected by uncontrolled hypertension is still unknown. Objective: The objective of this study is to improve blood pressure control in the older, low socioeconomic status population. The study will test two aims: First, we aim to evaluate the feasibility of conducting a randomized controlled trial by using an SMS-based approach among nonadherent, older patients of low socioeconomic status who have uncontrolled hypertension. Feasibility will be assessed in terms of recruitment rates per month (primary outcome); patient acceptability will be evaluated by monitoring retention rates and SMS response rates and using the validated Systems Usability Scale (secondary outcomes). Second, we aim to estimate the effects of the SMS approach on lowering blood pressure and adherence to antihypertensive medications. Methods: We will recruit 24 patients of low socioeconomic status with uncontrolled hypertension (systolic BP>140 mmHg or diastolic BP>90 mmHg) showing low medication adherence and taking at least two antihypertensives, who have presented to two outpatient clinics of Wake Forest Baptist Health (Winston Salem, North Carolina, USA). Participants will be randomly assigned to either SMS and HBPM (n=12) or usual care and HBPM (n=12) intervention. Clinicians adjusting the patients’ medications will be blinded to the study assignment. Text messages will be sent from a secure platform to assess medication adherence and HBPM on a weekly basis. The content and delivery frequency of the proposed SMS intervention are based on input from three focus groups conducted in Spring 2019. Participants in both study arms will receive education on HBPM and using an HBPM device. We hypothesize that we will successfully recruit 24 participants and the intervention will be acceptable to the participants. It will also improve medication adherence (assessed by question Medication Adherence Questionnaire scores) and blood pressure control. Results: Our study was funded in July 2020. As of May 2021, we have enrolled 6 participants. Conclusions: Our findings will help design a larger efficacy trial to advance the field of eHealth delivery systems particularly for older adults of low socioeconomic status. This study addresses a highly significant topic and targets a population of high morbidity and mortality that has been traditionally underrepresented in clinical trials. Trial Registration: ClinicalTrials.gov NCT03596242; https://clinicaltrials.gov/ct2/show/NCT03596242 International Registered Report Identifier (IRRID): PRR1-10.2196/18984 %M 33988513 %R 10.2196/18984 %U https://www.researchprotocols.org/2021/5/e18984 %U https://doi.org/10.2196/18984 %U http://www.ncbi.nlm.nih.gov/pubmed/33988513 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 5 %P e24494 %T Improving Medication Adherence Through Adaptive Digital Interventions (iMedA) in Patients With Hypertension: Protocol for an Interrupted Time Series Study %A Etminani,Kobra %A Göransson,Carina %A Galozy,Alexander %A Norell Pejner,Margaretha %A Nowaczyk,Sławomir %+ Center for Applied Intelligent Systems Research, Halmstad University, Kristian IV:s väg 3, Halmstad, 30118, Sweden, 46 35167332, kobra.etminani@hh.se %K medication adherence %K hypertension %K digital intervention %K mHealth %K artificial intelligence %D 2021 %7 12.5.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: There is a strong need to improve medication adherence (MA) for individuals with hypertension in order to reduce long-term hospitalization costs. We believe this can be achieved through an artificial intelligence agent that helps the patient in understanding key individual adherence risk factors and designing an appropriate intervention plan. The incidence of hypertension in Sweden is estimated at approximately 27%. Although blood pressure control has increased in Sweden, barely half of the treated patients achieved adequate blood pressure levels. It is a major risk factor for coronary heart disease and stroke as well as heart failure. MA is a key factor for good clinical outcomes in persons with hypertension. Objective: The overall aim of this study is to design, develop, test, and evaluate an adaptive digital intervention called iMedA, delivered via a mobile app to improve MA, self-care management, and blood pressure control for persons with hypertension. Methods: The study design is an interrupted time series. We will collect data on a daily basis, 14 days before, during 6 months of delivering digital interventions through the mobile app, and 14 days after. The effect will be analyzed using segmented regression analysis. The participants will be recruited in Region Halland, Sweden. The design of the digital interventions follows the just-in-time adaptive intervention framework. The primary (distal) outcome is MA, and the secondary outcome is blood pressure. The design of the digital intervention is developed based on a needs assessment process including a systematic review, focus group interviews, and a pilot study, before conducting the longitudinal interrupted time series study. Results: The focus groups of persons with hypertension have been conducted to perform the needs assessment in a Swedish context. The design and development of digital interventions are in progress, and the interventions are planned to be ready in November 2020. Then, the 2-week pilot study for usability evaluation will start, and the interrupted time series study, which we plan to start in February 2021, will follow it. Conclusions: We hypothesize that iMedA will improve medication adherence and self-care management. This study could illustrate how self-care management tools can be an additional (digital) treatment support to a clinical one without increasing burden on health care staff. Trial Registration: ClinicalTrials.gov NCT04413500; https://clinicaltrials.gov/ct2/show/NCT04413500 International Registered Report Identifier (IRRID): DERR1-10.2196/24494 %M 33978593 %R 10.2196/24494 %U https://www.researchprotocols.org/2021/5/e24494 %U https://doi.org/10.2196/24494 %U http://www.ncbi.nlm.nih.gov/pubmed/33978593 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 5 %N 5 %P e25503 %T Feasibility of a Voice-Enabled Medical Diary App (SpeakHealth) for Caregivers of Children With Special Health Care Needs and Health Care Providers: Mixed Methods Study %A Sezgin,Emre %A Noritz,Garey %A Lin,Simon %A Huang,Yungui %+ The Abigail Wexner Research Institute, Nationwide Children's Hospital, 700 Children's Drive, Columbus, OH, 43205, United States, 1 6143556814, esezgin1@gmail.com %K children with special health care needs %K care management %K care coordination %K voice-enabled mobile app %K health information technology %K voice assistant %K voice interaction %K mobile phone %D 2021 %7 11.5.2021 %9 Original Paper %J JMIR Form Res %G English %X Background: Children with special health care needs (CSHCN) require more than the usual care management and coordination efforts from caregivers and health care providers (HCPs). Health information and communication technologies can potentially facilitate these efforts to increase the quality of care received by CSHCN. Objective: In this study, we aim to assess the feasibility of a voice-enabled medical diary app (SpeakHealth) by investigating its potential use among caregivers and HCPs. Methods: Following a mixed methods approach, caregivers of CSHCN were interviewed (n=10) and surveyed (n=86) about their care management and communication technology use. Only interviewed participants were introduced to the SpeakHealth app prototype, and they tested the app during the interview session. In addition, we interviewed complex care HCPs (n=15) to understand their perception of the value of a home medical diary such as the SpeakHealth app. Quantitative data were analyzed using descriptive statistics and correlational analyses. Theoretical thematic analysis was used to analyze qualitative data. Results: The survey results indicated a positive attitude toward voice-enabled technology and features; however, there was no strong correlation among the measured items. The caregivers identified communication, information sharing, tracking medication, and appointments as fairly and highly important features of the app. Qualitative analysis revealed the following two overarching themes: enablers and barriers in care communication and enablers and barriers in communication technologies. The subthemes included parent roles, care communication technologies, and challenges. HCPs found the SpeakHealth app to be a promising tool for timely information collection that could be available for sharing information with the health system. Overall, the findings demonstrated a variety of needs and challenges for caregivers of CSHCN and opportunities for voice-enabled, interactive medical diary apps in care management and coordination. Caregivers fundamentally look for better information sharing and communication with HCPs. Health care and communication technologies can potentially improve care communication and coordination in addressing the patient and caregiver needs. Conclusions: The perspectives of caregivers and providers suggested both benefits and challenges in using the SpeakHealth app for medical note-taking and tracking health events at home. Our findings could inform researchers and developers about the potential development and use of a voice-enabled medical diary app. %M 33865233 %R 10.2196/25503 %U https://formative.jmir.org/2021/5/e25503 %U https://doi.org/10.2196/25503 %U http://www.ncbi.nlm.nih.gov/pubmed/33865233 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 9 %N 5 %P e26289 %T Postmarketing Safety Monitoring After Influenza Vaccination Using a Mobile Health App: Prospective Longitudinal Feasibility Study %A Nguyen,Minh Tam H %A Krause,Gérard %A Keller-Stanislawski,Brigitte %A Glöckner,Stephan %A Mentzer,Dirk %A Ott,Jördis J %+ PhD Programme Epidemiology, Hannover Biomedical Research School, Hannover Medical School, Hannover, Germany, 49 531 6181 3115, joerdis.ott@helmholtz-hzi.de %K mHealth %K mobile health %K digital health %K adverse event %K adverse event following immunization %K active reporting %K pharmacovigilance %K therapeutic use %K adverse effect %D 2021 %7 7.5.2021 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: For the safety monitoring of vaccinations postlicensure, reports of adverse events after immunization (AEFIs) are crucial. New technologies such as digital mobile apps can be used as an active approach to capture these events. We therefore conducted a feasibility study among recipients of the influenza vaccination using an app for assessment of the reporting of AEFIs. Objective: The goal of the research was to determine factors influencing adherence to and correct use of a newly developed app for individuals to report AEFI for 3 months using regular reminder functions, to identify determinants of AEFI occurrence and define reported AEFI types. Methods: We developed the app (SafeVac) and offered it to recipients of the influenza vaccination in 3 occupational settings in fall 2018. In this prospective longitudinal feasibility study, data on AEFIs were generated through SafeVac for 3 months. Using logistic and Cox regression, we assessed associations between app adherence, correct app entry, AEFIs, and sociodemographic parameters. Results: Of the individuals who logged into SafeVac, 61.4% (207/337) used the app throughout a 3-month period. App use adherence was negatively associated with female sex (odds ratio [OR] 0.47; CI 0.25-0.91) and correct app entry was negatively associated with older age (OR 0.96; CI 0.93-0.99) and lower education (OR 0.31; CI 0.13-0.76). AEFI occurrence was associated with female sex (hazard ratio 1.41; CI 1.01-1.96) and negatively with older age (hazard ratio 0.98; CI 0.97-0.99). The most common AEFIs reported were injection site pain (106/337), pain in extremity (103/337), and fatigue/asthenia (73/337). Conclusions: Digital AEFI reporting was feasible with SafeVac and generated plausible results for this observation period and setting. Studies directly comparing SafeVac with conventional passive reporting schemes could determine whether such digital approaches improve completeness, timeliness, and sensitivity of vaccine vigilance. Further studies should evaluate if these results are transferable to other vaccinations and populations and if introduction of such a tool has an influence on vaccination readiness and therefore vaccine safety. %M 33960950 %R 10.2196/26289 %U https://mhealth.jmir.org/2021/5/e26289 %U https://doi.org/10.2196/26289 %U http://www.ncbi.nlm.nih.gov/pubmed/33960950 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 9 %N 4 %P e19163 %T An Implementation Strategy to Expand Mobile Health Use in HIV Care Settings: Rapid Evaluation Study Using the Consolidated Framework for Implementation Research %A Cohn,Wendy F %A Canan,Chelsea E %A Knight,Sarah %A Waldman,Ava Lena %A Dillingham,Rebecca %A Ingersoll,Karen %A Schexnayder,Julie %A Flickinger,Tabor E %+ Department of Public Health Sciences, University of Virginia Cancer Center, University of Virginia, 560 Ray C Hunt Dr, PO Box 800765, Charlottesville, VA, 22908, United States, 1 434 964 7811, wfc2r@virginia.edu %K mHealth %K smartphone %K mobile health %K implementation strategy %K implementation science %K Consolidated Framework for Implementation Research %K HIV care engagement %K viral suppression %D 2021 %7 28.4.2021 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Mobile health (mHealth) apps can provide support to people living with a chronic disease by offering resources for communication, self-management, and social support. PositiveLinks (PL) is a clinic-deployed mHealth app designed to improve the health of people with HIV. In a pilot study, PL users experienced considerable improvements in care engagement and viral load suppression. To promote its expansion to other HIV clinics, we developed an implementation strategy consisting of training resources and on-demand program support. Objective: The objective of our study was to conduct an interim analysis of the barriers and facilitators to PL implementation at early adopting sites to guide optimization of our implementation strategy. Methods: Semistructured interviews with stakeholders at PL expansion sites were conducted. Analysis of interviews identified facilitators and barriers that were mapped to 22 constructs of the Consolidated Framework for Implementation Research (CFIR). The purpose of the analysis was to identify the facilitators and barriers to PL implementation in order to adapt the PL implementation strategy. Four Ryan White HIV clinics were included. Interviews were conducted with one health care provider, two clinic managers, and five individuals who coordinated site PL activities. Results: Ten common facilitators and eight common barriers were identified. Facilitators to PL implementation included PL’s fit with patient and clinic needs, PL training resources, and sites’ early engagement with their information technology personnel. Most barriers were specific to mHealth, including access to Wi-Fi networks, maintaining patient smartphone access, patient privacy concerns, and lack of clarity on how to obtain approvals for mHealth use. Conclusions: The CFIR is a useful framework for evaluating mHealth interventions. Although PL training resources were viewed favorably, we identified important barriers to PL implementation in a sample of Ryan White clinics. This enabled our team to expand guidance on identifying information technology stakeholders and procuring and managing mobile resources. Ongoing evaluation results continue to inform improvements to the PL implementation strategy, facilitating PL access for future expansion sites. %M 33908893 %R 10.2196/19163 %U https://mhealth.jmir.org/2021/4/e19163 %U https://doi.org/10.2196/19163 %U http://www.ncbi.nlm.nih.gov/pubmed/33908893 %0 Journal Article %@ 2561-6722 %I JMIR Publications %V 4 %N 2 %P e25811 %T Parent Experiences With Electronic Medication Monitoring in Pediatric Asthma Management: Qualitative Study %A Kan,Kristin %A Shaunfield,Sara %A Kanaley,Madeleine %A Chadha,Avneet %A Boon,Kathy %A Foster,Carolyn C %A Morales,Luis %A Labellarte,Patricia %A Vojta,Deneen %A Gupta,Ruchi S %+ Ann & Robert H. Lurie Children’s Hospital of Chicago, 225 E Chicago Ave, Chicago, IL, 60611, United States, 1 3122276785, kkan@luriechildrens.org %K pediatric asthma %K digital health %K outpatient care %K asthma management %K pediatric %K asthma %K parents %K caregivers %K Bluetooth sensors %K inhaler %D 2021 %7 23.4.2021 %9 Original Paper %J JMIR Pediatr Parent %G English %X Background: Electronic medication monitoring (EMM) is a digital tool that can be used for tracking daily medication use. Previous studies of EMM in asthma management have been conducted in adults or have examined pediatric interventions that use EMM for less than 1 year. To understand how to improve EMM-enhanced interventions, it is necessary to explore the experiences of parents of children with asthma, recruited from outpatient practices, who completed a 12-month intervention trial. Objective: The objective of our study was to use qualitative inquiry to answer the following questions: (1) how did using an EMM-enhanced intervention change parents'/caregivers’ experiences of managing their child’s asthma, and (2) what do parents recommend for improving the intervention in the future? Methods: Parents were recruited from the intervention arm of a multicomponent health intervention enhanced by Bluetooth-enabled sensors placed on inhaler medications. Semistructured interviews were conducted with 20 parents of children aged 4-12 years with asthma. Interviews were audio-recorded, transcribed, and inductively analyzed using a constant comparative approach. Results: Interview participants reflected an even mix of publicly and privately insured children and a diverse racial-ethnic demographic. Parents discussed 6 key themes related to their experience with the EMM-enhanced intervention for the management of their child's asthma: (1) compatibility with the family's lifestyle, (2) impact on asthma management, (3) impact on the child’s health, (4) emotional impact of the intervention, (5) child’s engagement in asthma management with the intervention, and (6) recommendations for future intervention design. Overall, parents reported that the 12-month EMM intervention was compatible with their daily lives, positively influenced their preventive and acute asthma management, and promoted their child's engagement in their own asthma management. While parents found the intervention acceptable and generally favorable, some parents identified compatibility issues for families with multiple caregivers and frustration when the technology malfunctioned. Conclusions: Parents generally viewed the intervention as a positive influence on the management of their child's asthma. However, our study also highlighted technology challenges related to having multiple caregivers, which will need to be addressed in future iterations for families. Attention must be paid to the needs of parents from low socioeconomic households, who may have more limited access to reliable internet or depend on other relatives for childcare. Understanding these family factors will help refine how a digital tool can be adopted into daily disease management of pediatric asthma. %M 33890861 %R 10.2196/25811 %U https://pediatrics.jmir.org/2021/2/e25811 %U https://doi.org/10.2196/25811 %U http://www.ncbi.nlm.nih.gov/pubmed/33890861 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 5 %N 4 %P e26213 %T A Brief Training Program to Support the Use of a Digital Pill System for Medication Adherence: Pilot Descriptive Study %A Chai,Peter R %A Bustamante,Maria J %A Goodman,Georgia %A Mohamed,Yassir %A Najarro,Jesse %A Sullivan,Matthew C %A Castillo-Mancilla,Jose %A Coyle,Ryan P %A Mayer,Kenneth H %A Rosen,Rochelle K %A Baumgartner,Susan L %A Alpert,Pamela E %A Boyer,Edward W %A O'Cleirigh,Conall %+ Department of Emergency Medicine, Brigham and Women's Hospital, 75 Francis Street, Boston, MA, 02411, United States, 1 617 732 5640, pchai@bwh.harvard.edu %K digital pill system %K technology training %K HIV prevention %K PrEP %K ingestible sensors %K mobile phone %D 2021 %7 23.4.2021 %9 Original Paper %J JMIR Form Res %G English %X Background: Digital pill systems (DPSs), which comprise ingestible radiofrequency sensors integrated into a gelatin capsule that overencapsulates a medication, can directly measure ingestion events. Objective: Teaching users to operate a DPS is vital to ensure the collection of actionable ingestion and adherence data. In this study, we aim to develop and pilot a training program, grounded in the Technology Acceptance Model, to instruct individuals on DPS operation. Methods: A two-part training program, comprising in-person and text message–based components, was used with HIV-negative men who have sex with men with nonalcohol substance use, who had enrolled in a 90-day pilot demonstration study using the DPS to measure adherence to pre-exposure prophylaxis. We assessed the number of responses to text check-ins, the number and types of episodes where technical support was requested, the resolutions of such issues, and engagement with the program over the study period. Participant feedback on the program was evaluated through qualitative user experience interviews. Results: A total of 15 participants were enrolled in and completed the program. Seven technical challenges related to DPS operations were reported across 5 participants. Most commonly, participants requested support connecting the wearable Reader device with their smartphone, charging the Reader, and operating the mobile app. A total of 6 issues were resolved asynchronously or in real time via phone; 1 required in-person evaluation and resolution. Preliminary qualitative findings indicate that both the in-person and remote follow-up components of the training program were perceived as acceptable. Suggested improvements included repeated DPS refresher sessions at in-person follow-up visits and enhanced written materials for the independent resolution of technological issues. Conclusions: A brief two-part DPS training program, drawing from individuals’ experiences and from the Technology Acceptance Model, can provide valuable insights for users. The program also identifies and addresses several areas of actual or potential challenges related to operating a DPS and allows for the resolution of such issues within the first week of DPS use. %M 33890863 %R 10.2196/26213 %U https://formative.jmir.org/2021/4/e26213 %U https://doi.org/10.2196/26213 %U http://www.ncbi.nlm.nih.gov/pubmed/33890863 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 9 %N 4 %P e25496 %T The Potential of mHealth as a Game Changer for the Management of Sickle Cell Disease in India %A Kumar,Ravindra %A Das,Aparup %+ ICMR-National Institute of Research in Tribal Health, ICMR-NIRTH Campus, Nagpur Road, PO Garha, Jabalpur, 482003, India, 91 7612370800, aparupdas@nirth.res.in %K sickle cell disease %K drug adherence %K mHealth %K India %D 2021 %7 13.4.2021 %9 Viewpoint %J JMIR Mhealth Uhealth %G English %X Sickle cell disease (SCD) is a chronic genetic disease that requires lifelong therapy and monitoring. Low drug adherence and poor monitoring may lead to an increase in morbidities and low quality of life. In the era of digital technology, various mobile health (mHealth) apps are being tested for their potential in increasing drug adherence in patients with SCD. We herewith discuss the applicability and feasibility of these mHealth apps for the management of SCD in India. %M 33847598 %R 10.2196/25496 %U https://mhealth.jmir.org/2021/4/e25496 %U https://doi.org/10.2196/25496 %U http://www.ncbi.nlm.nih.gov/pubmed/33847598 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 4 %P e24565 %T An Intervention for the Transition From Pediatric or Adolescent to Adult-Oriented HIV Care: Protocol for the Development and Pilot Implementation of iTransition %A Tanner,Amanda E %A Dowshen,Nadia %A Philbin,Morgan M %A Rulison,Kelly L %A Camacho-Gonzalez,Andres %A Lee,Susan %A Moore,Shamia J %A Fortenberry,J Dennis %A Hussen,Sophia A %+ Department of Public Health Education, University of North Carolina Greensboro, 437 Coleman Building, Greensboro, NC, 27402-6169, United States, 1 715 497 2885, aetanner@uncg.edu %K HIV %K mHealth %K transition to adult care %K young adult %K feasibility studies %K retention in care %K control groups %K United States %K telemedicine %K HIV infections %K mobile phone %D 2021 %7 7.4.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: In the United States, adolescents and young adults are disproportionately affected by HIV and have poorer HIV-related health outcomes than adults. Health care transition (HCT) from pediatric or adolescent to adult-oriented HIV care is associated with disruptions to youths’ care retention, medication adherence, and viral suppression. However, no evidence-based interventions exist to improve HCT outcomes for youth living with HIV. Objective: There are 2 phases of this project. Phase 1 involves the iterative development and usability testing of a Social Cognitive Theory–based mobile health (mHealth) HIV HCT intervention (iTransition). In phase 2, we will conduct a pilot implementation trial to assess iTransition’s feasibility and acceptability and to establish preliminary efficacy among youth and provider participants. Methods: The iterative phase 1 development process will involve in-person and virtual meetings and a design team comprising youth living with HIV and health care providers. The design team will both inform the content and provide feedback on the look, feel, and process of the iTransition intervention. In phase 2, we will recruit 100 transition-eligible youth across two clinical sites in Atlanta, Georgia, and Philadelphia, Pennsylvania, to participate in the historical control group (n=50; data collection only) or the intervention group (n=50) in a pilot implementation trial. We will also recruit 28 provider participants across the pediatric or adolescent and adult clinics at the two sites. Data collection will include electronic medical chart abstraction for clinical outcomes as well as surveys and interviews related to demographic and behavioral characteristics; Social Cognitive Theory constructs; and intervention feasibility, acceptability, and use. Analyses will compare historical control and intervention groups in terms of HCT outcomes, including adult care linkage (primary), care retention, and viral suppression (secondary). Interview data will be analyzed using content analysis to understand the experience with use and acceptability. Results: Phase 1 (development) of iTransition research activities began in November 2019 and is ongoing. The data collection for the phase 2 pilot implementation trial is expected to be completed in January 2023. Final results are anticipated in summer 2023. Conclusions: The development and pilot implementation trial of the iTransition intervention will fill an important gap in understanding the role of mHealth interventions to support HCT outcomes for youth living with HIV. International Registered Report Identifier (IRRID): DERR1-10.2196/24565 %M 33825691 %R 10.2196/24565 %U https://www.researchprotocols.org/2021/4/e24565 %U https://doi.org/10.2196/24565 %U http://www.ncbi.nlm.nih.gov/pubmed/33825691 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 9 %N 4 %P e23280 %T Staff Perceptions of Preimplementation Barriers and Facilitators to a Mobile Health Antiretroviral Therapy Adherence Counseling Intervention in South Africa: Qualitative Study %A McCreesh-Toselli,Siobhan %A Torline,John %A Gouse,Hetta %A Robbins,Reuben N %A Mellins,Claude A %A Remien,Robert H %A Rowe,Jessica %A Peton,Neshaan %A Rabie,Stephan %A Joska,John A %+ HIV Mental Health Research Unit, Department of Psychiatry and Mental Health, University of Cape Town, J Block, Groote Schuur Hospital, Observatory, South Africa, 27 21 404 2174, john.joska@uct.ac.za %K HIV/AIDS %K antiretroviral treatment %K low-resource settings %K mHealth %K Masivukeni %K Consolidated Framework for Implementation Research %K implementation research %K lay antiretroviral therapy adherence counselors %K mobile phone %D 2021 %7 6.4.2021 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: South Africa adopted a universal test and treatment program for HIV infection in 2015. The standard of care that people living with HIV receive consists of 3 sessions of readiness counseling delivered by lay counselors (LCs). In the largest antiretroviral therapy (ART) program worldwide, effective and early HIV and ART education and support are key for ensuring ART adoption, adherence, and retention in care. Having LCs to deliver readiness counseling allows for the wide task-sharing of this critical activity but carries the risks of loss of standardization, incomplete content delivery, and inadequate monitoring and supervision. Systems for ensuring that a minimum standard of readiness counseling is delivered to the growing number of people living with HIV are essential in the care cascade. In resource-constrained, high-burden settings, mobile health (mHealth) apps may potentially offer solutions to these treatment gaps by providing content structure and delivery records. Objective: This study aims to explore, at a large Cape Town–based nonprofit HIV care organization, the staff’s perceived preimplementation barriers and facilitators of an mHealth intervention (Masivukeni) developed as a structured app for ART readiness counseling. Methods: Masivukeni is a laptop-based app that incorporates written content, graphics, short video materials, and participant activities. In total, 20 participants were included in this study. To explore how an mHealth intervention might be adopted across different staff levels within the organization, we conducted 7 semistructured interviews (participants: 7/20, 35%) and 3 focus groups (participants in 2 focus groups: 4/20, 20%; participants in 1 focus group: 3/20, 15%) among LCs, supervisors, and their managers. In total, 20 participants were included in this study. Interviews lasted approximately 60 minutes, and focus groups ranged from 90 to 120 minutes. The Consolidated Framework for Implementation Research was used to explore the perceived implementation barriers and facilitators of the Masivukeni mHealth intervention. Results: Several potential facilitators of Masivukeni were identified. Multimedia and visual elements were generally regarded as aids in content delivery. The interactive learning components were notably helpful, whereas facilitated updates to the adherence curriculum were important to facilitators and managers. The potential to capture administrative information regarding LC delivery and client logging was regarded as an attractive feature. Barriers to implementation included security risks and equipment costs, the high volume of clients to be counseled, and variable computer literacy among LCs. There was uncertainty about the app’s appeal to older clients. Conclusions: mHealth apps, such as Masivukeni, were perceived as being well placed to address some of the needs of those who deliver ART adherence counseling in South Africa. However, the successful implementation of mHealth apps appeared to be dependent on overcoming certain barriers in this setting. %M 33821806 %R 10.2196/23280 %U https://mhealth.jmir.org/2021/4/e23280 %U https://doi.org/10.2196/23280 %U http://www.ncbi.nlm.nih.gov/pubmed/33821806 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 5 %N 3 %P e25810 %T Development of Coaching Support for LiveWell: A Smartphone-Based Self-Management Intervention for Bipolar Disorder %A Dopke,Cynthia A %A McBride,Alyssa %A Babington,Pamela %A Jonathan,Geneva K %A Michaels,Tania %A Ryan,Chloe %A Duffecy,Jennifer %A Mohr,David C %A Goulding,Evan H %+ Department of Psychiatry and Behavioral Sciences, Feinberg School of Medicine, Northwestern University, 303 E Chicago Ave., Suite 7-102, Chicago, IL, 60611, United States, 1 3125031189, e-goulding@fsm.northwestern.edu %K human support %K adherence %K self-management %K behavior change %K mHealth %K bipolar disorder %D 2021 %7 24.3.2021 %9 Viewpoint %J JMIR Form Res %G English %X Despite effective pharmacological treatment, bipolar disorder is a leading cause of disability due to recurrence of episodes, long episode durations, and persistence of interepisode symptoms. While adding psychotherapy to pharmacotherapy improves outcomes, the availability of adjunctive psychotherapy is limited. To extend the accessibility and functionality of psychotherapy for bipolar disorder, we developed LiveWell, a smartphone-based self-management intervention. Unfortunately, many mental health technology interventions suffer from high attrition rates, with users rapidly failing to maintain engagement with the intervention technology. Human support reduces this commonly observed engagement problem but does not consistently improve clinical and recovery outcomes. To facilitate ongoing efforts to develop human support for digital mental health technologies, this paper describes the design decisions, theoretical framework, content, mode, timing of delivery, and the training and supervision for coaching support of the LiveWell technology. This support includes clearly defined and structured roles that aim to encourage the use of the technology, self-management strategies, and communication with care providers. A clear division of labor is established between the coaching support roles and the intervention technology to allow lay personnel to serve as coaches and thereby maximize accessibility to the LiveWell intervention. %M 33759798 %R 10.2196/25810 %U https://formative.jmir.org/2021/3/e25810 %U https://doi.org/10.2196/25810 %U http://www.ncbi.nlm.nih.gov/pubmed/33759798 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 9 %N 3 %P e21128 %T Challenges of and Solutions for Developing Tailored Video Interventions That Integrate Multiple Digital Assets to Promote Engagement and Improve Health Outcomes: Tutorial %A Harshbarger,Camilla %A Burrus,Olivia %A Rangarajan,Sivakumar %A Bollenbacher,John %A Zulkiewicz,Brittany %A Verma,Rohit %A Galindo,Carla A %A Lewis,Megan A %+ Division of HIV/AIDS Prevention, Centers for Disease Control and Prevention, 1600 Clifton Road, MS8-5, Atlanta, GA, United States, 1 404 639 4267, uzz9@cdc.gov %K HIV video intervention %K patient-provider communication %K ART adherence %K digital interventions %K mobile interventions %K computer based interventions %K interactive technologies %D 2021 %7 23.3.2021 %9 Tutorial %J JMIR Mhealth Uhealth %G English %X Background: Video is a versatile and popular medium for digital health interventions. As mobile device and app technology advances, it is likely that video-based interventions will become increasingly common. Although clinic waiting rooms are complex and busy environments, they offer the opportunity to facilitate engagement with video-based digital interventions as patients wait to see their providers. However, to increase efficiency in public health, leverage the scalability and low cost of implementing digital interventions, and keep up with rapidly advancing technology and user needs, more design and development guidance is needed for video-based tailored interventions. Objective: We provide a tutorial for digital intervention researchers and developers to efficiently design and develop video-based tailored digital health interventions. We describe the challenges and solutions encountered with Positive Health Check (PHC), a hybrid app used to deliver a brief, interactive, individually tailored video-based HIV behavioral counseling intervention. PHC uses video clips and multimedia digital assets to deliver intervention content, including interactive tailored messages and graphics, a repurposed animated video, and patient and provider handouts generated in real time by PHC. Methods: We chronicle multiple challenges and solutions for the following: (1) using video as a medium to enhance user engagement, (2) navigating the complexity of linking a database of video clips with other digital assets, and (3) identifying the main steps involved in building an app that will seamlessly deliver to users individually tailored messages, graphics, and handouts. Results: We leveraged video to enhance user engagement by featuring “video doctors,” full-screen video, storyboards, and streamlined scripts. We developed an approach to link the database of video clips with other digital assets through script coding and flow diagrams of algorithms to deliver a tailored user experience. We identified the steps to app development by using keyframes to design the integration of video and digital assets, using agile development methods to gather iterative feedback from multidisciplinary teams, and creating an intelligent data-driven back-end solution to tailor message delivery to individual users. Conclusions: Video-based digital health interventions will continue to play an important role in the future of HIV prevention and treatment, as well as other clinical health practices. However, facilitating the adoption of an HIV video intervention in HIV clinical settings is a work in progress. Our experience in designing and developing PHC presented unique challenges due to the extensive use of a large database of videos tailored individually to each user. Although PHC focuses on promoting the health and well-being of persons with HIV, the challenges and solutions presented in this tutorial are transferable to the design and development of video-based digital health interventions focused on other areas of health. %M 33755025 %R 10.2196/21128 %U https://mhealth.jmir.org/2021/3/e21128 %U https://doi.org/10.2196/21128 %U http://www.ncbi.nlm.nih.gov/pubmed/33755025 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 9 %N 3 %P e25406 %T Digital Health Integration Assessment and Maturity of the United States Biopharmaceutical Industry: Forces Driving the Next Generation of Connected Autoinjectable Devices %A Rafiei,Ramin %A Williams,Chelsea %A Jiang,Jeannette %A Aungst,Timothy Dy %A Durrer,Matthias %A Tran,Dao %A Howald,Ralph %+ SHL Medical, Gubelstrasse 22, 6300, Zug, Switzerland, 1 5617135654, chelsea.williams@shl-medical.com %K digital health %K artificial intelligence %K drug delivery %K biopharma %K autoinjector %K injectable devices %K disease management %K autoimmune %K oncology %K rare diseases %D 2021 %7 18.3.2021 %9 Viewpoint %J JMIR Mhealth Uhealth %G English %X Autoinjectable devices continue to provide real-life benefits for patients with chronic conditions since their widespread adoption 30 years ago with the rise of macromolecules. Nonetheless, issues surrounding adherence, patient administration techniques, disease self-management, and data outcomes at scale persist despite product design innovation. The interface of drug device combination products and digital health technologies formulates a value proposition for next-generation autoinjectable devices to power the delivery of precision care at home and achieve the full potential of biologics. Success will largely be dependent on biopharma’s digital health maturity to implement this framework. This viewpoint measures the digital health maturity of the top 15 biopharmaceutical companies in the US biologics autoinjector market and establishes the framework for next-generation autoinjectable devices powering home-based precision care and the need for formal digital health training. %M 33621188 %R 10.2196/25406 %U https://mhealth.jmir.org/2021/3/e25406 %U https://doi.org/10.2196/25406 %U http://www.ncbi.nlm.nih.gov/pubmed/33621188 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 5 %N 3 %P e22659 %T Combining a Hudl App With Telehealth to Increase Home Exercise Program Adherence in People With Chronic Diseases Experiencing Financial Distress: Randomized Controlled Trial %A Van de Winckel,Ann %A Nawshin,Tanjila %A Byron,Casey %+ Division of Physical Therapy, Division of Rehabilitation Science, Department of Rehabilitation Medicine, Medical School, University of Minnesota, 420 Delaware St SE (MMC 388), Minneapolis, MN, 55455, United States, 1 612 625 1191, avandewi@umn.edu %K chronic disease %K spinal cord injury %K stroke %K telehealth %K telemedicine %K traumatic brain injury %D 2021 %7 18.3.2021 %9 Original Paper %J JMIR Form Res %G English %X Background: Patients with chronic diseases often need to adhere to long-term individualized home exercise programs (HEPs). Limited adherence to long-term exercise given during physical therapy (PT) visits reduces the capacity of exercise to manage or improve symptoms related to chronic disease. In addition, a lower socioeconomic status negatively impacts exercise adherence. To mitigate this, apps that motivate people to exercise could be a viable option. Using an app through telehealth may help adults with chronic diseases to achieve long-term HEP adherence. However, because apps for rehabilitation are an emerging field, the feasibility of the app needs to be evaluated. Objective: To address HEP adherence in participants with chronic diseases who are experiencing financial distress, we aim to evaluate the feasibility of and satisfaction with the Hudl Technique app and telehealth and satisfaction with PT care and to monitor HEP adherence and compliance (ie, percentage of participant-recorded videos sent) in participants using the app with telehealth compared with those using standard HEPs on paper. Methods: We recruited patients scheduled for outpatient PT. We performed a randomized controlled trial in which the experimental group received weekly HEP demonstrations through app videos on a tablet with feedback on their self-recorded HEP video performance from the telehealth physical therapist. The control group received HEPs on paper without feedback, as is customary in PT practice. Demographic, clinical, and health coverage information was collected for screening and baseline measurements. Adherence and compliance were evaluated. Both groups completed surveys at 8 and 24 weeks on their satisfaction with PT care, and the experimental group also completed a survey on their satisfaction with the app with telehealth use. Descriptive and nonparametric statistics were used for within-group and between-group comparisons and analyzed with JMP, version 13. Results: Overall, 45 adults with chronic diseases who were experiencing financial distress were randomized into experimental (23/45, 51%) and control (22/45, 49%) groups, with 74% (17/23) and 86% (19/22) participants completing the 24-week HEP, respectively. The experimental group had an HEP adherence frequency of 4 (SD 2) to 5 (SD 2) times per week at 8 and 24 weeks (P=.14), whereas HEP adherence decreased in the control group from 4 (SD 2) to 3 (SD 2) times per week (P=.07), with a significant difference (P=.01) between groups at 24 weeks. Of the total participants, 68% (15/22) sent videos. They sent 68% (16/24) of the requested number of videos on average. The average score for PT care satisfaction was maintained at 87% in the experimental group (P=.99), whereas it decreased from 89% at 8 weeks to 74% at 24 weeks (P=.008) in the control group. App-related adverse events were not observed. Conclusions: The Hudl app/telehealth platform is feasible for delivering HEPs and maintaining HEP adherence in participants with chronic diseases who are experiencing financial distress. Trial Registration: ClinicalTrials.gov NCT02659280; https://clinicaltrials.gov/ct2/show/NCT02659280 %M 33640865 %R 10.2196/22659 %U https://formative.jmir.org/2021/3/e22659 %U https://doi.org/10.2196/22659 %U http://www.ncbi.nlm.nih.gov/pubmed/33640865 %0 Journal Article %@ 2369-2529 %I JMIR Publications %V 8 %N 1 %P e21374 %T Adherence Patterns and Dose Response of Physiotherapy for Rotator Cuff Pathology: Longitudinal Cohort Study %A Burns,David %A Boyer,Philip %A Razmjou,Helen %A Richards,Robin %A Whyne,Cari %+ Sunnybrook Research Institute, Sunnybrook Health Sciences Centre, 2075 Bayview Ave, Room S620, Toronto, ON, M4N 3M5, Canada, 1 4164806100, d.burns@utoronto.ca %K rehabilitation %K treatment adherence and compliance %K wearable electronic devices %K machine learning %K rotator cuff %D 2021 %7 11.3.2021 %9 Original Paper %J JMIR Rehabil Assist Technol %G English %X Background: Physiotherapy is considered to be essential for the successful operative and nonoperative management of rotator cuff pathology; however, the extent to which patients adhere to assigned physiotherapy activities and how this impacts recovery is unknown. Objective: The purpose of this study was to measure the rate and patterns of participation in physiotherapy for rotator cuff disorders, assess the dose response between physiotherapy activity and recovery, and explore patient factors predictive of physiotherapy participation. Methods: We report a prospective longitudinal study of 42 patients undergoing physiotherapy for symptomatic rotator cuff pathology. The patients were issued a smartwatch that recorded inertial sensor data while they performed physiotherapy exercises both in the clinic and in the home setting. A machine learning approach was used to assess total physiotherapy participation from smartwatch inertial data. Primary outcomes were the Disabilities of the Arm Shoulder and Hand and numeric pain rating scale assessed every 4 weeks until 12 weeks follow-up. The relationships between participation, outcomes, and clinical patient variables were assessed in univariable analyses. Results: Mean physiotherapy exercise participation in clinic and at home were 11 minutes per week and 33 minutes per week, respectively, with patients participating in physiotherapy on 41% of days assigned to treatment. Home physiotherapy participation decreased significantly over time (P=.03). There was a statistically significant and clinically meaningful relationship between cumulative physiotherapy participation and recovery demonstrated by pain scores at 8 weeks (P=.02) and 12 weeks (P=.05) and disability scores at 8 weeks (P=.04) and 12 weeks (P=.04). Low patient expectations and self-efficacy were associated with low rates of physiotherapy participation. Conclusions: There was a low rate of participation in home shoulder physiotherapy exercise, and a statistically and clinically significant dose response of physiotherapy on treatment outcome in patients with rotator cuff pathology. The findings highlight the opportunity to develop novel methods and strategies to improve the participation in and efficacy of physiotherapy exercises for rotator cuff disorders. International Registered Report Identifier (IRRID): RR2-10.2196/17841 %M 33704076 %R 10.2196/21374 %U https://rehab.jmir.org/2021/1/e21374 %U https://doi.org/10.2196/21374 %U http://www.ncbi.nlm.nih.gov/pubmed/33704076 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 5 %N 2 %P e24561 %T A Mobile Health App to Support Patients Receiving Medication-Assisted Treatment for Opioid Use Disorder: Development and Feasibility Study %A Waselewski,Marika Elise %A Flickinger,Tabor Elisabeth %A Canan,Chelsea %A Harrington,William %A Franklin,Taylor %A Otero,Kori Nicole %A Huynh,Jacqueline %A Waldman,Ava Lena Davila %A Hilgart,Michelle %A Ingersoll,Karen %A Ait-Daoud Tiouririne,Nassima %A Dillingham,Rebecca Anne %+ Department of Family Medicine, University of Michigan Medical School, 1018 Fuller St, Ann Arbor, MI, 48104, United States, 1 734 647 3305, marikag@med.umich.edu %K opioid use disorder %K mHealth %K retention in care %K self-management %K opioids %K public health %K mobile phone %D 2021 %7 23.2.2021 %9 Original Paper %J JMIR Form Res %G English %X Background: Opioid use disorder (OUD) is a public health crisis with more than 2 million people living with OUD in the United States. Medication-assisted treatment (MAT) is an evidence-based approach for the treatment of OUD that relies on a combination of behavioral therapy and medication. Less than half of those living with OUD are accessing this treatment. Mobile technology can enhance the treatment of chronic diseases in readily accessible and cost-effective ways through self-monitoring and support. Objective: The aim of this study is to describe the adaptation of a mobile platform for patients undergoing treatment for OUD and preliminary pilot testing results. Methods: Our study was conducted with patient and provider participants at the University of Virginia MAT clinic and was approved by the institutional review board. The formative phase included semistructured interviews to understand the needs of patients with OUD, providers’ perspectives, and opportunities for MAT support via a mobile app. A second round of formative interviews used mock-ups of app features to collect feedback on feature function and desirability. Formative participants’ input from 16 interviews then informed the development of a functional smartphone app. Patient participants (n=25) and provider participants (n=3) were enrolled in a 6-month pilot study of the completed platform. Patient app use and usability interviews, including a system usability score and open-ended questions, were completed 1 month into the pilot study. Open-ended responses were analyzed for prevalent themes. Results: Formative interviews resulted in the development of a mobile app, named HOPE, which includes both evidence-based and participant-suggested features. The features included daily prompts for monitoring mood, stress, treatment adherence, and substance use; patient tracking of goals, reminders, and triggering or encouraging experiences; informational resources; an anonymous community board to share support with other patients; and secure messaging for communication between patients and providers. All patient participants engaged with at least one app feature during their first month of pilot study participation, and the daily self-monitoring prompts were the most used. Patients and providers reported high levels of system usability (mean 86.9, SD 10.2 and mean 83.3, SD 12.8, respectively). Qualitative analysis of open-ended usability questions highlighted the value of self-monitoring, access to support through the app, and perceived improvement in connection to care and communication for both patient and provider participants. Conclusions: The use of the HOPE program by pilot participants, high usability scoring, and positive perceptions from 1-month interviews indicate successful program development. By engaging with end users and eliciting feedback throughout the development process, we were able to create an app and a web portal that was highly usable and acceptable to study participants. Further work is needed to understand the program’s effect on clinical outcomes, patient linkage, and engagement in care. %M 33620324 %R 10.2196/24561 %U https://formative.jmir.org/2021/2/e24561 %U https://doi.org/10.2196/24561 %U http://www.ncbi.nlm.nih.gov/pubmed/33620324 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 2 %P e24893 %T Access to Technology and Preferences for an mHealth Intervention to Promote Medication Adherence in Pediatric Acute Lymphoblastic Leukemia: Approach Leveraging Behavior Change Techniques %A Heneghan,Mallorie B %A Hussain,Tasmeen %A Barrera,Leonardo %A Cai,Stephanie W %A Haugen,Maureen %A Morgan,Elaine %A Rossoff,Jenna %A Weinstein,Joanna %A Hijiya,Nobuko %A Cella,David %A Badawy,Sherif M %+ Division of Pediatric Hematology/Oncology, Department of Pediatrics, University of Utah, 100 N Mario Capecchi Drive, Salt Lake City, UT, 84113, United States, 1 801 662 4700, Mallorie.Heneghan@hsc.utah.edu %K acute lymphoblastic leukemia %K medication adherence %K behavior change technique %K oral chemotherapy %K mHealth %K patient-centered %D 2021 %7 18.2.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Suboptimal adherence to 6-mercaptopurine (6-MP) is prevalent in pediatric acute lymphoblastic leukemia (ALL) and associated with increased risk of relapse. Rapid uptake of personal technology makes mobile health (mHealth) an attractive platform to promote adherence. Objective: Study objectives were to examine access to mobile technology and preferences for an mHealth intervention to improve medication adherence in pediatric ALL. Methods: A cross-sectional survey was administered in oncology clinic to parents of children with ALL as well as adolescents and young adults (AYAs) with ALL receiving maintenance chemotherapy. Results: A total of 49 parents (median age [IQR] 39 [33-42] years; female 76% [37/49]) and 15 patients (median age [IQR] 17 [16-19]; male 80% [12/15]) participated. All parents and AYAs owned electronic tablets, smartphones, or both. Parents’ most endorsed mHealth app features included a list of medications (71%, 35/49), information about 6-MP (71%, 35/49), refill reminders (71%, 35/49), and reminders to take 6-MP (71%, 35/49). AYAs' most endorsed features included refill reminders (73%, 11/15), reminders to take 6-MP (73%, 11/15), and tracking 6-MP (73%, 11/15). Conclusions: Parents and AYAs reported ubiquitous access to mobile technology and strong interest in multiple adherence-specific mHealth app features. Parents and AYAs provided valuable insight into preferred features for a multifunctional behavioral intervention (mHealth app) to promote medication adherence in pediatric ALL. %M 33599621 %R 10.2196/24893 %U http://www.jmir.org/2021/2/e24893/ %U https://doi.org/10.2196/24893 %U http://www.ncbi.nlm.nih.gov/pubmed/33599621 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 9 %N 2 %P e23912 %T mHealth Strategies Related to HIV Postexposure Prophylaxis Knowledge and Access: Systematic Literature Review, Technology Prospecting of Patent Databases, and Systematic Search on App Stores %A Queiroz,Artur Acelino Francisco Luz Nunes %A Mendes,Isabel Amélia Costa %A de Godoy,Simone %A Velez Lapão,Luís %A Dias,Sónia %+ Department of General and Specialized Nursing, Escola de Enfermagem de Ribeirão Preto, Universidade de São Paulo, R Prof Hélio Lourenço, 3900 - Vila Monte Alegre, Ribeirão Preto, 14040-902, Brazil, 55 16 3315 4321, arturqueiroz@usp.br %K HIV %K eHealth %K mHealth %K postexposure prophylaxis %K PEP %K prevention %K mobile phone %D 2021 %7 16.2.2021 %9 Review %J JMIR Mhealth Uhealth %G English %X Background: Globally, the number of HIV cases continue to increase, despite the development of multiple prevention strategies. New cases of HIV have been reported disproportionately more in men who have sex with men and other vulnerable populations. Issues such as internalized and structural homophobia prevent these men from accessing prevention strategies such as postexposure prophylaxis (PEP). Mobile health (mHealth) interventions are known to be one of the newest and preferred options to enhance PEP knowledge and access. Objective: The aim of this study was to identify and analyze the mobile apps addressing PEP for HIV infections. Methods: We conducted a descriptive exploratory study in 3 sequential phases: systematic literature review, patent analysis, and systematic search of app stores. For the systematic review, we followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines adapted for an integrative review in the databases of PubMed, Web of Knowledge, Scopus, Cochrane, Embase, Science Direct, Eric, Treasure, and CINAHL. The patent analysis was performed by exploring the databases of the Brazilian National Institute of Industrial Property, the United States Patent and Trademark Office, and the European Patent Office. For the systematic search, we analyzed mHealth apps related to HIV in 2 major app libraries, that is, Google Play Store and App Store. The apps were evaluated by name, characteristics, functions, and availability in iPhone operating system/Android phones. Results: We analyzed 22 studies, of which 2 were selected for the final stage. Both studies present the use of apps as mHealth strategies aimed at improving the sexual health of men who have sex with men, and they were classified as decision support systems. The search in the patent databases showed only 1 result, which was not related to the topic since it was a drug intervention. In the app libraries, 25 apps were found and analyzed, with 15 (60%) apps available for Android systems but only 3 (12%) addressing PEP. In general, the apps inform about HIV and HIV prevention and treatment, with the focus users being health care providers, people with HIV, or the general population, but they have only limited features available, that is, mainly text, images, and videos. The 3 apps exclusively focusing on PEP were created by researchers from Brazilian universities. Conclusions: Our review found no connection between the scientific studies, registered patents, and the available apps related to PEP; this finding indicates that these available apps do not have a theoretical or a methodological background in their creation. Thus, since the scientific knowledge on HIV is not translated into technological products, preventing the emergence of new infections, especially in the more vulnerable groups, is difficult. In the future, researchers and the community must work in synergy to create more mHealth tools aimed at PEP. %M 33591289 %R 10.2196/23912 %U http://mhealth.jmir.org/2021/2/e23912/ %U https://doi.org/10.2196/23912 %U http://www.ncbi.nlm.nih.gov/pubmed/33591289 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 9 %N 2 %P e24080 %T Effectiveness of Mobile Health–Based Exercise Interventions for Patients with Peripheral Artery Disease: Systematic Review and Meta-Analysis %A Kim,Mihui %A Kim,Changhwan %A Kim,Eunkyo %A Choi,Mona %+ College of Nursing and Mo-Im Kim Nursing Research Institute, Yonsei University, 50-1 Yonsei-ro, Seodaemun-gu, Seoul, 03722, Republic of Korea, 82 2 2228 3341, monachoi@yuhs.ac %K peripheral artery disease %K mobile health %K exercise %K adherence %K meta-analysis %D 2021 %7 15.2.2021 %9 Review %J JMIR Mhealth Uhealth %G English %X Background: Peripheral artery disease (PAD) affects over 236 million people worldwide, and exercise interventions are commonly used to alleviate symptoms of this condition. However, no previous systematic review has evaluated the effects of mobile health (mHealth)–based exercise interventions for patients with PAD. Objective: This study aimed to assess the effect of mHealth-based exercise interventions on walking performance, functional status, and quality of life in patients with PAD. Methods: A systematic review and meta-analysis were conducted. We searched in seven databases to identify randomized controlled trials of patients with PAD published in English up to December 4, 2020. Studies were included if patients participated in mHealth-based exercise interventions and were assessed for walking performance. We analyzed pooled effect size on walking performance, functional status, and quality of life based on the standardized mean differences between groups. Results: A total of seven studies were selected for the systematic review, and six studies were included in the meta-analysis. The duration of interventions in the included studies was 12 to 48 weeks. In the pooled analysis, when compared with the control groups, the mHealth-based exercise intervention groups were associated with significant improvements in pain-free walking (95% CI 0.13-0.88), maximal walking (95% CI 0.03-0.87), 6-minute walk test (6MWT) distance (95% CI 0.59-1.24), and walking distance (95% CI 0.02-0.49). However, benefits of the interventions on walking speed, stair-climbing ability, and quality of life were not observed. Conclusions: mHealth-based exercise interventions for patients with PAD were beneficial for improving pain-free walking, maximal walking, and 6MWT distance. We found that exercise interventions using mHealth are an important strategy for improving the exercise effectiveness and adherence rate of patients with PAD. Future studies should consider the use of various and suitable functions of mHealth that can increase the adherence rates and improve the effectiveness of exercise. %M 33587042 %R 10.2196/24080 %U http://mhealth.jmir.org/2021/2/e24080/ %U https://doi.org/10.2196/24080 %U http://www.ncbi.nlm.nih.gov/pubmed/33587042 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 5 %N 2 %P e12218 %T Effectiveness of Text Message Reminders on Adherence to Inhaled Therapy in Patients With Asthma: Prospective Multicenter Randomized Clinical Trial %A Almonacid,Carlos %A Melero,Carlos %A López Viña,Antolín %A Cisneros,Carolina %A Pérez de Llano,Luis %A Plaza,Vicente %A García-Rivero,Juan Luis %A Romero Falcón,Auxiliadora %A Ramos,Jacinto %A Bazús González,Teresa %A Andrés Prado,María %A Muriel,Alfonso %+ Department of Respiratory Medicine, Instituto Ramón y Cajal de Investigación Sanitaria, University of Alcala de Henares, Ctra. De Colmenar Viejo, km. 9,100, Madrid, , Spain, 34 655 534 475, caralmsan@gmail.com %K asthma %K adherence %K SMS %K control %K cell phone %K inhaler %K Smartinhaler %D 2021 %7 9.2.2021 %9 Original Paper %J JMIR Form Res %G English %X Background: Poor adherence to inhaled medication in asthma patients is of great concern. It is one of the main reasons for inadequate asthma control. Objective: The goal of the research was to determine if motivational messages using short message service (SMS, or text) improved adherence to inhaled medication in patients with asthma. Methods: A prospective multicenter randomized parallel-group clinical trial was conducted in 10 asthma clinics in Spain. Adherence was assessed with electronic monitors (Smartinhaler, Adherium Ltd) connected to inhalers. Patients in the SMS group received psychologist-developed motivational messages every 3 days for 6 months. Results: There were 53 patients in the SMS group and 88 patients in the control group. After 6 months, mean electronic adherence was 70% (SD 17%) in the intervention group and 69% (SD 17%) in the control group (P=.82). Significant differences between the study groups in morning and evening adherence to inhaled therapy, asthma control, exhaled nitric oxide levels, or improvement of lung functions were not observed. Conclusions: Motivational messages were not useful to improve adherence to inhaled asthma medication compared with usual care. %M 33560235 %R 10.2196/12218 %U http://formative.jmir.org/2021/2/e12218/ %U https://doi.org/10.2196/12218 %U http://www.ncbi.nlm.nih.gov/pubmed/33560235 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 8 %N 1 %P e18328 %T Individualized Web-Based Attention Training With Evidence-Based Counseling to Address HIV Treatment Adherence and Psychological Distress: Exploratory Cohort Study %A Houston,Eric %A Fadardi,Javad Salehi %A Harawa,Nina T %A Argueta,Chris %A Mukherjee,Sukrit %+ Claremont Graduate University, 675 West Foothill Boulevard, Claremont, CA, 91711, United States, 1 909 621 8000, eric.houston@cgu.edu %K depression %K trauma %K HIV %K attention training %K implicit cognition %D 2021 %7 28.1.2021 %9 Original Paper %J JMIR Ment Health %G English %X Background: The prevalence of mood, trauma, and stressor-related disorders is disproportionately higher among people living with HIV than among individuals without the virus. Poor adherence to HIV treatment and heightened psychological distress have been linked to symptoms associated with these disorders. Objective: The objective of this exploratory pilot study was to develop and implement an intervention that combined individualized web-based attention training with evidence-based counseling to promote HIV treatment adherence and reduce psychological distress among people living with HIV. The study targeted African American and Latino young men who have sex with men, two population groups in the US that continue to experience disparities in HIV treatment outcomes. Methods: Study participants with elevated symptoms of depression and suboptimal adherence to antiretroviral therapy were recruited primarily through referrals from Los Angeles health and social service providers as well as postings on social media. Participants enrolled in the 4-week intervention received weekly counseling for adherence and daily access to web-based attention training via their personal mobile devices or computers. Results: Of the 14 participants who began the intervention, 12 (86%) completed all sessions and study procedures. Using a pretest-posttest design, findings indicate significant improvements in adherence, depressive symptoms, and attention processing. Overall, the proportion of participants reporting low adherence to antiretroviral therapy declined from 42% at baseline to 25% at intervention completion (P=.02, phi=0.68). Mean depressive symptoms measured by the 9 item Patient Health Questionnaire (PHQ-9) showed a substantial reduction of 36% (P=.002, Cohen d=1.2). In addition, participants’ attentional processing speeds for all types of stimuli pairings presented during attention training improved significantly (P=.01 and P=.02) and were accompanied by large effect sizes ranging from 0.78 to 1.0. Conclusions: Our findings support the feasibility of web-based attention training combined with counseling to improve antiretroviral therapy adherence among patients with psychological distress. Future research should include a larger sample, a control group, and longer-term follow-up. %M 33507152 %R 10.2196/18328 %U http://mental.jmir.org/2021/1/e18328/ %U https://doi.org/10.2196/18328 %U http://www.ncbi.nlm.nih.gov/pubmed/33507152 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 1 %P e24736 %T Examining a Digital Health Approach for Advancing Schizophrenia Illness Self-Management and Provider Engagement: Protocol for a Feasibility Trial %A Kidd,Sean %A McKenzie,Kwame %A Wang,Wei %A Agrawal,Sacha %A Voineskos,Aristotle %+ Department of Psychiatry, University of Toronto, CAMH, 1001 Queen Street West, 2-1, Toronto, ON, Canada, 1 647 239 1296, sean.kidd@camh.ca %K schizophrenia %K psychosis %K digital health %K mobile health %K smartphone %D 2021 %7 25.1.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: In schizophrenia spectrum populations, adherence to treatment is poor, community-based supports are limited, and efforts to foster illness self-management have had limited success. These challenges contribute to frequent, lengthy, and costly hospital readmissions and poor functional outcomes. Digital health strategies, in turn, hold considerable promise in the effort to address these problems. Objective: This feasibility trial will examine a digital health platform called App4Independence (A4i), which was designed to enhance illness self-management and treatment engagement for individuals with schizophrenia. Methods: Feasibility metrics in this single-blind, randomized trial include study recruitment and retention, rate of technology use, safety, and utility in clinical interactions. Other outcome metrics include symptomatology, treatment adherence, patient-provider alliance, and quality of life. In this trial, 160 study participants with schizophrenia spectrum diagnoses will be randomized to either treatment or control conditions, with pretest-posttest outcomes measured over a 6-month period. Results: This study was funded by the Canadian Institutes of Health Research in January 2020 and received Institutional Review Board approval on August 13, 2020. This study plans to begin recruiting in January 2021 and will be completed within 3 years. Data collection is projected to begin in January 2021. Conclusions: This research will provide critical information for the development of this new technology in the larger effort to address a key problem in the schizophrenia field—how to leverage technology to enhance illness self-management and care engagement in resource-limited service contexts. International Registered Report Identifier (IRRID): PRR1-10.2196/24736 %M 33492235 %R 10.2196/24736 %U http://www.researchprotocols.org/2021/1/e24736/ %U https://doi.org/10.2196/24736 %U http://www.ncbi.nlm.nih.gov/pubmed/33492235 %0 Journal Article %@ 2561-6722 %I JMIR Publications %V 4 %N 1 %P e14774 %T Monitoring Adherence Rate to Growth Hormone Therapy and Growth Outcomes in Taiwanese Children Using Easypod Connect: Observational Study %A Su,Pen-Hua %A Yang,Chen %A Chao,Mei-Chyn %A Chiang,Chung-Lin %+ School of Medicine, Chung-Shan Medical University, No. 110, Section 1, Jianguo North Rd., Taichung City, , Taiwan, 886 928 058 579, jen@csh.org.tw %K growth hormone %K adherence %K easypod %K eHealth %D 2021 %7 15.1.2021 %9 Original Paper %J JMIR Pediatr Parent %G English %X Background: Adherence to growth hormone therapy is difficult to detect reliably. Devices such as easypod have been developed for electronic recording of injections. The easypod connect observational study (ECOS) was an open-label, observational, multinational, phase IV study conducted in 24 countries around the world. The final results from ECOS in the Taiwanese cohort are reported in this paper. Objective: This study aimed to evaluate the adherence and long-term outcomes of growth hormone therapy in pediatric subjects using the easypod electromechanical device. Methods: Subjects (aged 2-18 years or >18 years without fusion of growth plates) who received Saizen (recombinant human growth hormone, somatropin) via the easypod device were enrolled in this study. The primary objective was to assess the level of adherence in subjects receiving Saizen via easypod. Results: In Taiwan, a total of 35 and 13 children fulfilled the criteria of full analysis set and complete analysis set, respectively. The mean (SD) age of the complete analysis set was 12.08 (2.72) years. All subjects were growth hormone–naïve, with 38% (5/13) females. The mean adherence rates of 13 subjects were 87.6% at 3 months and 84.3% at 6 months, that of 8 subjects was 81.0% at 9 months, and that of 4 subjects was 91.6% at 1 year. After 1 year of treatment, subjects had a median (Q1:Q3) change in height SD score of 0.30 (0.06:0.48), median height velocity of 6.50 (4.33:8.24) cm/year, and median change in height velocity SD score of 1.81 (–0.04:3.52). Conclusions: With the easypod device, patients with inadequate adherence and poor response to treatment can be identified. Adherence to growth hormone therapy administered via easypod was generally high in the first year of treatment but the adherence gradually decreased over time. Overall, growth outcomes after 1 year indicated a positive growth response to growth hormone treatment. Future efforts should be focused on personalized management of adherence by using the easypod system. %M 33448936 %R 10.2196/14774 %U https://pediatrics.jmir.org/2021/1/e14774 %U https://doi.org/10.2196/14774 %U http://www.ncbi.nlm.nih.gov/pubmed/33448936 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 1 %P e18021 %T Assessing the Effectiveness and Acceptability of a Personalized Mobile Phone App in Improving Adherence to Oral Hygiene Advice in Orthodontic Patients: Protocol for a Feasibility Study and a Randomized Controlled Trial %A Sharif,Mohammad Owaise %A Newton,Jonathon Timothy %A Cunningham,Susan J %+ Eastman Dental Institute, University College London, Rockefeller Building, 21 University Street, London, WC1E 6DE, United Kingdom, 44 02034561067, mohammad.sharif.16@ucl.ac.uk %K orthodontics %K adherence %K smartphone apps %K mobile phone apps %K personalized health care %K information provision %D 2021 %7 13.1.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: Orthodontic treatment is a common health care intervention; treatment duration can be lengthy (2-3 years on average), and adherence to treatment advice is therefore essential for successful outcomes. It has been reported that up to 43% of patients fail to complete treatment, and there are currently no useful predictors of noncompletion. Given that the National Health Service England annual expenditure on primary-care orthodontic treatment is in excess of £200 million (US $267 million), noncompletion of treatment represents a significant inefficient use of public resources. Improving adherence to treatment is therefore essential. This necessitates behavior change, and interventions that improve adherence and are designed to elicit behavioral change must address an individual’s capability, opportunity, and motivation. Mobile phones are potentially an invaluable tool in this regard, as they are readily available and can be used in a number of ways to address an individual’s capability, opportunity, and motivation. Objective: This study will assess the effectiveness and acceptability of a personalized mobile phone app in improving adherence to orthodontic treatment advice by way of a randomized controlled trial. Methods: This study will be conducted in 2 phases at the Eastman Dental Hospital, University College London Hospitals Foundation Trust. Phase 1 is feasibility testing of the My Braces app. Participants will be asked to complete the user version of the Mobile Application Rating Scale. The app will be amended following analysis of the responses, if appropriate. Phase 2 is a randomized controlled trial to test the effectiveness and acceptability of the My Braces app. Results: This study was approved by the London – Bloomsbury Research Ethics Committee on November 5, 2019 (reference 19/LO/1555). No patients have been recruited to date. The anticipated start date for recruitment to phase 1 is October 2020. Conclusions: Given the availability, affordability, and versatility of mobile phones, it is proposed that they will aid in improving adherence to treatment advice and hence improve treatment completion rates. If effective, the applicability of this methodology to developing behavior change/modification interventions and improving adherence to treatment across health care provides an exciting opportunity. Trial Registration: ClinicalTrials.gov NCT04184739; https://clinicaltrials.gov/ct2/show/NCT04184739 International Registered Report Identifier (IRRID): PRR1-10.2196/18021 %M 33439142 %R 10.2196/18021 %U http://www.researchprotocols.org/2021/1/e18021/ %U https://doi.org/10.2196/18021 %U http://www.ncbi.nlm.nih.gov/pubmed/33439142 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 5 %N 1 %P e13770 %T Mobile App–Based Self-Report Questionnaires for the Assessment and Monitoring of Bipolar Disorder: Systematic Review %A Chan,Eric C %A Sun,Yuting %A Aitchison,Katherine J %A Sivapalan,Sudhakar %+ Department of Psychiatry, University of Alberta, 1E1 Walter Mackenzie Health Sciences Center, 8440 112 St NW, Edmonton, AB, T6G 2B7, Canada, 1 7802332709, echantai@ualberta.ca %K mobile apps %K mental health %K bipolar disorder %K smartphone %K cell phone %D 2021 %7 8.1.2021 %9 Review %J JMIR Form Res %G English %X Background: Bipolar disorder is a chronic, progressive illness characterized by recurrent episodes of mania and depression. Self-report scales have historically played a significant role in the monitoring of bipolar symptoms. However, these tools rely on episodic memory, which can be unreliable and do not allow the clinician to monitor brief episodic symptoms or the course of symptoms over shorter periods of time. Mobile app–based questionnaires have been suggested as a tool to improve monitoring of patients with bipolar disorder. Objective: This paper aims to determine the feasibility and validity of mobile app–based self-report questionnaires. Methods: We performed a systematic review of the literature according to the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. The PubMed, PsycInfo, Web of Science, Ovid MEDLINE, and EMBASE databases were searched for papers published in English that assessed adherence to and the validity of mobile app–based self-report questionnaires. Relevant studies published from database creation to May 22, 2020, were identified, and results examining the validity of and rates of adherence to app-based self-report questionnaires are reported. Results: A total of 13 records were identified for inclusion in this review. Of these studies, 4 assessed the concurrent validity of mobile app–based self-report tools, with the majority of findings indicating significant associations between data collected using these tools and the Young Mania Rating Scale, Hamilton Depression Rating Scale-17, or Montgomery-Åsberg Depression Rating Scale (P<.001 to P=.24). Three studies comparing the variability or range of symptoms between patients with bipolar disorder and healthy controls suggested that these data are capable of differentiating between known groups. Two studies demonstrated statistically significant associations between data collected via mobile app–based self-report tools and instruments assessing other clinically important factors. Adherence rates varied across the studies examined. However, good adherence rates (>70%) were observed in all but 1 study using a once-daily assessment. There was a wide range of adherence rates observed in studies using twice-daily assessments (42%-95%). Conclusions: These findings suggest that mobile app–based self-report tools are valid in the assessment of symptoms of mania and depression in euthymic patients with bipolar disorder. Data collected using these tools appear to differ between patients with bipolar disorder and healthy controls and are significantly associated with other clinically important measures. It is unclear at this time whether these tools can be used to detect acute episodes of mania or depression in patients with bipolar disorder. Adherence data indicate that patients with bipolar disorder show good adherence to self-report assessments administered daily for the duration of the study periods evaluated. %M 33416510 %R 10.2196/13770 %U https://formative.jmir.org/2021/1/e13770 %U https://doi.org/10.2196/13770 %U http://www.ncbi.nlm.nih.gov/pubmed/33416510 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 5 %N 1 %P e20636 %T Cancer Patients’ Perceived Value of a Smartphone App to Enhance the Safety of Home-Based Chemotherapy: Feasibility Study %A Kongshaug,Nina %A Skolbekken,John-Arne %A Faxvaag,Arild %A Hofsli,Eva %+ Cancer Clinic, St. Olav's University Hospital, Postbox 8905, Trondheim, 7491, Norway, 47 99703704, nina.kongshaug@stolav.no %K mhealth %K mobile app %K smartphone app %K oral chemotherapy %K patient safety %K home-based cancer treatment %D 2021 %7 6.1.2021 %9 Original Paper %J JMIR Form Res %G English %X Background: Oral anticancer therapies can be self-administered by patients outside the hospital setting, which poses challenges of adherence to a drug plan and monitoring of side effects. Modern information technology may be developed and implemented to address these pertinent issues. Objective: The aim of this study was to explore how a smartphone app developed through a stepwise, iterative process can help patients using oral chemotherapy to take their drug, and to report adherence and side effects in a reliable and verifiable manner. Methods: Fourteen patients starting capecitabine treatment were included in this study and used the smartphone app in addition to regular follow up of capecitabine treatment. Nine of these patients fulfilled the treatment plan and were interviewed based on a semistructured interview guide and the System Usability Scale (SUS). In addition, two focus groups were completed with 7 oncologists and 7 oncology nurses, respectively. Interview data were analyzed in accordance with the principles of systematic text condensation. Features of the app were also assessed. Results: The smartphone app provided the patients with a feeling of reassurance regarding correct adherence of their oral chemotherapy treatment. They used the app as a memory tool about their treatment and possible serious side effects, as well as for treatment education. Patients expressed concerns about using the app to report side effects that were not considered to be obviously serious, fearing overreporting. The health personnel expressed an overall positive attitude to integrate this new tool in their everyday work. Conclusions: Patients on oral chemotherapy treatment at home felt safe and found the app to be helpful. The app promoted learning about their treatment and made the patients more independent of the cancer clinic, reducing the need for the clinic’s limited resources for follow up of patients on oral anticancer medications. %M 33404505 %R 10.2196/20636 %U https://formative.jmir.org/2021/1/e20636 %U https://doi.org/10.2196/20636 %U http://www.ncbi.nlm.nih.gov/pubmed/33404505 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 1 %P e19770 %T A Community-Developed, Web-Based Mobile App Intervention Addressing Social Work and Legal Needs of Black Sexual Minority Men Living With HIV: Protocol for a Randomized Comparison Trial %A Miyashita Ochoa,Ayako %A Paneda,Christian Corpuz %A Wu,Elizabeth SC %A Maxwell,Katherine Elizabeth %A Garth,Gerald %A Smith,Terry %A Holloway,Ian Walter %+ Department of Social Welfare, UCLA Luskin School of Public Affairs, 337 Charles E Young Dr E, Los Angeles, CA, 90095, United States, 1 310 825 7840, holloway@luskin.ucla.edu %K HIV %K AIDS %K mobile apps %K African Americans %K men’s health %K sexual minority %K treatment adherence %K mobile phones %D 2021 %7 6.1.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: Black sexual minority men (BSMM) are disproportionately affected by HIV. Los Angeles County (LAC) carries a substantial burden of the HIV epidemic in California. Negative effects of both psychosocial and structural barriers highlight the timely need to increase HIV treatment among BSMM. Successful HIV interventions based on social media and mobile phone technology have been demonstrated. This protocol describes LINX LA, a study that tests LINX, a web-based mobile app that provides tailored social services, legal resources, and peer support for BSMM living with HIV (BSMM+) in LAC using a randomized comparison trial. Objective: During phase 1, the LINX LA study aims to engage in an iterative design process to develop the LINX App using qualitative data to inform and tailor the mobile app technology and its functionality. In phase 2 of LINX LA, we will test the efficacy of the LINX App compared with the LINX App Plus to improve HIV treatment outcomes (ie, antiretroviral therapy adherence, viral suppression) among BSMM+ in LAC by addressing social work and legal needs and developing a forum for peer support. Methods: In this study funded by the California HIV/AIDS Research Program, we will recruit and enroll BSMM+ participants (aged ≥18 years) in LAC (N=400) to participate in a 12-month study that includes access to the LINX App, which provides a forum for peer support and tailored content aimed at improving the use of social and legal resources. All participants will also receive survey-based interviews at 3 time points (at baseline and 6- and 12-month intervals) and weekly text message surveys that assess medication and treatment adherence. Treatment adherence and viral suppression will be extracted from medical record data. Half of the participants will also be randomly assigned to receive 3 individualized coaching sessions (at 1-, 3-, and 6-month intervals) and the ability to directly message their coach via the LINX App. Over the course of the study, LINX App participants will receive a minimum of US $130 in cash and LINX App Plus participants will receive a minimum of US $190. We hypothesize that participants enrolled in LINX App Plus will demonstrate greater improvement in HIV outcomes compared with LINX App participants. Results: The LINX study will test the efficacy of a web-based mobile app intervention for BSMM+ in LAC (N=400). The LINX App seeks to increase participants’ knowledge of HIV; to facilitate access to necessary social and legal services, including information and referrals; and to increase social support across participants by providing a mediated forum for engagement. Conclusions: The implementation of LINX LA aims to develop and test a culturally tailored approach to improve the HIV treatment outcomes of BSMM+. International Registered Report Identifier (IRRID): PRR1-10.2196/19770 %M 33404514 %R 10.2196/19770 %U https://www.researchprotocols.org/2021/1/e19770 %U https://doi.org/10.2196/19770 %U http://www.ncbi.nlm.nih.gov/pubmed/33404514 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 1 %P e18029 %T Using a Mobile Health Intervention (DOT Selfie) With Transfer of Social Bundle Incentives to Increase Treatment Adherence in Tuberculosis Patients in Uganda: Protocol for a Randomized Controlled Trial %A Sekandi,Juliet Nabbuye %A Onuoha,Nicole Amara %A Buregyeya,Esther %A Zalwango,Sarah %A Kaggwa,Patrick Evans %A Nakkonde,Damalie %A Kakaire,Robert %A Atuyambe,Lynn %A Whalen,Christopher C %A Dobbin,Kevin K %+ Global Health Institute, College of Public Health, University of Georgia, 100 Foster Road, Athens, GA, 30606, United States, 1 706 542 5257, jsekandi@uga.edu %K tuberculosis %K mHealth %K digital health %K eHealth %K directly observed therapy %K video observed therapy %K DOT Selfie %K treatment adherence %K Africa %D 2021 %7 5.1.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: The World Health Organization’s End TB Strategy envisions a world free of tuberculosis (TB)—free of deaths, disease, and suffering due to TB—by 2035. Nonadherence reduces cure rates, prolongs infectiousness, and contributes to the emergence of multidrug-resistant TB (MDR-TB). Moreover, MDR-TB is a growing, complex, and costly problem that presents a major obstacle to TB control. Directly observed therapy (DOT) for treatment adherence monitoring is the recommended standard; however, it is challenging to implement at scale because it is labor-intensive. Mobile health interventions can facilitate remote adherence monitoring and minimize the costs and inconveniences associated with standard DOT. Objective: The study aims to evaluate the effectiveness of using video directly observed therapy (VDOT) plus incentives to improve medication adherence in TB treatment versus usual-care DOT in an African context. Methods: The DOT Selfie study is an open-label, randomized controlled trial (RCT) with 2 parallel groups, in which 144 adult patients with TB aged 18-65 years will be randomly assigned to receive the usual-care DOT monitoring or VDOT as the intervention. The intervention will consist of a smartphone app, a weekly internet subscription, translated text message reminders, and incentives for those who adhere. The participant will use a smartphone to record and send time-stamped encrypted videos showing their daily medication ingestion. This video component will directly substitute the need for daily face-to-face meetings between the health provider and patients. We hypothesize that the VDOT intervention will be more effective because it allows patients to swallow their pills anywhere, anytime. Moreover, patients will receive mobile-phone–based “social bundle” incentives to motivate adherence to continued daily submission of videos to the health system. The health providers will log into a secured computer system to verify treatment adherence, document missed doses, investigate the reasons for missed doses, and follow prespecified protocol measures to re-establish medication adherence. The primary endpoint is the adherence level as measured by the fraction of expected doses observed over the treatment period. The main secondary outcome will be time-to-treatment completion in both groups. Results: This study was funded in 2019. Enrollment began in July and is expected to be completed by November 2020. Data collection and follow-up are expected to be completed by June 2021. Results from the analyses based on the primary endpoint are expected to be submitted for publication by December 2021. Conclusions: This random control trial will be among the first to evaluate the effectiveness of VDOT within an African setting. The results will provide robust scientific evidence on the implementation and adoption of mobile health (mHealth) tools, coupled with incentives to motivate TB medication adherence. If successful, VDOT will apply to other low-income settings and a range of chronic diseases with lifelong treatment, such as HIV/AIDs. Trial Registration: ClinicalTrials.gov NCT04134689; http://clinicaltrials.gov/ct2/show/NCT04134689 International Registered Report Identifier (IRRID): DERR1-10.2196/18029 %M 32990629 %R 10.2196/18029 %U https://www.researchprotocols.org/2021/1/e18029 %U https://doi.org/10.2196/18029 %U http://www.ncbi.nlm.nih.gov/pubmed/32990629 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 9 %N 12 %P e23480 %T Recruitment of Youth Living With HIV to Optimize Adherence and Virologic Suppression: Testing the Design of Technology-Based Community Health Nursing to Improve Antiretroviral Therapy (ART) Clinical Trials %A Agwu,Allison Lorna %A Yusuf,Hasiya Eihuri %A D'Angelo,Lawrence %A Rathore,Mobeen %A Marchesi,Jeanette %A Rowell,Julia %A Smith,Raina %A Toppins,Jackie %A Trexler,Constance %A Carr,Rashida %A Johnson,Betty %A Selden,Aaron Keith %A Mahmoudi,Saniyyah %A Black,Susan %A Guadamuz,Jisell %A Huettner,Steven %A Trent,Maria %+ Department of Pediatric and Adult Infectious Diseases, Johns Hopkins School of Medicine, 200 North Wolfe Street, Baltimore, MD, 21287, United States, 1 4106143917, ageorg10@jhmi.edu %K adolescent %K youth %K community health nursing %K HIV %K adherence %K viral suppression %K mobile health %D 2020 %7 11.12.2020 %9 Protocol %J JMIR Res Protoc %G English %X Background: Despite advances in HIV diagnosis and treatment, adolescents and young adults 12-25 years old have high HIV incidence, poor engagement and retention in treatment, and low rates of adherence and virologic suppression when compared to their older counterparts. HIV has emerged as a chronic disease for which antiretroviral therapy (ART) adherence is critical for virologic suppression and long-term survival. Virologic suppression has been elusive for many youth with HIV (YHIV). Novel strategies designed to facilitate health care systems’ support for YHIV between medical visits are essential for improving ART adherence, virologic suppression, and long-term survival. Objective: The aim of this study is to compare the effectiveness of a technology-enhanced community health nursing intervention (TECH2CHECK) to a standard of care (SOC) control group for improving ART adherence and subsequent viral suppression using a randomized trial design. The objectives are to assess the feasibility, acceptability, and cost-effectiveness of TECH2CHECK as compared to SOC for management of HIV in the outpatient setting and to examine the sustainability of self-care behavior, adherence, and virologic suppression among youth following the intervention period. Methods: We will recruit 120 adherence-challenged YHIV being followed at clinics specializing in HIV care in the Baltimore-Washington metropolitan area and in Jacksonville. Eligible participants complete an audio, computer-assisted self-interview and are randomized to either TECH2CHECK intervention or the SOC (60 participants in each arm). The primary outcome of interest is virologic suppression (viral load <20 copies/mL) and improved treatment adherence. Participants in the intervention arm receive community health nursing visits at 2 weeks, 6 weeks, 10 weeks, 14 weeks, and 26 weeks. The intervention arm also receives SMS messaging comprising daily adherence and appointment reminders and positive reinforcement for medication adherence daily for 2 weeks, on alternate days for 2 weeks, thrice weekly for 1 month, weekly for 3 months, and every 2 weeks for the rest of the study duration. The control group receives appointment reminders and SOC per clinic protocol. Exploratory analysis will be conducted to determine differences in medication adherence and virologic suppression in the 2 arms and to assess cost-effectiveness and study feasibility and acceptability. Results: In the first 23 months of the study (July 2018-April 2020), 56 (55%) of 102 eligible patients were enrolled and randomized. At present, participating youths are primarily African American (53/56, 95%), male (37/56, 66%), and ≥18 years old (53/56, 95%). Follow-up study visits, as required per the protocol, have been completed by 77% (43/56), 94% (45/48), 95% (37/39), 96% (24/25), and 100% (10/10) of participants at the 1-month, 3-month, 6-month, 12-month, and 18-month follow-ups, respectively. Conclusions: Preliminary accrual and retention data suggest that TECH2CHECK is feasible and acceptable. Trial Registration: ClinicalTrials.gov NCT03600103 https://clinicaltrials.gov/ct2/show/NCT03600103 International Registered Report Identifier (IRRID): DERR1-10.2196/23480 %M 33306036 %R 10.2196/23480 %U https://www.researchprotocols.org/2020/12/e23480 %U https://doi.org/10.2196/23480 %U http://www.ncbi.nlm.nih.gov/pubmed/33306036 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 9 %N 12 %P e21592 %T A Culturally Adapted SMS Text Messaging Intervention to Promote Antiretroviral Therapy Adherence Among African Americans: Protocol for a Single-Arm Trial %A Kohli,Maulika %A Pasipanodya,Elizabeth C %A Montoya,Jessica L %A Marquine,Maria %A Hoenigl,Martin %A Serrano,Vanessa %A Cushman,Clint %A Garcia,Rogelio %A Kua,John %A Gant,Verna %A Rojas,Sarah %A Moore,David J %+ HIV Neurobehavioral Research Program, University of California San Diego, 220 Dickinson St # B, San Diego, CA, 92103, United States, 1 619 543 5093, djmoore@health.ucsd.edu %K medication adherence %K behavior modification %K short message service %K mHealth %K HIV/AIDS %D 2020 %7 10.12.2020 %9 Original Paper %J JMIR Res Protoc %G English %X Background: African Americans are disproportionally affected by HIV and have poorer rates of antiretroviral therapy (ART) adherence compared to other racial or ethnic groups in the United States. Factors associated with poor HIV disease outcomes are commonly associated with sociostructural barriers that prevent engagement with and retention in HIV care. SMS text messaging interventions to promote ART adherence among predominantly non-Hispanic White persons with HIV (PWH) have been shown to be efficacious; however, limited research has been devoted to culturally tailoring interventions for underrepresented racial/ethnic groups. Considering African Americans show poorer engagement along the HIV care continuum, we developed an individualized and culturally tailored two-way SMS text messaging intervention to improve ART adherence and associated virologic suppression among African American PWH. Objective: In this paper we describe the protocol of a culturally tailored individualized Texting for Adherence Building (iTAB) intervention in a 24- to 48-week, single-arm study. Methods: We developed a culturally tailored iTAB intervention, which we are implementing in a 24- to 48-week, single-arm study. Participants were recruited from the Family Health Centers of San Diego (FHCSD), a federally qualified health center. Patient inclusion criteria were (1) receiving care at the FHCSD, (2) living with HIV, (3) self-identification as Black, African American, or of African ancestry, (4) English speaking, (5) age 18 or older, (6) currently on ART, and (7) able to provide informed consent. Study enrollment began in November 2017 and closed in July 2019. A total of 90 participants from the FHCSD enrolled in the iTAB intervention, and we anticipate completing data collection in July 2020. Participants were assisted in individualizing and customizing their SMS text message preferences at the baseline study visit. Self-assessment measures are collected at baseline, interim, and final study visits. Problems related to sending/receiving SMS text messages and barriers to ART adherence are assessed at each interim study visit. The FHCSD staff monitors and tracks participants’ daily SMS text message responses to ART adherence reminders using a clinical dashboard. Results: We hypothesize that the proportion of individuals achieving HIV virologic suppression (viral load <40 copies/mL) will be greater at the end of the intervention period compared to the proportion prior to study implementation. Additionally, we anticipate that rates of virologic suppression at the end of the intervention among participants receiving iTAB will be comparable to those among the general FHCSD non-African American population who did not receive iTAB. Finally, we anticipate a high response rate to iTAB SMS text messages as well as positive participant feedback at the end of the intervention with regard to the acceptability of, satisfaction with, and perceived efficacy of iTAB. Conclusions: The iTAB intervention is a novel individualized two-way SMS text messaging intervention that has been culturally tailored for use among African Americans with HIV. We anticipate that iTAB will demonstrate efficacy in future randomized control trials and will be supportive of medication adherence among other populations facing health disparities. International Registered Report Identifier (IRRID): DERR1-10.2196/21592 %M 33300885 %R 10.2196/21592 %U https://www.researchprotocols.org/2020/12/e21592 %U https://doi.org/10.2196/21592 %U http://www.ncbi.nlm.nih.gov/pubmed/33300885 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 9 %N 12 %P e20360 %T Mobile App (UPrEPU) to Monitor Adherence to Pre-exposure Prophylaxis in Men Who Have Sex With Men: Protocol for a User-Centered Approach to Mobile App Design and Development %A Strong,Carol %A Wu,Huei-Jiuan %A Tseng,Yuan-Chi %A Yuan,Chien-Wen %A Yu,Yi-Fang %A Liao,Jay Chiehen %A Chen,Yi-Wen %A Hung,Yi-Chen %A Li,Chia-Wen %A Huang,Po-Hsien %A Ko,Nai-Ying %A Ku,Stephane Wen-Wei %+ Department of Public Health, College of Medicine, National Cheng Kung University Hospital, 8F-8068, No 138, ShengLi Rd, North District, Tainan City, 704, Taiwan, 886 6 2353535 ext 5963, carol.chiajung@gmail.com %K mobile apps %K pre-exposure prophylaxis %K event-driven %K sexual behavior %K men who have sex with men %K user-centered design approach %D 2020 %7 1.12.2020 %9 Protocol %J JMIR Res Protoc %G English %X Background: Daily and on-demand pre-exposure prophylaxis (PrEP) has been well demonstrated to effectively prevent HIV acquisition for men who have sex with men (MSM). More than half of the MSM PrEP users in Taiwan prefer on-demand PrEP; however, on-demand PrEP involves a complicated dosing regimen because it requires precoital and postcoital dosing and sex events are hard to anticipate. Although there are a growing number of mobile apps designed to improve access to HIV prevention services and HIV medication adherence, few mobile apps focus on adherence to PrEP or are designed to accommodate a complicated, on-demand PrEP dosing schedule. Objective: The aim of this project is to evaluate the usability of a newly developed mobile app (UPrEPU) to assist MSM PrEP users to self-monitor their adherence to either daily or on-demand PrEP using a user-centered scheme. Methods: This research will be conducted in 2 phases: app development and usability study. In the app development phase, we will first conduct formative research with end users and stakeholders through in-depth interviews; the results will provide PrEP users’ and PrEP navigators’ personas as material used in the app conceptualization stage. PrEP navigators are individuals in the health care system that help HIV-negative individuals who need assistance in accessing PrEP care. A low-fidelity prototype of the app feature will be formatted by applying a participatory design approach to engage PrEP users, designers, and app developers in the design process of the app. Then, a high-fidelity prototype of the app will be developed for the usability study and refined iteratively by the multidisciplinary team and new internal testers. Internal testers include the research team consisting of experts in public health, infectious disease, and industrial design and a close network of the research team that is taking PrEP. In the usability study phase, we will enroll 70 MSM PrEP users and follow them up for 4 months. Usability, feasibility, and effectiveness of adherence monitoring will be evaluated. Results: Refinement of the UPrEPU app is currently ongoing. The usability study commenced in May 2020. Conclusions: The UPrEPU app is one of the first apps designed to help MSM PrEP users to self-manage their PrEP schedule better regardless of dosing modes. With a design-thinking approach and adapting to the cultural context in Taiwan’s MSM population, this novel app will have substantial potential to be acceptable and feasible and contribute to the reduction of new HIV infections. Trial Registration: ClinicalTrials.gov NCT04248790; https://clinicaltrials.gov/ct2/show/NCT04248790 International Registered Report Identifier (IRRID): PRR1-10.2196/20360 %M 33258793 %R 10.2196/20360 %U https://www.researchprotocols.org/2020/12/e20360 %U https://doi.org/10.2196/20360 %U http://www.ncbi.nlm.nih.gov/pubmed/33258793 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 12 %P e18074 %T Stakeholder Feedback of Electronic Medication Adherence Products: Qualitative Analysis %A Faisal,Sadaf %A Ivo,Jessica %A McDougall,Aidan %A Patel,Tejal %+ School of Pharmacy, University of Waterloo, 10 Victoria St S, Kitchener, ON, N2G 1C5, Canada, 1 519 888 4567 ext 21337, t5patel@uwaterloo.ca %K medication nonadherence %K technology %K aged %K patient preferences %K eHealth %K qualitative research %K adherence %D 2020 %7 1.12.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: Medication management among older adults continues to be a challenge, and innovative electronic medication adherence products have been developed to address this need. Objective: The aim of this study is to examine user experience with electronic medication adherence products, with particular emphasis on features, usefulness, and preferences. Methods: Older adults, caregivers, and health care providers tested the usability of 22 electronic medication adherence products. After testing 5 products, participants were invited to participate in a one-on-one interview to investigate their perceptions and experiences with the features, usefulness, and preference for electronic medication adherence products tested. The interviews were audio recorded, transcribed, and analyzed using exploratory inductive coding to generate themes. The first 13 interviews were independently coded by 2 researchers. The percentage agreement and Cohen kappa after analyzing those interviews were 79% and 0.79, respectively. A single researcher analyzed the remaining interviews. Results: Of the 37 participants, 21 (57%) were older adults, 5 (14%) were caregivers, and 11 (30%) were health care providers. The themes and subthemes generated from the qualitative analysis included product factors (subthemes: simplicity and product features, including availability and usability of alarms, portability, restricted access to medications, and storage capacity) and user factors (subthemes: sentiment, affordability, physical and cognitive capability, and technology literacy and learnability). Conclusions: Electronic medication adherence products have the potential to enable independent medication management in older adults. The choice of a particular product should be made after considering individual preferences for product features, affordability, and the sentiment of the users. Older adults, caregivers, and health care providers prefer electronic medication adherence products that are simple to set up and use, are portable, have easy-to-access medication compartments, are secure, and have adequate storage capacity. %M 33258778 %R 10.2196/18074 %U https://www.jmir.org/2020/12/e18074 %U https://doi.org/10.2196/18074 %U http://www.ncbi.nlm.nih.gov/pubmed/33258778 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 12 %P e22631 %T Mobile Texting and Lay Health Supporters to Improve Schizophrenia Care in a Resource-Poor Community in Rural China (LEAN Trial): Randomized Controlled Trial Extended Implementation %A Cai,Yiyuan %A Gong,Wenjie %A He,Hua %A Hughes,James P %A Simoni,Jane %A Xiao,Shuiyuan %A Gloyd,Stephen %A Lin,Meijuan %A Deng,Xinlei %A Liang,Zichao %A He,Wenjun %A Dai,Bofeng %A Liao,Jing %A Hao,Yuantao %A Xu,Dong (Roman) %+ School of Public Health, Sun Yat-sen University, No 74 Zhongshan Road 2, Yuexiu District, Guangzhou, China, 86 020 87335523, haoyt@mail.sysu.edu.cn %K medication adherence %K mobile texting %K lay health worker %K resource-poor community %K primary health care %K quality of care %K mHealth %K schizophrenia %D 2020 %7 1.12.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: Schizophrenia is a severe and disabling condition that presents a dire health equity challenge. Our initial 6-month trial (previously reported) using mobile texting and lay health supporters, called LEAN, significantly improved medication adherence from 0.48 to 0.61 (adjusted mean 0.11, 95% CI 0.03 to 0.20, P=.007) for adults with schizophrenia living in a resource-poor village in rural China. Objective: We explored the effectiveness of our texting program in improving participants’ medication adherence, functioning, and symptoms in an extended implementation of the intervention after its initial phase. Methods: In an approximated stepped-wedge wait-list design randomized controlled trial, 277 community-dwelling villagers with schizophrenia were assigned 1:1 in phase 1 into intervention and wait-list control groups. The intervention group received (1) lay health supporters (medication or care supervisors), (2) e-platform (mobile-texting reminders and education message) access, (3) a token gift for positive behavioral changes, and (4) integration with the existing government community-mental health program (the 686 Program) while the wait-listed control group initially only received the 686 Program. Subsequently (in the extended period), both groups received the LEAN intervention plus the 686 Program. The primary outcome was antipsychotic medication adherence (percentage of dosages taken over the past month assessed by unannounced home-based pill counts). The secondary outcomes were symptoms measured during visits to 686 Program psychiatrists using the Clinical Global Impression scale for schizophrenia and functioning measured by trained student assessors using the World Health Organization Disability Assessment Schedule 2.0. Other outcomes included data routinely collected in the 686 Program system (refill records, rehospitalization due to schizophrenia, death for any reason, suicide, wandering, and violent behaviors). We used intention-to-treat analysis and missing data were imputed. A generalized estimating equation model was used to assess program effects on antipsychotics medication adherence, symptoms, and functioning. Results: Antipsychotics medication adherence improved from 0.48 in the control period to 0.58 in the extended intervention period (adjusted mean difference 0.11, 95% CI 0.04 to 0.19; P=.004). We also noted an improvement in symptoms (adjusted mean difference –0.26, 95% CI –0.50 to –0.02; P=.04; Cohen d effect size 0.20) and a reduction in rehospitalization (0.37, 95% CI 0.18 to 0.76; P=.007; number-needed-to-treat 8.05, 95% CI 4.61 to 21.41). There was no improvement in functioning (adjusted mean difference 0.02, 95% CI –0.01 to 0.06; P=.18; Cohen d effect size 0.04). Conclusions: In an extended implementation, our intervention featuring mobile texting messages and lay health workers in a resource-poor community setting was more effective than the 686 Program alone in improving medication adherence, improving symptoms, and reducing rehospitalization. Trial Registration: Chinese Clinical Trial Registry; ChiCTR-ICR-15006053 https://tinyurl.com/y5hk8vng %M 33258788 %R 10.2196/22631 %U https://www.jmir.org/2020/12/e22631 %U https://doi.org/10.2196/22631 %U http://www.ncbi.nlm.nih.gov/pubmed/33258788 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 8 %N 11 %P e19154 %T Opportunities for Mobile App–Based Adherence Support for Children With Tuberculosis in South Africa %A Morse,Rachel M %A Myburgh,Hanlie %A Reubi,David %A Archey,Ava E %A Busakwe,Leletu %A Garcia-Prats,Anthony J %A Hesseling,Anneke C %A Jacobs,Stephanie %A Mbaba,Sharon %A Meyerson,Kyla %A Seddon,James A %A van der Zalm,Marieke M %A Wademan,Dillon T %A Hoddinott,Graeme %+ Desmond Tutu Tuberculosis Centre, Department of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Lower Level Clinical Building, Francie van Zijl Drive, Cape Town, 7505, South Africa, 27 823416810, hmyburgh@sun.ac.za %K eHealth %K mHealth %K tuberculosis %K pediatric tuberculosis %K adherence %D 2020 %7 11.11.2020 %9 Viewpoint %J JMIR Mhealth Uhealth %G English %X Tuberculosis is the number one infectious cause of death globally. Young children, generally those younger than 5 years, are at the highest risk of progressing from tuberculosis infection to tuberculosis disease and of developing the most severe forms of tuberculosis. Most current tuberculosis drug formulations have poor acceptability among children and require consistent adherence for prolonged periods of time. These challenges complicate children’s adherence to treatment and caregivers’ daily administration of the drugs. Rapid developments in mobile technologies and apps present opportunities for using widely available technology to support national tuberculosis programs and patient treatment adherence. Pilot studies have demonstrated that mobile apps are a feasible and acceptable means of enhancing children’s treatment adherence for other chronic conditions. Despite this, no mobile apps that aim to promote adherence to tuberculosis treatment have been developed for children. In this paper, we draw on our experiences carrying out research in clinical pediatric tuberculosis studies in South Africa. We present hypothetical scenarios of children’s adherence to tuberculosis medication to suggest priorities for behavioral and educational strategies that a mobile app could incorporate to address some of the adherence support gaps faced by children diagnosed with tuberculosis. We argue that a mobile app has the potential to lessen some of the negative experiences that children associate with taking tuberculosis treatment and to facilitate a more positive treatment adherence experience for children and their caregivers. %M 33174850 %R 10.2196/19154 %U https://mhealth.jmir.org/2020/11/e19154 %U https://doi.org/10.2196/19154 %U http://www.ncbi.nlm.nih.gov/pubmed/33174850 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 9 %N 11 %P e21659 %T Artificial Intelligence–Powered Smartphone App to Facilitate Medication Adherence: Protocol for a Human Factors Design Study %A Roosan,Don %A Chok,Jay %A Karim,Mazharul %A Law,Anandi V %A Baskys,Andrius %A Hwang,Angela %A Roosan,Moom R %+ Department of Pharmacy Practice and Administration, College of Pharmacy, Western University of Health Sciences, 309 E 2nd St, Pomona, CA, 91766, United States, 1 9094698778, droosan@westernu.edu %K artificial intelligence %K smartphone app %K patient cognition %K complex medication information %K medication adherence %K machine learning %K mobile phone %D 2020 %7 9.11.2020 %9 Protocol %J JMIR Res Protoc %G English %X Background: Medication Guides consisting of crucial interactions and side effects are extensive and complex. Due to the exhaustive information, patients do not retain the necessary medication information, which can result in hospitalizations and medication nonadherence. A gap exists in understanding patients’ cognition of managing complex medication information. However, advancements in technology and artificial intelligence (AI) allow us to understand patient cognitive processes to design an app to better provide important medication information to patients. Objective: Our objective is to improve the design of an innovative AI- and human factor–based interface that supports patients’ medication information comprehension that could potentially improve medication adherence. Methods: This study has three aims. Aim 1 has three phases: (1) an observational study to understand patient perception of fear and biases regarding medication information, (2) an eye-tracking study to understand the attention locus for medication information, and (3) a psychological refractory period (PRP) paradigm study to understand functionalities. Observational data will be collected, such as audio and video recordings, gaze mapping, and time from PRP. A total of 50 patients, aged 18-65 years, who started at least one new medication, for which we developed visualization information, and who have a cognitive status of 34 during cognitive screening using the TICS-M test and health literacy level will be included in this aim of the study. In Aim 2, we will iteratively design and evaluate an AI-powered medication information visualization interface as a smartphone app with the knowledge gained from each component of Aim 1. The interface will be assessed through two usability surveys. A total of 300 patients, aged 18-65 years, with diabetes, cardiovascular diseases, or mental health disorders, will be recruited for the surveys. Data from the surveys will be analyzed through exploratory factor analysis. In Aim 3, in order to test the prototype, there will be a two-arm study design. This aim will include 900 patients, aged 18-65 years, with internet access, without any cognitive impairment, and with at least two medications. Patients will be sequentially randomized. Three surveys will be used to assess the primary outcome of medication information comprehension and the secondary outcome of medication adherence at 12 weeks. Results: Preliminary data collection will be conducted in 2021, and results are expected to be published in 2022. Conclusions: This study will lead the future of AI-based, innovative, digital interface design and aid in improving medication comprehension, which may improve medication adherence. The results from this study will also open up future research opportunities in understanding how patients manage complex medication information and will inform the format and design for innovative, AI-powered digital interfaces for Medication Guides. International Registered Report Identifier (IRRID): PRR1-10.2196/21659 %M 33164898 %R 10.2196/21659 %U http://www.researchprotocols.org/2020/11/e21659/ %U https://doi.org/10.2196/21659 %U http://www.ncbi.nlm.nih.gov/pubmed/33164898 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 8 %N 10 %P e17470 %T Patients’ Experiences of Using Smartphone Apps to Support Self-Management and Improve Medication Adherence in Hypertension: Qualitative Study %A McBride,Ciara M %A Morrissey,Eimear C %A Molloy,Gerard J %+ School of Psychology, National Univeristy of Ireland Galway, University Road, Galway, H91 TK33, Ireland, 353 91524411, mcbrideciara5@gmail.com %K hypertension %K self-management %K mobile applications %K feasibility %K usability %K medication adherence %K qualitative research %K digital technology %K mobile phone %D 2020 %7 28.10.2020 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Worldwide, hypertension control rates remain suboptimal despite clinically effective antihypertensive drug therapy. Patient failure to take medication as prescribed (ie, nonadherence) is the most important factor contributing to poor control. Smartphone apps can facilitate the delivery of evidence-based behavior change techniques to improve adherence and may provide a scalable, usable, and feasible method to deliver self-management support. Objective: The aim of this study is to explore patients’ experiences of the usability and feasibility of smartphone apps to support self-management and improve medication adherence in hypertension. Methods: A qualitative descriptive study was conducted. A total of 11 people living with hypertension from the West of Ireland were sampled purposively and interviewed about their experience of using a self-management app for a 4-week period, which included two key functionalities: self-monitoring of blood pressure (BP) and medication reminders. Thematic analysis was carried out on the semistructured interview data. Results: Participants’ age ranged from 43 to 74 years (mean 62 years, SD 9.13). Three themes were identified: digital empowerment of self-management, human versus digital systems, and digital sustainability. Although patients’ experience of using the technology to self-monitor BP was one of empowerment, characterized by an enhanced insight and understanding into their condition, control, and personal responsibility, the reminder function was only feasible for patients who reported unintentional nonadherence to treatment. Patients experienced the app as a sustainable tool to support self-management and found it easy to use, including those with limited technological competence. Conclusions: The study’s findings provide new insights into the experience of using apps to support medication adherence in hypertension. Overall, the data support apps as a usable and feasible method to aid self-management of hypertension and highlight the need for personalized functionality, particularly with regard to medication adherence reminder strategies. The study’s findings challenge the perspective that the use of these technologies to support self-management can inevitably add to the burden of treatment experienced by patients. %M 33112251 %R 10.2196/17470 %U http://mhealth.jmir.org/2020/10/e17470/ %U https://doi.org/10.2196/17470 %U http://www.ncbi.nlm.nih.gov/pubmed/33112251 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 8 %N 10 %P e21759 %T The Effect of Smartphone App–Based Interventions for Patients With Hypertension: Systematic Review and Meta-Analysis %A Xu,Hongxuan %A Long,Huanyu %+ The Key Laboratory of Geriatrics, Beijing Institute of Geriatrics, Beijing Hospital, National Center of Gerontology, National Health Commission, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, No 1 DaHua Road, Dong Dan, Beijing, 100730, China, 86 13524791942, xueramber@gmail.com %K hypertension %K smartphone %K blood pressure %K mobile %K lifestyle %K adherence %K smartphone app %K medication adherence %D 2020 %7 19.10.2020 %9 Review %J JMIR Mhealth Uhealth %G English %X Background: Hypertension is a major cause of cardiovascular disease, which is the leading cause of premature death. People with hypertension who do not comply with recommended treatment strategies have a higher risk of heart attacks and strokes, leading to hospitalization and consequently greater health care costs. The smartphone, which is now ubiquitous, offers a convenient tool to aid in the treatment of hypertension through the use of apps targeting lifestyle management, and such app-based interventions have shown promising results. In particular, recent evidence has shown the feasibility, acceptability, and success of digital interventions in changing the behavior of people with chronic conditions. Objective: The aim of this study was to systematically compile available evidence to determine the overall effect of smartphone apps on blood pressure control, medication adherence, and lifestyle changes for people with hypertension. Methods: This systematic review was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) statement guidelines. Databases were searched to identify randomized controlled trials related to the influence of an app-based intervention in people with hypertension. Data extracted from the included studies were subjected to a meta-analysis to compare the effects of the smartphone app intervention to a control. Results: Eight studies with a total of 1657 participants fulfilled the inclusion criteria. Pooled analysis of 6 studies assessing systolic blood pressure showed a significant overall effect in favor of the smartphone intervention (weighted mean difference –2.28, 95% CI –3.90-0.66). Pooled analysis of studies assessing medication adherence demonstrated a significant effect (P<.001) in favor of the intervention group (standard mean difference 0.38, 95% CI 0.26-0.50) with low heterogeneity (I2=0%). No difference between groups was demonstrated with respect to physical activity. Conclusions: A smartphone intervention leads to a reduction in blood pressure and an increase in medication adherence for people with hypertension. Future research should focus on the effect of behavior coaching apps on medication adherence, lifestyle change, and blood pressure reduction. %M 33074161 %R 10.2196/21759 %U http://mhealth.jmir.org/2020/10/e21759/ %U https://doi.org/10.2196/21759 %U http://www.ncbi.nlm.nih.gov/pubmed/33074161 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 8 %N 10 %P e20480 %T Effect of a Mobile App for the Pharmacotherapeutic Follow-Up of Patients With Cancer on Their Health Outcomes: Quasi-Experimental Study %A Collado-Borrell,Roberto %A Escudero-Vilaplana,Vicente %A Ribed,Almudena %A Gonzalez-Anleo,Cristina %A Martin-Conde,Maite %A Romero-Jimenez,Rosa %A Iglesias-Peinado,Irene %A Herranz-Alonso,Ana %A Sanjurjo-Saez,Maria %+ Hospital General Universitario Gregorio Marañon, Dr. Esquerdo 46, Madrid, Spain, 34 915867714, vicente.escudero@salud.madrid.org %K e-OncoSalud %K app %K smartphone %K oral antineoplastic agent %K oncology %D 2020 %7 16.10.2020 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Oral antineoplastic agents (OAAs) have revolutionized cancer management. However, they have been reported with adverse side effects and drug-drug interactions. Moreover, patient adherence to OAA treatment is critical. Mobile apps can enable remote and real-time pharmacotherapeutic monitoring of patients, while also promoting patient autonomy in their health care. Objective: The primary objective was to analyze the effect of using a mobile app for the follow-up of patients with oncohematological malignancies undergoing treatment with OAAs on their health outcomes. The secondary objectives were to analyze the role of the app in communication with health care professionals and patient satisfaction with the app. Methods: We performed a comparative, quasi-experimental study based on a prepost intervention with 101 patients (control group, n=51, traditional pharmacotherapeutic follow-up vs intervention group, n=50, follow-up through e-OncoSalud, a custom-designed app that promotes follow-up at home and the safety of patients receiving OAAs). The effect of this app on drug safety, adherence to treatment, and quality of life was evaluated. Results: With regard to drug safety, 73% (37/51) of the patients in the control group and 70% (35/50) of the patients in the intervention group (P=.01) presented with drug-related problems. The probability of detecting an insufficiently treated health problem in the intervention group was significantly higher than that in the control group (P=.04). The proportion of patients who presented with side effects in the intervention group was significantly lower than that in the control group (P>.99). In the control group, 49% (25/51) of the patients consumed some health resources during the first 6 months of treatment compared with 36% (18/50) of the patients in the intervention group (P=.76). Adherence to treatment was 97.6% (SD 7.9) in the intervention group, which was significantly higher than that in the control group (92.9% [SD 10.0]; P=.02). The EuroQol-5D in the intervention group yielded a mean (SD) index of 0.875 (0.156), which was significantly higher than that in the control group (0.741 [0.177]; P<.001). Approximately 60% (29/50) of the patients used the messaging module to communicate with pharmacists. The most frequent types of messages were acknowledgments (77/283, 27.2%), doubts about contraindications and interactions with OAAs (70/283, 24.7%), and consultations for adverse reactions to treatment (39/283, 13.8%). The satisfaction with the app survey conducted in the intervention group yielded an overall mean (SD) score of 9.1 (0.4) out of 10. Conclusions: Use of e-OncoSalud for the real-time follow-up of patients receiving OAAs facilitated the optimization of some health outcomes. The intervention group had significantly higher health-related quality of life and adherence to treatment than the control group. Further, the probability of the intervention group presenting with side effects was significantly lower than that of the control group. %M 33064100 %R 10.2196/20480 %U http://mhealth.jmir.org/2020/10/e20480/ %U https://doi.org/10.2196/20480 %U http://www.ncbi.nlm.nih.gov/pubmed/33064100 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 8 %N 10 %P e22733 %T Event-Level Association Between Daily Alcohol Use and Same-Day Nonadherence to Antiretroviral Therapy Among Young Men Who Have Sex With Men and Trans Women Living With HIV: Intensive Longitudinal Study %A Turner,Caitlin Marie %A Trujillo,Dillon %A Le,Victory %A Wilson,Erin C %A Arayasirikul,Sean %+ Trans Research Unit for Equity, Center for Public Health Research, San Francisco Department of Public Health, 25 Van Ness, Ste 500, San Francisco, CA, 94102, United States, 1 4155549018, caitlin.turner@sfdph.org %K ecological momentary assessment %K event-level %K alcohol %K antiretroviral therapy %K men who have sex with men %K trans women %K adherence %D 2020 %7 15.10.2020 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Young trans women (TW) and men who have sex with men (MSM) are disproportionately impacted by HIV. Optimizing adherence to antiretroviral therapy (ART) is one mechanism by which public health experts aim to achieve favorable HIV health outcomes while reducing disease transmission. However, alcohol use is prevalent among young TW and MSM and threatens optimal adherence. In addition, the daily variations in alcohol use and ART adherence and their association with each other are poorly understood, warranting more appropriate methodological approaches, such as analysis of ecological momentary assessment (EMA) data. Objective: The aim of this analysis is to characterize the association between daily alcohol use and same-day ART nonadherence captured by an EMA study of young MSM and TW living with HIV in San Francisco. Methods: Young MSM and TW enrolled in the Health eNav digital HIV care navigation intervention were included in the analytic sample (N=113). Data on alcohol and ART use were collected by daily EMA surveys administered via text messaging and were analyzed over 30 days of follow-up. A multivariable mixed-effects logistic regression model adjusting for baseline sociodemographic characteristics was specified to investigate whether daily alcohol use was associated with same-day ART nonuse. Results: Daily alcohol use was associated with higher same-day ART nonuse. On average, participants drank alcohol on 15.20 (SD 8.93) days and used ART on 15.19 (SD 10.16) days out of 30 days. Daily alcohol use was associated with 1.89 (95% CI 1.14-3.15) times the adjusted odds of same-day ART nonuse for each participant. Conclusions: Results are consistent with other analyses of daily alcohol and ART use and underscore the importance of individually targeted interventions that are sensitive to each participant’s dynamic risk environment. International Registered Report Identifier (IRRID): RR2-10.2196/16406 %M 33055070 %R 10.2196/22733 %U http://mhealth.jmir.org/2020/10/e22733/ %U https://doi.org/10.2196/22733 %U http://www.ncbi.nlm.nih.gov/pubmed/33055070 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 10 %P e19179 %T Measurement Properties of Existing Patient-Reported Outcome Measures on Medication Adherence: Systematic Review %A Kwan,Yu Heng %A Weng,Si Dun %A Loh,Dionne Hui Fang %A Phang,Jie Kie %A Oo,Livia Jia Yi %A Blalock,Dan V %A Chew,Eng Hui %A Yap,Kai Zhen %A Tan,Corrinne Yong Koon %A Yoon,Sungwon %A Fong,Warren %A Østbye,Truls %A Low,Lian Leng %A Bosworth,Hayden Barry %A Thumboo,Julian %+ Program in Health Services and Systems Research,, Duke-NUS Medical School, 8 College Road, Singapore, 169857, Singapore, 65 63778465, yuheng_02071988@hotmail.com %K systematic review %K reliability and validity %K medication adherence %K patient reported outcome measures %D 2020 %7 9.10.2020 %9 Review %J J Med Internet Res %G English %X Background: Medication adherence is essential for improving the health outcomes of patients. Various patient-reported outcome measures (PROMs) have been developed to measure medication adherence in patients. However, no study has summarized the psychometric properties of these PROMs to guide selection for use in clinical practice or research. Objective: This study aims to evaluate the quality of the PROMs used to measure medication adherence. Methods: This study was guided by the PRISMA (Preferred Reporting Items for Systematic Review and Meta-Analysis) guidelines. Relevant articles were retrieved from the EMBASE, PubMed, Cochrane Library, Web of Science, and CINAHL (Cumulative Index to Nursing and Allied Health Literature) databases. The PROMs were then evaluated based on the COnsensus-based Standards for the selection of health Measurement Instruments (COSMIN) guidelines. Results: A total of 121 unique medication adherence PROMs from 214 studies were identified. Hypotheses testing for construct validity and internal consistency were the most frequently assessed measurement properties. PROMs with at least a moderate level of evidence for ≥5 measurement properties include the Adherence Starts with Knowledge 20, Compliance Questionnaire-Rheumatology, General Medication Adherence Scale, Hill-Bone Scale, Immunosuppressant Therapy Barrier Scale, Medication Adherence Reasons Scale (MAR-Scale) revised, 5-item Medication Adherence Rating Scale (MARS-5), 9-item MARS (MARS-9), 4-item Morisky Medication Adherence Scale (MMAS-4), 8-item MMAS (MMAS-8), Self-efficacy for Appropriate Medication Adherence Scale, Satisfaction with Iron Chelation Therapy, Test of Adherence to Inhalers, and questionnaire by Voils. The MAR-Scale revised, MMAS-4, and MMAS-8 have been administered electronically. Conclusions: This study identified 121 PROMs for medication adherence and provided synthesized evidence for the measurement properties of these PROMs. The findings from this study may assist clinicians and researchers in selecting suitable PROMs to assess medication adherence. %M 33034566 %R 10.2196/19179 %U https://www.jmir.org/2020/10/e19179 %U https://doi.org/10.2196/19179 %U http://www.ncbi.nlm.nih.gov/pubmed/33034566 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 8 %N 10 %P e18985 %T A Mobile App Specifically Designed to Facilitate Exercise in Parkinson Disease: Single-Cohort Pilot Study on Feasibility, Safety, and Signal of Efficacy %A Landers,Merrill R %A Ellis,Terry D %+ Department of Physical Therapy, School of Integrative Health Sciences, University of Nevada, Las Vegas, 4505 Maryland Parkway, Box 453029, Las Vegas, NV, 89154, United States, 1 7028951377, merrill.landers@unlv.edu %K Parkinson disease %K smartphone %K mobile phone %K telehealth %K telerehabilitation %K digital health %K physical therapy %D 2020 %7 5.10.2020 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Many people with Parkinson disease do not have access to exercise programs that are specifically tailored to their needs and capabilities. This mobile app allows people with Parkinson disease to access Parkinson disease–specific exercises that are individually tailored using in-app demographic questions and performance tests which are fed into an algorithm which in turn produces a video-guided exercise program. Objective: To test the feasibility, safety, and signal of efficacy of a mobile app that facilitates exercise for people with Parkinson disease. Methods: A prospective, single-cohort design of people with Parkinson disease who had downloaded the 9zest app for exercise was used for this 12-week pilot study. Participants, who were recruited online, were encouraged to exercise with the full automated app for ≥150 minutes each week. The primary endpoints were feasibility (app usage and usability questions) and safety (adverse events and falls). The primary endpoints for signal of efficacy were a comparison of the in-app baseline and 8-week outcomes on the 30-second Sit-To-Stand (STS) test, Timed Up and Go (TUG) test, and the Parkinson’s Disease Questionnaire 8 (PDQ8). Results: For feasibility, of the 28 participants that completed the study, 12 participants averaged >150 minutes of app usage per week (3 averaged 120-150, 4 averaged 90-120, and 9 averaged less than 90 minutes). A majority of participants (>74%) felt the exercise was of value (16/19; 9 nonrespondents), provided adequate instruction (14/19; 9 nonrespondents), and was appropriate for level of function (16/19; 9 nonrespondents). For safety, there were no serious adverse events that occurred during the app-guided exercise. There were 4 reports of strain/sprain injuries while using the app among 3 participants, none of which necessitated medical attention. For signal of efficacy, there was improvement for each of the primary endpoints: STS (P=.01), TUG (P<.001), and PDQ8 (P=.01). Conclusions: Independent, video-guided exercise using a mobile app designed for exercise in Parkinson disease was safe and feasible though there was variability in app usage. Despite this, the results provide evidence for a signal of efficacy as there were improvements in 3 of the 3 outcomes. Trial Registration: ClinicalTrials.gov NCT03459586; https://clinicaltrials.gov/ct2/show/NCT03459586 %M 33016887 %R 10.2196/18985 %U https://mhealth.jmir.org/2020/10/e18985 %U https://doi.org/10.2196/18985 %U http://www.ncbi.nlm.nih.gov/pubmed/33016887 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 8 %N 10 %P e18351 %T An Interactive Text Messaging Intervention to Improve Adherence to Option B+ Prevention of Mother-to-Child HIV Transmission in Kenya: Cost Analysis %A Chen,Yilin %A Ronen,Keshet %A Matemo,Daniel %A Unger,Jennifer A %A Kinuthia,John %A John-Stewart,Grace %A Levin,Carol %+ Department of Global Health, University of Washington, 1959 NE Pacific St, Seattle, WA, 98105, United States, 1 206 744 3790, clevin@uw.edu %K mHealth %K cost analysis %K prevention of mother-to-child transmission %K antiretroviral therapy adherence %K Kenya %K mobile phone %D 2020 %7 2.10.2020 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Mobile health (mHealth) approaches offer potentially affordable ways to support the care of HIV-infected patients in overstretched health care systems. However, only few studies have analyzed the costs associated with mHealth solutions for HIV care. Objective: The aim of this study was to estimate the total incremental costs and incremental cost per beneficiary of an interactive SMS text messaging support intervention within a clinical trial. Methods: The Mobile WAChX trial (NCT02400671) evaluates an interactive semiautomated SMS text messaging intervention to improve adherence to antiretroviral therapy and retention in care among peripartum women infected with HIV in Kenya to reduce the mother-to-child transmission of HIV. Women were randomized to receive one-way versus two-way SMS text messages. Messages were sent weekly, and these messages included motivational and educational content and visit reminders; two-way messaging enabled prompt consultation with the nurse as needed. Microcosting methods were used to collect resource-use data related to implementing the Mobile WAChX SMS text messaging intervention. At 2 sites (Nairobi and Western Kenya), we conducted semistructured interviews with health personnel to identify startup and recurrent activities by obtaining information on the personnel, supplies, and equipment. Data on expenditures and prices from project expense reports, administrative records, and published government salary data were included to estimate the total incremental costs. Using a public provider perspective, we estimated incremental unit costs per beneficiary and per contact during 2017. Results: The weighted average annual incremental costs for the two-way SMS text messaging group were US $3725 per facility, US $62 per beneficiary, and US $0.85 per contact to reach 115 beneficiaries. For the one-way SMS text messaging group, the weighted average annual incremental costs were US $2542 per facility, US $41 per beneficiary, and US $0.66 per contact to reach 117 beneficiaries. The largest cost shares were for the personnel: 48.2% (US $1794/US $3725) in two-way and 32.4% (US $825/US $2542) in one-way SMS text messaging groups. Costs associated with software development and communication accounted for 29.9% (US $1872/US $6267) of the costs in both intervention arms (US $1042 vs US $830, respectively). Conclusions: Cost information for budgeting and financial planning is relevant for implementing mHealth interventions in national health plans. Given the proportion of costs related to systems development, it is likely that costs per beneficiary will decline with the scale-up of the interventions. %M 33006562 %R 10.2196/18351 %U https://mhealth.jmir.org/2020/10/e18351 %U https://doi.org/10.2196/18351 %U http://www.ncbi.nlm.nih.gov/pubmed/33006562 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 9 %P e21749 %T Behavior Change Text Messages for Home Exercise Adherence in Knee Osteoarthritis: Randomized Trial %A Bennell,Kim %A Nelligan,Rachel K %A Schwartz,Sarah %A Kasza,Jessica %A Kimp,Alexander %A Crofts,Samuel JC %A Hinman,Rana S %+ Department of Physiotherapy, University of Melbourne, Centre for Health, Exercise and Sports Medicine, Level 7, Alan Gilbert Building, 161 Barry St, Carlton, 3053, Australia, 61 383444135, k.bennell@unimelb.edu.au %K knee osteoarthritis %K exercise %K patient compliance %K mobile phone %K randomized controlled trial %D 2020 %7 28.9.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: Exercise is a core recommended treatment for knee osteoarthritis (OA), yet adherence declines, particularly following cessation of clinician supervision. Objective: This study aims to evaluate whether a 24-week SMS intervention improves adherence to unsupervised home exercise in people with knee OA and obesity compared with no SMS. Methods: A two-group superiority randomized controlled trial was performed in a community setting. Participants were people aged 50 years with knee OA and BMI ≥30 kg/m2 who had undertaken a 12-week physiotherapist-supervised exercise program as part of a preceding clinical trial. Both groups were asked to continue their home exercise program unsupervised three times per week for 24 weeks and were randomly allocated to a behavior change theory–informed, automated, semi-interactive SMS intervention addressing exercise barriers and facilitators or to control (no SMS). Primary outcomes were self-reported home exercise adherence at 24 weeks measured by the Exercise Adherence Rating Scale (EARS) Section B (0-24, higher number indicating greater adherence) and the number of days exercised in the past week (0-3). Secondary outcomes included self-rated adherence (numeric rating scale), knee pain, physical function, quality of life, global change, physical activity, self-efficacy, pain catastrophizing, and kinesiophobia. Results: A total of 110 participants (56 SMS group and 54 no SMS) were enrolled and 99 (90.0%) completed both primary outcomes (48/56, 86% SMS group and 51/54, 94% no SMS). At 24 weeks, the SMS group reported higher EARS scores (mean 16.5, SD 6.5 vs mean 13.3, SD 7.0; mean difference 3.1, 95% CI 0.8-5.5; P=.01) and more days exercised in the past week (mean 1.8, SD 1.2 vs mean 1.3, SD 1.2; mean difference 0.6, 95% CI 0.2-1.0; P=.01) than the control group. There was no evidence of between-group differences in secondary outcomes. Conclusions: An SMS program increased self-reported adherence to unsupervised home exercise in people with knee OA and obesity, although this did not translate into improved clinical outcomes. Trial Registration: Australian New Zealand Clinical Trials Registry 12617001243303; https://tinyurl.com/y2ud7on5 International Registered Report Identifier (IRRID): RR2-10.1186/s12891-019-2801-z %M 32985994 %R 10.2196/21749 %U http://www.jmir.org/2020/9/e21749/ %U https://doi.org/10.2196/21749 %U http://www.ncbi.nlm.nih.gov/pubmed/32985994 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 8 %N 9 %P e17135 %T Development and Evaluation of a Tailored Mobile Health Intervention to Improve Medication Adherence in Black Patients With Uncontrolled Hypertension and Type 2 Diabetes: Pilot Randomized Feasibility Trial %A Schoenthaler,Antoinette %A Leon,Michelle %A Butler,Mark %A Steinhaeuser,Karsten %A Wardzinski,William %+ Department of Population Health, NYU School of Medicine, Center for Healthful Behavior Change, NYU Langone Health, 180 Madison Ave, 7th floor, New York, NY, 10016, United States, 1 6465013434, antoinette.schoenthaler@nyumc.org %K mHealth %K medication adherence %K hypertension %K type 2 diabetes %K African Americans %D 2020 %7 23.9.2020 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Research has underscored the need to develop socioculturally tailored interventions to improve adherence behaviors in minority patients with hypertension (HTN) and type 2 diabetes (T2D). Novel mobile health (mHealth) approaches are potential methods for delivering tailored interventions to minority patients with increased cardiovascular risk. Objective: This study aims to develop and evaluate the acceptability and preliminary efficacy of a tailored mHealth adherence intervention versus attention control (AC) on medication adherence, systolic blood pressure (SBP), diastolic blood pressure (DBP), and hemoglobin A1c (HbA1c) at 3 months in 42 Black patients with uncontrolled HTN and/or T2D who were initially nonadherent to their medications. Methods: This was a two-phase pilot study consisting of a formative phase and a clinical efficacy phase. The formative phase consisted of qualitative interviews with 10 members of the target patient population (7/10, 70% female; mean age 65.8 years, SD 5.6) to tailor the intervention based on the Information-Motivation-Behavioral skills model of adherence. The clinical efficacy phase consisted of a 3-month pilot randomized controlled trial to evaluate the tailored mHealth intervention versus an AC. The tablet-delivered intervention included a tailoring survey, an individualized adherence profile, and a personalized list of interactive adherence-promoting modules, whereas AC included the tailoring survey and health education videos delivered on the tablet. Acceptability was assessed through semistructured exit interviews. Medication adherence was assessed using the 8-item Morisky Medication Adherence Scale, whereas blood pressure and HbA1c were assessed using automated devices. Results: In phase 1, thematic analysis of the semistructured interviews revealed the following 5 major barriers to adherence: disruptions in daily routine, forgetfulness, concerns about adverse effects, preference for natural remedies, and burdens of medication taking. Patients recommended the inclusion of modules that address improving patient-provider communication, peer vignettes, and stress reduction strategies to facilitate adherence. A total of 42 Black patients (23/42, 55% male; mean age 57.6 years, SD 11.1) participated in the clinical efficacy pilot trial. At 3 months, both groups showed significant improvements in adherence (mean 1.35, SD 1.60; P<.001) and SBP (−4.76 mm Hg; P=.04) with no between-group differences (P=.50 and P=.10). The decreases in DBP and HbA1c over time were nonsignificant (−1.97 mm Hg; P=.20; and −0.2%; P=.45, respectively). Patients reported high acceptability of the intervention for improving their adherence. Conclusions: This pilot study demonstrated preliminary evidence on the acceptability of a tailored mHealth adherence intervention among a sample of Black patients with uncontrolled HTN and T2D who were initially nonadherent to their medications. Future research should explore whether repeated opportunities to use the mHealth intervention would result in improvements in behavioral and clinical outcomes over time. Modifications to the intervention as a result of the pilot study should guide future efforts. Trial Registration: ClinicalTrials.gov NCT01643473; http://clinicaltrials.gov/ct2/show/ NCT01643473 %M 32965230 %R 10.2196/17135 %U http://mhealth.jmir.org/2020/9/e17135/ %U https://doi.org/10.2196/17135 %U http://www.ncbi.nlm.nih.gov/pubmed/32965230 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 9 %N 9 %P e18640 %T A Mobile Gaming Intervention for Persons on Pre-Exposure Prophylaxis: Protocol for Intervention Development and Randomized Controlled Trial %A Whiteley,Laura %A Olsen,Elizabeth %A Mena,Leandro %A Haubrick,Kayla %A Craker,Lacey %A Hershkowitz,Dylan %A Brown,Larry K %+ Department of Psychiatry and Human Behavior, Warren Alpert Medical School, Brown University, 700 Butler Drive, Providence, RI, , United States, 1 401 455 6430, laura_whiteley@brown.edu %K pre-exposure prophylaxis (PrEP) %K adherence %K mobile gaming intervention %K HIV prevention %K men who have sex with men (MSM) %D 2020 %7 14.9.2020 %9 Protocol %J JMIR Res Protoc %G English %X Background: In the United States, young minority men who have sex with men (MSM) are the most likely to become infected with HIV. Pre-exposure prophylaxis (PrEP) is an efficacious and promising prevention strategy. However, PrEP’s safety and effectiveness can be greatly compromised by suboptimal adherence to treatment. To maximize the positive impact of PrEP, it is necessary to combine its prescription with cost-effective behavioral interventions that promote adherence and decrease HIV risk behaviors. In this project, we developed a theoretically informed app/gaming intervention to engage young MSM in learning information, practicing behaviors, and improving motivation for HIV preventative behaviors and PrEP adherence. Objective: The goal of this project was to develop and test a cutting-edge, engaging, and entertaining app/gaming intervention for improving adherence to PrEP and building HIV prevention knowledge, skills, and behavior. Methods: This study was conducted in two phases. In the developmental phase, we conducted qualitative interviews with young MSM (n=20) to guide the development of the gaming intervention. In the randomized controlled trial, we tested the preliminary efficacy of the gaming intervention compared to a comparison condition among young MSM. Subjects were recruited from the University of Mississippi Medical Center HIV/STI testing clinics (n=60). Results: Institutional review board approval was received in February 2015. Research activities began in June 2015 and are still ongoing. Conclusions: This app/gaming intervention aimed to improve PrEP adherence and HIV preventative behaviors in young MSM. Engaging young MSM in learning information, practicing behaviors, and improving motivation for increased adherence to PrEP has the potential to decrease HIV seroconversion. It is important to develop interventions that are enjoyable, engaging, and easily incorporated into clinical settings. Trial Registration: ClinicalTrials.gov RCT02611362; https://tinyurl.com/y65gkuwr International Registered Report Identifier (IRRID): DERR1-10.2196/18640 %M 32924954 %R 10.2196/18640 %U http://www.researchprotocols.org/2020/9/e18640/ %U https://doi.org/10.2196/18640 %U http://www.ncbi.nlm.nih.gov/pubmed/32924954 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 7 %N 9 %P e21378 %T Detection of Behavioral Anomalies in Medication Adherence Patterns Among Patients With Serious Mental Illness Engaged With a Digital Medicine System %A Knights,Jonathan %A Heidary,Zahra %A Cochran,Jeffrey M %+ Otsuka Pharmaceutical Development & Commercialization, 508 Carnegie Center Drive, Princeton, NJ, 08540, United States, 1 6095246788, jonathan.knights@otsuka-us.com %K digital medicine %K mobile phone %K entropy rate %K Markov chains %K medication adherence %K contextual anomaly %K psychiatric disorders %D 2020 %7 10.9.2020 %9 Original Paper %J JMIR Ment Health %G English %X Background: Adherence to medication is often represented in the form of a success percentage over a period of time. Although noticeable changes to aggregate adherence levels may be indicative of unstable medication behavior, a lack of noticeable changes in aggregate levels over time does not necessarily indicate stability. The ability to detect developing changes in medication-taking behavior under such conditions in real time would allow patients and care teams to make more timely and informed decisions. Objective: This study aims to develop a method capable of identifying shifts in behavioral (medication) patterns at the individual level and subsequently assess the presence of such shifts in retrospective clinical trial data from patients with serious mental illness. Methods: We defined the term adherence volatility as “the degree to which medication ingestion behavior fits expected behavior based on historically observed data” and defined a contextual anomaly system around this concept, leveraging the empirical entropy rate of a stochastic process as the basis for formulating anomaly detection. For the presented methodology, each patient’s evolving behavior is used to dynamically construct the expectation bounds for each future interval, eliminating the need to rely on model training or a static reference sequence. Results: Simulations demonstrated that the presented methodology identifies anomalous behavior patterns even when aggregate adherence levels remain constant and highlight the temporal dependence inherent in these anomalies. Although a given sequence of events may present as anomalous during one period, that sequence should subsequently contribute to future expectations and may not be considered anomalous at a later period—this feature was demonstrated in retrospective clinical trial data. In the same clinical trial data, anomalous behavioral shifts were identified at both high- and low-adherence levels and were spread across the whole treatment regimen, with 77.1% (81/105) of the population demonstrating at least one behavioral anomaly at some point in their treatment. Conclusions: Digital medicine systems offer new opportunities to inform treatment decisions and provide complementary information about medication adherence. This paper introduces the concept of adherence volatility and develops a new type of contextual anomaly detection, which does not require an a priori definition of normal and allows expectations to evolve with shifting behavior, removing the need to rely on training data or static reference sequences. Retrospective analysis from clinical trial data highlights that such an approach could provide new opportunities to meaningfully engage patients about potential shifts in their ingestion behavior; however, this framework is not intended to replace clinical judgment, rather to highlight elements of data that warrant attention. The evidence provided here identifies new areas for research and seems to justify additional explorations in this area. %M 32909950 %R 10.2196/21378 %U https://mental.jmir.org/2020/9/e21378 %U https://doi.org/10.2196/21378 %U http://www.ncbi.nlm.nih.gov/pubmed/32909950 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 8 %N 8 %P e14739 %T mHealth Interventions to Promote Anti-Retroviral Adherence in HIV: Narrative Review %A Lee,Stephen B %A Valerius,Joanne %+ Department of Medicine, Division of Infectious Diseases, University of Saskatchewan College of Medicine, Regina General Hospital, Unit 4E, Regina, SK, S4P 0W5, Canada, 1 306 766 4247, leestephenz@gmail.com %K mHealth %K HIV %K antiretroviral %K adherence %K mobile phone %D 2020 %7 28.8.2020 %9 Review %J JMIR Mhealth Uhealth %G English %X Background: Antiretrovirals (ARVs) are key in the management of HIV. Although no cure exists, ARVs help patients live healthy lives and prevent transmission to others. Adherence to complex regimens is paramount to outcomes and in avoiding the emergence of drug-resistant viruses. The goal of therapy is to reach an undetectable viral load. However, adherence is a common problem, stemming from issues such as mental health, chaotic home situations, and busy work schedules. Mobile health (mHealth) represents a new approach in improving medication adherence, and multiple studies have been performed in this area. Objective: This study aims to review the current implementation of mHealth in the management of HIV among different groups of patients. Methods: We used PubMed, Academic Search Elite, and 1 journal database with various search terms to review the current implementation of mHealth in HIV care. Results: Titles and abstracts were screened, and 61 papers were identified and fully reviewed. The literature was divided into lower- and higher-income nations, as defined by the United Nations. A total of 20 studies with quantitative results were identified, with 10 being text- and SMS-based interventions (the majority of these being in lower-income countries) and 8 being smartphone-based apps (primarily in higher-income countries). The majority of these studies determined whether there was an effect on adherence or biochemical parameters (viral load and CD4 count). Various qualitative studies have also been conducted, and many have focused on determining the specific design of interventions that were successful (frequency of messaging, types of messages, etc) as well as priorities for patients with regard to mHealth interventions. Conclusions: There seems to be a role of mHealth in the management of HIV in lower-income nations; however, the optimal design of an intervention needs to be delineated. In higher-income countries, where the 2 significant risk factors were injection drugs and men who have sex with men, the benefit was less clear, and more research is needed. %M 32568720 %R 10.2196/14739 %U https://mhealth.jmir.org/2020/8/e14739 %U https://doi.org/10.2196/14739 %U http://www.ncbi.nlm.nih.gov/pubmed/32568720 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 9 %N 8 %P e15680 %T Improving Retention in Care and Promoting Adherence to HIV Treatment: Protocol for a Multisite Randomized Controlled Trial of Mobile Phone Text Messaging %A Tanue,Elvis Asangbeng %A Nsagha,Dickson Shey %A Theophile,Nana Njamen %A Assob,Jules Clement Nguedia %+ Department of Public Health and Hygiene, Faculty of Health Sciences, University of Buea, PO Box 12, Buea, 00237, Cameroon, 237 677499429, dsnsagha@gmail.com %K adherence %K antiretroviral %K HIV %K randomized controlled trial %K retention in care %K text messaging %D 2020 %7 27.8.2020 %9 Original Paper %J JMIR Res Protoc %G English %X Background: The World Health Organization has prioritized the use of new technologies to assist in health care delivery in resource-limited settings. Findings suggest that the use of SMS on mobile phones is an advantageous application in health care delivery, especially in communities with an increasing use of this device. Objective: The main aim of this trial is to assess whether sending weekly motivational text messages (SMS) through mobile phones versus no text messaging will improve retention in care and promote adherence to treatment and health outcomes among patients receiving HIV treatment in Fako Division of Cameroon. Methods: This is a multisite randomized controlled single-blinded trial. Computer-generated random block sizes shall be used to produce a randomization list. Participants shall be randomly allocated into the intervention and control groups determined by serially numbered sealed opaque envelopes. The 156 participants will either receive the mobile phone text message or usual standard of care. We hypothesize that sending weekly motivational SMS reminders will produce a change in behavior to enhance retention; treatment adherence; and, hence, health outcomes. Participants shall be evaluated and data collected at baseline and then at 2, 4, and 6 months after the launch of the intervention. Text messages shall be sent out, and the delivery will be recorded. Primary outcome measures are retention in care and adherence to treatment. Secondary outcomes are clinical (weight, body mass index), biological (virologic suppression, tuberculosis coinfection), quality of life, treatment discontinuation, and mortality. The analysis shall be by intention-to-treat. Analysis of covariates shall be performed to determine factors influencing outcomes. Results: Recruitment and random allocation are complete; 160 participants were allocated into 3 groups (52 in the single SMS, 55 in the double SMS, and 53 in the control). Data collection and analysis are ongoing, and statistical results will be available by the end of August 2019. Conclusions: The interventions will contribute to an improved understanding of which intervention types can be feasible in improving retention in care and promoting adherence to antiretroviral therapy. Trial Registration: Pan African Clinical Trial Registry in South Africa PACTR201802003035922; https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=3035 International Registered Report Identifier (IRRID): DERR1-10.2196/15680 %M 32852282 %R 10.2196/15680 %U http://www.researchprotocols.org/2020/8/e15680/ %U https://doi.org/10.2196/15680 %U http://www.ncbi.nlm.nih.gov/pubmed/32852282 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 8 %P e17015 %T Improving Patients’ Medication Adherence and Outcomes in Nonhospital Settings Through eHealth: Systematic Review of Randomized Controlled Trials %A Wong,Zoie SY %A Siy,Braylien %A Da Silva Lopes,Katharina %A Georgiou,Andrew %+ Graduate School of Public Health, St. Luke's International University, 5/F, 3-6-2 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan, 81 07041295996, zoiesywong@gmail.com %K eHealth %K self-administered drug %K self-management %K medication adherence %K nonhospital settings %K randomized controlled trial %D 2020 %7 20.8.2020 %9 Review %J J Med Internet Res %G English %X Background: Electronic health (eHealth) refers to the use of information and communication technologies for health. It plays an increasingly important role in patients’ medication management. Objective: To assess evidence on (1) whether eHealth for patients’ medication management can improve drug adherence and health outcomes in nonhospital settings and (2) which eHealth functions are commonly used and are effective in improving drug adherence. Methods: We searched for randomized controlled trials (RCTs) on PubMed, MEDLINE, CINAHL, EMBASE, EmCare, ProQuest, Scopus, Web of Science, ScienceDirect, and IEEE Xplore, in addition to other published sources between 2000 and 2018. We evaluated the studies against the primary outcome measure of medication adherence and multiple secondary health care outcome measures relating to adverse events, quality of life, patient satisfaction, and health expenditure. The quality of the studies included was assessed using the Cochrane Collaboration’s Risk of Bias (RoB) tool. Results: Our initial search yielded 9909 records, and 24 studies met the selection criteria. Of these, 13 indicated improvement in medication adherence at the significance level of P<.1 and 2 indicated an improved quality of life at the significance level of P<.01. The top 3 functions that were employed included mechanisms to communicate with caregivers, monitoring health features, and reminders and alerts. eHealth functions of providing information and education, and dispensing treatment and administration support tended to favor improved medication adherence outcomes (Fisher exact test, P=.02). There were differences in the characteristics of the study population, intervention design, functionality provided, reporting adherence, and outcome measures among the included studies. RoB assessment items, including blinding of outcome assessment and method for allocation concealment, were not explicitly reported in a large number of studies. Conclusions: All the studies included were designed for patient home-based care application and provided a mechanism to communicate with caregivers. A targeted study population such as older patients should be considered to maximize the public health impact on the self-management of diseases. Trial Registration: International Prospective Register of Systematic Reviews (PROSPERO) CRD42018096627; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=96627 %M 32663145 %R 10.2196/17015 %U http://www.jmir.org/2020/8/e17015/ %U https://doi.org/10.2196/17015 %U http://www.ncbi.nlm.nih.gov/pubmed/32663145 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 8 %P e19861 %T Text Messaging Adherence Intervention for Adolescents and Young Adults with Chronic Kidney Disease: Pilot Randomized Controlled Trial and Stakeholder Interviews %A Eaton,Cyd %A Comer,Margaret %A Pruette,Cozumel %A Psoter,Kevin %A Riekert,Kristin %+ Pulmonary & Critical Care Medicine, Johns Hopkins University School of Medicine, 5501 Hopkins Bayview Circle, Baltimore, MD, 21224, United States, 1 410 550 3988, ceaton4@jhmi.edu %K medication adherence %K mobile health %K pediatrics %K kidney diseases %K kidney %K mHealth %K adherence %K adolescent %K young adult %K intervention %D 2020 %7 14.8.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: Up to one-third of adolescents and young adults (11-21 years old) with chronic kidney disease exhibit suboptimal rates of adherence to renal-protective antihypertensive medications. Mobile health interventions may promote higher adherence to these medicines in these individuals, but empirical research is needed to inform best practices for applying these modalities. Objective: In this multiphase investigation, we developed and tested a theoretically informed text messaging intervention based on the COM-B model, a well-established health intervention framework stating that capability, opportunity, and motivation interactively modify health behaviors, to improve participants’ antihypertensive medication adherence in a pilot randomized controlled trial. Qualitative data on user experiences were obtained. Methods: In phase 1, intervention messages (Reminder+COM-B Message) were developed via stakeholder engagement of participants and pediatric nephrologists. In phase 2, the Reminder+COM-B Message intervention was tested against a Reminder-only Message active control condition in an 8-week pilot randomized controlled trial. The primary outcome was daily electronically monitored antihypertensive medication adherence and secondary outcomes included pre-post participant surveys of adherence self-efficacy, adherence barriers, outcome expectancies for taking medicine, and motivation for and importance of taking medicine. In phase 3, qualitative interviews related to user experiences were conducted with participants in the Reminder+COM-B Message intervention group. Results: Following phase 1, 34 participants (mean age 16.59 years, 41% female, 38% African American/Black, 35% hypertension diagnosis) completed the phase 2 pilot randomized controlled trial (n=18 in the Reminder+COM-B Message intervention group, n=16 in the Reminder-only Message active control group). All participants in the Reminder+COM-B Message intervention group completed a phase 3 qualitative interview. Overall, study procedures were feasible and the Reminder+COM-B Message intervention was acceptable to the participants (eg, 15/18 participants reported reading the majority of messages sent to them, 0/18 reported that the messages reduced their desire to take medicine). Prerandomization, there were no significant group differences in the rate of change in daily adherence over time. However, postrandomization, there was a significant group by time interaction (B=.01, P=.04) in which daily adherence decreased significantly over time in the Reminder-only Message active control group but remained stable in the Reminder+COM-B Message intervention group. There were no significant differences between groups in pre-post changes in survey responses. Qualitative interviews revealed participants’ perceptions of how the Reminder+COM-B Message intervention changed adherence behavior and highlighted several areas for improving the intervention (eg, adapt messaging timing, intensity, and content to match daily adherence, send praise when medicine is taken). Conclusions: The Reminder+COM-B Message intervention was feasible and acceptable to adolescents/young adults and demonstrated potential to promote participants’ daily medication adherence beyond simple reminders. Further research is needed to determine the Reminder+COM-B Message intervention’s mechanisms of adherence behavior change and to incorporate qualitative participant feedback into a modified version of this intervention to enhance its acceptability. Trial Registration: ClinicalTrials.gov NCT03651596; https://clinicaltrials.gov/ct2/show/NCT03651596 %M 32795983 %R 10.2196/19861 %U http://www.jmir.org/2020/8/e19861/ %U https://doi.org/10.2196/19861 %U http://www.ncbi.nlm.nih.gov/pubmed/32795983 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 8 %P e17834 %T Impact of a Multicomponent Digital Therapeutic Mobile App on Medication Adherence in Patients with Chronic Conditions: Retrospective Analysis %A Wiecek,Elyssa %A Torres-Robles,Andrea %A Cutler,Rachelle Louise %A Benrimoj,Shalom Isaac %A Garcia-Cardenas,Victoria %+ Graduate School of Health, University of Technology Sydney, , Sydney, , Australia, +61 (02) 9514 9297, victoria.garciacardenas@uts.edu.au %K medication adherence %K medication compliance %K mobile phone %K mobile apps %K mHealth %K gamification %D 2020 %7 12.8.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: Strategies to improve medication adherence are widespread in the literature; however, their impact is limited in real practice. Few patients persistently engage long-term to improve health outcomes, even when they are aware of the consequences of poor adherence. Despite the potential of mobile phone apps as a tool to manage medication adherence, there is still limited evidence of the impact of these innovative interventions. Real-world evidence can assist in minimizing this evidence gap. Objective: The objective of this study was to analyze the impact over time of a previously implemented digital therapeutic mobile app on medication adherence rates in adults with any chronic condition. Methods: A retrospective observational study was performed to assess the adherence rates of patients with any chronic condition using Perx Health, a digital therapeutic that uses multiple components within a mobile health app to improve medication adherence. These components include gamification, dosage reminders, incentives, educational components, and social community components. Adherence was measured through mobile direct observation of therapy (MDOT) over 3-month and 6-month time periods. Implementation adherence, defined as the percentage of doses in which the correct dose of a medication was taken, was assessed across the study periods, in addition to timing adherence or percentage of doses taken at the appropriate time (±1 hour). The Friedman test was used to compare differences in adherence rates over time. Results: We analyzed 243 and 130 patients who used the app for 3 months and 6 months, respectively. The average age of the 243 patients was 43.8 years (SD 15.5), and 156 (64.2%) were female. The most common medications prescribed were varenicline, rosuvastatin, and cholecalciferol. The median implementation adherence was 96.6% (IQR 82.1%-100%) over 3 months and 96.8% (IQR 87.1%-100%) over 6 months. Nonsignificant differences in adherence rates over time were observed in the 6-month analysis (Fr(2)=4.314, P=.505) and 3-month analysis (Fr(2)=0.635, P=.728). Similarly, the timing adherence analysis revealed stable trends with no significant changes over time. Conclusions: Retrospective analysis of users of a medication adherence management mobile app revealed a positive trend in maintaining optimal medication adherence over time. Mobile technology utilizing gamification, dosage reminders, incentives, education, and social community interventions appears to be a promising strategy to manage medication adherence in real practice. %M 32784183 %R 10.2196/17834 %U http://www.jmir.org/2020/8/e17834/ %U https://doi.org/10.2196/17834 %U http://www.ncbi.nlm.nih.gov/pubmed/32784183 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 8 %N 7 %P e18465 %T Development and Preliminary Evaluation of the Effects of an mHealth Web-Based Platform (HappyAir) on Adherence to a Maintenance Program After Pulmonary Rehabilitation in Patients With Chronic Obstructive Pulmonary Disease: Randomized Controlled Trial %A Jiménez-Reguera,Begoña %A Maroto López,Eva %A Fitch,Shane %A Juarros,Lourdes %A Sánchez Cortés,Marta %A Rodríguez Hermosa,Juan Luis %A Calle Rubio,Myriam %A Hernández Criado,María Teresa %A López,Marta %A Angulo-Díaz-Parreño,Santiago %A Martín-Pintado-Zugasti,Aitor %A Vilaró,Jordi %+ Ramon Llull University, Padilla 326, Barcelona, Spain, 34 932 533 256, jordi.gestos@gmail.com %K adherence %K pulmonary rehabilitation %K mHealth %K COPD %K chronic obstructive pulmonary disease %D 2020 %7 31.7.2020 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Pulmonary rehabilitation is one of the main interventions to reduce the use of health resources, and it promotes a reduction in chronic obstructive pulmonary disease (COPD) costs. mHealth systems in COPD aim to improve adherence to maintenance programs after pulmonary rehabilitation by promoting the change in attitude and behavior necessary for patient involvement in the management of the disease. Objective: This study aimed to assess the effects of an integrated care plan based on an mHealth web-based platform (HappyAir) on adherence to a 1-year maintenance program applied after pulmonary rehabilitation in COPD patients. Methods: COPD patients from three hospitals were randomized to a control group or an intervention group (HappyAir group). Patients from both groups received an 8-week program of pulmonary rehabilitation and educational sessions about their illness. After completion of the process, only the HappyAir group completed an integrated care plan for 10 months, supervised by an mHealth system and therapeutic educator. The control group only underwent the scheduled check-ups. Adherence to the program was rated using a respiratory physiotherapy adherence self-report (CAP FISIO) questionnaire. Other variables analyzed were adherence to physical activity (Morisky-Green Test), quality of life (Chronic Obstructive Pulmonary Disease Assessment Test, St. George’s Respiratory Questionnaire, and EuroQOL-5D), exercise capacity (6-Minute Walk Test), and lung function. Results: In total, 44 patients were recruited and randomized in the control group (n=24) and HappyAir group (n=20). Eight patients dropped out for various reasons. The CAP FISIO questionnaire results showed an improvement in adherence during follow-up period for the HappyAir group, which was statistically different compared with the control group at 12 months (56.1 [SD 4.0] vs 44.0 [SD 13.6]; P=.004) after pulmonary rehabilitation. Conclusions: mHealth systems designed for COPD patients improve adherence to maintenance programs as long as they are accompanied by disease awareness and patient involvement in management. Trial Registration: ClinicalTrials.gov NCT04479930; https://clinicaltrials.gov/ct2/show/NCT04479930 %M 32513646 %R 10.2196/18465 %U http://mhealth.jmir.org/2020/7/e18465/ %U https://doi.org/10.2196/18465 %U http://www.ncbi.nlm.nih.gov/pubmed/32513646 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 8 %N 7 %P e17658 %T A Comprehensive App That Improves Tuberculosis Treatment Management Through Video-Observed Therapy: Usability Study %A Guo,Xujun %A Yang,Yarui %A Takiff,Howard E %A Zhu,Minmin %A Ma,Jianping %A Zhong,Tao %A Fan,Yuzheng %A Wang,Jian %A Liu,Shengyuan %+ Department of Tuberculosis Control and Prevention, Shenzhen Nanshan Centre for Chronic Disease Control, 7 Huaming Road, Nanshan District, Shenzhen, 518054, China, 86 0755 26407238, liushenglb@126.com %K tuberculosis %K management %K video-observed therapy %K directly observed therapy %K mobile phone %D 2020 %7 31.7.2020 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Treatment of pulmonary tuberculosis (TB) requires at least six months and is compromised by poor adherence. In the directly observed therapy (DOT) scheme recommended by the World Health Organization, the patient is directly observed taking their medications at a health post. An alternative to DOT is video-observed therapy (VOT), in which the patients take videos of themselves taking the medication and the video is uploaded into the app and reviewed by a health care worker. We developed a comprehensive TB management system by using VOT that is installed as an app on the smartphones of both patients and health care workers. It was implemented into the routine TB control program of the Nanshan District of Shenzhen, China. Objective: The aim of this study was to compare the effectiveness of VOT with that of DOT in managing the treatment of patients with pulmonary TB and to evaluate the acceptance of VOT for TB management by patients and health care workers. Methods: Patients beginning treatment between September 2017 and August 2018 were enrolled into the VOT group and their data were compared with the retrospective data of patients who began TB treatment and were managed with routine DOT between January 2016 and August 2017. Sociodemographic characteristics, clinical features, treatment adherence, positive findings of sputum smears, reporting of side effects, time and costs of transportation, and satisfaction were compared between the 2 treatment groups. The attitudes of the health care workers toward the VOT-based system were also analyzed. Results: This study included 158 patients in the retrospective DOT group and 235 patients in the VOT group. The VOT group showed a significantly higher fraction of doses observed (P<.001), less missed observed doses (P<.001), and fewer treatment discontinuations (P<.05) than the DOT group. Over 79.1% (186/235) of the VOT patients had >85% of their doses observed, while only 16.4% (26/158) of the DOT patients had >85% of their doses observed. All patients were cured without recurrences. The VOT management required significantly (P<.001) less median patient time (300 minutes vs 1240 minutes, respectively) and transportation costs (¥53 [US $7.57] vs ¥276 [US $39.43], respectively; P<.001) than DOT. Significantly more patients (191/235, 81.3%) in the VOT group preferred their treatment method compared to those on DOT (37/131, 28.2%) (P<.001), and 92% (61/66) of the health care workers thought that the VOT method was more convenient than DOT for managing patients with TB. Conclusions: Implementation of the VOT-based system into the routine program of TB management was simple and it significantly increased patient adherence to their drug regimens. Our study shows that a comprehensive VOT-based TB management represents a viable and improved evolution of DOT. %M 32735222 %R 10.2196/17658 %U https://mhealth.jmir.org/2020/7/e17658 %U https://doi.org/10.2196/17658 %U http://www.ncbi.nlm.nih.gov/pubmed/32735222 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 8 %N 7 %P e16634 %T Explaining Differences in the Acceptability of 99DOTS, a Cell Phone–Based Strategy for Monitoring Adherence to Tuberculosis Medications: Qualitative Study of Patients and Health Care Providers %A Thomas,Beena E %A Kumar,J Vignesh %A Onongaya,Chidiebere %A Bhatt,Spurthi N %A Galivanche,Amith %A Periyasamy,Murugesan %A Chiranjeevi,M %A Khandewale,Amit Subhash %A Ramachandran,Geetha %A Shah,Daksha %A Haberer,Jessica E %A Mayer,Kenneth H %A Subbaraman,Ramnath %+ Department of Public Health and Community Medicine, Tufts University School of Medicine, 136 Harrison Ave, MV237, Boston, MA, 02111, United States, 1 6176360985, ramnath.subbaraman@tufts.edu %K tuberculosis %K medication adherence %K mobile phone %K mHealth %K implementation science %K qualitative research %D 2020 %7 31.7.2020 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: 99DOTS is a cell phone–based strategy for monitoring tuberculosis (TB) medication adherence that has been rolled out to more than 150,000 patients in India’s public health sector. A considerable proportion of patients stop using 99DOTS during therapy. Objective: This study aims to understand reasons for variability in the acceptance and use of 99DOTS by TB patients and health care providers (HCPs). Methods: We conducted qualitative interviews with individuals taking TB therapy in the government program in Chennai and Vellore (HIV-coinfected patients) and Mumbai (HIV-uninfected patients) across intensive and continuation treatment phases. We conducted interviews with HCPs who provide TB care, all of whom were involved in implementing 99DOTS. Interviews were transcribed, coded using a deductive approach, and analyzed with Dedoose 8.0.35 software (SocioCultural Research Consultants, LLC). The findings of the study were interpreted using the unified theory of acceptance and use of technology, which highlights 4 constructs associated with technology acceptance: performance expectancy, effort expectancy, social influences, and facilitating conditions. Results: We conducted 62 interviews with patients with TB, of whom 30 (48%) were HIV coinfected, and 31 interviews with HCPs. Acceptance of 99DOTS by patients was variable. Greater patient acceptance was related to perceptions of improved patient-HCP relationships from increased phone communication, TB pill-taking habit formation due to SMS text messaging reminders, and reduced need to visit health facilities (performance expectancy); improved family involvement in TB care (social influences); and from 99DOTS leading HCPs to engage positively in patients’ care through increased outreach (facilitating conditions). Lower patient acceptance was related to perceptions of reduced face-to-face contact with HCPs (performance expectancy); problems with cell phone access, literacy, cellular signal, or technology fatigue (effort expectancy); high TB- and HIV-related stigma within the family (social influences); and poor counseling in 99DOTS by HCPs or perceptions that HCPs were not acting upon adherence data (facilitating conditions). Acceptance of 99DOTS by HCPs was generally high and related to perceptions that the 99DOTS adherence dashboard and patient-related SMS text messaging alerts improve quality of care, the efficiency of care, and the patient-HCP relationship (performance expectancy); that the dashboard is easy to use (effort expectancy); and that 99DOTS leads to better coordination among HCPs (social influences). However, HCPs described suboptimal facilitating conditions, including inadequate training of HCPs in 99DOTS, unequal changes in workload, and shortages of 99DOTS medication envelopes. Conclusions: In India’s government TB program, 99DOTS had high acceptance by HCPs but variable acceptance by patients. Although some factors contributing to suboptimal patient acceptance are modifiable, other factors such as TB- and HIV-related stigma and poor cell phone accessibility, cellular signal, and literacy are more difficult to address. Screening for these barriers may facilitate targeting of 99DOTS to patients more likely to use this technology. %M 32735220 %R 10.2196/16634 %U http://mhealth.jmir.org/2020/7/e16634/ %U https://doi.org/10.2196/16634 %U http://www.ncbi.nlm.nih.gov/pubmed/32735220 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 7 %P e16856 %T Perceptions and Acceptability of Digital Interventions Among Tuberculosis Patients in Cambodia: Qualitative Study of Video-Based Directly Observed Therapy %A Rabinovich,Lila %A Molton,James Steven %A Ooi,Wei Tsang %A Paton,Nicholas Iain %A Batra,Shelly %A Yoong,Joanne %+ Center for Economic and Social Research, University of Southern California, 1090 Vermont Avenue, NW, Washington, DC, 20005, United States, 1 2138210537, lilarabi@usc.edu %K directly observed therapy %K video recording %K telemedicine %K mobile health %K mHealth %K tuberculosis %K low-income settings %K developing countries %K patient acceptance of health care %K patient acceptability %K Cambodia %D 2020 %7 27.7.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: Despite the development of effective drugs for treatment, tuberculosis remains one of the leading causes of death from an infectious disease worldwide. One of the greatest challenges to tuberculosis control is patient adherence to treatment. Recent research has shown that video-based directly observed therapy is a feasible and effective approach to supporting treatment adherence in high-income settings. However, few studies have explored the potential for such a solution in a low- or middle-income country setting. Globally, these countries’ rapidly rising rate of mobile penetration suggests that the potential for translation of these results may be high. Objective: We sought to examine patient perceptions related to the use of mobile health, and specifically video-based directly observed therapy, in a previously unstudied patient demographic: patients with tuberculosis in a low-income country setting (Cambodia). Methods: We conducted a cross-sectional qualitative study in urban and periurban areas in Cambodia, consisting of 6 focus groups with tuberculosis patients who were receiving treatment (standard directly observed therapy) through a nongovernmental organization. Results: Familiarity with mobile technology and apps was widespread in this population, and overall willingness to consider a mobile app for video-based directly observed therapy was high. However, we identified potential challenges. First, patients very much valued their frequent in-person interactions with their health care provider, which may be reduced with the video-based directly observed therapy intervention. Second, there may be technical issues to address, including how to make the app suitable for illiterate participants. Conclusions: While video-based directly observed therapy is a promising technology, even in country settings where mobile penetration is reportedly almost universal, it should be introduced with caution. However, the results were generally promising and yielded important insights that not only will be translated into the further adaptation of key features of video-based directly observed therapy for tuberculosis patients in Cambodia, but also can inform the future design and successful implementation of video-based directly observed therapy interventions in low- and middle-income settings more generally. %M 32716309 %R 10.2196/16856 %U https://www.jmir.org/2020/7/e16856 %U https://doi.org/10.2196/16856 %U http://www.ncbi.nlm.nih.gov/pubmed/32716309 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 8 %N 7 %P e17534 %T User Engagement Among Diverse Adults in a 12-Month Text Message–Delivered Diabetes Support Intervention: Results from a Randomized Controlled Trial %A Nelson,Lyndsay A %A Spieker,Andrew %A Greevy,Robert %A LeStourgeon,Lauren M %A Wallston,Kenneth A %A Mayberry,Lindsay S %+ Department of Medicine, Vanderbilt University Medical Center, 2525 West End Ave, Suite 450, Nashville, TN, 37203, United States, 1 6158757621, lyndsay.a.nelson@vumc.org %K engagement %K text messaging %K mobile health %K mHealth %K mobile phone %K technology %K diabetes mellitus, type 2 %K self-management %K self-care %K medication adherence %D 2020 %7 21.7.2020 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Text message–delivered interventions are a feasible and scalable approach for improving chronic disease self-care and reducing health disparities; however, information on long-term user engagement with these interventions is limited. Objective: The aim of this study is to examine user engagement in a 12-month text message–delivered intervention supporting diabetes self-care, called REACH (Rapid Education/Encouragement And Communications for Health), among racially and socioeconomically diverse patients with type 2 diabetes (T2D). We explored time trends in engagement, associations between patient characteristics and engagement, and whether the addition of a human component or allowing patients to change their text frequency affected engagement. Qualitative data informed patients’ subjective experience of their engagement. Methods: We recruited patients with T2D for a randomized trial evaluating mobile phone support relative to enhanced treatment as usual. This analysis was limited to participants assigned to the intervention. Participants completed a survey and hemoglobin A1c (HbA1c) test and received REACH text messages, including self-care promotion texts, interactive texts asking about medication adherence, and adherence feedback texts. For the first 6 months, texts were sent daily, and half of the participants also received monthly phone coaching. After 6 months, coaching stopped, and participants had the option to receive fewer texts for the subsequent 6 months. We defined engagement via responses to the interactive texts and responses to a follow-up interview. We used regression models to analyze associations with response rate and thematic and structural analysis to understand participants’ reasons for responding to the texts and their preferred text frequency. Results: The participants were, on average, aged 55.8 (SD 9.8) years, 55.2% (137/248) female, and 52.0% (129/248) non-White; 40.7% (101/248) had ≤ a high school education, and 40.7% (101/248) had an annual household income .99, .86, and .74, respectively) and 2-month (P values=.80, .84, and .82, respectively) postintervention. ART adherence also did not improve in each group over the same period. MIST was perceived to be a beneficial tool based on the process evaluation results. Conclusions: Although MIST did not enhance medication adherence to HIV treatments, mainly owing to the ceiling effect, it was perceived to be beneficial among the participants of this study. Our process evaluation provided useful data to further develop MIST for bigger and long-term mobile phone app–assisted intervention RCTs in the future. Trial Registration: ClinicalTrials.gov NCT03794648; https://clinicaltrials.gov/ct2/show/NCT03794648 %M 32217500 %R 10.2196/15702 %U http://mhealth.jmir.org/2020/3/e15702/ %U https://doi.org/10.2196/15702 %U http://www.ncbi.nlm.nih.gov/pubmed/32217500 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 8 %N 3 %P e14680 %T Supporting the Medication Adherence of Older Mexican Adults Through External Cues Provided With Ambient Displays: Feasibility Randomized Controlled Trial %A Zárate-Bravo,Ernesto %A García-Vázquez,Juan-Pablo %A Torres-Cervantes,Engracia %A Ponce,Gisela %A Andrade,Ángel G %A Valenzuela-Beltrán,Maribel %A Rodríguez,Marcela D %+ Facultad de Ingeniería, Universidad Autónoma de Baja California, Ave Alvaro Obregón, S/N, Col Nueva, Mexicali, 21100, Mexico, 52 6865664270 ext 1301, marcerod@uabc.edu.mx %K health information systems %K family caregiver %K aged %K medication adherence %D 2020 %7 2.3.2020 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Problems with prospective memory, which refers to the ability to remember future intentions, cause deficits in basic and instrumental activities of daily living, such as taking medications. Older adults show minimal deficits when they rely on mostly preserved and relatively automatic associative retrieval processes. On the basis of this, we propose to provide external cues to support the automatic retrieval of an intended action, that is, to take medicines. To reach this end, we developed the Medication Ambient Display (MAD), a system that unobtrusively presents relevant information (unless it requires the users’ attention) and uses different abstract modalities to provide external cues that enable older adults to easily take their medications on time and be aware of their medication adherence. Objective: This study aimed to assess the adoption and effect of external cues provided through ambient displays on medication adherence in older adults. Methods: A total of 16 older adults, who took at least three medications and had mild cognitive impairment, participated in the study. We conducted a 12-week feasibility study in which we used a mixed methods approach to collect qualitative and quantitative evidence. The study included baseline, intervention, and postintervention phases. Half of the participants were randomly allocated to the treatment group (n=8), and the other half was assigned to the control group (n=8). During the study phases, research assistants measured medication adherence weekly through the pill counting technique. Results: The treatment group improved their adherence behavior from 80.9% at baseline to 95.97% using the MAD in the intervention phase. This decreased to 76.71% in the postintervention phase when the MAD was no longer being used. Using a one-way repeated measures analysis of variance and a post hoc analysis using the Tukey honestly significant difference test, we identified a significant statistical difference between the preintervention and intervention phases (P=.02) and between the intervention and postintervention phases (P=.002). In addition, the medication adherence rate of the treatment group (95.97%) was greater than that of the control group (88.18%) during the intervention phase. Our qualitative results showed that the most useful cues were the auditory reminders, followed by the stylized representations of medication adherence. We also found that the MAD’s external cues not only improved older adults’ medication adherence but also mediated family caregivers’ involvement. Conclusions: The findings of this study demonstrate that using ambient modalities for implementing external cues is useful for drawing the attention of older adults to remind them to take medications and to provide immediate awareness on adherence behavior. Trial Registration: ClinicalTrials.gov NCT04289246; https://tinyurl.com/ufjcz97 %M 32130164 %R 10.2196/14680 %U http://mhealth.jmir.org/2020/3/e14680/ %U https://doi.org/10.2196/14680 %U http://www.ncbi.nlm.nih.gov/pubmed/32130164 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 8 %N 2 %P e16266 %T Effect of a Mobile Phone–Based Glucose-Monitoring and Feedback System for Type 2 Diabetes Management in Multiple Primary Care Clinic Settings: Cluster Randomized Controlled Trial %A Yang,Yeoree %A Lee,Eun Young %A Kim,Hun-Sung %A Lee,Seung-Hwan %A Yoon,Kun-Ho %A Cho,Jae-Hyoung %+ Division of Endocrinology and Metabolism, Department of Internal Medicine, Seoul St Mary’s Hospital, College of Medicine, The Catholic University of Korea, 222 Banpo-daero, Seocho-gu, Seoul, 06591, Republic of Korea, 82 2 2258 6008, drhopper@ikoob.com %K diabetes mellitus, type 2 %K primary care %K mHealth %K telehealth %D 2020 %7 26.2.2020 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Recent evidence of the effectiveness of mobile phone–based diabetes management systems is generally based on studies conducted in tertiary hospitals or professional diabetes clinics. Objective: This study aimed to evaluate the clinical efficacy and applicability of a mobile phone–based glucose-monitoring and feedback system for the management of type 2 diabetes mellitus (T2DM) in multiple primary care clinic settings. Methods: In this multicenter, cluster-randomized controlled, open trial, 13 primary care clinics in Seoul and other large cities in South Korea were voluntarily recruited. Overall, 150 (9 clinics) and 97 (4 clinics) participants with T2DM were assigned to the intervention and control groups, respectively (2:1 allocation). Every month, participants in both groups attended face-to-face physicians’ consultation for the management of diabetes in the clinic. For the intervention group, participants were required to upload their daily self-monitoring of blood glucose (SMBG) results using the mobile phone app in addition to outpatient care for 3 months. The results were automatically transmitted to the main server. Physicians had to check their patients’ SMBG results through an administrator’s website and send a short feedback message at least once a week. At baseline and 3 months, both groups had anthropometry and blood tests, including hemoglobin A1c (HbA1c), and responded to questionnaires about treatment satisfaction and compliance. Results: At 3 months, participants in the intervention group showed significantly more improvement in HbA1c (adjusted mean difference to control −0.30%, 95% CI −0.50 to −0.11; P=.003) and fasting plasma glucose (−17.29 mg/dL, 95% CI −29.33 to −5.26; P=.005) than those in the control group. In addition, there was significantly more reduction in blood pressure, and the score regarding treatment satisfaction and motivation for medication adherence increased more in the intervention group than in the control group. In the subgroup analyses, the effect on glycemic control was more significant among younger patients and higher baseline HbA1c levels. Conclusions: The mobile phone–based glucose-monitoring and feedback system was effective in glycemic control when applied in primary care clinic settings. This system could be utilized effectively with diverse institutions and patients. Trial Registration: Clinical Research Information Service (CRIS) https://tinyurl.com/tgqawbz %M 32130172 %R 10.2196/16266 %U http://mhealth.jmir.org/2020/2/e16266/ %U https://doi.org/10.2196/16266 %U http://www.ncbi.nlm.nih.gov/pubmed/32130172 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 8 %N 2 %P e14466 %T Using Goal-Directed Design to Create a Mobile Health App to Improve Patient Compliance With Hypertension Self-Management: Development and Deployment %A Duan,Huilong %A Wang,Zheyu %A Ji,Yumeng %A Ma,Li %A Liu,Fang %A Chi,Mingwei %A Deng,Ning %A An,Jiye %+ College of Biomedical Engineering and Instrument Science, Ministry of Education Key Laboratory of Biomedical Engineering, Zhejiang University, 38 Zheda Rd, Zhouyiqing Bldg 512, Yuquan Campus, Hangzhou, China, 86 571 2295 2693, zju.dengning@gmail.com %K goal-directed design %K smartphone %K mobile health %K patients %K hypertension self-management %K mobile phone %D 2020 %7 25.2.2020 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Hypertension is a lifestyle-induced chronic disease that threatens the lives of patients. Control of hypertension requires patients to follow self-management regimes; unfortunately, however, patient compliance with hypertension self-management is low, especially in developing countries. Improvement of patient compliance is premised on meeting patient needs. Mobile health apps are becoming increasingly popular for self-management of chronic diseases. However, few mobile apps have been designed to meet patient needs for hypertension self-management. Objective: The goal of this study was to develop a mobile health app to improve patient compliance with hypertension self-management and evaluate the effectiveness of the app in terms of patient compliance. Methods: The goal-directed design method was applied to guide study design. We divided the study into 4 stages. Stages 1 to 3 comprised the development process. To improve the applicability of the goal-directed design method to chronic disease management, we extracted elements of user models concerned with patient compliance and defined a concrete process for user modeling. In stage 1, personas of hypertensive patients were built using qualitative and quantitative methods. Clustering methods based on questionnaire responses were used to group patients. Qualitative interviews were conducted to identify the needs of different groups. In stage 2, several functional modules were designed to meet the needs of different groups based on the results from stage 1. In stage 3, prototypes of functional modules were designed and implemented as a real app. Stage 4 was the deployment process, in which we conducted a pilot study to investigate patient compliance after using the app. Patient compliance was calculated through the frequency with which they took blood pressure measurements. In addition, qualitative interviews were conducted to learn the underlying reasons for the compliance results. Results: In stage 1, patients were divided into 3 groups based on 82 valid questionnaire responses. Eighteen patients from the different groups (7, 5, and 6 patients) were interviewed, and the needs of the groups were summarized as follows: improve self-management ability, enhance self-management motivation, and receive self-management support. In stages 2 and 3, 6 functional modules were designed and implemented based on specified needs, and the usability of the app was improved through usability tests. In stage 4, 143 patients were recruited to use different versions of the app for 2 months. Results show that patient compliance improved as functional modules were added (P<.001) and was maintained at a high level (rate of 0.73). Interview results from 32 patients show that the design of the app met different needs; thus, patients were more compliant with it. Conclusions: This study developed a mobile health app for hypertension self-management using the goal-directed design method. The app proved to be effective for improving patient compliance with hypertension self-management. %M 32130161 %R 10.2196/14466 %U http://mhealth.jmir.org/2020/2/e14466/ %U https://doi.org/10.2196/14466 %U http://www.ncbi.nlm.nih.gov/pubmed/32130161 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 4 %N 2 %P e14888 %T Using an Electronic Medication Event–Monitoring System for Antiretroviral Therapy Self-Management Among African American Women Living With HIV in Rural Florida: Cohort Study %A Lucero,Robert %A Williams,Renessa %A Esalomi,Tanisia %A Alexander-Delpech,Paula %A Cook,Christa %A Bjarnadottir,Ragnhildur I %+ Department of Family, Community, and Health Systems Science, Southern HIV & Alcohol Research Consortium, University of Florida, College of Nursing, 1225 Center Drive, Gainesville, FL, United States, 1 3522736370, rlucero@ufl.edu %K medication adherence %K medication therapy management %K self-management %K HIV %K African Americans %D 2020 %7 19.2.2020 %9 Original Paper %J JMIR Form Res %G English %X Background: HIV remains a significant health issue in the United States and disproportionately affects African Americans. African American women living with HIV (AAWH) experience a particularly high number of barriers when attempting to manage their HIV care, including antiretroviral therapy (ART) adherence. To enable the development and assessment of effective interventions that address these barriers to support ART adherence, there is a critical need to understand more fully the use of objective measures of ART adherence among AAWH, including electronic medication dispensers for real-time surveillance. Objective: This study aimed to evaluate the use of the Wisepill medication event–monitoring system (MEMS) and compare the objective and subjective measures of ART adherence. Methods: We conducted a 30-day exploratory pilot study of the MEMS among a convenience sample of community-dwelling AAWH (N=14) in rural Florida. AAWH were trained on the use of the MEMS to determine the feasibility of collecting, capturing, and manipulating the MEMS data for an objective measure of ART adherence. Self-reported sociodemographic information, including a self-reported measure of ART adherence, was also collected from AAWH. Results: We found that the majority of participants were successful at using the electronic MEMS. Daily use of the MEMS tended to be outside of the usual time participants took their medication. Three 30-day medication event patterns were found that characterized ART adherence, specifically uniform and nonuniform medication adherence and nonuniform medication nonadherence. There were relatively few MEMS disruptions among study participants. Overall, adjusted daily ART adherence was 81.08% and subjective ART adherence was 77.78%. Conclusions: This pilot study on the use and evaluation of the Wisepill MEMS among AAWH in rural Florida is the first such study in the United States. The findings of this study are encouraging because 10 out of 12 participants consistently used the MEMS, there were relatively few failures, and objective adjusted daily and overall subjective ART adherence were very similar. On the basis of these findings, we think researchers should consider using the Wisepill MEMS in future studies of AAWH and people living with HIV in the United States after taking into account our practical suggestions. The following practical considerations are suggested when measuring objective medication adherence: (1) before using an MEMS, be familiar with the targeted populations’ characteristics; (2) choose an MEMS that aligns with the participants’ day-to-day activities; (3) ensure the MEMS’ features and resulting data support the research goals; (4) assess the match among the user’s ability, wireless features of the MEMS, and the geographic location of the participants; and (5) consider the cost of MEMS and the research budget. %M 32130114 %R 10.2196/14888 %U http://formative.jmir.org/2020/2/e14888/ %U https://doi.org/10.2196/14888 %U http://www.ncbi.nlm.nih.gov/pubmed/32130114 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 8 %N 2 %P e15957 %T A Mobile App (mHeart) to Detect Medication Nonadherence in the Heart Transplant Population: Validation Study %A Gomis-Pastor,Mar %A Roig,Eulalia %A Mirabet,Sonia %A T De Pourcq,Jan %A Conejo,Irene %A Feliu,Anna %A Brossa,Vicens %A Lopez,Laura %A Ferrero-Gregori,Andreu %A Barata,Anna %A Mangues,M Antonia %+ Pharmacy Department, Hospital de la Santa Creu i Sant Pau, San Quintin nº89 PC 08041, Barcelona, 08026, Spain, 34 636060364, mar@margomis.com %K self-report %K patient-reported outcome measures %K behavioral sciences %K treatment adherence and compliance %K transplantation %K early medical intervention %K telemedicine %K mobile health %K validation studies %K patient satisfaction %D 2020 %7 4.2.2020 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Medication nonadherence in heart transplant recipients (HTxR) is related to graft loss and death. mHeart is a mobile app that uses electronic patient-reported outcome measures (ePROMs) to identify and manage medication nonadherence in the outpatient heart transplant (HTx) population. Objective: The study primarily aimed to validate mHeart to measure medication nonadherence in early stage HTxR by assessing the psychometric properties of ePROMs. The secondary aims were to (1) measure patient satisfaction with the mHeart tool and its usability and (2) explore the impact of a theory-based treatment on medication nonadherence rates to determine its scalability to larger research. Methods: A prospective study was conducted in the outpatient clinic of a tertiary hospital. All consecutive early stage HTxR (<1.5 years from HTx) were included. The ePROM psychometric properties assessed were validity, reliability, responsiveness, interpretability, and burden. ePROMs comprised the 4-item Morisky-Green-Levine questionnaire and an adapted version of the Haynes-Sackett questionnaire. The Simplified Medication Adherence Questionnaire (SMAQ) was also applied on-site. Three consecutive medication nonadherence assessments were performed by a transplant pharmacist. To improve medication nonadherence, theory-based interventions were delivered in a 1-month period. Patient satisfaction was assessed by a semiquantitative Web-based survey at the end of the study. Results: We included 31 early stage HTxR (age: mean 54 years, SD 12 years), and 71% (22/31) of them were men. The HTxR were taking a mean 13 (SD 4; range 7-18) drugs per day. A total of 42% (13/31) of patients were unaware of the consequences of medication nonadherence, and 39% (12/31) of patients were nonadherent to immunosuppressive treatment. The content validity measure showed excellent levels of expert panel agreement for the Haynes-Sacket (14/14, 100%) and Morisky-Green-Levine (13/14, 93%) questionnaires. SMAQ and Morisky-Green-Levine ePROMs showed similar measurement domains (convergent validity, phi=0.6, P<.001), which, as expected, differed from Haynes-Sackett ePROMs (divergent validity, phi=0.3, P=.12). Reliability assessment revealed a very strong association between ePROM and on-site PROMs (phi>0.7, P<.001). Reproducibility was moderate (Haynes-Sackett κ=0.6, P<.002) or poor (Morisky-Green-Levine κ=0.3, P=.11) because of unexpected improved medication adherence rates during the test-retest period. According to responsiveness, the theory-based multifaceted intervention program improved medication nonadherence by 16% to 26% (P<.05). A burden analysis showed that ePROMs could potentially overcome traditional on-site limitations (eg, automatic recording of ePROM responses in the hospital information system). The mean score for overall patient satisfaction with the mHeart approach was 9 (SD 2; score range: 0-10). All 100% (29/29) of patients surveyed reported that they would recommend the mHeart platform to other HTxR. Conclusions: ePROMs adhered to the quality standards and successfully identified medication nonadherence in the HTx population, supporting their widespread use. The theory-based intervention program showed a promising improvement in medication adherence rates and produced excellent patient satisfaction and usability scores in HTxR. %M 32014839 %R 10.2196/15957 %U https://mhealth.jmir.org/2020/2/e15957 %U https://doi.org/10.2196/15957 %U http://www.ncbi.nlm.nih.gov/pubmed/32014839 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 8 %N 1 %P e15146 %T Usability and Utility of a Mobile App to Improve Medication Adherence Among Ambulatory Care Patients in Malaysia: Qualitative Study %A Chew,Sara %A Lai,Pauline Siew Mei %A Ng,Chirk Jenn %+ Department of Primary Care Medicine, University of Malaya, Jalan Universiti, Kuala Lumpur, 50603, Malaysia, 60 379493920, plai@ummc.edu.my %K medication adherence app %K usability testing %K utility testing %D 2020 %7 31.1.2020 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: To date, several medication adherence apps have been developed. However, the existing apps have been developed without involving relevant stakeholders and were not subjected to mobile health app guidelines. In addition, the usability and utility of these apps have not been tested with end users. Objective: This study aimed to describe the usability and utility testing of a newly developed medication adherence app—Med Assist—among ambulatory care patients in Malaysia. Methods: The Med Assist app was developed based on the Theory of Planned Behavior and the Nielson usability model. Beta testing was conducted from March to May 2016 at a primary care clinic in Kuala Lumpur. Ambulatory care patients who scored ≥40% on the electronic health literacy scale, were aged ≥21 years, and were taking two or more long-term medications were recruited. Two rounds of in-depth interviews were conducted with each participant. The first interview, which was conducted upon participant recruitment, was to assess the usability of Med Assist. Participants were asked to download Med Assist on their phone and perform two tasks (register themselves on Med Assist and enter at least one medication). Participants were encouraged to “concurrently think aloud” when using Med Assist, while nonverbal cues were observed and recorded. The participants were then invited for a second interview (conducted ≥7 days after the first interview) to assess the utility of Med Assist after using the app for 1 week. This was done using “retrospective probing” based on a topic guide developed for utilities that could improve medication adherence. Results: Usability and utility testing was performed for the Med Assist app (version P4). A total of 13 participants were recruited (6 men, 7 women) for beta testing. Three themes emerged from the usability testing, while three themes emerged from the utility testing. From the usability testing, participants found Med Assist easy to use and user friendly, as they were able to complete the tasks given to them. However, the details required when adding a new medication were found to be confusing despite displaying information in a hierarchical order. Participants who were caregivers as well as patients found the multiple-user support and pill buddy utility useful. This suggests that Med Assist may improve the medication adherence of patients on multiple long-term medications. Conclusions: The usability and utility testing of Med Assist with end users made the app more patient centered in ambulatory care. From the usability testing, the overall design and layout of Med Assist were simple and user friendly enough for participants to navigate through the app and add a new medication. From the participants’ perspectives, Med Assist was a useful and reliable tool with the potential to improve medication adherence. In addition, utilities such as multiple user support and a medication refill reminder encouraged improved medication management. %M 32003748 %R 10.2196/15146 %U http://mhealth.jmir.org/2020/1/e15146/ %U https://doi.org/10.2196/15146 %U http://www.ncbi.nlm.nih.gov/pubmed/32003748 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 8 %N 1 %P e14557 %T The Florida Mobile Health Adherence Project for People Living With HIV (FL-mAPP): Longitudinal Assessment of Feasibility, Acceptability, and Clinical Outcomes %A Escobar-Viera,César %A Zhou,Zhi %A Morano,Jamie P %A Lucero,Robert %A Lieb,Spencer %A McIntosh,Sean %A Clauson,Kevin A %A Cook,Robert L %+ Center for Research on Media, Technology, and Health, University of Pittsburgh, 230 McKee Place, Suite 600, Pittsburgh, PA, 15213, United States, 1 412 692 4297, escobar-viera@pitt.edu %K mHealth %K HIV %K ART adherence %K feasibility %K acceptability %D 2020 %7 8.1.2020 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: For people living with HIV (PLWH), antiretroviral therapy (ART) adherence is crucial to attain better health outcomes. Although research has leveraged consumer health information technologies to enhance ART adherence, no study has evaluated feasibility and clinical outcomes associated with the usage of a commercially available, regularly updated mobile health (mHealth) app for improving ART adherence among PLWH. Objective: This study aimed to assess the feasibility, acceptability, and clinical outcomes of Care4Today, an existing, free, biprogrammatic mHealth app for improving ART adherence among PLWH. Methods: The Florida mHealth Application Adherence Project (FL-mAPP) was a 90-day longitudinal pilot study conducted in 3 public HIV clinics in Florida, United States. After obtaining informed consent, 132 participants completed a survey and then were given the option to try an existing mHealth app to help with ART adherence. Of these, 33.3% (44/132) declined, 31.1% (41/132) agreed but never used the app, and 35.6% (47/132) used the app. All were asked to complete follow-up surveys at 30 days and 90 days after enrollment. Usage data were used to assess feasibility. Clinical outcomes of self-reported ART adherence and chart-obtained HIV viral load and CD4+ T-cell counts were compared among those who used the platform (users) versus those who did not (nonusers). Participants and HIV care providers also provided responses to open-ended questions about what they liked and did not like about the app; comments were analyzed using thematic analysis. Results: Of 132 participants, 47 (35.6%) and 85 (64.4%) were categorized as users and nonusers, respectively. Among users, a Kaplan-Meier plot showed that 25 persons (53%) continued using the app after the 90-day follow-up. At 30-day follow-up, 13 (81.3%) of those who used the mHealth app reported ≥95% ART adherence, compared with 17 (58.6%) nonusers (P=.12). Overall, 39 (82%) users liked or somewhat liked using the platform. Participants’ favorite features were medication reminders, ability to create custom reminders, and adherence reports. Conclusions: This longitudinal study found that a commercially available medication adherence mHealth app was a feasible and acceptable intervention to improve ART adherence among PLWH and engaged in clinical care across 3 public HIV clinics in the state of Florida. Overall, participants liked the Care4Today app and thought the medication reminders were their favorite feature. Generally, self-reports of ART adherence were better among users than nonusers, both at 30- and 90-day follow-ups. Further clinical research needs to address user fatigue for improving app usage. %M 31913127 %R 10.2196/14557 %U https://mhealth.jmir.org/2020/1/e14557 %U https://doi.org/10.2196/14557 %U http://www.ncbi.nlm.nih.gov/pubmed/31913127 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 7 %N 11 %P e12442 %T Assessment of a Mobile App by Adolescents and Young Adults With Cystic Fibrosis: Pilot Evaluation %A Rudolf,Isa %A Pieper,Katharina %A Nolte,Helga %A Junge,Sibylle %A Dopfer,Christian %A Sauer-Heilborn,Annette %A Ringshausen,Felix C %A Tümmler,Burkhard %A von Jan,Ute %A Albrecht,Urs-Vito %A Fuge,Jan %A Hansen,Gesine %A Dittrich,Anna-Maria %+ Pediatric Pneumology, Allergology, and Neonatology, Hannover Medical School, Carl-Neuberg-Straße 1, Hannover, 30625, Germany, 49 17615329785, dittrich.anna-maria@mh-hannover.de %K mobile phone %K mobile phone app %K mHealth %K self-management %K adolescence %K cystic fibrosis %D 2019 %7 21.11.2019 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Cystic fibrosis (CF) continues to be the most common life-limiting chronic pulmonary disease in adolescents and young adults. Treatment of CF demands a high treatment time investment to slow the progression of lung function decline, the most important contributor to morbidity and mortality. Adherence is challenging in CF due to the high treatment burden and the lack of immediate health consequences in case of nonadherence. Lung function decline is particularly pronounced in the transition phase between 12 and 24 years of age. The improvement of self-management and self-responsibility and independence from parents and desire for normalcy are conflicting aspects for many adolescents with CF, which influence adherence to the time-consuming pulmonary therapy. Mobile health (mHealth) care apps could help to support self-management and independence and thereby reconcile seemingly conflicting goals to improve adherence, quality of life, and ultimately CF life expectancy. Objective: This study aimed to (1) assess user behavior and satisfaction among adolescents and young adults with CF over an observation period of three months using an mHealth app; (2) identify areas of improvement for this mHealth app; and (3) compare overall and disease-specific satisfaction, lung function, and anthropometry before and after using the mHealth app. Methods: A total of 27 adolescents and young adults with CF (age range 12-24 years, mean age 16 years, SD 3 years; 14 females, 11 males) used a free mHealth app for three months of whom 25 provided questionnaire data for analysis at the end of the study. Data collection was carried out using questionnaires on usage characteristics and life satisfaction, and standardized assessment of lung function and anthropometry. Results: The use of the reminder function for medication declined from 70% (15/21) of the participants at week 4 to 65% (13/20) at week 8 of the observation period. At the end of the study, only 17% (4/23) of the participants wanted to continue using the app. Nevertheless, 56% (14/25) of participants saw the mobile app as a support for everyday life. Potential improvements targeting hedonistic qualities were identified to improve mHealth app adherence. Comparisons of satisfaction with different life aspects hinted at improvements or stabilization for the subitem respiration and the subitem lack of handicap by CF, suggesting that app use might stabilize certain CF-specific aspects of the weighted satisfaction with life. Lung function and anthropometry were not affected consistently. Conclusions: Most of the patients did not want to continue using the app after the study period. Only a few CF-specific aspects of weighted life satisfaction were possibly stabilized by the mHealth app; clinical parameters were not affected. Adaptation of the functions to adolescent-specific needs could improve the long-term use and thus positively affect the disease course. %M 31750841 %R 10.2196/12442 %U https://mhealth.jmir.org/2019/11/e12442 %U https://doi.org/10.2196/12442 %U http://www.ncbi.nlm.nih.gov/pubmed/31750841 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 7 %N 11 %P e13741 %T Exploring the Patterns of Use and Acceptability of Mobile Phones Among People Living With HIV to Improve Care and Treatment: Cross-Sectional Study in Three Francophone West African Countries %A Lepère,Phillipe %A Touré,Yélamikan %A Bitty-Anderson,Alexandra M %A Boni,Simon P %A Anago,Gildas %A Tchounga,Boris %A Touré,Pendadiago %A Minga,Albert %A Messou,Eugène %A Kanga,Guillaume %A Koule,Serge %A Poda,Armel %A Calmy,Alexandra %A Ekouevi,Didier K %A Coffie,Patrick A %+ Institut de Santé Globale, Université de Genève, Suisse, 24 rue du Général-Dufour, 1205 Genève, Genève, Switzerland, 41 +33673777280, lepere.p@wanadoo.fr %K acceptability %K mHealth %K PLHIV %K West Africa %D 2019 %7 13.11.2019 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: The use of mobile technology in health care (mobile health [mHealth]) could be an innovative way to improve health care, especially for increasing retention in HIV care and adherence to treatment. However, there is a scarcity of studies on mHealth among people living with HIV (PLHIV) in West and Central Africa. Objective: The aim of this study was to assess the acceptability of an mHealth intervention among PLHIV in three countries of West Africa. Methods: A cross-sectional study among PLHIV was conducted in 2017 in three francophone West African countries: Côte d’Ivoire, Burkina Faso, and Togo. PLHIV followed in the six preselected HIV treatment and care centers, completed a standardized questionnaire on mobile phone possession, acceptability of mobile phone for HIV care and treatment, preference of mobile phone services, and phone sharing. Descriptive statistics and logistic regression were used to describe variables and assess factors associated with mHealth acceptability. Results: A total of 1131 PLHIV—643 from Côte d’Ivoire, 239 from Togo, and 249 from Burkina Faso—participated in the study. Median age was 44 years, and 76.1% were women (n=861). Almost all participants owned a mobile phone (n=1107, 97.9%), and 12.6% (n=140) shared phones with a third party. Acceptability of mHealth was 98.8%, with the majority indicating their preference for both phone calls and text messages. Factors associated with mHealth acceptability were having a primary school education or no education (adjusted odds ratio=7.15, 95% CI 5.05-10.12; P<.001) and waiting over one hour before meeting a medical doctor on appointment day (adjusted odds ratio=1.84, 95% CI 1.30-2.62; P=.01). Conclusions: The use of mHealth in HIV treatment and care is highly acceptable among PLHIV and should be considered a viable tool to allow West and Central African countries to achieve the Joint United Nations Programme on HIV/AIDS 90-90-90 goals. %M 31719023 %R 10.2196/13741 %U https://mhealth.jmir.org/2019/11/e13741 %U https://doi.org/10.2196/13741 %U http://www.ncbi.nlm.nih.gov/pubmed/31719023 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 11 %P e15356 %T A Mobile Health App to Improve HIV Medication Adherence: Protocol for a Pilot Randomized Controlled Trial %A Ramsey,Susan %A Ames,Evan %A Uber,Julia %A Habib,Samia %A Clark,Seth %+ The Warren Alpert Medical School of Brown University, 111 Plain Street, Providence, RI, 02903, United States, 1 4014447831, Susan_Ramsey@brown.edu %K HIV %K medication adherence %K mobile health %D 2019 %7 13.11.2019 %9 Protocol %J JMIR Res Protoc %G English %X Background: Adherence to antiretroviral therapy (ART) is essential for allowing persons living with HIV to live longer, healthier lives. However, a large portion of this population has suboptimal adherence and are not virally suppressed. Conventional interventions aimed at improving ART adherence lack portability and scalability, and improvements in adherence are not often sustained. Mobile health (mHealth) ART interventions offer a low-cost and accessible method of improving adherence, but many have limited functionality and do not offer comprehensive support. The combination of an mHealth intervention with a face-to-face adherence intervention and interactive health coaching feature may offer sufficient support in a manner that is sensitive to resource limitations that are often found in HIV treatment settings. This paper details the protocol of a study designed to evaluate the potential of an enhanced mHealth intervention for improving ART adherence. Objective: The primary objective of this study is to assess the feasibility and acceptability of the Fitbit Plus app enhanced with a face-to-face LifeSteps session (Fitbit Plus condition) for improving ART adherence. In addition, we will determine the preliminary efficacy of the intervention by calculating treatment effect sizes. Methods: This study will be conducted in 2 phases. The intervention will be developed and piloted with a small group of participants during phase 1. Pilot participants will provide feedback that will be used to refine the intervention for phase 2. In phase 2, a preliminary randomized controlled trial (RCT) comparing Fitbit Plus with a condition that approximates the standard of care (SOC) will be conducted with 60 persons living with HIV. Interviews will be conducted with RCT participants at baseline, and follow-up interviews will be conducted at 1, 3, 6, and 12 months. ART adherence is the primary outcome and will be monitored throughout the study via electronic pill boxes. Effect sizes will be generated using a fractional logit model estimated by generalized estimating equations. Results: Phase 1 of this trial is complete; data collection for phase 2 is ongoing. Follow-ups with enrolled participants will conclude in January 2020. Conclusions: This study will contribute to the literature on ART adherence and may produce an efficacious intervention. Owing to a small sample size, there may be insufficient power to detect statistically significant differences between Fitbit Plus and SOC. However, if Fitbit Plus is found to be acceptable and feasible and yields promising effect size estimates, this pilot study could serve as the foundation for a larger, fully powered trial of Fitbit Plus. Trial Registration: ClinicalTrials.gov NCT02676128; https://clinicaltrials.gov/ct2/show/NCT02676128 International Registered Report Identifier (IRRID): DERR1-10.2196/15356 %M 31719030 %R 10.2196/15356 %U http://www.researchprotocols.org/2019/11/e15356/ %U https://doi.org/10.2196/15356 %U http://www.ncbi.nlm.nih.gov/pubmed/31719030 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 3 %N 4 %P e13286 %T Passive Monitoring of Short-Acting Beta-Agonist Use via Digital Platform in Patients With Chronic Obstructive Pulmonary Disease: Quality Improvement Retrospective Analysis %A Chen,Jessica %A Kaye,Leanne %A Tuffli,Michael %A Barrett,Meredith A %A Jones-Ford,Shelanda %A Shenouda,Tina %A Gondalia,Rahul %A Henderson,Kelly %A Combs,Veronica %A Van Sickle,David %A Stempel,David A %+ Propeller Health, 47 Maiden Lane, 3rd Floor, San Francisco, CA, United States, 1 608 251 0470, leanne.kaye@propellerhealth.com %K chronic obstructive pulmonary disease %K telemedicine %K quality improvement, feasibility %K nebulizers and vaporizers %K health services %D 2019 %7 23.10.2019 %9 Original Paper %J JMIR Form Res %G English %X Background: Digital health programs assist patients with chronic obstructive pulmonary disease (COPD) to better manage their disease. Technological and adoption barriers have been perceived as a limitation. Objective: The aim of the research was to evaluate a digital quality improvement pilot in Medicare-eligible patients with COPD. Methods: COPD patients were enrolled in a digital platform to help manage their medications and symptoms as part of their routine clinical care. Patients were provided with electronic medication monitors (EMMs) to monitor short-acting beta-agonist (SABA) use passively and a smartphone app to track use trends and receive feedback. Providers also had access to data collected via a secure website and were sent email notifications if a patient had a significant change in their prescribed inhaler use. Providers then determined if follow-up was needed. Change in SABA use and feasibility outcomes were evaluated at 3, 6, and 12 months. Results: A total of 190 patients enrolled in the pilot. At 3, 6, and 12 months, patients recorded significant reductions in daily and nighttime SABA use and increases in SABA-free days (all P<.001). Patient engagement, as measured by the ratio of daily active use to monthly active use, was >90% at both 6 and 12 months. Retention at 6 months was 81% (154/190). Providers were sent on average two email notifications per patient during the 12-month program. Conclusions: A digital health program integrated as part of standard clinical practice was feasible and had low provider burden. The pilot demonstrated significant reduction in SABA use and increased SABA-free days among Medicare-eligible COPD patients. Further, patients readily adopted the digital platform and demonstrated strong engagement and retention rates at 6 and 12 months. %M 31647471 %R 10.2196/13286 %U http://formative.jmir.org/2019/4/e13286/ %U https://doi.org/10.2196/13286 %U http://www.ncbi.nlm.nih.gov/pubmed/31647471 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 7 %N 10 %P e14619 %T A Short Message Service Intervention to Support Adherence to Home-Based Strengthening Exercise for People With Knee Osteoarthritis: Intervention Design Applying the Behavior Change Wheel %A Nelligan,Rachel K %A Hinman,Rana S %A Atkins,Lou %A Bennell,Kim L %+ Centre for Health Exercise and Sports Medicine, Department of Physiotherapy, The University of Melbourne, 161 Barry Street, Parkville, 3010, Australia, 61 3 8344 0556, k.bennell@unimelb.edu.au %K text messaging %K mobile phone %K knee osteoarthritis %K exercise %D 2019 %7 18.10.2019 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Knee osteoarthritis is a chronic condition with no known cure. Treatment focuses on symptom management, with exercise recommended as a core component by all clinical practice guidelines. However, long-term adherence to exercise is poor among many people with knee osteoarthritis, which limits its capacity to provide sustained symptom relief. To improve exercise outcomes, scalable interventions that facilitate exercise adherence are needed. SMS (short message service) interventions show promise in health behavior change. The Behavior Change Wheel (BCW) is a widely used framework that provides a structured approach to designing behavior change interventions and has been used extensively in health behavior change intervention design. Objective: The study aimed to describe the development of, and rationale for, an SMS program to support exercise adherence in people with knee osteoarthritis using the BCW framework. Methods: The intervention was developed in two phases. Phase 1 involved using the BCW to select the target behavior and associated barriers, facilitators, and behavior change techniques (BCTs). Phase 2 involved design of the program functionality and message library. Messages arranged into a 24-week schedule were provided to an external company to be developed into an automated SMS program. Results: The target behavior was identified as participation in self-directed home-based strengthening exercise 3 times a week for 24 weeks. A total of 13 barriers and 9 facilitators of the behavior and 20 BCTs were selected to use in the intervention. In addition, 198 SMS text messages were developed and organized into a 24-week automated program that functions by prompting users to self-report the number of home exercise sessions completed each week. Users who reported ≥3 exercise sessions/week (adherent) received positive reinforcement messages. Users who reported <3 exercise sessions/week (nonadherent) were asked to select a barrier (from a list of standardized response options) that best explains why they found performing the exercises challenging in the previous week. This automatically triggers an SMS containing a BCT suggestion relevant to overcoming the selected barrier. Users also received BCT messages to facilitate exercise adherence, irrespective of self-reported adherence. Conclusions: This study demonstrates application of the BCW to guide development of an automated SMS intervention to support exercise adherence in knee osteoarthritis. Future research is needed to assess whether the intervention improves adherence to the prescribed home-based strengthening exercise. %M 31628786 %R 10.2196/14619 %U https://mhealth.jmir.org/2019/10/e14619 %U https://doi.org/10.2196/14619 %U http://www.ncbi.nlm.nih.gov/pubmed/31628786 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 7 %N 10 %P e14404 %T Electronic Health Interventions to Improve Adherence to Antiretroviral Therapy in People Living With HIV: Systematic Review and Meta-Analysis %A Wang,Ziqi %A Zhu,Yaxin %A Cui,Liyuan %A Qu,Bo %+ School of Public Health, China Medical University, 77 Puhe Road, Shenyang North New Area, Shenyang, 110122, China, 86 18900910198, bqu@cmu.edu.cn %K HIV %K highly active antiretroviral therapy %K medication adherence %K eHealth %D 2019 %7 16.10.2019 %9 Review %J JMIR Mhealth Uhealth %G English %X Background: Electronic health (eHealth) is increasingly used for self-management and service delivery of HIV-related diseases. With the publication of studies increasingly focusing on antiretroviral therapy (ART) adherence, this makes it possible to quantitatively and systematically assess the effectiveness and feasibility of eHealth interventions. Objective: The purpose of this review was to explore the effectiveness of eHealth interventions on improving ART adherence in people living with HIV. The effects of different intervention characteristics, participant characteristics, and study characteristics were also assessed. Methods: We systematically searched MEDLINE (via PubMed), EMBASE, the Cochrane Central Register of Controlled Trials, and 3 conference abstract databases using search terms related to HIV, ART, adherence, and eHealth interventions. We independently screened the studies, extracted the data, and assessed the study quality and then compared the information in pairs. Articles published in English that used randomized controlled trials to assess eHealth interventions to improve ART adherence of people living with HIV were identified. We extracted the data including study characteristics, participant characteristics, intervention characteristics, and outcome measures. The Cochrane risk-of-bias tool was used to assess the risk of bias and study overall quality. Odds ratios, Cohen d, and their 95% CIs were estimated using random-effects models. We also performed multiple subgroup analyses and sensitivity analyses to define any sources of heterogeneity. Results: Among 3941 articles identified, a total of 19 studies (including 21 trials) met the inclusion criteria. We found 8 trials from high-income countries and 13 trials from low- and middle-income countries. Furthermore, at baseline, the health status of participants in 14 trials was healthy. Of the trials included, 7 of 21 used personality content, 12 of 21 used a 2-way communication strategy, and 7 of 21 used medical content. In the pooled analysis of 3937 participants (mean age: 35 years; 47.16%, 1857/3937 females), eHealth interventions significantly improved the ART adherence of people living with HIV (pooled Cohen d=0.25; 95% CI 0.05 to 0.46; P=.01). The interventions were also correlated with improved biochemical outcomes reported by 11 trials (pooled Cohen d=0.25; 95% CI 0.11 to 0.38; P<.001). The effect was sensitive to sample size (Q=5.56; P=.02) and study duration (Q=8.89; P=.003), but it could not be explained by other moderators. The primary meta-analysis result was stable in the 3 sensitivity analyses. Conclusions: Some of the eHealth interventions may be used as an effective method to increase the ART adherence of people living with HIV. Considering that most of the trials included a small sample size and were conducted for a short duration, these results should be interpreted with caution. Future studies need to determine the features of eHealth interventions to better improve ART adherence along with long-term effectiveness of interventions, effectiveness of real-time adherence monitoring, enhancement of study design, and influences on biochemical outcomes. %M 31621641 %R 10.2196/14404 %U https://mhealth.jmir.org/2019/10/e14404 %U https://doi.org/10.2196/14404 %U http://www.ncbi.nlm.nih.gov/pubmed/31621641 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 7 %N 9 %P e14914 %T A Smartphone App to Improve Medication Adherence in Patients With Type 2 Diabetes in Asia: Feasibility Randomized Controlled Trial %A Huang,Zhilian %A Tan,Eberta %A Lum,Elaine %A Sloot,Peter %A Boehm,Bernhard Otto %A Car,Josip %+ Centre for Population Health Sciences, Lee Kong Chian School of Medicine, Nanyang Technological University, Clinical Sciences Building, Level 18, 11 Mandalay Road, Singapore, 308232, Singapore, 65 65141221, zhuang014@e.ntu.edu.sg %K smartphone apps %K mobile phone apps %K medication adherence %K type 2 diabetes %K feasibility trial %K pilot study %D 2019 %7 12.09.2019 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: The efficacy of smartphone apps for improving medication adherence in type 2 diabetes is not well studied in Asian populations. Objective: This study aimed to determine the feasibility, acceptability, and clinical outcomes of using a smartphone app to improve medication adherence in a multiethnic Asian population with type 2 diabetes. Methods: We block randomized 51 nonadherent and digitally literate patients with type 2 diabetes between the ages of 21 and 75 years into two treatment arms (control: usual care; intervention: usual care+Medisafe app) and followed them up for 12 weeks. Recruitment occurred at a public tertiary diabetes specialist outpatient center in Singapore. The intervention group received email reminders to complete online surveys monthly, while the control group only received an email reminder(s) at the end of the study. Barriers to medication adherence and self-appraisal of diabetes were assessed using the Adherence Starts with Knowledge-12 (ASK-12) and Appraisal of Diabetes Scale (ADS) questionnaires at baseline and poststudy in both groups. Perception toward medication adherence and app usage, attitude, and satisfaction were assessed in the intervention group during and after the follow-up period. Sociodemographic data were collected at baseline. Clinical data (ie, hemoglobin A1c, body mass index, low-density lipoprotein, high-density lipoprotein, and total cholesterol levels) were extracted from patients’ electronic medical records. Results: A total of 51 (intervention group: 25 [49%]; control group: 26 [51%]) participants were randomized, of which 41 (intervention group: 22 [88.0%]; control group: 19 [73.1%]) completed the poststudy survey. The baseline-adjusted poststudy ASK-12 score was significantly lower in the intervention group than in the control group (mean difference: 4.7, P=.01). No changes were observed in the clinical outcomes. The average 12-week medication adherence rate of participants tracked by the app was between 38.3% and 100% in the intervention group. The majority (>80%) of the participants agreed that the app was easy to use and made them more adherent to their medication. Conclusions: Our feasibility study showed that among medication-nonadherent patients with type 2 diabetes, a smartphone app intervention was acceptable, improved awareness of medication adherence, and reduced self-reported barriers to medication adherence, but did not improve clinical outcomes in a developed Asian setting. %M 31516127 %R 10.2196/14914 %U http://mhealth.jmir.org/2019/9/e14914/ %U https://doi.org/10.2196/14914 %U http://www.ncbi.nlm.nih.gov/pubmed/31516127 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 7 %N 9 %P e13608 %T Mobile Apps for Medication Management: Review and Analysis %A Tabi,Katarina %A Randhawa,Abnashi Singh %A Choi,Fiona %A Mithani,Zamina %A Albers,Friederike %A Schnieder,Maren %A Nikoo,Mohammadali %A Vigo,Daniel %A Jang,Kerry %A Demlova,Regina %A Krausz,Michael %+ Department of Psychiatry, University of British Columbia, 430-5950 University Boulevard, Vancouver, BC, V6T1Z3, Canada, 1 604 875 3525, katarina.tabi@gmail.com %K eHealth %K mHealth %K drugs %K pharmaceuticals %K therapy %D 2019 %7 11.09.2019 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Pharmacotherapy remains one of the major interventional strategies in medicine. However, patients from all age groups and conditions face challenges when taking medications, such as integrating them into the daily routine, understanding their effects and side effects, and monitoring outcomes. In this context, a reliable medication management tool adaptable to the patient’s needs becomes critical. As most people have a mobile phone, mobile apps offer a platform for such a personalized support tool available on the go. Objective: This study aimed to provide an overview of available mobile apps, focusing on those that help patients understand and take their medications. We reviewed the existing apps and provided suggestions for future development based on the concept understand and manage, instead of the conventional adhere to medication. This concept aims to engage and empower patients to be in charge of their health, as well as see medication as part of a broader clinical approach, working simultaneously with other types of interventions or lifestyle changes, to achieve optimal outcomes. Methods: We performed a Web search in the iOS Apple App Store and Android Google Play Store, using 4 search terms: medication management, pill reminder, medication health monitor, and medication helper. We extracted information from the app store descriptions for each eligible app and categorized into the following characteristics: features, author affiliation, specialty, user interface, cost, and user rating. In addition, we conducted Google searches to obtain more information about the author affiliation. Results: A total of 328 apps (175 Android and 153 iOS) were categorized. The majority of the apps were developed by the software industry (73%, 11/15), a minority of them were codeveloped by health care professionals (15%, 3/20) or academia (2.1%; 7/328). The most prevalent specialty was diabetes (23 apps). Only 7 apps focused on mental health, but their content was highly comprehensive in terms of features and had the highest prevalence of the education component. The most prevalent features were reminder, symptom tracker, and ability to share data with a family member or doctor. In addition, we highlighted the features considered innovative and listed practical suggestions for future development and innovations. Conclusions: We identified detailed characteristics of the existing apps, with the aim of informing future app development. Ultimately, the goal was to provide users with effective mobile health solutions, which can be expected to improve their engagement in the treatment process and long-term well-being. This study also highlighted the need for improved standards for reporting on app stores. Furthermore, it underlined the need for a platform to offer health app users an ongoing evaluation of apps by health professionals in addition to other users and to provide them with tools to easily select an appropriate and trustworthy app. %M 31512580 %R 10.2196/13608 %U http://mhealth.jmir.org/2019/9/e13608/ %U https://doi.org/10.2196/13608 %U http://www.ncbi.nlm.nih.gov/pubmed/31512580 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 7 %N 8 %P e12574 %T Relationship Between Adherence to Remote Monitoring and Patient Characteristics: Observational Study in Women With Pregnancy-Induced Hypertension %A Vandenberk,Thijs %A Lanssens,Dorien %A Storms,Valerie %A Thijs,Inge M %A Bamelis,Lotte %A Grieten,Lars %A Gyselaers,Wilfried %A Tang,Eileen %A Luyten,Patrick %+ Faculty of Medicine and Life Sciences, Hasselt University, Agoralaan, Diepenbeek, 3590, Belgium, 32 11268111, thijsvandenberk@hotmail.com %K remote monitoring %K gestational hypertensive diseases %K monitoring, ambulatory %K hypertension, pregnancy-induced %K surveys and questionnaires %K treatment adherence and compliance %D 2019 %7 28.08.2019 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Pregnancy-induced hypertension (PIH) is associated with high levels of morbidity and mortality in mothers, fetuses, and newborns. New technologies, such as remote monitoring (RM), were introduced in 2015 into the care of patients at risk of PIH in Ziekenhuis Oost-Limburg (Genk, Belgium) to improve both maternal and neonatal outcomes. In developing new strategies for obstetric care in pregnant women, including RM, it is important to understand the psychosocial characteristics associated with adherence to RM to optimize care. Objective: The aim of this study was to explore the role of patients’ psychosocial characteristics (severity of depression or anxiety, cognitive factors, attachment styles, and personality traits) in their adherence to RM. Methods: Questionnaires were sent by email to 108 mothers the day after they entered an RM program for pregnant women at risk of PIH. The Generalized Anxiety Disorder Assessment-7 and Patient Health Questionnaire-9 (PHQ-9) were used to assess anxiety and the severity of depression, respectively; an adaptation of the Pain Catastrophizing Scale was used to assess cognitive factors; and attachment and personality were measured with the Experiences in Close Relationships-Revised Scale (ECR-R), the Depressive Experiences Questionnaire, and the Multidimensional Perfectionism Scale, respectively. Results: The moderate adherence group showed significantly higher levels of anxiety and depression, negative cognitions, and insecure attachment styles, especially compared with the over adherence group. The low adherence group scored significantly higher than the other groups on other-oriented perfectionism. There were no significant differences between the good and over adherence groups. Single linear regression showed that the answers on the PHQ-9 and ECR-R questionnaires were significantly related to the adherence rate. Conclusions: This study demonstrates the relationships between adherence to RM and patient characteristics in women at risk of PIH. Alertness toward the group of women who show less than optimal adherence is essential. These findings call for further research on the management of PIH and the importance of individual tailoring of RM in this patient group. Trial Registration: ClinicalTrials.gov NCT03509272; https://clinicaltrials.gov/ct2/show/NCT03509272 %M 31464190 %R 10.2196/12574 %U http://mhealth.jmir.org/2019/8/e12574/ %U https://doi.org/10.2196/12574 %U http://www.ncbi.nlm.nih.gov/pubmed/31464190 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 7 %N 8 %P e15021 %T Association Between User Engagement of a Mobile Health App for Gout and Improvements in Self-Care Behaviors: Randomized Controlled Trial %A Serlachius,Anna %A Schache,Kiralee %A Kieser,Anel %A Arroll,Bruce %A Petrie,Keith %A Dalbeth,Nicola %+ Department of Psychological Medicine, Faculty of Medical and Health Sciences, University of Auckland, Private Bag 92019, Victoria Street West, Auckland, 1142, New Zealand, 64 9 9233073, a.serlachius@auckland.ac.nz %K mobile apps %K mHealth %K gout %K chronic disease %K user engagement %K illness perceptions %D 2019 %7 13.08.2019 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Mobile health (mHealth) apps represent a promising approach for improving health outcomes in patients with chronic illness, but surprisingly few mHealth interventions have investigated the association between user engagement and health outcomes. We aimed to examine the efficacy of a recommended, commercially available gout self-management app for improving self-care behaviors and to assess self-reported user engagement of the app in a sample of adults with gout. Objective: Our objective was to examine differences in self-reported user engagement between a recommended gout app (treatment group) and a dietary app (active control group) over 2 weeks as well as to examine any differences in self-care behaviors and illness perceptions. Methods: Seventy-two adults with gout were recruited from the community and three primary and secondary clinics. Participants were randomized to use either Gout Central (n=36), a self-management app, or the Dietary Approaches to Stop Hypertension Diet Plan (n=36), an app based on a diet developed for hypertension, for 2 weeks. The user version of the Mobile Application Rating Scale (uMARS, scale: 1 to 5) was used after the 2 weeks to assess self-reported user engagement, which included an open-ended question. Participants also completed a self-report questionnaire on self-care behaviors (scale: 1-5 for medication adherence and diet and 0-7 for exercise) and illness perceptions (scale: 0-10) at baseline and after the 2-week trial. Independent samples t tests and analysis of covariance were used to examine differences between groups at baseline and postintervention. Results: Participants rated the gout app as more engaging (mean difference –0.58, 95% CI –0.96 to –0.21) and more informative (mean difference –0.34, 95% CI –0.67 to –0.01) than the dietary app at the 2-week follow-up. The gout app group also reported a higher awareness of the importance of gout (mean difference –0.64, 95% CI –1.27 to –0.003) and higher knowledge/understanding of gout (mean difference –0.70, 95% CI –1.30 to –0.09) than the diet app group at follow-up. There were no significant differences in self-care behaviors between the two groups postintervention. The gout app group also demonstrated stronger negative beliefs regarding the impact of gout (mean difference –2.43, 95% CI –3.68 to –1.18), stronger beliefs regarding the severity of symptoms (mean difference –1.97, 95% CI –3.12 to –0.82), and a stronger emotional response to gout (mean difference –2.38, 95% CI –3.85 to –0.90) at follow-up. Participant feedback highlighted the importance of tracking health-related information, customizing to the target group/individual, providing more interactive features, and simplifying information. Conclusions: Participants found the commercially available gout app more engaging. However, these findings did not translate into differences in self-care behaviors. The gout app group also demonstrated stronger negative illness perceptions at the follow-up. Overall, these findings suggest that the development of gout apps would benefit from a user-centered approach with a focus on daily, long-term self-care behaviors as well as modifying illness beliefs. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12617001052325; https://anzctr.org.au/Trial/Registration/TrialReview.aspx?id=373217. %M 31411147 %R 10.2196/15021 %U http://mhealth.jmir.org/2019/8/e15021/ %U https://doi.org/10.2196/15021 %U http://www.ncbi.nlm.nih.gov/pubmed/31411147 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 7 %N 8 %P e13452 %T A Multidimensional Electronic Hydroxyurea Adherence Intervention for Children With Sickle Cell Disease: Single-Arm Before-After Study %A Creary,Susan %A Chisolm,Deena %A Stanek,Joseph %A Hankins,Jane %A O'Brien,Sarah H %+ Nationwide Children's Hospital, The Ohio State University, FOB 3rd Floor, Columbus, OH, 43205, United States, 1 614 722 3563, susan.creary@nationwidechildrens.org %K hydroxyurea %K children %K sickle cell disease %K mobile health %K mhealth %K adherence %K textmessaging %D 2019 %7 08.08.2019 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Hydroxyurea is a disease-modifying medication for patients with sickle cell disease (SCD). Despite demonstrated efficacy, hydroxyurea nonadherence in clinical practice is common and results in worse health outcomes for nonadherent patients. Mobile Directly Observed Therapy (Mobile DOT) is a pilot-tested, electronic, multidimensional hydroxyurea adherence intervention for children with SCD. Mobile DOT includes sending daily text message reminders to patients to take hydroxyurea, patients recording and sending daily videos that capture their hydroxyurea administrations for the research team to review and track adherence, providing personalized feedback to patients about their adherence, and providing small monetary incentives to patients if they achieve high hydroxyurea adherence. Objective: This study aimed to determine if Mobile DOT increases hydroxyurea adherence in children with SCD and to explore its impact on hematologic and clinical outcomes. Methods: This was a single-arm, 6-month intervention study of patients with SCD on hydroxyurea who were aged ≤19 years and reported having access to an electronic device. Participants’ hydroxyurea adherence when they received Mobile DOT was compared with their adherence 6 months before and after receiving Mobile DOT. Participants’ medication possession ratio (MPR) was calculated from their pharmacy dispensing records and was used to measure adherence. Laboratory and clinical outcomes were abstracted from participants’ electronic medical records. Infrequently hospitalized patients who received at least 160 days of the intervention were considered to be engaged participants. Results: Of 91 patients who were approached, 55 enrolled and 34 engaged with Mobile DOT. The median age of the engaged participants was 10 years (range 2-18.8 years), and 21 (62%, 21/34) participants were male, 28 (82%, 21/34) had hemoglobin SS SCD, and 19 (56%, 19/34) were prescribed hydroxyurea for at least a year before enrollment. With Mobile DOT, engaged participants’ median MPR increased from 61.7% to 84.4% (P<.001) and significantly more (67% vs 30%; P=.002) achieved ≥80% hydroxyurea adherence compared with baseline values. Engaged participants’ mean fetal hemoglobin (HgbF) levels and mean corpuscular volumes (MCV) improved significantly after 6 months of Mobile DOT (P=.04 and P=.001, respectively), but their adherence, HgbF levels, and MCV returned to baseline values during the 6 months after the intervention. Hospitalizations and the clinical outcomes that were measured occurred infrequently during the study. Nonengagement was associated with being female and having a recent SCD complication. In addition, having insufficient electronic data, being unable to quickly complete Mobile DOT each day, and not perceiving that Mobile DOT was beneficial may have further decreased engagement. Conclusions: Mobile DOT shows promise as an effective intervention for some children with SCD. Modifications that may improve recruitment, reduce attrition, and increase engagement were identified and could increase the impact that Mobile DOT has on children with SCD. Trial Registration: ClinicalTrials.gov NCT02578017; https://clinicaltrials.gov/ct2/show/NCT02578017 %M 31397291 %R 10.2196/13452 %U https://mhealth.jmir.org/2019/8/e13452/ %U https://doi.org/10.2196/13452 %U http://www.ncbi.nlm.nih.gov/pubmed/31397291 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 21 %N 7 %P e14373 %T Assessment of Medication Adherence Using a Medical App Among Patients With Multiple Sclerosis Treated With Interferon Beta-1b: Pilot Digital Observational Study (PROmyBETAapp) %A Limmroth,Volker %A Hechenbichler,Klaus %A Müller,Christian %A Schürks,Markus %+ Bayer Vital GmbH, Neurologie, Immunologie & Ophthalmologie, Leverkusen, 51368, Germany, 49 2143051455, markus.schuerks@bayer.com %K digital observational study %K BETACONNECT %K myBETAapp %K interferon beta-1b %K multiple sclerosis %K medication adherence %K medication compliance %K medication persistence %D 2019 %7 29.07.2019 %9 Original Paper %J J Med Internet Res %G English %X Background: Accurate measurement of medication adherence using classical observational studies typically depends on patient self-reporting and is often costly and slow. In contrast, digital observational studies that collect data directly from the patient may pose minimal burden to patients while facilitating accurate, timely, and cost-efficient collection of real-world data. In Germany, ~80% of patients with multiple sclerosis (MS) treated with interferon beta 1b (Betaferon) use an electronic autoinjector (BETACONNECT), which automatically records every injection. Patients may also choose to use a medical app (myBETAapp) to document injection data and their well-being (using a “wellness tracker” feature). Objective: The goal of this pilot study was to establish a digital study process that allows the collection of medication usage data and to assess medication usage among patients with MS treated with interferon beta-1b who use myBETAapp. Methods: The PROmyBETAapp digital observational study was a mixed prospective and retrospective, noninterventional, cohort study conducted among users of myBETAapp in Germany (as of December 2017: registered accounts N=1334; actively used accounts N=522). Between September and December 2017, users received two invitations on their app asking them to participate. Interested patients were provided detailed information and completed an electronic consent process. Data from consenting patients’ devices were collected retrospectively starting from the first day of usage if historical data were available in the database and collected prospectively following consent attainment. In total, 6 months of data on medication usage behavior were collected along with 3 months of wellness tracker data. Descriptive statistics were used to analyze persistence, compliance, and adherence to therapy. Results: Of the 1334 registered accounts, 96 patients (7.2%) provided informed consent to participate in the study. Of these, one patient withdrew consent later. For another patient, injection data could not be recorded during the study period. Follow-up of the remaining 94 patients ended in May 2018. The mean age of participants was 46.6 years, and 50 (53%) were female. Over the 6-month study period, persistence with myBETAapp usage was 96% (90/94), mean compliance was 94% of injections completed, and adherence (persistence and ≥80% compliance) was 89% (84/94). There was no apparent difference between male and female participants and no trend across age groups. The wellness tracker was used by 21% of participants (20/94), with a mean of 3.1 entries per user. Conclusions: This study provides important information on medication usage among patients with MS treated with interferon beta-1b and on consenting behavior of patients in digital studies. In future studies, this approach may allow patients’ feedback to be rapidly implemented in existing digital solutions. Trial Registration: ClinicalTrials.gov NCT03134573; https://clinicaltrials.gov/ct2/show/NCT03134573 %M 31359863 %R 10.2196/14373 %U http://www.jmir.org/2019/7/e14373/ %U https://doi.org/10.2196/14373 %U http://www.ncbi.nlm.nih.gov/pubmed/31359863 %0 Journal Article %@ 2561-9128 %I JMIR Publications %V 2 %N 2 %P e12305 %T A Postoperative Pain Management Mobile App (Panda) for Children at Home After Discharge: Usability and Feasibility %A Dunsmuir,Dustin %A Wu,Helen %A Sun,Terri %A West,Nicholas C %A Lauder,Gillian R %A Görges,Matthias %A Ansermino,J Mark %+ Department of Anesthesiology, Pharmacology & Therapeutics, University of British Columbia, Room V3-353, Clinical Support Building, 950 W 28th Ave, Vancouver, BC, V5Z 4H4, Canada, 1 604 875 2000 ext 5318, DDunsmuir@cw.bc.ca %K pain management %K pain, postoperative period %K outpatients %K mobile apps %K child %K parents %D 2019 %7 04.07.2019 %9 Original Paper %J JMIR Perioper Med %G English %X Background: Emphasis on outpatient pediatric surgical procedures places the burden of responsibility for postoperative pain management on parents or guardians. Panda is a mobile phone app that provides scheduled medication alerts and allows parents to track their child’s pain and medication administration. We have previously tested and optimized the usability and feasibility of Panda within the hospital setting. Objective: The purpose of this study was to evaluate and optimize the usability and feasibility of Panda for use at home based on alert response adherence (response to any medication notification within 1 hour) and parents’ satisfaction. Methods: Parents or guardians of children aged 3 to 18 years undergoing day surgery were recruited to use Panda at home for 1 to 7 days to manage their scheduled medications and to assess their child’s pain. After the surgical procedure, a research assistant guided parents through app setup before independent use at home. We aimed to recruit 10 child-caregiver pairs in each of three rounds of evaluation. Each user’s adherence with the recommended medication alerts was analyzed through audit-trail data generated during the use of the app. We used the Computer System Usability Questionnaire and a poststudy phone interview to evaluate the app’s ease of use and identify major barriers to adoption. Suggestions provided during the interviews were used to improve the app between each round. Results: Twenty-nine child-caregiver pairs participated in three rounds, using the app for 1 to 5 days. Alert response adherence (response to any medication notification within 1 hour) improved as the study progressed: participants responded to a median 30% (interquartile range [IQR] 22%-33%) of alerts within 1 hour in round 1, and subsequently to median 60% (IQR 44%-64%) in round 2 and median 64% (IQR 56%-72%) in round 3 (P=.005). Similarly, response times decreased from median 131 (IQR 77-158) minutes in round 1 to median 31 (IQR 18-61) minutes in round 2 and median 10 (IQR 2-14) minutes in round 3 (P=.002). Analysis of interview feedback from the first two rounds revealed usability issues, such as complaints of too many pages and trouble hearing app alerts, which were addressed to streamline app function, as well as improve visual appearance and audible alerts. Conclusions: It is feasible for parents or guardians to use Panda at home to manage their child’s medication schedule and track their pain. Simple modifications to the app’s alert sounds and user interface improved response times. %M 33393928 %R 10.2196/12305 %U https://periop.jmir.org/2019/2/e12305/ %U https://doi.org/10.2196/12305 %U http://www.ncbi.nlm.nih.gov/pubmed/33393928 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 7 %N 7 %P e12900 %T Attitudes, Beliefs, and Willingness Toward the Use of mHealth Tools for Medication Adherence in the Florida mHealth Adherence Project for People Living With HIV (FL-mAPP): Pilot Questionnaire Study %A Morano,Jamie P %A Clauson,Kevin %A Zhou,Zhi %A Escobar-Viera,César G %A Lieb,Spencer %A Chen,Irene K %A Kirk,David %A Carter,Willie M %A Ruppal,Michael %A Cook,Robert L %+ Department of Infectious Diseases and International Medicine, Morsani College of Medicine, University of South Florida, 12901 Bruce B Downs Blvd, MDC 19, Tampa, FL, 33612-4799, United States, 1 813 844 8297, jamie.morano@post.harvard.edu %K mHealth %K mobile phone app %K app %K HIV %K antiretroviral therapy adherence %K persons living with HIV %K HIV care continuum %K digital health %K medication adherence %K mobile health %D 2019 %7 03.07.2019 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Antiretroviral (ART) adherence among people living with HIV (PLWH) continues to be a challenge despite advances in HIV prevention and treatment. Mobile health (mHealth) interventions are increasingly deployed as tools for ART adherence. However, little is known about the uptake and attitudes toward commercially available, biprogrammatic mobile apps (ie, designed for both smartphone and short message service [SMS] messaging) among demographically diverse PLWH. Objectives: The Florida mHealth Adherence Project for PLWH (FL-mAPP) is an innovative pilot study that aimed to determine the acceptability of a commercially available, biprogrammatic mHealth intervention platform to ensure medication adherence and gauge the current attitudes of PLWH toward current and future mHealth apps. Methods: A predeveloped, commercially available, biprogrammatic mHealth platform (Care4Today Mobile Health Manager, Johnson & Johnson, New Brunswick, NJ) was deployed, with self-reported ART adherence recorded in the app and paper survey at both short term (30-day) or long-term (90-day) follow-ups. Consented participants completed baseline surveys on sociodemographics and attitudes, beliefs, and willingness toward the use of mHealth interventions for HIV care using a 5-point Likert scale. Chi-square tests and multivariate logistic regression analyses identified correlations with successful uptake of the mHealth platform. Results: Among 132 PLWH, 66% (n=87) initially agreed to use the mHealth platform, of which 54% (n=47) successfully connected to the platform. Of the 87 agreeing to use the mHealth platform, we found an approximate 2:1 ratio of persons agreeing to try the smartphone app (n=59) versus the SMS text messages (n=28). Factors correlating with mHealth uptake were above high school level education (adjusted odds ratio 2.65; P=.05), confidence that a clinical staff member would assist with mHealth app use (adjusted odds ratio 2.92, P=.048), belief that PLWH would use such an mHealth app (adjusted odds ratio 2.89; P=.02), and ownership of a smartphone in contrast to a “flip-phone” model (adjusted odds ratio 2.80; P=.05). Of the sample, 70.2% (n=92) reported daily interest in receiving medication adherence reminders via an app (80.4% users versus 64.7% nonusers), although not significantly different among the user groups (P=.06). In addition, 34.8% (n=16) of mHealth users reported a theoretical “daily” interest and 68.2% (n=58) of non-mHealth users reported no interest in using an mHealth app for potentially tracking alcohol or drug intake (P=.002). Conclusions: This commercially available, biprogrammatic mHealth platform showed feasibility and efficacy for enhanced ART and medication adherence within public health clinics and successfully included older age groups. Successful use of the platform among demographically diverse PLWH is important for HIV implementation science and promising for uptake on a larger scale. %M 31271150 %R 10.2196/12900 %U http://mhealth.jmir.org/2019/7/e12900/ %U https://doi.org/10.2196/12900 %U http://www.ncbi.nlm.nih.gov/pubmed/31271150 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 3 %N 2 %P e13558 %T The Feasibility of a Using a Smart Button Mobile Health System to Self-Track Medication Adherence and Deliver Tailored Short Message Service Text Message Feedback %A Bartlett Ellis,Rebecca J %A Hill,James H %A Kerley,K Denise %A Sinha,Arjun %A Ganci,Aaron %A Russell,Cynthia L %+ Science of Nursing Care Department, Indiana University School of Nursing, 600 Barnhill Drive, E423, Indianapolis, IN, 46202, United States, 1 (317) 274 0047, rjbartle@iu.edu %K medication adherence %K medication compliance %K behavior change %D 2019 %7 25.06.2019 %9 Original Paper %J JMIR Form Res %G English %X Background: As many as 50% of people experience medication nonadherence, yet studies for detecting nonadherence and delivering real-time interventions to improve adherence are lacking. Mobile health (mHealth) technologies show promise to track and support medication adherence. Objective: The study aimed to evaluate the feasibility and acceptability of using an mHealth system for medication adherence tracking and intervention delivery. The mHealth system comprises a smart button device to self-track medication taking, a companion smartphone app, a computer algorithm used to determine adherence and then deliver a standard or tailored SMS (short message service) text message on the basis of timing of medication taking. Standard SMS text messages indicated that the smartphone app registered the button press, whereas tailored SMS text messages encouraged habit formation and systems thinking on the basis of the timing the medications were taken. Methods: A convenience sample of 5 adults with chronic kidney disease (CKD), who were prescribed antihypertensive medication, participated in a 52-day longitudinal study. The study was conducted in 3 phases, with a standard SMS text message sent in phases 1 (study days 1-14) and 3 (study days 46-52) and tailored SMS text messages sent during phase 2 (study days 15-45) in response to participant medication self-tracking. Medication adherence was measured using: (1) the smart button and (2) electronic medication monitoring caps. Concordance between these 2 methods was evaluated using percentage of measurements made on the same day and occurring within ±5 min of one another. Acceptability was evaluated using qualitative feedback from participants. Results: A total of 5 patients with CKD, stages 1-4, were enrolled in the study, with the majority being men (60%), white (80%), and Hispanic/Latino (40%) of middle age (52.6 years, SD 22.49; range 20-70). The mHealth system was successfully initiated in the clinic setting for all enrolled participants. Of the expected 260 data points, 36.5% (n=95) were recorded with the smart button and 76.2% (n=198) with electronic monitoring. Concordant events (n=94), in which events were recorded with both the smart button and electronic monitoring, occurred 47% of the time and 58% of these events occurred within ±5 min of one another. Participant comments suggested SMS text messages were encouraging. Conclusions: It was feasible to recruit participants in the clinic setting for an mHealth study, and our system was successfully initiated for all enrolled participants. The smart button is an innovative way to self-report adherence data, including date and timing of medication taking, which were not previously available from measures that rely on recall of adherence. Although the selected smart button had poor concordance with electronic monitoring caps, participants were willing to use it to self-track medication adherence, and they found the mHealth system acceptable to use in most cases. %M 31237568 %R 10.2196/13558 %U http://formative.jmir.org/2019/2/e13558/ %U https://doi.org/10.2196/13558 %U http://www.ncbi.nlm.nih.gov/pubmed/31237568 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 6 %P e13351 %T “Smartphone Medication Adherence Saves Kidneys” for Kidney Transplantation Recipients: Protocol for a Randomized Controlled Trial %A McGillicuddy,John %A Chandler,Jessica %A Sox,Luke %A Mueller,Martina %A Nemeth,Lynne %A Baliga,Prabhakar %A Treiber,Frank %+ College of Nursing, Medical University of South Carolina, 99 Jonathan Lucas Street, Charleston, SC,, United States, 1 843 792 1928, chandlje@musc.edu %K mHealth %K kidney transplant %K medication adherence %K digital health %D 2019 %7 21.06.2019 %9 Protocol %J JMIR Res Protoc %G English %X Background: Kidney transplant recipients’ poor medication adherence and poor control of comorbidities, particularly hypertension, are risk factors for graft rejection, graft loss, and death. Few randomized controlled trials (RCTs) have been successful in improving sustained medication adherence and blood pressure control among kidney transplantation recipients. We provide rationale for an RCT evaluating a mobile health medical self-management system for kidney transplantation recipients called Smartphone Medication Adherence Saves Kidneys (SMASK). Objective: Our objective is to determine whether SMASK is efficacious in improving medication adherence and sustaining blood pressure control among kidney transplantation recipients with uncontrolled hypertension and poor medication adherence compared to an enhanced standard care. Methods: This two-arm, 6-month, phase II single-site efficacy RCT will involve 80 kidney transplantation recipients. Participants will be randomly assigned to the SMASK intervention arm or control arm. SMASK includes multilevel components: automated reminders from an electronic medication tray; tailored text messages and motivational feedback, guided by the self-determination theory; and automated summary reports for providers. Evaluations will be conducted preintervention, at 3 and 6 months, and posttrial at 12 months. Specific aims are to test the hypotheses that compared to standard care, the SMASK cohort will demonstrate significantly improved changes at 3, 6, and 12 months in the primary outcome variables medication adherence (proportion with electronic monitor-derived score >0.90) and blood pressure control (proportion meeting and sustaining adherence to the Kidney Disease Improving Global Outcomes [KDIGO] guidelines for blood pressure control); the secondary outcome variables provider adherence to KDIGO guidelines, measured by timing of medication changes and changes in self-determination theory constructs; and the exploratory outcome variables estimated glomerular filtration rate, variability in calcineurin inhibitor trough levels, and proportion of patients meeting and sustaining the 24-hour ambulatory blood pressure below 130/80 mm Hg. After the 6-month evaluation, interviews with a random sample of SMASK subjects (n=20) and health care providers (n=3-5) will assess user reactions including acceptability, usability, and aids/barriers to sustainability. Data from the RCT and interviews will be triangulated to further refine and optimize SMASK and prepare for a multisite effectiveness RCT. Results: The SMASK project received funding from National Institute of Diabetes and Digestive and Kidney Diseases in June 2016, obtained institutional review board approval in April 2016, and began data collection in July 2016. As of July 2018, we completed enrollment with a total of 80 participants. Conclusions: This study will provide data regarding the efficacy of SMASK to improve medication adherence and blood pressure control in a cohort of hypertensive kidney transplant recipients. An efficacious SMASK intervention will pave the way for a larger, multicenter, effectiveness RCT powered sufficiently to evaluate clinical events in a real-world setting and with the potential to demonstrate improved outcomes at lower cost than standard care. International Registered Report Identifier (IRRID): DERR1-10.2196/13351 %M 31228175 %R 10.2196/13351 %U http://www.researchprotocols.org/2019/6/e13351/ %U https://doi.org/10.2196/13351 %U http://www.ncbi.nlm.nih.gov/pubmed/31228175 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 21 %N 6 %P e12505 %T Mobile Apps for Increasing Treatment Adherence: Systematic Review %A Pérez-Jover,Virtudes %A Sala-González,Marina %A Guilabert,Mercedes %A Mira,José Joaquín %+ Departamento Psicología de la Salud, Universidad Miguel Hernández, Altamira Building, Avda de la Universidad s/n, Elche, 03202, Spain, 34 966658600 ext 8984, mguilabert@umh.es %K mobile health %K medication alert systems %K medication adherence %D 2019 %7 18.06.2019 %9 Review %J J Med Internet Res %G English %X Background: It is estimated that 20% to 50% of patients do not take their medication correctly, and this leads to increased morbidity and inefficacy of therapeutic approaches. Fostering treatment adherence is a priority objective for all health systems. The growth of mobile apps to facilitate therapeutic adherence has significantly increased in recent years. However, the effectiveness of the apps for this purpose has not been evaluated. Objective: This study aimed to analyze whether mobile apps are perceived as useful for managing medication at home and if they actually contribute to increasing treatment adherence in patients. Methods: We carried out a systematic review of research published using Scopus, Cochrane Library, ProQuest, and MEDLINE databases and analyzed the information about their contribution to increasing therapeutic adherence and the perceived usefulness of mobile apps. This review examined studies published between 2000 and 2017. Results: Overall, 11 studies fulfilled the inclusion criteria. The sample sizes of these studies varied between 16 and 99 participants. In addition, 7 studies confirmed that the mobile app increased treatment adherence. In 5 of them, the before and after adherence measures suggested significant statistical improvements, when comparing self-reported adherence and missed dose with a percentage increase ranging between 7% and 40%. The users found mobile apps easy to use and useful for managing their medication. The patients were mostly satisfied with their use, with an average score of 8.1 out of 10. Conclusions: The use of mobile apps helps increase treatment adherence, and they are an appropriate method for managing medication at home. %M 31215517 %R 10.2196/12505 %U http://www.jmir.org/2019/6/e12505/ %U https://doi.org/10.2196/12505 %U http://www.ncbi.nlm.nih.gov/pubmed/31215517 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 7 %N 6 %P e8130 %T A Medication Adherence App for Children With Sickle Cell Disease: Qualitative Study %A Curtis,Kristina %A Lebedev,Anastasiya %A Aguirre,Elisa %A Lobitz,Stephan %+ Health Behaviour and Interventions Research, Faculty of Health and Life Sciences, Coventry University, Richard Crossman Building, 4th Floor, Coventry, CV1 5FB, United Kingdom, 44 07916142132, kristina.curtis@coventry.ac.uk %K children %K adolescents %K sickle cell disease %K medication adherence %K models, theoretical %K mHealth %D 2019 %7 18.06.2019 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Young people with sickle cell disease (SCD) often demonstrate low medication adherence and low motivation for effectively self-managing their condition. The growing sophistication of mobile phones and their popularity among young people render them a promising platform for increasing medication adherence. However, so far, few apps targeting SCD have been developed from research with the target population and underpinned with theory and evidence. Objective: The aim of this study was to develop a theory-and-evidence-based medication adherence app to support children and adolescents with SCD. Methods: The Behavior Change Wheel (BCW), a theoretically based intervention development framework, along with a review of the literature, 10 interviews with children and adolescents with SCD aged between 12 and 18 years, and consultation with experts informed app development. Thematic analysis of interviews provided relevant theoretical and evidence-based components to underpin the design and development of the app. Results: Findings suggested that some patients had lapses in memory for taking their medication (capability); variation in beliefs toward the effectiveness of medication and confidence in self-managing their condition (motivation); a limited time to take medication; and barriers and enablers within the changing context of social support during the transition into adulthood (opportunity). Steps were taken to select the appropriate behavioral change components (involving behavior change techniques [BCTs] such as information on antecedents, prompts/cues; self-monitoring of the behavior; and social support) and translate them into app features designed to overcome these barriers to medication adherence. Conclusions: Patients with SCD have complex barriers to medication adherence necessitating the need for comprehensive models of behavior change to analyze the problem. Children and adolescents require an app that goes beyond simple medication reminders and takes into account the patient’s beliefs, emotions, and environmental barriers to medication adherence. %M 31215518 %R 10.2196/mhealth.8130 %U http://mhealth.jmir.org/2019/6/e8130/ %U https://doi.org/10.2196/mhealth.8130 %U http://www.ncbi.nlm.nih.gov/pubmed/31215518 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 7 %N 5 %P e10465 %T User Preferences and Persona Design for an mHealth Intervention to Support Adherence to Cardiovascular Disease Medication in Singapore: A Multi-Method Study %A Haldane,Victoria %A Koh,Joel Jun Kai %A Srivastava,Aastha %A Teo,Krichelle Wei Qi %A Tan,Yao Guo %A Cheng,Rui Xiang %A Yap,Yi Cheng %A Ong,Pei-Shi %A Van Dam,Rob M %A Foo,Jie Min %A Müller-Riemenschneider,Falk %A Koh,Gerald Choon-Huat %A Foong,Pin Sym %A Perel,Pablo %A Legido-Quigley,Helena %+ Institute of Health Policy, Management and Evaluation, University of Toronto, 155 College St, 4th Floor, Toronto, ON,, Canada, 1 416 978 4326, v.haldane@mail.utoronto.ca %K personas %K biopsychosocial personas %K qualitative %K ASCVD %K adherence %K patient perspectives %D 2019 %7 28.05.2019 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: The use of mobile health (mHealth) has gained popularity globally, including for its use in a variety of health interventions, particularly through short message service (SMS) text messaging. However, there are challenges to the use of mHealth, particularly among older users who have a large heterogeneity in usability and accessibility barriers when using technology. Objective: In order to better understand and conceptualize the diversity of users and give insight into their particular needs, we turned to persona creation. Personas are user archetypes created through data generated from multi-method inquiry with actual target users. Personas are an appropriate yet largely underutilized component of current mHealth research. Methods: Leveraging data from a multi-method study conducted in Singapore with an ethnically diverse population including Chinese, Malay, and Indian participants, we used a proforma to analyze data from the qualitative component (ie, 20 in-depth interviews) and quantitative component (ie, 100 interviewer-guided surveys). We then identified key characteristics, including technology use and preferences as well as adherence factors, to synthesize five personas reflective of persons over the age of 40 years in Singapore with atherosclerotic cardiovascular disease (ASCVD) or ASCVD risk factors, such as hypertension. Results: We present five personas typologized as (1) The Quiet Analog, (2) The Busy Grandparent, (3) The Socializer, (4) The Newly Diagnosed, and (5) The Hard-to-Reach. We report on four key characteristics: health care access, medication adherence, mobile phone technology usage (ie, ownership, access, and utilization), and interest in mHealth. Finally, we provide insights into how these personas may be used in the design and implementation of an mHealth intervention. Our work demonstrates how multi-method data can create biopsychosocial personas that can be used to explore and address the diversity in behaviors, preferences, and needs in user groups. Conclusions: With wider adoption of mHealth, it is important that we consider user-centered design techniques and design thinking in order to create meaningful, patient-centered interventions for adherence to medications. Future research in this area should include greater exploration of how these five personas can be used to better understand how and when is best to deliver mHealth interventions in Singapore and beyond. %M 31140445 %R 10.2196/10465 %U http://mhealth.jmir.org/2019/5/e10465/ %U https://doi.org/10.2196/10465 %U http://www.ncbi.nlm.nih.gov/pubmed/31140445 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 7 %N 4 %P e11720 %T To Text or Not to Text: Electronic Message Intervention to Improve Treatment Adherence Versus Matched Historical Controls %A Oppezzo,Marily A %A Stanton,Michael V %A Garcia,Ariadna %A Rigdon,Joseph %A Berman,Jae R %A Gardner,Christopher D %+ Stanford Prevention Research Center, Stanford University School of Medicine, 1265 Welch Road, Stanford, CA, 94305-5411, United States, 1 650 723 6254, moppezzo@stanford.edu %K treatment adherence %K intervention %K short message service %K mobile health %K propensity score %D 2019 %7 09.04.2019 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Ensuring treatment adherence is important for the internal validity of clinical trials. In intervention studies where touch points decrease over time, there is even more of an adherence challenge. Trials with multiple cohorts offer an opportunity to innovate on ways to increase treatment adherence without compromising the integrity of the study design, and previous cohorts can serve as historical controls. Electronically delivered nudges offer low-cost opportunities to increase treatment adherence. Objective: This study aimed to evaluate the effectiveness of electronic messages (e-messages) on treatment adherence to the last cohort of a parent weight loss intervention during the second half of a year-long trial, when intervention checkpoint frequency decreases. Treatment adherence is measured by intervention class attendance and adherence to the intervention diet. Methods: All participants in the last cohort (cohort 5, n=128) of a large randomized weight loss study were offered an e-message intervention to improve participant adherence during the last 6 months of a 1-year weight loss program. Overall, 3 to 4 electronic weekly messages asked participants about intervention diet adherence. A propensity score model was estimated using 97 participants who opted to receive e-messages and 31 who declined in cohort 5 and used to pair match cohort 5 e-message participants to a historical control group from cohorts 1 to 4. Moreover, 88 participants had complete data, yielding 176 participants in the final analyses. After matching, intervention and matched control groups were compared on (1) proportion of class attendance between the 6 and 12 month study endpoints, (2) diet adherence, as measured by total carbohydrate grams for low-carbohydrate (LC) and total fat grams for low-fat (LF) diets at 12 months, and (3) weight change from 6 to 12 months. The dose-response relationship between the proportion of text messages responded to and the 3 outcomes was also investigated. Results: Compared with matched controls, receiving e-messages had no effect on (1) treatment adherence; class attendance after 6 months +4.6% (95% CI −4.43 to 13.68, P=.31), (2) adherence; LC −2.5 g carbohydrate, 95% CI −29.9 to 24.8, P=.85; LF +6.2 g fat, 95% CI −4.1 to 17.0, P=.26); or on (3) the secondary outcome of weight change in the last 6 months; +0.3 kg (95% CI −1.0 to 1.5, P=.68). There was a positive significant response correlation between the percentage of messages to which participants responded and class attendance (r=.45, P<.001). Conclusions: Although this e-message intervention did not improve treatment adherence, future studies can learn from this pilot and may incorporate more variety in the prompts and more interaction to promote more effective user engagement. Uniquely, this study demonstrated the potential for innovating within a multicohort trial using propensity score–matched historical control subjects. Trial Registration: ClinicalTrials.gov NCT01826591; https://clinicaltrials.gov/ct2/show/NCT01826591 International Registered Report Identifier (IRRID): RR2-10.1016/j.cct.2016.12.021 %M 30964436 %R 10.2196/11720 %U https://mhealth.jmir.org/2019/4/e11720/ %U https://doi.org/10.2196/11720 %U http://www.ncbi.nlm.nih.gov/pubmed/30964436 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 7 %N 4 %P e10904 %T Text Messaging to Enhance Behavioral Health Treatment Engagement Among Justice-Involved Youth: Qualitative and User Testing Study %A Tolou-Shams,Marina %A Yonek,Juliet %A Galbraith,Katharine %A Bath,Eraka %+ Department of Psychiatry, Weill Institute of Neurosciences, University of California, San Francisco, 401 Parnassus Ave, San Francisco, CA,, United States, 1 415 206 2212, marina.tolou-shams@ucsf.edu %K juvenile delinquency %K treatment adherence and compliance %K mental health %K short message service text messaging %D 2019 %7 05.04.2019 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Mental health and substance use disorders are highly prevalent in justice-involved youth, yet only 8% of court-involved, nonincarcerated (CINI) youth in need of treatment receive it. Dual diagnosis (co-occurring psychiatric and substance use disorders) in justice-involved youth is highly predictive of recidivism. Identifying novel approaches, such as the use of mobile health (mHealth) technologies, to close this gap between need and receipt of behavioral health treatment for the CINI population could potentially offset rates of reoffending into adulthood. Text-messaging (short message service, SMS) interventions have demonstrated efficacy in improving treatment adherence and other associated outcomes in other vulnerable youth populations, but development and testing of mHealth interventions to improve behavioral health treatment rates and outcomes for CINI youth are lacking. Objective: This study aimed to collect qualitative data from key stakeholders to inform the development of a theoretically grounded, family-based text-messaging (SMS) intervention targeting CINI youth’s behavioral health treatment engagement; additionally, the aim was to conduct end-user testing over 6 months with CINI youth and caregivers to determine intervention feasibility and acceptability. Methods: CINI youth and caregivers were referred from a California-based Juvenile Probation Department and community-based provider organizations providing services for justice-involved youth. Eligibility criteria included the following: being a justice-involved youth or a caregiver of a justice-involved youth, English speaking, youth aged 13 to 17 years old and either referred to or currently attending mental health or substance use treatment, and youth and caregiver have access to a cell phone with text-messaging capability. Results: Overall, 28 individuals participated in focus groups and interviews—8 youth, 5 caregivers, and 15 juvenile justice (JJ) personnel. Three major themes emerged: (1) texting among JJ personnel and CINI youth and caregivers in their caseload is common but not systematic, (2) stigma and privacy are perceived as barriers to texting youth about behavioral health treatment appointments, and (3) messages should be short, simple, relatable, positive, and personalized. In total, 9 participants (7 youth and 2 caregivers) participated in end-user testing and rated the intervention as useful, helpful, and supportive. Conclusions: Text messaging (SMS) is an acceptable and feasible means of reminding CINI youth to attend behavioral health treatment appointments. Future implementation challenges include making text messaging (SMS) personalized and tailored but not resource intensive (eg, requiring one-to-one, 24/7 human contact) and identifying which systems will deliver and sustain the intervention. Text messaging (SMS) among justice personnel, youth, and their caregivers is already widespread, but lack of clear guidelines about privacy, confidentiality, and information sharing poses ethical conundrums. Future hybrid-type research designs that explore the efficacy of the intervention while also studying ethical, system, and policy-level factors associated with using digital health interventions to improve CINI youth outcomes is a key next step. %M 30950808 %R 10.2196/10904 %U https://mhealth.jmir.org/2019/4/e10904/ %U https://doi.org/10.2196/10904 %U http://www.ncbi.nlm.nih.gov/pubmed/30950808 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 7 %N 4 %P e11687 %T Mobile Health for Tuberculosis Management in South India: Is Video-Based Directly Observed Treatment an Acceptable Alternative? %A Kumar,Anil A %A De Costa,Ayesha %A Das,Arundathi %A Srinivasa,GA %A D'Souza,George %A Rodrigues,Rashmi %+ Department of Community Health, St John's Medical College, St John's National Academy of Health Sciences, Koramangala 4th Block, Bangalore, 560034, India, 91 9845389538, rashmijr@gmail.com %K medical informatics %K tuberculosis %K mHealth %K adherence %K mobile phone %K reminder %K SMS %K voice call %K DOT %K vDOT %K video DOT %D 2019 %7 03.04.2019 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: With the availability of low-cost mobile devices and the ease of internet access, mobile health (mHealth) is digitally revolutionizing the health sector even in resource-constrained settings. It is however necessary to assess end-user perceptions before deploying potential interventions. Objective: This study aimed to assess the mobile phone usage patterns and the acceptability of mobile phone support during care and treatment in patients with tuberculosis (TB) in South India. Methods: This exploratory study was conducted at an urban private tertiary care teaching hospital and nearby public primary-level health care facilities in Bangalore, South India. We recruited 185 patients with TB through consecutive sampling. Subsequent to written informed consent, participants responded to an interviewer-administered pretested questionnaire. The questionnaire included questions on demographics, phone usage patterns, and the benefits of using of mobile phone technology to improve health outcomes and treatment adherence. Frequency, mean, median, and SD or interquartile range were used to describe the data. Bivariate associations were assessed between demographics, clinical details, phone usage, and mHealth communication preferences using the chi-square test and odds ratios. Associations with a P value ≤.20 were included in a logistic regression model. A P value of <.05 was considered significant. Results: Of the 185 participants, 151 (81.6%) used a mobile phone, and half of them owned a smartphone. The primary use of the mobile phone was to communicate over voice calls (147/151, 97.4%). The short message service (SMS) text messaging feature was used by only 66/151 (43.7%) mobile phone users. A total of 87 of the 151 mobile phone users (57.6%) knew how to use the camera. Only 41/151 (27.2%) mobile phone users had used their mobile phones to communicate with their health care providers. Although receiving medication reminders via mobile phones was acceptable to all participants, 2 participants considered repeated reminders as an intrusion of their privacy. A majority of the participants (137/185, 74.1%) preferred health communications via voice calls. Of the total participants, 123/185 (66.5%) requested reminders to be sent only at specific times during the day, 22/185 (11.9%) suggested reminders should synchronize with their prescribed medication schedule, whereas 40/185 (21.6%) did not have any time preferences. English literacy was associated with a preference for SMS in comparison with voice calls. Most participants (142/185, 76.8%) preferred video-based directly observed treatment when compared with in-person directly observed treatment. Conclusions: Although mobile phones for supporting health and treatment adherence were acceptable to patients with TB, mHealth interventions should consider language, mode of communication, and preferred timing for communication to improve uptake. %M 30942696 %R 10.2196/11687 %U http://mhealth.jmir.org/2019/4/e11687/ %U https://doi.org/10.2196/11687 %U http://www.ncbi.nlm.nih.gov/pubmed/30942696 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 7 %N 4 %P e12652 %T Improving Linkage to and Retention in Care in Newly Diagnosed HIV-Positive Patients Using Smartphones in South Africa: Randomized Controlled Trial %A Venter,Willem Daniel Francois %A Fischer,Alex %A Lalla-Edward,Samanta Tresha %A Coleman,Jesse %A Lau Chan,Vincent %A Shubber,Zara %A Phatsoane,Mothepane %A Gorgens,Marelize %A Stewart-Isherwood,Lynsey %A Carmona,Sergio %A Fraser-Hurt,Nicole %+ Wits Reproductive Health and HIV Institute, University of Witwatersrand, Hillbrow Health Precinct, 22 Esselen St, Johannesburg, 2001, South Africa, 27 011 358 5500, afischer@wrhi.ac.za %K cell phones %K HIV %K app %K Africa %K linkage to care %K patient information %D 2019 %7 02.04.2019 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: South Africa provides free antiretroviral therapy for almost 5 million people living with HIV, but only 71% of the eligible people are on treatment, representing a shortfall in the care cascade, especially among men and youth. Many developing countries have expanded access to smartphones; success in health apps raises the possibility of improving this cascade. Objective: SmartLink is a health app for Android smartphones providing HIV-related laboratory results, information, support, and appointment reminders to engage and link patients to care. This study aimed to evaluate the ability of SmartLink to improve linkage to care for HIV-positive smartphone owners. Methods: This study was a multisite randomized controlled trial in Johannesburg. The intervention arm received the app (along with referral to a treatment site) and the control arm received the standard of care (referral alone). Linkage to care was confirmed by an HIV-related blood test reported on the National Health Laboratory Service database between 2 weeks and 8 months after initiation. Results: A total of 345 participants were recruited into the study; 64.9% (224/345) of the participants were female and 44.1% (152/345) were aged less than 30 years. In addition, 46.7% (161/345) were employed full time, 95.9% (331/345) had at least secondary school education, and 35.9% (124/345) were from Zimbabwe. Linkage to care between 2 weeks and 8 months was 48.6% (88/181) in the intervention arm versus 45.1% (74/164) in the control (P=.52) and increased to 64.1% (116/181) and 61.0% (100/164) (P=.55), respectively, after the initial 8-month period. Moreover, youth aged 18 to 30-years showed a statistically significant 20% increase in linkage to care for the intervention group. Conclusions: Youth aged less than 30 years have been historically difficult to reach with traditional interventions, and the SmartLink app provides a proof of concept that this population reacts to mobile health interventions that engage patients in HIV care. Trial Registration: ClinicalTrials.gov NCT02756949; https://clinicaltrials.gov/ct2/show/NCT02756949 (Archived by WebCite at http://www.webcitation.org/6z1GTJCNW) %M 30938681 %R 10.2196/12652 %U https://mhealth.jmir.org/2019/4/e12652/ %U https://doi.org/10.2196/12652 %U http://www.ncbi.nlm.nih.gov/pubmed/30938681 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 7 %N 3 %P e12411 %T Effective Engagement of Adolescent Asthma Patients With Mobile Health–Supporting Medication Adherence %A Kosse,Richelle C %A Bouvy,Marcel L %A Belitser,Svetlana V %A de Vries,Tjalling W %A van der Wal,Piet S %A Koster,Ellen S %+ Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, PO Box 80082, Utrecht, 3508 TB, Netherlands, 31 (0)30 253 7324, M.L.Bouvy@uu.nl %K adolescent %K asthma %K medication adherence %K pharmacists %K telemedicine %D 2019 %7 27.03.2019 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Mobile health (mHealth) apps have the potential to support patients’ medication use and are therefore increasingly used. Apps with broad functionality are suggested to be more effective; however, not much is known about the actual use of different functionalities and the effective engagement. Objective: The aim of this study was to explore the use and the effective engagement of adolescents (aged 12 to 18 years) with the Adolescent Adherence Patient Tool (ADAPT). Methods: The ADAPT intervention consisted of an app for patients, which was connected to a management system for their pharmacist. The aim of the ADAPT intervention was to improve medication adherence and, therefore, the app contained multiple functionalities: questionnaires to monitor symptoms and adherence, medication reminders, short movies, pharmacist chat, and peer chat. For this study, data of the ADAPT study and a cluster randomized controlled trial were used. Adolescents with asthma had 6 months’ access to the ADAPT intervention, and all app usage was securely registered in a log file. Results: In total, 86 adolescents (mean age 15.0, SD 2.0 years) used the ADAPT app 17 times (range 1-113) per person. Females used the app more often than males (P=.01) and for a longer period of time (P=.03). On average, 3 different functionalities were used, and 13% of the adolescents used all functionalities of the app. The questionnaires to monitor symptoms and adherence were used by most adolescents. The total app use did not affect adherence; however, activity in the pharmacist chat positively affected medication adherence (P=.03), in particular, if patients sent messages to their pharmacist (P=.01). Conclusions: mHealth apps for adolescents with asthma should contain different functionalities to serve the diverging needs and preferences of individual patients. Suggested key functionalities to promote use and effectiveness in adolescents with asthma are questionnaires to monitor symptoms and a health care provider chat. %M 30916664 %R 10.2196/12411 %U http://mhealth.jmir.org/2019/3/e12411/ %U https://doi.org/10.2196/12411 %U http://www.ncbi.nlm.nih.gov/pubmed/30916664 %0 Journal Article %@ 2291-9279 %I JMIR Publications %V 7 %N 1 %P e11861 %T Creating a Theoretically Grounded Gaming App to Increase Adherence to Pre-Exposure Prophylaxis: Lessons From the Development of the Viral Combat Mobile Phone Game %A Whiteley,Laura %A Mena,Leandro %A Craker,Lacey K %A Healy,Meredith Garver %A Brown,Larry K %+ Department of Psychiatry, Warren Alpert Medical School, Brown University, Residency Training Program-Brown University-Butler Hospital, 345 Blackstone Boulevard, Providence, RI, 02906, United States, 1 401 455 6375, laura_whiteley@brown.edu %K cell phone %K HIV %K young adult %K sexual and gender minorities %D 2019 %7 27.03.2019 %9 Original Paper %J JMIR Serious Games %G English %X Background: In the United States, young minority men who have sex with men (MSM) are most likely to become infected with HIV. The use of antiretroviral medications to reduce the risk of acquiring HIV infection (pre-exposure prophylaxis, PrEP) is an efficacious and promising prevention strategy. There have been significant advances regarding PrEP, including the definitive demonstration that PrEP reduces HIV acquisition and the development of clinical prescribing guidelines. Despite these promising events, the practical implementation of PrEP can be challenging. Data show that PrEP’s safety and effectiveness could be greatly compromised by suboptimal adherence to treatment, and there is concern about the potential for an increase in HIV risk behavior among PrEP users. Due to these challenges, the prescribing of PrEP should be accompanied by behavioral interventions to promote adherence. Objective: This study aimed to develop an immersive, action-oriented iPhone gaming intervention to improve motivation for adherence to PrEP. Methods: Game development was guided by social learning theory, taking into consideration the perspectives of young adult MSM who are taking PrEP. A total of 20 young men who have sex with men (YMSM; aged 18-35 years) were recruited from a sexually transmitted infection (STI), HIV testing, and PrEP care clinic in Jackson, Mississippi, between October 2016 and June 2017. They participated in qualitative interviews guided by the information-motivation-behavioral skills (IMB) model of behavior change. The mean age of participants was 26 years, and all the participants identified as male. Acceptability of the game was assessed with the Client Service Questionnaire and session evaluation form. Results: A number of themes emerged that informed game development. YMSM taking PrEP desired informational game content that included new and comprehensive details about the effectiveness of PrEP, details about PrEP as it relates to doctors’ visits, and general information about STIs other than HIV. Motivational themes that emerged were the desire for enhancement of future orientation; reinforcement of positive influences from partners, parents, and friends; collaboration with health care providers; decreasing stigma; and a focus on personal relevance of PrEP-related medical care. Behavioral skills themes centered around self-efficacy and strategies for adherence to PrEP and self-care. Conclusions: We utilized youth feedback, IMB, and agile software development to create a multilevel, immersive, action-oriented iPhone gaming intervention to improve motivation for adherence to PrEP. There is a dearth of gaming interventions for persons on PrEP. This study is a significant step in working toward the development and testing of an iPhone gaming intervention to decrease HIV risk and promote adherence to PrEP for YMSM. %M 30916652 %R 10.2196/11861 %U http://games.jmir.org/2019/1/e11861/ %U https://doi.org/10.2196/11861 %U http://www.ncbi.nlm.nih.gov/pubmed/30916652 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 21 %N 3 %P e11486 %T The Association Between Medication Adherence for Chronic Conditions and Digital Health Activity Tracking: Retrospective Analysis %A Quisel,Tom %A Foschini,Luca %A Zbikowski,Susan M %A Juusola,Jessie L %+ Evidation Health, 167 2nd Avenue, San Mateo, CA,, United States, 1 650 279 8855, jjuusola@evidation.com %K activity tracker %K health behavior %K eHealth %K mHealth %K medication adherence %D 2019 %7 20.03.2019 %9 Original Paper %J J Med Internet Res %G English %X Background: Chronic diseases have a widespread impact on health outcomes and costs in the United States. Heart disease and diabetes are among the biggest cost burdens on the health care system. Adherence to medication is associated with better health outcomes and lower total health care costs for individuals with these conditions, but the relationship between medication adherence and health activity behavior has not been explored extensively. Objective: The aim of this study was to examine the relationship between medication adherence and health behaviors among a large population of insured individuals with hypertension, diabetes, and dyslipidemia. Methods: We conducted a retrospective analysis of health status, behaviors, and medication adherence from medical and pharmacy claims and health behavior data. Adherence was measured in terms of proportion of days covered (PDC), calculated from pharmacy claims using both a fixed and variable denominator methodology. Individuals were considered adherent if their PDC was at least 0.80. We used step counts, sleep, weight, and food log data that were transmitted through devices that individuals linked. We computed metrics on the frequency of tracking and the extent to which individuals engaged in each tracking activity. Finally, we used logistic regression to model the relationship between adherent status and the activity-tracking metrics, including age and sex as fixed effects. Results: We identified 117,765 cases with diabetes, 317,340 with dyslipidemia, and 673,428 with hypertension between January 1, 2015 and June 1, 2016 in available data sources. Average fixed and variable PDC for all individuals ranged from 0.673 to 0.917 for diabetes, 0.756 to 0.921 for dyslipidemia, and 0.756 to 0.929 for hypertension. A subgroup of 8553 cases also had health behavior data (eg, activity-tracker data). On the basis of these data, individuals who tracked steps, sleep, weight, or diet were significantly more likely to be adherent to medication than those who did not track any activities in both the fixed methodology (odds ratio, OR 1.33, 95% CI 1.29-1.36) and variable methodology (OR 1.37, 95% CI 1.32-1.43), with age and sex as fixed effects. Furthermore, there was a positive association between frequency of activity tracking and medication adherence. In the logistic regression model, increasing the adjusted tracking ratio by 0.5 increased the fixed adherent status OR by a factor of 1.11 (95% CI 1.06-1.16). Finally, we found a positive association between number of steps and adherent status when controlling for age and sex. Conclusions: Adopters of digital health activity trackers tend to be more adherent to hypertension, diabetes, and dyslipidemia medications, and adherence increases with tracking frequency. This suggests that there may be value in examining new ways to further promote medication adherence through programs that incentivize health tracking and leveraging insights derived from connected devices to improve health outcomes. %M 30892271 %R 10.2196/11486 %U http://www.jmir.org/2019/3/e11486/ %U https://doi.org/10.2196/11486 %U http://www.ncbi.nlm.nih.gov/pubmed/30892271 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 3 %N 1 %P e11578 %T Development of PositiveLinks: A Mobile Phone App to Promote Linkage and Retention in Care for People With HIV %A Laurence,Colleen %A Wispelwey,Erin %A Flickinger,Tabor E %A Grabowski,Marika %A Waldman,Ava Lena %A Plews-Ogan,Erin %A Debolt,Claire %A Reynolds,George %A Cohn,Wendy %A Ingersoll,Karen %A Dillingham,Rebecca %+ Department of Medicine, University of Virginia School of Medicine, PO Box 801379, Charlottesville, VA, 22908, United States, 1 434 982 0103, Rd8v@hscmail.mcc.virginia.edu %K mHealth %K HIV %K treatment adherence and compliance %K retention in care %D 2019 %7 20.03.2019 %9 Original Paper %J JMIR Form Res %G English %X Background: Linkage to and retention in HIV care are challenging, especially in the Southeastern United States. The rise in mobile phone app use and the potential for an app to deliver just in time messaging provides a new opportunity to improve linkage and retention among people living with HIV (PLWH). Objective: This study aimed to develop an app to engage, link, and retain people in care. We evaluated the acceptability, feasibility, and impact of the app among users. Methods: App development was informed by principles of chronic disease self-management and formative interviews with PLWH. Once developed, the app was distributed among participants, and usability feedback was incorporated in subsequent iterations. We interviewed app users after 3 weeks to identify usability issues, need for training on the phone or app, and to assess acceptability. We tracked and analyzed usage of app features for the cohort over 2 years. Results: A total of 77 participants used the app during the pilot study. The query response rate for the first 2 years was 47.7%. Query response declined at a rate of 0.67% per month. The community message board was the most popular feature, and 77.9% (60/77) of users posted on the board at least once during the 2 years. Conclusions: The PositiveLinks app was feasible and acceptable among nonurban PLWH. High participation on the community message board suggests that social support from peers is important for people recently diagnosed with or returning to care for HIV. %M 30892269 %R 10.2196/11578 %U http://formative.jmir.org/2019/1/e11578/ %U https://doi.org/10.2196/11578 %U http://www.ncbi.nlm.nih.gov/pubmed/30892269 %0 Journal Article %@ 2371-4379 %I JMIR Publications %V 4 %N 1 %P e10350 %T Perceptions and Acceptability of Text Messaging for Diabetes Care in Primary Care in Argentina: Exploratory Study %A Moyano,Daniela %A Morelli,Daniela %A Santero,Marilina %A Belizan,Maria %A Irazola,Vilma %A Beratarrechea,Andrea %+ Institute for Clinical Effectiveness and Health Policy (IECS), Dr Emilio Ravignani 2024, Buenos Aires, C1414CPV, Argentina, 54 114777 8767, dmoyano@iecs.org.ar %K mobile phones %K short message service %K diabetes mellitus %K public health %K qualitative research %D 2019 %7 18.03.2019 %9 Original Paper %J JMIR Diabetes %G English %X Background: Engagement in self-care behaviors that are essential to optimize diabetes care is challenging for many patients with diabetes. mHealth interventions have been shown to be effective in improving health care outcomes in diabetes. However, more research is needed on patient perceptions to support these interventions, especially in resource settings in low- and middle-income countries. Objective: The goal of the research was to explore perceptions and acceptability of a short message service (SMS) text messaging intervention for diabetes care in underserved people with diabetes in Argentina. Methods: A qualitative exploratory methodology was adopted as part of the evaluation of a program to strengthen diabetes services in primary care clinics located in low-resource settings. The diabetes program included a text messaging intervention for people with diabetes. A total of 24 semistructured telephone interviews were conducted with people with diabetes. Results: Twenty-four middle-aged persons with diabetes were interviewed. Acceptability was considered adequate in terms of its actual use, frequency, and the role of texts as a reminder. We found that text messages could be a mediating device in the patient’s learning processes. Also, being exposed to the texts seemed to help bring about changes in risk perception and care practices and to function as psychosocial support. Another relevant finding was the role of text messaging as a potential facilitator in diabetes care. In this sense, we observed a strong association between receiving text messages and having a better patient-physician relationship. Additionally, social barriers that affect diabetes care such as socioeconomic and psychosocial vulnerability were identified. Conclusions: Our findings show positive contributions of a text messaging intervention for the care of people with diabetes. We consider that an SMS strategy has potential to be replicated in other contexts. However, further studies are needed to explore its sustainability and long-term impact from the perspective of patients. %M 30882362 %R 10.2196/10350 %U http://diabetes.jmir.org/2019/1/e10350/ %U https://doi.org/10.2196/10350 %U http://www.ncbi.nlm.nih.gov/pubmed/30882362 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 3 %P e11416 %T Triggered Escalating Real-Time Adherence Intervention to Promote Rapid HIV Viral Suppression Among Youth Living With HIV Failing Antiretroviral Therapy: Protocol for a Triggered Escalating Real-Time Adherence Intervention %A Amico,K Rivet %A Dunlap,Amanda %A Dallas,Ronald %A Lindsey,Jane %A Heckman,Barbara %A Flynn,Patricia %A Lee,Sonia %A Horvath,Keith %A West Goolsby,Rachel %A Hudgens,Michael %A Filipowicz,Teresa %A Polier,Melissa %A Hill,Emily %A Mueller Johnson,Megan %A Miller,Jessica %A Neilan,Anne %A Ciaranello,Andrea %A Gaur,Aditya %+ School of Public Health, Department of Health Behavior and Health Education, University of Michigan, 1415 Washington Heights, Ann Arbor, MI, 48109-2029, United States, 1 810 360 8716, ramico@umich.edu %K HIV %K adolescents %K medication adherence %K telemedicine %D 2019 %7 18.03.2019 %9 Protocol %J JMIR Res Protoc %G English %X Background: Youth living with HIV (YLWH) are confronted with many self-care challenges that can be experienced as overwhelming in the context of normal developmental processes that characterize adolescence and young adulthood. A sizable minority of YLWH have unsuppressed viral loads in the United States attributable to antiretroviral therapy (ART) nonadherence. Interventions to promote sustained viral suppression in YLWH are needed. Objective: The aim of this study is to evaluate the efficacy of the Triggered Escalating Real-Time Adherence (TERA) intervention in comparison with standard of care (SOC) in YLWH (aged 13-24 years) failing ART on (1) primary outcome measures—HIV viral suppression (VLS), defined as both <200 copies/ml and <50 copies/ml at 12 weeks, and (2) secondary outcome measures—VLS rates and rates of ART adherence at 24, 36, and 48 weeks as well as patterns of adherence over time as measured by an electronic dose monitoring (EDM) device. Methods: The TERA study is a phase 2, multisite clinical trial conducted with 120 YLWH failing ART (randomized 1:1 to TERA or SOC) at participating clinical sites within the Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN). Participants are followed for a total of 48 weeks. For TERA arm participants, the first 12 weeks involve delivery of the intervention. For all participants, clinical outcomes are collected throughout follow-up, and adherence is assessed using EDM over the full 48 weeks. During the 12-week intervention period, TERA arm participants receive 3 remote coaching sessions delivered in clinic via videoconferencing timed to coincide with baseline and follow-up clinical visits, text message reminders when the EDM has not been opened at dose time (which escalate to 2-way theory-informed short message service coaching interactions in response to real-time nonadherence), and review of dosing graphs produced by EDM at follow-up visits. Results: Launch dates for enrollment varied by site. Enrollment began in April 2018 and is expected to be completed by August 2019, with results presented by the second quarter of 2021. Conclusions: Effective, generalizable, and scalable approaches to rapidly assist YLWH failing to achieve and sustain VLS may have a substantial impact on individual health and efforts to curb transmission. Coaching for a brief but intensive period from remote coaches and using communication channels common to youth may offer multiple unique advantages in promoting self-care. Trial Registration: ClinicalTrials.gov NCT03292432; https://clinicaltrials.gov/ct2/show/NCT03292432 (Archived by WebCite at http://www.webcitation.org/768J8ijjp). International Registered Report Identifier (IRRID): DERR1-10.2196/11416 %M 30882360 %R 10.2196/11416 %U http://www.researchprotocols.org/2019/3/e11416/ %U https://doi.org/10.2196/11416 %U http://www.ncbi.nlm.nih.gov/pubmed/30882360 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 7 %N 3 %P e11108 %T Perspectives on Acceptance and Use of a Mobile Health Intervention for the Prevention of Atherosclerotic Cardiovascular Disease in Singapore: Mixed-Methods Study %A Haldane,Victoria %A Tan,Yao Guo %A Teo,Krichelle Wei Qi %A Koh,Joel Jun Kai %A Srivastava,Aastha %A Cheng,Rui Xiang %A Yap,Yi Cheng %A Ong,Pei-Shi %A van Dam,Rob M %A Foo,Jie Min %A Müller-Riemenschneider,Falk %A Koh,Gerald Choon-Huat %A Perel,Pablo %A Legido-Quigley,Helena %+ Institute of Health Policy, Management & Evaluation, University of Toronto, 155 College Street 4th Floor, Toronto, ON, M5T 3M6, Canada, 1 416 978 4326, v.haldane@mail.utoronto.ca %K atherosclerosis %K mHealth %K eHealth %K patient-centered care %K patient acceptance of health care %K medication adherence %D 2019 %7 14.03.2019 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Cardiovascular disease, including atherosclerotic cardiovascular disease (ASCVD), is a growing public health threat globally and many individuals remain undiagnosed, untreated, and uncontrolled. Simultaneously, mobile health (mHealth) interventions using short messaging service (SMS) have gained popularity globally. There is an opportunity for innovative approaches such as mHealth to encourage and enable adherence to medications for ASCVD and its risk factors. Objective: This study aimed to understand mobile technology acceptance, use, and facilitating conditions among the study population ahead of the design of an mHealth intervention. Methods: Using data from a mixed-methods study conducted in Singapore, we conducted a cross-sectional survey with 100 participants and in-depth, semistructured interviews with 20 patients. All participants were over the age of 40 years with ASCVD or its risk factors. Interviews were conducted in English and Mandarin and if needed translated to English. Nvivo 11 (QSR International) was used for analyses. Results: Participants reported their perspectives on technology use and preferences, including low or sporadic mobile phone use and usability concerns including small screen and text size, among others; the benefit of previous mHealth use in creating a favorable opinion of SMS for health information; trust in both the source of mHealth SMS, as well as in treatment; the formation of habits; and fear of sequelae or death for facilitating intention to use an mHealth intervention and adhere to medication. We also highlighted a case that underscored the importance of the period after diagnosis in habit forming as an opportunity for an mHealth intervention. Conclusions: We explored both technology- and adherence-related factors that influence a patient’s intention to use an mHealth intervention for adherence to ASCVD medication in Singapore. We highlighted the importance of identifying the right opportunity to engage with patients and promote an mHealth intervention for adherence, such as immediately following diagnosis when patients are establishing medication-taking habits. %M 30869651 %R 10.2196/11108 %U http://mhealth.jmir.org/2019/3/e11108/ %U https://doi.org/10.2196/11108 %U http://www.ncbi.nlm.nih.gov/pubmed/30869651 %0 Journal Article %@ 2561-7605 %I JMIR Publications %V 2 %N 1 %P e11599 %T Evaluating the Impact of Music & Memory’s Personalized Music and Tablet Engagement Program in Wisconsin Assisted Living Communities: Pilot Study %A Ford II,James H %A Dodds,Debby %A Hyland,Julie %A Potteiger,Michael %+ School of Pharmacy, University of Wisconsin–Madison, 777 Highland Avenue, Madison, WI, 53705, United States, 1 6082624748, jhfordii@wisc.edu %K Music & Memory %K assisted living facilities %K quality of life %K agitation %K medication adherance %K iPod %K iPad %K implementation science %K patient participation %D 2019 %7 14.03.2019 %9 Original Paper %J JMIR Aging %G English %X Background: Individuals with Alzheimer disease or related dementia represent a significant and growing segment of the older adult (aged 65 years and above) population. In addition to physical health concerns, including comorbid medical conditions, these individuals often exhibit behavioral and psychological symptoms of dementia (BPSD). The presence of BPSD in long-term care residential facilities can disrupt resident’s care and impact staff. Nonpharmacological interventions such as personalized music and tablet engagement maintain cognitive function, improve quality of life (QOL), and mitigate BPSD for older adults with dementia. Evidence of the impact of such interventions in assisted living communities (ALCs) is needed for widespread adoption and sustainment of these technologies. Objective: The aim of this study was to assess the impact of Music & Memory’s personalized music and tablet engagement (PMATE) program on QOL, agitation, and medication use for residents living in 6 Wisconsin ALCs. Methods: The data collected were on the utilization of iPods and iPads by the residents. Residents’ outcomes were assessed using the Pittsburgh Agitation Scale, the Quality of Life in Late Stage Dementia scale, and self-reported medication use. A mixed-methods approach was utilized to examine the impact of the PMATE program on these outcomes. Descriptive statistics were calculated. A paired t test explored changes in residents’ QOL. A 1-way analysis of variance was utilized to examine changes in resident’s agitation and QOL based on the resident’s utilization of the PMATE program. Qualitative interviews were conducted with the individuals responsible for PMATE implementation in the ALC. Residents excluded from the analysis were those who passed away, were discharged, or refused to participate. Results: A total of 5 apps, based on average times used by residents, were identified. In all, 4 of the 5 apps were rated as being useful to promote residents’ engagement. PMATE utilization was not associated with changes in the residents’ agitation levels or antipsychotic medication use over time. Over a 3-month period, the change in residents’ QOL was significant (P=.047), and the differences across ALCs were also significant (F25=3.76, P=.02). High utilizers of the PMATE program (>2500 min over 3 months) showed greater improvements in QOL as compared with low utilizers (a change of −5.90 points vs an increase of 0.43 points). The difference was significant (P=.03). Similar significant findings were found between the high- and midutilizers. Conclusions: The study is one of the first to explore the impact of Music & Memory’s PMATE program on residents living in ALCs. Findings suggest that higher utilization over time improves residents’ QOL. However, a more comprehensive study with improved data collection efforts across multiple ALCs is needed to confirm these preliminary findings. %M 31518259 %R 10.2196/11599 %U http://aging.jmir.org/2019/1/e11599/ %U https://doi.org/10.2196/11599 %U http://www.ncbi.nlm.nih.gov/pubmed/31518259 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 6 %N 3 %P e12493 %T Technological Interventions for Medication Adherence in Adult Mental Health and Substance Use Disorders: A Systematic Review %A Steinkamp,Jackson M %A Goldblatt,Nathaniel %A Borodovsky,Jacob T %A LaVertu,Amy %A Kronish,Ian M %A Marsch,Lisa A %A Schuman-Olivier,Zev %+ Outpatient Addiction Services, Department of Psychiatry, Cambridge Health Alliance, 26 Central Street, Outpatient Addiction Services, Somerville, MA, 02143, United States, 1 617 591 6056, zschuman@cha.harvard.edu %K systematic review %K mental health %K substance-related disorders %K mHealth %K psychiatry %K medication adherence %K medication compliance %D 2019 %7 12.03.2019 %9 Original Paper %J JMIR Ment Health %G English %X Background: Medication adherence is critical to the effectiveness of psychopharmacologic therapy. Psychiatric disorders present special adherence considerations, notably an altered capacity for decision making and the increased street value of controlled substances. A wide range of interventions designed to improve adherence in mental health and substance use disorders have been studied; recently, many have incorporated information technology (eg, mobile phone apps, electronic pill dispensers, and telehealth). Many intervention components have been studied across different disorders. Furthermore, many interventions incorporate multiple components, making it difficult to evaluate the effect of individual components in isolation. Objective: The aim of this study was to conduct a systematic scoping review to develop a literature-driven, transdiagnostic taxonomic framework of technology-based medication adherence intervention and measurement components used in mental health and substance use disorders. Methods: This review was conducted based on a published protocol (PROSPERO: CRD42018067902) in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses systematic review guidelines. We searched 7 electronic databases: MEDLINE, EMBASE, PsycINFO, the Cochrane Central Register of Controlled Trials, Web of Science, Engineering Village, and ClinicalTrials.gov from January 2000 to September 2018. Overall, 2 reviewers independently conducted title and abstract screens, full-text screens, and data extraction. We included all studies that evaluate populations or individuals with a mental health or substance use disorder and contain at least 1 technology-delivered component (eg, website, mobile phone app, biosensor, or algorithm) designed to improve medication adherence or the measurement thereof. Given the wide variety of studied interventions, populations, and outcomes, we did not conduct a risk of bias assessment or quantitative meta-analysis. We developed a taxonomic framework for intervention classification and applied it to multicomponent interventions across mental health disorders. Results: The initial search identified 21,749 results; after screening, 127 included studies remained (Cohen kappa: 0.8, 95% CI 0.72-0.87). Major intervention component categories include reminders, support messages, social support engagement, care team contact capabilities, data feedback, psychoeducation, adherence-based psychotherapy, remote care delivery, secure medication storage, and contingency management. Adherence measurement components include self-reports, remote direct visualization, fully automated computer vision algorithms, biosensors, smart pill bottles, ingestible sensors, pill counts, and utilization measures. Intervention modalities include short messaging service, mobile phone apps, websites, and interactive voice response. We provide graphical representations of intervention component categories and an element-wise breakdown of multicomponent interventions. Conclusions: Many technology-based medication adherence and monitoring interventions have been studied across psychiatric disease contexts. Interventions that are useful in one psychiatric disorder may be useful in other disorders, and further research is necessary to elucidate the specific effects of individual intervention components. Our framework is directly developed from the substance use disorder and mental health treatment literature and allows for transdiagnostic comparisons and an organized conceptual mapping of interventions. %M 30860493 %R 10.2196/12493 %U http://mental.jmir.org/2019/3/e12493/ %U https://doi.org/10.2196/12493 %U http://www.ncbi.nlm.nih.gov/pubmed/30860493 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 7 %N 3 %P e9904 %T Experience of Using an App in HIV Patients Older Than 60 Years: Pilot Program %A Olalla,Julián %A García de Lomas,Jose María %A Márquez,Efrén %A González,Francisco Jesús %A Del Arco,Alfonso %A De La Torre,Javier %A Prada,Jose Luis %A Cantudo,Francisca %A Martín,María Dolores %A Nieto,Miriam %A Perez Stachowski,Javier %A García-Alegría,Javier %+ Unidad de Medicina Interna Hospital Costa del Sol, A-7, Km 187,, Marbella, 29603, Spain, 34 951976669 ext 125, julio.olalla@gmail.com %K HIV %K aging %K internet %D 2019 %7 06.03.2019 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: New technologies can promote knowledge of HIV infection among patients suffering from this disease. Older patients with HIV infection represent an increasingly large group that could benefit from the use of specific apps. Objective: The aim of the study was to observe the acceptability and use of a mobile app on HIV infection in patients at least 60 years old and offer them the possibility of anonymously establishing contact with their peers. Methods: A series of clinical and psychosocial parameters were studied in 30 HIV-infected patients of over 60 years. The patients must be at least 60 years old, with a follow-up in the outpatient clinic for at least 1 year and without pathologies that limit his or her life expectancy to less than a year. They must know how to read and write. To be part of the group assigned to the app, they had to have their own smartphone and confirm that they were connected to the internet from that device. Overall, 15 of them were randomized to use an app and 15 were in the control group. All tests were repeated after 6 months. Results: The median age of patients was 66.5 years. Among them, 29 patients had an undetectable viral load at baseline. The median number of comorbid diseases was 2. Overall, 11 of them lived with their partners and 19 lived alone. They spent an average of 5 hours a day sitting down, and 56% (17/30) of them referred high physical activity. They scored 4 out of 5 for general quality of life perception. Moreover, 80% (24/30) presented high adherence to their treatment, and the average number of concomitant medications was 5. In the 6-min walking test, they covered a distance of 400 meters, and 3 of them desaturated during the test. The 15 patients made frequent use of the app, with 2407 sessions and an average of 7 min and 56 seconds time of use with a total of 13,143 screen views. During the 6 months of the trial, 3 non-AIDS events took place. There were no significant modifications to body mass index, blood pressure measurements, lipid profile, or immuno-virology information data. There were no differences in the questionnaire scores for perception of quality of life, confessed physical activity, or antiretroviral treatment (ART) and non-ART treatment adherence. Conclusions: Significant differences between studied parameters were not objectified in these patients, possibly because this trial has significant limitations, such as a small sample size and only a brief follow-up period. However, patients did use the app frequently, making this a possible intervention to be proposed in future subsequent studies. %M 30839281 %R 10.2196/mhealth.9904 %U https://mhealth.jmir.org/2019/3/e9904/ %U https://doi.org/10.2196/mhealth.9904 %U http://www.ncbi.nlm.nih.gov/pubmed/30839281 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 7 %N 2 %P e11638 %T Change in Patient Comfort Using Mobile Phones Following the Use of an App to Monitor Tuberculosis Treatment Adherence: Longitudinal Study %A Do,Diana %A Garfein,Richard S %A Cuevas-Mota,Jazmine %A Collins,Kelly %A Liu,Lin %+ University of California San Diego, School of Medicine, 9500 Gilman Drive, MC-0507, La Jolla, CA, 92093-0507, United States, 1 1 858 822 3018, rgarfein@ucsd.edu %K mHealth %K medication adherence monitoring %K mobile phone %K video technology %K tuberculosis %D 2019 %7 01.02.2019 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: As mHealth apps proliferate, it is necessary for patients to feel capable and comfortable using devices that run them. However, limited research is available on changes in comfort level before and after the use of an mHealth app. Objective: The objective of this study was to determine whether patients with tuberculosis who used an mHealth app called Video Directly Observed Therapy (VDOT) to monitor their antituberculosis treatment became more comfortable using mobile phones after the intervention and to identify factors associated with change in comfort. Methods: We analyzed data from a longitudinal study assessing the feasibility and acceptability of the VDOT app among patients receiving antituberculosis treatment from public health departments in San Diego, San Francisco, and New York City. Comfort levels on six domains of mobile phone use (making phone calls, taking pictures, recording videos, text messaging, internet and email use on the phone) were measured on a 10-point scale (1=very uncomfortable; 10=very comfortable) at the start and end of treatment using VDOT via telephone interviews. The main outcomes were change in comfort level on each domain (recoded as binary measures) and an overall change score (sum of individual measures). Linear and logistic regression analyses were performed to assess whether sociodemographics, risk factors, and VDOT perceptions were associated with change of comfort measures. Results: Among 120 participants with complete data, mean age was 39.8 years (SD 14.8, range 18-87 years), 46.7% (56/120) were female, and 76.7% (92/120) were foreign born. The combined comfort level at baseline was high overall (mean 48.8, SD 14.2, interquartile range 43.0-60.0) and the mean comfort score increased by 1.92 points at follow-up (P=.07). Statistically significant increases in comfort on individual domains included taking pictures (P=.02) and recording videos (P=.002). Females were more likely to have increased comfort in using the internet on the phone compared to males (odds ratio [OR] 3.03, 95% CI 1.08-8.52, P=.04). Participants who worked less hours per week were more likely to have increased comfort recording videos although this did not meet statistical significance (OR 1.03, 95% CI 1.00-1.05, P=.06). Conclusions: Findings suggest that, despite a high level of comfort using mobile phones at baseline, experience using the VDOT app was associated with increased comfort using mobile phone features. Additional research involving participants with lower baseline mobile phone experience is needed. An implication of these findings is that as patients begin to use mHealth apps for one health condition, they could acquire skills and confidence to more quickly adapt to using mHealth apps for other conditions. %M 30707103 %R 10.2196/11638 %U https://mhealth.jmir.org/2019/2/e11638/ %U https://doi.org/10.2196/11638 %U http://www.ncbi.nlm.nih.gov/pubmed/30707103 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 7 %N 1 %P e11919 %T Mobile Phone Apps Targeting Medication Adherence: Quality Assessment and Content Analysis of User Reviews %A Park,Jamie Yea Eun %A Li,Jenny %A Howren,Alyssa %A Tsao,Nicole Wen %A De Vera,Mary %+ Faculty of Pharmaceutical Sciences, University of British Columbia, 2405 Wesbrook Mall, Vancouver, BC, V6T 1Z3, Canada, 1 604 827 2138, mdevera@mail.ubc.ca %K medication adherence %K mobile apps %K mHealth %D 2019 %7 31.01.2019 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: With the accessibility and widespread use of mobile phones, mobile phone apps targeting medication adherence may be useful tools to help patients take medications as prescribed. Objective: Our objectives were to (1) characterize and assess mobile phone medication adherence apps guided by a conceptual framework on the focus of adherence interventions and (2) conduct a content analysis of Web-based reviews to explore users’ perspectives and experiences with mobile phone medication adherence apps. Methods: We searched for mobile phone medication adherence apps using keyword searches in Apple and Android operating systems. We characterized all apps in terms of number of downloads, ratings, languages, cost, and disease target. We categorized apps according to 4 key features of (1) alerting to take medication, (2) tracking medication taking, (3) reminding to refill or indicating amount of medication left, and (4) storing medication information. We then selected representative apps from each operating system for detailed quality assessment and user testing. We also downloaded Web-based reviews for these selected apps and conducted a qualitative content analysis using an inductive approach involving steps of initial open coding, construction of categories, and abstraction into themes. Results: We identified 704 apps (443 from Apple and 261 from Android). The majority of apps across both operating systems had 1 or 2 features—specifically, 37.2% (165/443) and 38.1% (169/443) of Apple apps, respectively, and 41.4% (108/261) and 31.4% (108/261) of Android apps, respectively. Quality assessment and user testing of 20 selected apps revealed apps varied in quality and commonly focused on behavioral strategies to enhance medication adherence through alerts, reminders, and logs. A total of 1323 eligible Web-based reviews from these 20 selected apps were analyzed, and the following themes emerged: (1) features and functions appreciated by users, which included the ability to set up customized medication regimen details and reminders, monitor other health information (eg, vitals, supplements, and manage multiple people or pets), support health care visits (eg, having a list of medications and necessary health information in 1 app); (2) negative user experiences that captured technical difficulties (glitches, confusing app navigation, and poor interoperability), dosage schedule, and reminder setup inflexibility; and (3) desired functions and features related to optimization of information input, improvement of reminders, and upgrading app performance (better synchronization or backup of data and interoperability). Conclusions: A large number of mobile phone medication adherence apps are currently available. The majority of apps have features representing a behavioral approach to intervention. Findings of the content analysis offer mostly positive feedback as well as insights into current limitations and improvements that could be addressed in current and future medication adherence apps. %M 30702435 %R 10.2196/11919 %U http://mhealth.jmir.org/2019/1/e11919/ %U https://doi.org/10.2196/11919 %U http://www.ncbi.nlm.nih.gov/pubmed/30702435 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 21 %N 1 %P e10421 %T Identifying Brief Message Content for Interventions Delivered via Mobile Devices to Improve Medication Adherence in People With Type 2 Diabetes Mellitus: A Rapid Systematic Review %A Long,Hannah %A Bartlett,Yvonne K %A Farmer,Andrew J %A French,David P %+ Manchester Centre for Health Psychology, School of Health Sciences, University of Manchester, Coupland 1 Building, Coupland Street, Manchester, M13 9PL, United Kingdom, 44 161 275 2605, david.french@manchester.ac.uk %K medication adherence %K diabetes mellitus %K systematic review %K text messaging %K mHealth %K self-management %D 2019 %7 09.01.2019 %9 Review %J J Med Internet Res %G English %X Background: Current interventions to support medication adherence in people with type 2 diabetes are generally resource-intensive and ineffective. Brief messages, such as those delivered via short message service (SMS) systems, are increasingly used in digital health interventions to support adherence because they can be delivered on a wide scale and at low cost. The content of SMS text messages is a crucial intervention feature for promoting behavior change, but it is often unclear what the rationale is for chosen wording or any underlying mechanisms targeted for behavioral change. There is little guidance for developing and optimizing brief message content for use in mobile device–delivered interventions. Objective: This review aimed to (1) identify theoretical constructs (ie, the targets that interventions aim to change) and behavioral strategies (ie, features of intervention content) found to be associated with medication adherence in patients with type 2 diabetes and (2) map these onto a standard taxonomy for behavior change techniques (BCTs, that is, active ingredients of interventions used to promote behavioral change, to produce an evidence-based set of approaches that have shown promise of improving adherence in previous studies and which could be further tested in digital health interventions. Methods: A rapid systematic review of existing relevant systematic reviews was conducted. MEDLINE and PsycINFO databases were searched from inception to April 10, 2017. Inclusion criteria were (1) systematic reviews of quantitative data if the studies reviewed identified predictors of or correlates with medication adherence or evaluated medication adherence–enhancing interventions and included adult participants taking medication to manage a chronic physical health condition, and (2) systematic reviews of qualitative studies of experiences of medication adherence for adult participants with type 2 diabetes. Data were extracted on review characteristics and BCTs, theoretical constructs, or behavioral strategies associated with improved adherence. Constructs and strategies were mapped onto the BCT version 1 taxonomy. Results: A total of 1701 references were identified; 25 systematic reviews (19 quantitative reviews, 3 qualitative reviews, and 3 mixed-method reviews) were included. Moreover, 20 theoretical constructs (eg, self-efficacy) and 19 behavioral strategies (eg, habit analysis) were identified in the included reviews. In total, 46 BCTs were identified as being related to medication adherence in type 2 diabetes (eg, habit formation, prompts or cues, and information about health consequences). Conclusions: We identified 46 promising BCTs related to medication adherence in type 2 diabetes on which the content of brief messages delivered through mobile devices to improve adherence could be based. By using explicit systematic review methods and linking our findings to a standardized taxonomy of BCTs, we have described a novel approach for the development of digital message content. Future brief message interventions that aim to support medication adherence could incorporate the identified BCTs. %M 30626562 %R 10.2196/10421 %U https://www.jmir.org/2019/1/e10421/ %U https://doi.org/10.2196/10421 %U http://www.ncbi.nlm.nih.gov/pubmed/30626562 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 7 %N 1 %P e203 %T Comparison of mHealth and Face-to-Face Interventions for Smoking Cessation Among People Living With HIV: Meta-Analysis %A Uthman,Olalekan A %A Nduka,Chidozie U %A Abba,Mustapha %A Enriquez,Rocio %A Nordenstedt,Helena %A Nalugoda,Fred %A Kengne,Andre P %A Ekström,Anna M %+ Warwick-Centre for Applied Health Research and Delivery, Division of Health Sciences, University Warwick, Gibbet Hill campus, Coventry, CV4 7AL, United Kingdom, 44 2476573163, olalekan.uthman@warwick.ac.uk %K HIV %K mHealth %K smoking cessation %D 2019 %7 07.01.2019 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: The prevalence of smoking among people living with HIV (PLHIV) is higher than that reported in the general population, and it is a significant risk factor for noncommunicable diseases in this group. Mobile phone interventions to promote healthier behaviors (mobile health, mHealth) have the potential to reach a large number of people at a low cost. It has been hypothesized that mHealth interventions may not be as effective as face-to-face strategies in achieving smoking cessation, but there is no systematic evidence to support this, especially among PLHIV. Objective: This study aimed to compare two modes of intervention delivery (mHealth vs face-to-face) for smoking cessation among PLHIV. Methods: Literature on randomized controlled trials (RCTs) investigating effects of mHealth or face-to-face intervention strategies on short-term (4 weeks to <6 months) and long-term (≥6 months) smoking abstinence among PLHIV was sought. We systematically reviewed relevant RCTs and conducted pairwise meta-analyses to estimate relative treatment effects of mHealth and face-to-face interventions using standard care as comparison. Given the absence of head-to-head trials comparing mHealth with face-to-face interventions, we performed adjusted indirect comparison meta-analyses to compare these interventions. Results: A total of 10 studies involving 1772 PLHIV met the inclusion criteria. The average age of the study population was 45 years, and women comprised about 37%. In the short term, mHealth-delivered interventions were significantly more efficacious in increasing smoking cessation than no intervention control (risk ratio, RR, 2.81, 95% CI 1.44-5.49; n=726) and face-to-face interventions (RR 2.31, 95% CI 1.13-4.72; n=726). In the short term, face-to-face interventions were no more effective than no intervention in increasing smoking cessation (RR 1.22, 95% CI 0.94-1.58; n=1144). In terms of achieving long-term results among PLHIV, there was no significant difference in the rates of smoking cessation between those who received mHealth-delivered interventions, face-to-face interventions, or no intervention. Trial sequential analysis showed that only 15.16% (726/1304) and 5.56% (632/11,364) of the required information sizes were accrued to accept or reject a 25% relative risk reduction for short- and long-term smoking cessation treatment effects. In addition, sequential monitoring boundaries were not crossed, indicating that the cumulative evidence may be unreliable and inconclusive. Conclusions: Compared with face-to-face interventions, mHealth-delivered interventions can better increase smoking cessation rate in the short term. The evidence that mHealth increases smoking cessation rate in the short term is encouraging but not sufficient to allow a definitive conclusion presently. Future research should focus on strategies for sustaining smoking cessation treatment effects among PLHIV in the long term. %M 30617044 %R 10.2196/mhealth.9329 %U https://mhealth.jmir.org/2019/1/e203/ %U https://doi.org/10.2196/mhealth.9329 %U http://www.ncbi.nlm.nih.gov/pubmed/30617044 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 6 %N 12 %P e11724 %T Mobile-Based Oral Chemotherapy Adherence–Enhancing Interventions: Scoping Review %A Skrabal Ross,Xiomara %A Gunn,Kate M %A Patterson,Pandora %A Olver,Ian %+ Cancer Research Institute, University of South Australia, GPO Box 2471, Adelaide, 5001, Australia, 61 0410900975, xioyen@gmail.com %K medication adherence %K antineoplastic agents %K neoplasms %K cell phone %K text messaging %K mobile apps %K review %K mHealth %D 2018 %7 21.12.2018 %9 Review %J JMIR Mhealth Uhealth %G English %X Background: Adherence to oral chemotherapy is crucial to maximize treatment outcomes and avoid health complications in cancer patients. Mobile phones are widely available worldwide, and evidence that this technology can be successfully employed to increase medication adherence for the treatment of other chronic diseases (eg, diabetes) is well established. However, the extent to which there is evidence that mobile phone–based interventions improve adherence to oral chemotherapy is unknown. Objective: This scoping review aims to explore what is known about mobile phone–delivered interventions designed to enhance adherence to oral chemotherapy, to examine the reported findings on the utility of these interventions in increasing oral chemotherapy adherence, and to identify opportunities for development of future interventions. Methods: This study followed Arksey and O’Malley’s scoping review methodological framework. Results: The review search yielded 5 studies reporting on 4 interventions with adults (aged >18 years) diagnosed with diverse cancer types. All interventions were considered acceptable, useful, and feasible. The following themes were evident: text messages and mobile apps were the main methods of delivering these interventions, the 2 most commonly employed oral chemotherapy adherence–enhancing strategies were management and reporting of drug-related symptoms and reminders to take medication, the importance of stakeholders’ engagement in intervention design, and the overall positive perceptions of delivery features. Areas for future research identified by this review include the need for further studies to evaluate the impact of mobile phone–delivered interventions on adherence to oral chemotherapy as well as the relevance for future studies to incorporate design frameworks and economic evaluations and to explore the moderator effect of high anxiety, poor baseline adherence, and longer time taking prescribed drug on adherence to oral chemotherapy. Conclusions: Despite the increasing body of evidence on the use of mobile phones to deliver medication adherence–enhancing interventions in chronic diseases, literature on the oral chemotherapy context is lacking. This review showed that existing interventions are highly acceptable and useful to cancer patients. The engagement of stakeholders as well as the use of a design framework are important elements in the development of mobile phone–delivered interventions that can be translated into oncology settings. %M 30578182 %R 10.2196/11724 %U http://mhealth.jmir.org/2018/12/e11724/ %U https://doi.org/10.2196/11724 %U http://www.ncbi.nlm.nih.gov/pubmed/30578182 %0 Journal Article %@ 2369-1999 %I JMIR Publications %V 4 %N 2 %P e12 %T Barriers and Facilitators of Using Sensored Medication Adherence Devices in a Diverse Sample of Patients With Multiple Myeloma: Qualitative Study %A Asfaw,Alemseged Ayele %A Yan,Connie H %A Sweiss,Karen %A Wirth,Scott %A Ramirez,Victor H %A Patel,Pritesh R %A Sharp,Lisa K %+ Pharmacy Systems, Outcomes & Policy, College of Pharmacy, University of Illinois at Chicago, MC871, 833 South Wood Street, Chicago, IL, 60612, United States, 1 312 355 3569, sharpl@uic.edu %K antineoplastic therapy %K challenges %K race/ethnicity %K medication adherence %K multiple myeloma %D 2018 %7 12.11.2018 %9 Original Paper %J JMIR Cancer %G English %X Background: Many recently approved medications to manage multiple myeloma (MM) are oral, require supportive medications to prevent adverse effects, and are taken under complex schedules. Medication adherence is a concern; however, little attention has been directed toward understanding adherence in MM or associated barriers and facilitators. Advanced sensored medication devices (SMDs) offer opportunities to intervene; however, acceptability among patients with MM, particularly African American patients, is untested. Objective: This study aimed to explore patients’ (1) perceptions of their health before MM including experiences with chronic medications, (2) perceptions of adherence barriers and facilitators, and (3) attitudes toward using SMDs. Methods: An in-person, semistructured, qualitative interview was conducted with a convenience sample of patients being treated for MM. Patients were recruited from within an urban, minority-serving, academic medical center that had an established cancer center. A standardized interview guide included questions targeting medication use, attitudes, adherence, barriers, and facilitators. Demographics included the use of cell phone technology. Patients were shown 2 different pill bottles with sensor technology—Medication Event Monitoring System and the SMRxT bottle. After receiving information on the transmission ability of the bottles, patients were asked to discuss their reactions and concerns with the idea of using such a device. Medical records were reviewed to capture information on medication and diagnoses. The interviews were audio-recorded and transcribed. Interviews were independently coded by 2 members of the team with a third member providing guidance. Results: A total of 20 patients with a mean age of 56 years (median=59 years; range=29-71 years) participated in this study and 80% (16/20) were African American. In addition, 18 (90%, 18/20) owned a smartphone and 85% (17/20) were comfortable using the internet, text messaging, and cell phone apps. The average number of medications reported per patient was 13 medications (median=10; range=3-24). Moreover, 14 (70%, 14/20) patients reported missed doses for a range of reasons such as fatigue, feeling ill, a busy schedule, forgetting, or side effects. Interest in using an SMD ranged from great interest to complete lack of interest. Examples of concerns related to the SMDs included privacy issues, potential added cost, and the size of the bottle (ie, too large). Despite the concerns, 60% (12/20) of the patients expressed interest in trying a bottle in the future. Conclusions: Results identified numerous patient-reported barriers and facilitators to missed doses of oral anticancer therapy. Many appear to be potentially mutable if uncovered and addressed. SMDs may allow for capture of these data. Although patients expressed concerns with SMDs, most remained willing to use one. A feasibility trial with SMDs is planned. %M 30425032 %R 10.2196/cancer.9918 %U http://cancer.jmir.org/2018/2/e12/ %U https://doi.org/10.2196/cancer.9918 %U http://www.ncbi.nlm.nih.gov/pubmed/30425032 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 7 %N 11 %P e11289 %T The Ready to Reduce Risk (3R) Study for a Group Educational Intervention With Telephone and Text Messaging Support to Improve Medication Adherence for the Primary Prevention of Cardiovascular Disease: Protocol for a Randomized Controlled Trial %A Byrne,Jo L %A Dallosso,Helen M %A Rogers,Stephen %A Gray,Laura J %A Waheed,Ghazala %A Patel,Prashanth %A Gupta,Pankaj %A Doherty,Yvonne %A Davies,Melanie %A Khunti,Kamlesh %+ Diabetes Research Centre, University of Leicester, Leicester General Hospital, Leicester, LE5 4PW, United Kingdom, 44 116 258 4005, kk22@leicester.ac.uk %K medication adherence %K cardiovascular diseases %K primary prevention %K educational intervention %K telephone support %K text messaging support %D 2018 %7 12.11.2018 %9 Protocol %J JMIR Res Protoc %G English %X Background: Poor adherence to cardiovascular medications is associated with worse clinical outcomes. Evidence for effective education interventions that address medication adherence for the primary prevention of cardiovascular disease is lacking. The Ready to Reduce Risk (3R) study aims to investigate whether a complex intervention, involving group education plus telephone and text messaging follow-up support, can improve medication adherence and reduce cardiovascular risk. Objective: This protocol paper details the design and rationale for the development of the 3R intervention and the study methods used. Methods: This is an open and pragmatic randomized controlled trial with 12 months of follow-up. We recruited participants from primary care and randomly assigned them at a 1:1 frequency, stratified by sex and age, to either a control group (usual care from a general practitioner) or an intervention group involving 2 facilitated group education sessions with telephone and text messaging follow-up support, with a theoretical underpinning and using recognized behavioral change techniques. The primary outcome was medication adherence to statins. The primary measure was an objective, novel, urine-based biochemical measure of medication adherence. We also used the 8-item Morisky Medication Adherence Scale to assess medication adherence. Secondary outcomes were changes in total cholesterol, blood pressure, high-density lipoprotein, total cholesterol to high-density lipoprotein ratio, body mass index, waist to hip ratio, waist circumference, smoking behavior, physical activity, fruit and vegetable intake, patient activation level, quality of life, health status, health and medication beliefs, and overall cardiovascular disease risk score. We also considered process outcomes relating to acceptability and feasibility of the 3R intervention. Results: We recruited 212 participants between May 2015 and March 2017. The 12-month follow-up data collection clinics were completed in April 2018, and data analysis will commence once all study data have been collected and verified. Conclusions: This study will identify a potentially clinically useful and effective educational intervention for the primary prevention of cardiovascular disease. Medication adherence to statins is being assessed using a novel urine assay as an objective measure, in conjunction with other validated measures. Trial Registration: International Standard Randomized Controlled Trial Number ISRCTN16863160; http://www.isrctn.com/ISRCTN16863160 (Archived by WebCite at http://www.webcitation.org/734PqfdQw) International Registered Report Identifier (IRRID): DERR1-10.2196/11289 %M 30425027 %R 10.2196/11289 %U http://www.researchprotocols.org/2018/11/e11289/ %U https://doi.org/10.2196/11289 %U http://www.ncbi.nlm.nih.gov/pubmed/30425027 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 6 %N 11 %P e11131 %T Simulated Clinical Encounters Using Patient-Operated mHealth: Experimental Study to Investigate Patient-Provider Communication %A Tunnell,Harry %A Faiola,Anthony %A Bolchini,Davide %A Bartlett Ellis,Rebecca %+ School of Informatics and Computing, Department of Human-Centered Computing, Indiana University, 535 West Michigan Street, IT 475, Indianapolis, IN, 46202, United States, 1 317 278 4636, hadtunne@iupui.edu %K medical informatics %K personal health record %K medication reconciliation %D 2018 %7 01.11.2018 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: This study investigates patient-centered mobile health (mHealth) technology in terms of the secondary user experience (UX). Specifically, it examines how personal mobile technology, under patient control, can be used to improve patient-provider communication about the patient’s health care during their first visit to a provider. Common ground, a theory about language use, is used as the theoretical basis to examine interactions. A novel concept of this study is that it is one of the first empirical studies to explore the relative meaningfulness of a secondary UX for specific health care tasks. Objective: The objective of this study was to investigate the extent that patient-operated mHealth technology can be designed to improve the communication between the patient and provider during an initial face-to-face encounter. Methods: The experimental study was conducted in 2 large Midwestern cities from February 2016 to May 2016. A custom-designed smartphone app prototype was used as the study treatment. The experimental design was posttest-only control group and included video-recorded simulated face-to-face clinical encounters in which an actor role-played a patient. Experienced clinicians consisting of doctors (n=4) and nurses (n=8) were the study participants. A thematic analysis of qualitative data was performed. Quantitative data collected from time on task measurements were analyzed using descriptive statistics. Results: Three themes that represent how grounding manifested during the encounter, what it meant for communication during the encounter, and how it influenced the provider’s perception of the patient emerged from the qualitative analysis. The descriptive statistics were important for inferring evidence of efficiency and effectiveness of communication for providers. Overall, encounter and task times averaged slightly faster in almost every instance for the treatment group than that in the control group. Common ground clearly was better in the treatment group, indicating that the idea of designing for the secondary UX to improve provider outcomes has merit. Conclusions: Combining the notions of common ground, human-computer interaction design, and smartphone technology resulted in a prototype that improved the efficiency and effectiveness of face-to-face collaboration for secondary users. The experimental study is one of the first studies to demonstrate that an investment in the secondary UX for high payoff tasks has value but that not all secondary UXs are meaningful for design. This observation is useful for prioritizing how resources should be applied when considering the secondary UX. %M 30389652 %R 10.2196/11131 %U https://mhealth.jmir.org/2018/11/e11131/ %U https://doi.org/10.2196/11131 %U http://www.ncbi.nlm.nih.gov/pubmed/30389652 %0 Journal Article %@ 2291-9279 %I JMIR Publications %V 6 %N 4 %P e10213 %T Digital Gaming to Improve Adherence Among Adolescents and Young Adults Living With HIV: Mixed-Methods Study to Test Feasibility and Acceptability %A Castel,Amanda D %A Qasmieh,Saba %A Greenberg,Daniel %A Ellenberger,Nicole %A Howell,Tyriesa Howard %A Griffith,Caleb %A Wilbourn,Brittany C %A Ganesan,Kavitha %A Hussein,Nadia %A Ralte,Gabriel %A Rakhmanina,Natella %+ Department of Epidemiology and Biostatistics, Milken Institute School of Public Health, George Washington University, 5th Floor, 950 New Hampshire Avenue Northwest, Washington, DC,, United States, 1 202 994 8325, acastel@gwu.edu %K youth %K HIV %K adherence %K video games %K Wisepill %K adolescents %K digital technology %K serious games %D 2018 %7 15.10.2018 %9 Original Paper %J JMIR Serious Games %G English %X Background: An estimated 50% of adolescents and young adults (AYA) living with HIV are failing to adhere to prescribed antiretroviral treatment (ART). Digital games are effective in chronic disease management; however, research on gaming to improve ART adherence among AYA is limited. Objective: We assessed the feasibility and acceptability of video gaming to improve AYA ART adherence. Methods: Focus group discussions and surveys were administered to health care providers and AYA aged 13 to 24 years living with HIV at a pediatric HIV program in Washington, DC. During focus group discussions, AYA viewed demonstrations of 3 game prototypes linked to portable Wisepill medication dispensers. Content analysis strategies and thematic coding were used to identify adherence themes and gaming acceptance and feasibility. Likert scale and descriptive statistics were used to summarize response frequencies. Results: Providers (n=10) identified common adherence barriers and strategies, including use of gaming analogies to improve AYA ART adherence. Providers supported exploration of digital gaming as an adherence intervention. In 6 focus group discussions, 12 AYA participants identified disclosure of HIV status and irregular daily schedules as major barriers to ART and use of alarms and pillboxes as reminders. Most AYA were very or somewhat likely to use the demonstrated game prototypes to help with ART adherence and desired challenging, individually tailored, user-friendly games with in-game incentives. Game prototypes were modified accordingly. Conclusions: AYA and their providers supported the use of digital games for ART adherence support. Individualization and in-game incentives were preferable and informed the design of an interactive technology-based adherence intervention among AYA living with HIV. %M 30322838 %R 10.2196/10213 %U http://games.jmir.org/2018/4/e10213/ %U https://doi.org/10.2196/10213 %U http://www.ncbi.nlm.nih.gov/pubmed/30322838 %0 Journal Article %@ 2561-6722 %I JMIR Publications %V 1 %N 2 %P e8 %T Smartphones for Real-time Assessment of Adherence Behavior and Symptom Exacerbation for High-Risk Youth with Asthma: Pilot Study %A Teufel II,Ronald John %A Patel,Sachin K %A Shuler,Anita B %A Andrews,Anne L %A Nichols,Michelle %A Ebeling,Myla D %A Dawley,Erin %A Mueller,Martina %A Ruggiero,Kenneth J %A Treiber,Frank A %+ Division of General Pediatrics, Department of Pediatrics, Medical University of South Carolina, 135 Rutledge Avenue, Charleston, SC, 29401, United States, 1 843 876 8512, teufelr@musc.edu %K children %K ecological momentary assessment %K medication adherence %K medication monitoring device %K mHealth %K mobile phone %K symptoms %K youth %D 2018 %7 5.10.2018 %9 Original Paper %J JMIR Pediatr Parent %G English %X Background: Youth with asthma who have poor medication adherence, have limited access to care, and are frequently seen in the acute care setting are often termed “high risk.” Objective: This study aimed to design and test the feasibility of using smartphone technology to assess contextual factors that may impact changes in daily medication adherence and to identify new symptom episodes among high-risk youth with asthma in their home environment. Methods: Youth aged 8-17 years with high-risk asthma from 2 children’s hospitals were eligible for the 2-month study. An app was downloaded on participants’ phones at enrollment. Daily text message (short message service) reminders were sent to complete ecological momentary assessment of asthma symptoms and other contextual factors such as emotional state using the app. Bluetooth inhaler devices were used to record timestamps of inhaler use with the ability to review and manually enter data. The acceptability was assessed with surveys, key informant interviews (KII), and frequency of days with asthma data. KII data were used in an iterative design approach to identify challenges, strengths, and suggestions for maximizing use. Generalized linear mixed modeling was used to preliminarily explore contextual factors associated with changes in daily adherence. Results: We enrolled 14 children aged 8-16 years (13/14, 93% were African Americans). Over the 2-month study period, participants reported coughing (42/110, 38%), wheezing (8/111, 7%), chest tightness (9/109, 8%), boredom (57/109, 52%), and 10 new asthma symptom episodes. The controller medication adherence was 30%, which increased significantly on days with asthma symptoms or boredom. Data were received on 89% (606/681) of study days. Surveys and KIIs suggest acceptability among youth and their caregivers. Challenges reported during the study included lost or damaged phones and available memory. Conclusions: Youth and their caregivers reported the acceptability of using smartphones for real-time asthma monitoring. Overall, the controller medication adherence was low but increased significantly on days with reported asthma symptoms or boredom, suggesting that daily contextual factors may be associated with a change in the adherence behavior. %M 31518299 %R 10.2196/pediatrics.9796 %U http://pediatrics.jmir.org/2018/2/e8/ %U https://doi.org/10.2196/pediatrics.9796 %U http://www.ncbi.nlm.nih.gov/pubmed/31518299 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 6 %N 9 %P e10456 %T Smartphone-Based Contingency Management Intervention to Improve Pre-Exposure Prophylaxis Adherence: Pilot Trial %A Mitchell,John T %A LeGrand,Sara %A Hightow-Weidman,Lisa B %A McKellar,Mehri S %A Kashuba,Angela DM %A Cottrell,Mackenzie %A McLaurin,Tony %A Satapathy,Goutam %A McClernon,F Joseph %+ Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, 2608 Erwin Road, Pavilion East, Suite 300, Durham, NC, 27705, United States, 1 919 681 0012, john.mitchell@duke.edu %K HIV %K preexposure prophylaxis %K mobile health %D 2018 %7 10.09.2018 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Pre-exposure prophylaxis (PrEP) provides a strong preventative benefit to individuals at risk for HIV. While PrEP adherence is highly correlated with its efficacy, adherence rates are variable both across and within persons. Objective: The objective of this study was to develop and pilot-test a smartphone-based intervention, known as mSMART, that targets PrEP adherence. mSMART provides contingency management in the form of monetary incentives for daily PrEP adherence based on a real-time adherence assessment using a camera-based medication event-monitoring tool as well as medication reminders, PrEP education, individualized behavioral strategies to address PrEP adherence barriers, and medication adherence feedback. Methods: This was a 4-week open-label, phase I trial in a community sample of young men who have sex with men already on PrEP (N=10). Results: Although adherence composite scores corresponding to PrEP biomarkers indicated that 90% (9/10) of the sample already had an acceptable baseline adherence in the protective range, by the end of the 4-week period, the scores improved for 30% (3/10) of the sample—adherence did not worsen for any participants. Participants reported mean PrEP adherence rates of 91% via daily entries in mSMART. At the end of the 4-week period, participants indicated acceptable ratings of satisfaction, usability, and willingness to recommend mSMART to others. There were no technical difficulties associated with smartphone compatibility, user misunderstandings about mSMART features that interfered with daily use, or study attrition. Conclusions: This study is the first to apply contingency management to PrEP adherence. Findings indicated that mSMART is feasible and acceptable. Such an adherence intervention administered via a user-friendly smartphone app can allow for widespread dissemination. Future efficacy trials are needed. Trial Registration: ClinicalTrials.gov NCT02895893; https://clinicaltrials.gov/ct2/show/NCT02895893 (Accessed by Webcite at http://www.webcitation.org/72JskjDJq) %M 30201601 %R 10.2196/10456 %U http://mhealth.jmir.org/2018/9/e10456/ %U https://doi.org/10.2196/10456 %U http://www.ncbi.nlm.nih.gov/pubmed/30201601 %0 Journal Article %@ 2369-2960 %I JMIR Publications %V 4 %N 3 %P e64 %T eHealth Literacy in People Living with HIV: Systematic Review %A Han,Hae-Ra %A Hong,Hyejeong %A Starbird,Laura E %A Ge,Song %A Ford,Athena D %A Renda,Susan %A Sanchez,Michael %A Stewart,Jennifer %+ School of Nursing, The Johns Hopkins University, 525 N Wolfe Street, Baltimore, MD,, United States, 1 410 614 2669, hhan@son.jhmi.edu %K eHealth literacy %K HIV %K systematic review %K mobile phones %D 2018 %7 10.09.2018 %9 Review %J JMIR Public Health Surveill %G English %X Background: In the era of eHealth, eHealth literacy is emerging as a key concept to promote self-management of chronic conditions such as HIV. However, there is a paucity of research focused on eHealth literacy for people living with HIV (PLWH) as a means of improving their adherence to HIV care and health outcome. Objective: The objective of this study was to critically appraise the types, scope, and nature of studies addressing eHealth literacy as a study variable in PLWH. Methods: This systematic review used comprehensive database searches, such as PubMed, EMBASE, CINAHL, Web of Science, and Cochrane, to identify quantitative studies targeting PLWH published in English before May 2017 with eHealth literacy as a study variable. Results: We identified 56 unique records, and 7 papers met the eligibility criteria. The types of study designs varied (descriptive, n=3; quasi-experimental, n=3; and experimental, n=1) and often involved community-based settings (n=5), with sample sizes ranging from 18 to 895. In regards to instruments used, 3 studies measured eHealth literacy with validated instruments such as the eHealth Literacy Scale (eHEALS); 2 studies used full or short versions of Test of Functional Health Literacy in Adults, whereas the remaining 2 studies used study-developed questions. The majority of studies included in the review reported high eHealth literacy among the samples. The associations between eHealth literacy and health outcomes in PLWH were not consistent. In the areas of HIV transmission risk, retention in care, treatment adherence, and virological suppression, the role of eHealth literacy is still not fully understood. Furthermore, the implications for future research are discussed. Conclusions: Understanding the role of eHealth literacy is an essential step to encourage PLWH to be actively engaged in their health care. Avenues to pursue in the role of eHealth literacy and PLWH should consider the development and use of standardized eHealth literacy definitions and measures. %M 30201600 %R 10.2196/publichealth.9687 %U http://publichealth.jmir.org/2018/3/e64/ %U https://doi.org/10.2196/publichealth.9687 %U http://www.ncbi.nlm.nih.gov/pubmed/30201600 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 6 %N 9 %P e10274 %T Development and Feasibility Testing of an mHealth (Text Message and WeChat) Intervention to Improve the Medication Adherence and Quality of Life of People Living with HIV in China: Pilot Randomized Controlled Trial %A Guo,Yan %A Xu,Zhimeng %A Qiao,Jiaying %A Hong,Y Alicia %A Zhang,Hanxi %A Zeng,Chengbo %A Cai,Weiping %A Li,Linghua %A Liu,Cong %+ Department of Health Promotion and Community Health Sciences, School of Public Health, Texas A&M University, 212 Adriance Lab Road, MS 1266, College Station, TX, 77843, United States, 1 979 436 9343, yhong@sph.tamhsc.edu %K mHealth %K social media %K medication adherence %K people living with HIV %K randomized controlled trial %D 2018 %7 04.09.2018 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Most people living with HIV (PLWH) reside in middle- and low-income countries with limited access to health services. Thus, cost-effective interventions that can reach a large number of PLWH are urgently needed. Objective: The objective of our study was to assess the feasibility and acceptability of an mHealth intervention among PLWH in China. Methods: Based on previous formative research, we designed an mHealth intervention program that included sending weekly reminders to participants via text messages (short message service, SMS) and articles on HIV self-management three times a week via a popular social media app WeChat. A total of 62 PLWH recruited from an HIV outpatient clinic were randomly assigned to intervention or control group. The intervention lasted for 3 months, and all participants were assessed for their medication adherence, presence of depression, quality of life (QoL), and CD4 (cluster of differentiation 4) counts. Upon completing the intervention, we interviewed 31 participants to further assess the feasibility and acceptability of the study. Results: At baseline, the intervention and control groups did not differ in terms of demographic characteristics or any of the major outcome measures. About 85% (53/62) of the participants completed the intervention, and they provided valuable feedback on the design and content of the intervention. Participants preferred WeChat as the platform for receiving information and interactive communication for ease of access. Furthermore, they made specific recommendations about building trust, interactive features, and personalized feedback. In the follow-up assessment, the intervention and control groups did not differ in terms of major outcome measures. Conclusions: This pilot study represents one of the first efforts to develop a text messaging (SMS)- and WeChat-based intervention that focused on improving the medication adherence and QoL of PLWH in China. Our data indicates that an mHealth intervention is feasible and acceptable to this population. The data collected through this pilot study will inform the future designs and implementations of mHealth interventions in this vulnerable population. We recommend more innovative mHealth interventions with rigorous designs for the PLWH in middle- and low-income countries. Trial Registration: Chinese Clinical Trial Registry ChiCTR1800017987; http://www.chictr.org.cn/showprojen.aspx?proj=30448 (Archived by WebCite at http://www.webcitation.org/71zC7Pdzs) Registered Report Ientifier: RR1-10.2196/ %M 30181109 %R 10.2196/10274 %U http://mhealth.jmir.org/2018/9/e10274/ %U https://doi.org/10.2196/10274 %U http://www.ncbi.nlm.nih.gov/pubmed/30181109 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 6 %N 7 %P e10211 %T A Realistic Talking Human Embodied Agent Mobile Phone Intervention to Promote HIV Medication Adherence and Retention in Care in Young HIV-Positive African American Men Who Have Sex With Men: Qualitative Study %A Dworkin,Mark %A Chakraborty,Apurba %A Lee,Sangyoon %A Monahan,Colleen %A Hightow-Weidman,Lisa %A Garofalo,Robert %A Qato,Dima %A Jimenez,Antonio %+ Division of Epidemiology and Biostatistics, School of Public Health, University of Illinois at Chicago, 1603 W Taylor Street, Chicago, IL, 60612, United States, 1 312 413 0348, mdworkin@uic.edu %K adherence %K mHealth %K HIV %K African American %K men who have sex with men %K avatar, embodied agent %D 2018 %7 31.07.2018 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Avatars and embodied agents are a promising innovation for human health intervention because they may serve as a relational agent that might augment user engagement in a behavioral change intervention and motivate behavioral change such as antiretroviral adherence and retention in care. Objective: This study aimed to develop a theory-driven talking avatar-like embodied agent mobile phone intervention guided by the information-motivation-behavioral skills model to promote HIV medication adherence and retention in care in young African American men who have sex with men (MSM). Methods: We performed 5 iterative focus groups in Chicago with HIV-positive African American MSM aged 18-34 years to inform the ongoing development of a mobile phone app. Participants for the focus groups were recruited from 4 University of Illinois at Chicago Community Outreach Intervention Project sites located in different high HIV incidence areas of the city and the University of Illinois at Chicago HIV clinic using fliers and word of mouth. The focus group data analysis included developing an ongoing list of priorities for app changes and discussion between two of the investigators based on the project timeline, resources, and to what extent they served the app’s objectives. Results: In this study, 16 men participated, including 3 who participated in two groups. The acceptability for an embodied agent app was universal in all 5 focus groups. The app included the embodied agent response to questions and antiretroviral regimen information, adherence tracking, CD4 count and viral load tracking, motivational spoken messages, and customizability. Concerns that were identified and responded to in the development process included privacy, stigma, avoiding the harsh or commanding tone of voice, avoiding negative motivational statements, and making reminder functions for a variety of health care interactions. Conclusions: An avatar-like embodied agent mHealth approach was acceptable to young HIV-positive African American MSM. Its relational nature may make it an effective method of informing, motivating, and promoting health behavioral skills. Furthermore, the app’s ease of access, stigma-free environment, and audiovisual format may help overcome some adherence barriers reported in this population. %M 30064971 %R 10.2196/10211 %U http://mhealth.jmir.org/2018/7/e10211/ %U https://doi.org/10.2196/10211 %U http://www.ncbi.nlm.nih.gov/pubmed/30064971 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 6 %N 7 %P e10671 %T You Will Know That Despite Being HIV Positive You Are Not Alone: Qualitative Study to Inform Content of a Text Messaging Intervention to Improve Prevention of Mother-to-Child HIV Transmission %A Fairbanks,Jade %A Beima-Sofie,Kristin %A Akinyi,Pamela %A Matemo,Daniel %A Unger,Jennifer A %A Kinuthia,John %A O'Malley,Gabrielle %A Drake,Alison L %A John-Stewart,Grace %A Ronen,Keshet %+ Department of Global Health, University of Washington, 325 9th Avenue, Seattle, WA, 98104, United States, 1 206 685 4363, keshet@uw.edu %K HIV %K ART %K PMTCT %K SMS text messaging %K adherence %K retention %D 2018 %7 19.07.2018 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Prevention of mother-to-child HIV transmission (PMTCT) relies on long-term adherence to antiretroviral therapy (ART). Mobile health approaches, such as text messaging (short message service, SMS), may improve adherence in some clinical contexts, but it is unclear what SMS content is desired to improve PMTCT-ART adherence. Objective: We aimed to explore the SMS content preferences related to engagement in PMTCT care among women, male partners, and health care workers. The message content was used to inform an ongoing randomized trial to enhance the PMTCT-ART adherence. Methods: We conducted 10 focus group discussions with 87 HIV-infected pregnant or postpartum women and semistructured individual interviews with 15 male partners of HIV-infected women and 30 health care workers from HIV and maternal child health clinics in Kenya. All interviews were recorded, translated, and transcribed. We analyzed transcripts using deductive and inductive approaches to characterize women’s, partners’, and health care workers’ perceptions of text message content. Results: All women and male partners, and most health care workers viewed text messages as a useful strategy to improve engagement in PMTCT care. Women desired messages spanning 3 distinct content domains: (1) educational messages on PMTCT and maternal child health, (2) reminder messages regarding clinic visits and adherence, and (3) encouraging messages that provide emotional support. While all groups valued reminder and educational messages, women highlighted emotional support more than the other groups (partners or health care workers). In addition, women felt that encouraging messages would assist with acceptance of their HIV status, support disclosure, improve patient-provider relationship, and provide support for HIV-related challenges. All 3 groups valued not only messages to support PMTCT or HIV care but also messages that addressed general maternal child health topics, stressing that both HIV- and maternal child health–related messages should be part of an SMS system for PMTCT. Conclusions: Women, male partners, and health care workers endorsed SMS text messaging as a strategy to improve PMTCT and maternal child health outcomes. Our results highlight the specific ways in which text messaging can encourage and support HIV-infected women in PMTCT to remain in care, adhere to treatment, and care for themselves and their children. Trial Registration: ClinicalTrials.gov NCT02400671; https://clinicaltrials.gov/ct2/show/NCT02400671 (Archived by WebCite at http://www.webcitation.org/70W7SVIVJ) %M 30026177 %R 10.2196/10671 %U http://mhealth.jmir.org/2018/7/e10671/ %U https://doi.org/10.2196/10671 %U http://www.ncbi.nlm.nih.gov/pubmed/30026177 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 6 %N 7 %P e152 %T Health Care Provider Utilization and Cost of an mHealth Intervention in Vulnerable People Living With HIV in Vancouver, Canada: Prospective Study %A Campbell,Amber R %A Kinvig,Karen %A Côté,Hélène CF %A Lester,Richard T %A Qiu,Annie Q %A Maan,Evelyn J %A Alimenti,Ariane %A Pick,Neora %A Murray,Melanie CM %+ Division of Infectious Disease, Department of Medicine, University of British Columbia, E600B, 4500 Oak Street, Vancouver, BC, V6H 3N1, Canada, 1 604 875 2212, melanie.murray@cw.bc.ca %K HIV %K mHealth %K health care provider %K cost %K health care utilization %K adherence %D 2018 %7 09.07.2018 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Improving adherence to combined antiretroviral therapy (cART) can be challenging, especially among vulnerable populations living with HIV. Even where cART is available free of charge, social determinants of health act as barriers to optimal adherence rates. Patient-centered approaches exploiting mobile phone communications (mHealth) have been shown to improve adherence to cART and promote achievement of suppressed HIV plasma viral loads. However, data are scarce on the health care provider (HCP) time commitments and health care costs associated with such interventions. This knowledge is needed to inform policy and programmatic implementation. Objective: The purpose of this study was to approximate the resources required and to provide an estimate of the costs associated with running an mHealth intervention program to improve medication adherence in people living with HIV (PLWH). Methods: This prospective study of HCP utilization and costs was embedded within a repeated measures effectiveness study of the WelTel short-message service (SMS) mHealth program. The study included 85 vulnerable, nonadherent PLWH in Vancouver, Canada, and resulted in improved medication adherence and HIV plasma viral load among participants. Study participants were provided mobile phones with unlimited texting (where required) and received weekly bidirectional text messages to inquire on their status for one year. A clinic nurse triaged and managed participants' responses, immediately logging all patient interactions by topic, HCP involvement, and time dedicated to addressing issues raised by participants. Interaction costs were determined in Canadian dollars based on HCP type, median salary within our health authority, and their time utilized as part of the intervention. Results: Participant-identified problems within text responses included health-related, social, and logistical issues. Taken together, management of problems required a median of 43 minutes (interquartile range, IQR 17-99) of HCP time per participant per year, for a median yearly cost of Can $36.72 (IQR 15.50-81.60) per participant who responded with at least one problem. The clinic nurse who monitored the texts solved or managed 65% of these issues, and the remaining were referred to a variety of other HCPs. The total intervention costs, including mobile phones, plans, and staffing were a median Can $347.74/highly vulnerable participant per year for all participants or Can $383.18/highly vulnerable participant per year for those who responded with at least one problem. Conclusions: Bidirectional mHealth programs improve HIV care and treatment outcomes for PLWH. Knowledge about the HCP cost associated, here less than Can $50/year, provides stakeholders and decision makers with information relevant to determining the feasibility and sustainability of mHealth programs in a real-world setting. Trial Registration: ClinicalTrials.gov NCT02603536; https://clinicaltrials.gov/ct2/show/NCT02603536 (Archived by WebCite at http://www.webcitation.org/70IYqKUjV). %M 29986845 %R 10.2196/mhealth.9493 %U http://mhealth.jmir.org/2018/7/e152/ %U https://doi.org/10.2196/mhealth.9493 %U http://www.ncbi.nlm.nih.gov/pubmed/29986845 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 6 %N 5 %P e129 %T Identifying Medication Management Smartphone App Features Suitable for Young Adults With Developmental Disabilities: Delphi Consensus Study %A Salgado,Teresa M %A Fedrigon,Alexa %A Riccio Omichinski,Donna %A Meade,Michelle A %A Farris,Karen B %+ Department of Clinical Pharmacy, College of Pharmacy, University of Michigan, 428 Church Street, Ann Arbor, MI, 48109, United States, 1 734 763 5150, kfarris@umich.edu %K developmental disabilities %K intellectual disability %K mobile applications %K self-management %K telemedicine %K young adult %D 2018 %7 23.05.2018 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Smartphone apps can be a tool to facilitate independent medication management among persons with developmental disabilities. At present, multiple medication management apps exist in the market, but only 1 has been specifically designed for persons with developmental disabilities. Before initiating further app development targeting this population, input from stakeholders including persons with developmental disabilities, caregivers, and professionals regarding the most preferred features should be obtained. Objective: The aim of this study was to identify medication management app features that are suitable to promote independence in the medication management process by young adults with developmental disabilities using a Delphi consensus method. Methods: A compilation of medication management app features was performed by searching the iTunes App Store, United States, in February 2016, using the following terms: adherence, medication, medication management, medication list, and medication reminder. After identifying features within the retrieved apps, a final list of 42 features grouped into 4 modules (medication list, medication reminder, medication administration record, and additional features) was included in a questionnaire for expert consensus rating. A total of 52 experts in developmental disabilities, including persons with developmental disabilities, caregivers, and professionals, were invited to participate in a 3-round Delphi technique. The purpose was to obtain consensus on features that are preferred and suitable to promote independence in the medication management process among persons with developmental disabilities. Consensus for the first, second, and third rounds was defined as ≥90%, ≥80%, and ≥75% agreement, respectively. Results: A total of 75 responses were received over the 3 Delphi rounds—30 in the first round, 24 in the second round, and 21 in the third round. At the end of the third round, cumulative consensus was achieved for 60% (12/20) items in the medication list module, 100% (3/3) in the medication reminder module, 67% (2/3) in the medication administration record module, and 63% (10/16) in the additional features module. In addition to the medication list, medication reminder, and medication administration record features, experts selected the following top 3 most important additional features: automatic refills through pharmacies; ability to share medication information from the app with providers; and ability to share medication information from the app with family, friends, and caregivers. The top 3 least important features included a link to an official drug information source, privacy settings and password protection, and prescription refill reminders. Conclusions: Although several mobile apps for medication management exist, few are specifically designed to support persons with developmental disabilities in the complex medication management process. Of the 42 different features assessed, 64% (27/42) achieved consensus for inclusion in a future medication management app. This study provides information on the features of a medication management app that are most important to persons with developmental disabilities, caregivers, and professionals. %M 29792292 %R 10.2196/mhealth.9527 %U http://mhealth.jmir.org/2018/5/e129/ %U https://doi.org/10.2196/mhealth.9527 %U http://www.ncbi.nlm.nih.gov/pubmed/29792292 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 6 %N 5 %P e122 %T Acceptability and Feasibility of Real-Time Antiretroviral Therapy Adherence Interventions in Rural Uganda: Mixed-Method Pilot Randomized Controlled Trial %A Musiimenta,Angella %A Atukunda,Esther C %A Tumuhimbise,Wilson %A Pisarski,Emily E %A Tam,Melanie %A Wyatt,Monique A %A Ware,Norma C %A Haberer,Jessica E %+ Mbarara University of Science and Technology, Angella Musiimenta, PhD, Mbarara, PO Box 653, Uganda, 256 776820598, amusiimenta@must.ac.ug %K real-time adherence monitoring %K SMS %K mobile health technologies %K antiretroviral therapy %K acceptability %K feasibility study %D 2018 %7 17.05.2018 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Wireless electronic adherence monitors can detect antiretroviral therapy (ART) adherence lapses and trigger interventions in real time, thus potentially avoiding unnecessary HIV viremia. Evidence about the acceptability and feasibility of these monitors and associated interventions, however, is limited. Objective: The aim of this study was to assess the acceptability and feasibility of real-time adherence monitoring linked to text messaging (short message service, SMS) reminders and notifications to support adherence among individuals living with HIV who are taking ART in rural southwestern Uganda. Methods: Individuals living with HIV who were initiating ART were enrolled in a pilot randomized controlled trial and followed up for 9 months. Participants received a real-time adherence monitor and were randomized to one of the following study arms: (1) scheduled SMS, (2) SMS triggered by missed or delayed doses, or (3) no SMS. SMS notifications were also sent to 45 patient-identified social supporters for sustained adherence lapses in the scheduled SMS and triggered SMS arms. Study participants and social supporters participated in qualitative semistructured in-depth interviews on acceptability and feasibility of this technology. An inductive, content analytic approach, framed by the unified theory of acceptance and use of technology model, was used to analyze qualitative data. Quantitative feasibility data, including device functionality and SMS tracking data, were recorded based upon device metrics collected electronically and summarized descriptively. Results: A total of 63 participants participated in the study. Participants reported that real-time monitoring intervention linked to SMS reminders and notifications are generally acceptable; the predominant feedback was perceived utility—the intervention was beneficial in motivating and reminding patients to take medication, as well as enabling provision of social support. The intervention was found to be technically feasible, as data were obtained from most participants as expected most of the time. Potential challenges included the impact of the technology on confidentiality, shared phone ownership, usability skills, and availability of electricity. Conclusions: Real-time adherence monitoring integrated with SMS reminders and social support notifications is a generally acceptable (based primarily on perceived utility) and feasible intervention in a resource-limited country. Future efforts should focus on optimized device design, user training to overcome the challenges we encountered, cost effectiveness studies, as well as studying the monitoring aspect of the device without accompanying interventions. Trial Registration: ClinicalTrials.gov NCT01957865; https://clinicaltrials.gov/ct2/show/NCT01957865 (Archived by WebCite at http://www.webcitation.org/6zFiDlXDa) %M 29773527 %R 10.2196/mhealth.9031 %U http://mhealth.jmir.org/2018/5/e122/ %U https://doi.org/10.2196/mhealth.9031 %U http://www.ncbi.nlm.nih.gov/pubmed/29773527 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 6 %N 4 %P e87 %T Interactive Two-Way mHealth Interventions for Improving Medication Adherence: An Evaluation Using The Behaviour Change Wheel Framework %A Chiang,Nicole %A Guo,Michael %A Amico,K Rivet %A Atkins,Lou %A Lester,Richard T %+ Independent Researcher, 452D, Heather Pavilion East, VGH, 2733 Heather Street, Vancouver, BC, V5Z 3J5, Canada, 1 604 875 4588, sisi.sote.create@gmail.com %K mHealth %K chronic disease %K medication adherence %K primary health care %K disease management %D 2018 %7 12.04.2018 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Medication adherence is an important but highly complex set of behaviors, which for life-threatening and infectious diseases such as HIV carry critical consequences for individual and public health. There is growing evidence that mobile phone text messaging interventions (mHealth) connecting providers with patients positively impact medication adherence, particularly two-way engagement platforms that require bidirectional communication versus one-way in which responses are not mandatory. However, mechanisms of action have not been well defined. The Behavior Change Wheel is a comprehensive framework for behavior change that includes an all-encompassing model of behavior known as Capability Opportunity Motivation-Behavior and is complemented by a taxonomy of behavior change techniques. Evaluating mHealth interventions for medication adherence using these tools could provide useful insights that may contribute to optimizing their integration into the healthcare system and successful scaling-up. Objective: This study aimed to help address the current knowledge gap regarding how two-way mHealth interventions for medication adherence may work by applying the Behavior Change Wheel to characterize WelTel: an interactive digital health outreach platform with robust evidence for improving adherence to antiretroviral therapy. Methods: To characterize how WelTel may promote medication adherence, we applied the Behavior Change Wheel to systematically (1) generate a behavioral diagnosis through mapping known antiretroviral therapy adherence barriers onto the Capability Opportunity Motivation-Behavior model of behavior, (2) specify the behavior change techniques that WelTel delivers, (3) link identified behavior change techniques to corresponding intervention functions of the Behavior Change Wheel, and (4) connect these behavior change techniques and intervention functions to respective Capability Opportunity Motivation-Behavior influences on behavior to determine potential mechanisms of action. Results: Our evaluation of WelTel using the Behavior Change Wheel suggests that most of its impact is delivered primarily through its personalized communication component, in which 8 different behavior change techniques were identified and linked with 5 intervention functions (environmental restructuring, enablement, education, persuasion, and training). Its mechanisms of action in promoting antiretroviral therapy adherence may involve addressing all Capability Opportunity Motivation-Behavior influences on behavior (physical and psychological capability, physical and social opportunity, reflective and automatic motivation). Conclusions: Systematically unpacking the potential active ingredients of effective interventions facilitates the creation and implementation of more parsimonious, tailored, and targeted approaches. Evaluating WelTel using the Behavior Change Wheel has provided valuable insights into how and why such interactive two-way mHealth interventions may produce greater impact than one-way in addressing both nonintentional and intentional forms of nonadherence. The application of the Behavior Change Wheel for evidence synthesis across mHealth interventions targeting various conditions would contribute to strengthening the knowledge base regarding how they may work to impact medication adherence behavior. %M 29650504 %R 10.2196/mhealth.9187 %U http://mhealth.jmir.org/2018/4/e87/ %U https://doi.org/10.2196/mhealth.9187 %U http://www.ncbi.nlm.nih.gov/pubmed/29650504 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 6 %N 3 %P e62 %T Medication Adherence Apps: Review and Content Analysis %A Ahmed,Imran %A Ahmad,Niall Safir %A Ali,Shahnaz %A Ali,Shair %A George,Anju %A Saleem Danish,Hiba %A Uppal,Encarl %A Soo,James %A Mobasheri,Mohammad H %A King,Dominic %A Cox,Benita %A Darzi,Ara %+ Undergraduate Department of Medicine, Imperial College London, Level 2, Faculty Building South Kensington Campus, London, SW7 2AZ, United Kingdom, 44 7533568682, Imran.ahmed92@outlook.com %K medication adherence %K patient compliance %K mobile apps %K telemedicine %K smartphone %K reminder systems %K treatment outcome %D 2018 %7 16.03.2018 %9 Review %J JMIR Mhealth Uhealth %G English %X Background: Medication adherence is an expensive and damaging problem for patients and health care providers. Patients adhere to only 50% of drugs prescribed for chronic diseases in developed nations. Digital health has paved the way for innovative smartphone solutions to tackle this challenge. However, despite numerous apps available claiming to improve adherence, a thorough review of adherence apps has not been carried out to date. Objective: The aims of this study were to (1) review medication adherence apps available in app repositories in terms of their evidence base, medical professional involvement in development, and strategies used to facilitate behavior change and improve adherence and (2) provide a system of classification for these apps. Methods: In April 2015, relevant medication adherence apps were identified by searching the Apple App Store and the Google Play Store using a combination of relevant search terms. Data extracted included app store source, app price, documentation of health care professional (HCP) involvement during app development, and evidence base for each respective app. Free apps were downloaded to explore the strategies used to promote medication adherence. Testing involved a standardized medication regimen of three reminders over a 4-hour period. Nonadherence features designed to enhance user experience were also documented. Results: The app repository search identified a total of 5881 apps. Of these, 805 fulfilled the inclusion criteria initially and were tested. Furthermore, 681 apps were further analyzed for data extraction. Of these, 420 apps were free for testing, 58 were inaccessible and 203 required payment. Of the 420 free apps, 57 apps were developed with HCP involvement and an evidence base was identified in only 4 apps. Of the paid apps, 9 apps had HCP involvement, 1 app had a documented evidence base, and 1 app had both. In addition, 18 inaccessible apps were produced with HCP involvement, whereas 2 apps had a documented evidence base. The 420 free apps were further analyzed to identify strategies used to improve medication adherence. This identified three broad categories of adherence strategies, reminder, behavioral, and educational. A total of 250 apps utilized a single method, 149 apps used two methods, and only 22 apps utilized all three methods. Conclusions: To our knowledge, this is the first study to systematically review all available medication adherence apps on the two largest app repositories. The results demonstrate a concerning lack of HCP involvement in app development and evidence base of effectiveness. More collaboration is required between relevant stakeholders to ensure development of high quality and relevant adherence apps with well-powered and robust clinical trials investigating the effectiveness of these interventions. A sound evidence base will encourage the adoption of effective adherence apps, and thus improve patient welfare in the process. %M 29549075 %R 10.2196/mhealth.6432 %U http://mhealth.jmir.org/2018/3/e62/ %U https://doi.org/10.2196/mhealth.6432 %U http://www.ncbi.nlm.nih.gov/pubmed/29549075 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 7 %N 3 %P e59 %T Improving Transplant Medication Safety Through a Pharmacist-Empowered, Patient-Centered, mHealth-Based Intervention: TRANSAFE Rx Study Protocol %A Fleming,James N %A Treiber,Frank %A McGillicuddy,John %A Gebregziabher,Mulugeta %A Taber,David J %+ Department of Pharmacy, Medical University of South Carolina, 150 Ashley Avenue, Charleston, SC, 29414, United States, 1 843 792 5868, fleminj@musc.edu %K telemedicine %K mhealth %K transplant %K clinical trial %K errors %K adherence %D 2018 %7 02.03.2018 %9 Protocol %J JMIR Res Protoc %G English %X Background: Medication errors, adverse drug events, and nonadherence are the predominant causes of graft loss in kidney transplant recipients and lead to increased healthcare utilization. Research has demonstrated that clinical pharmacists have the unique education and training to identify these events early and develop strategies to mitigate or prevent downstream sequelae. In addition, studies utilizing mHealth interventions have demonstrated success in improving the control of chronic conditions that lead to kidney transplant deterioration. Objective: The goal of the prospective, randomized TRANSAFE Rx study is to measure the clinical and economic effectiveness of a pharmacist-led, mHealth-based intervention, as compared to usual care, in kidney transplant recipients. Methods: TRANSAFE Rx is a 12-month, parallel, two-arm, 1:1 randomized controlled clinical trial involving 136 participants (68 in each arm) and measuring the clinical and economic effectiveness of a pharmacist-led intervention which utilizes an innovative mobile health application to improve medication safety and health outcomes, as compared to usual posttransplant care. Results: The primary outcome measure of this study will be the incidence and severity of MEs and ADRs, which will be identified, categorized, and compared between the intervention and control cohorts. The exploratory outcome measures of this study are to compare the incidence and severity of acute rejections, infections, graft function, graft loss, and death between research cohorts and measure the association between medication safety issues and these events. Additional data that will be gathered includes sociodemographics, health literacy, depression, and support. Conclusions: With this report we describe the study design, methods, and outcome measures that will be utilized in the ongoing TRANSAFE Rx clinical trial. Trial Registration: ClinicalTrials.gov NCT03247322: https://clinicaltrials.gov/ct2/show/NCT03247322 (Archived by WebCite at http://www.webcitation.org/6xcSUnuzW) %M 29500161 %R 10.2196/resprot.9078 %U https://www.researchprotocols.org/2018/3/e59/ %U https://doi.org/10.2196/resprot.9078 %U http://www.ncbi.nlm.nih.gov/pubmed/29500161 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 6 %N 3 %P e47 %T Patient Involvement With Home-Based Exercise Programs: Can Connected Health Interventions Influence Adherence? %A Argent,Rob %A Daly,Ailish %A Caulfield,Brian %+ Beacon Hospital, University College Dublin Beacon Academy, Sandyford, Dublin, D18, Ireland, 353 01 540 4646, rob.argent@insight-centre.org %K patient compliance %K rehabilitation %K exercise therapy %K biomedical technology %K review %D 2018 %7 01.03.2018 %9 Viewpoint %J JMIR Mhealth Uhealth %G English %X Adherence to home exercise in rehabilitation is a significant problem, with estimates of nonadherence as high as 50%, potentially having a detrimental effect on clinical outcomes. In this viewpoint, we discuss the many reasons why patients may not adhere to a prescribed exercise program and explore how connected health technologies have the ability to offer numerous interventions to enhance adherence; however, it is hard to judge the efficacy of these interventions without a robust measurement tool. We highlight how well-designed connected health technologies, such as the use of mobile devices, including mobile phones and tablets, as well as inertial measurement units, provide us with the opportunity to better support the patient and clinician, with a data-driven approach that incorporates features designed to increase adherence to exercise such as coaching, self-monitoring and education, as well as remotely monitor adherence rates more objectively. %M 29496655 %R 10.2196/mhealth.8518 %U https://mhealth.jmir.org/2018/3/e47/ %U https://doi.org/10.2196/mhealth.8518 %U http://www.ncbi.nlm.nih.gov/pubmed/29496655 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 6 %N 2 %P e43 %T Exploring the Influence of a Smartphone App (Young with Diabetes) on Young People’s Self-Management: Qualitative Study %A Husted,Gitte Reventlov %A Weis,Janne %A Teilmann,Grete %A Castensøe-Seidenfaden,Pernille %+ Pediatric and Adolescent Department, Nordsjællands Hospital, University of Copenhagen, Dyrehavevej 29, 1511, Hillerød, 3400, Denmark, 45 48294650, pernille.castensoee-seidenfaden@regionh.dk %K mHealth %K diabetes mellitus, type 1 %K youth %K self-management %K qualitative research %D 2018 %7 28.02.2018 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Adequate self-management is the cornerstone of preventing type 1 diabetes mellitus (T1DM) complications. However, T1DM self-management is challenging for young people, who often struggle during the transition from childhood to adulthood. The mobile health (mHealth) app Young with Diabetes (YWD) was developed in collaboration with young people to enhance their T1DM self-management during this transition. Objective: The purpose of this study was to explore the influence of YWD on young people’s self-management during a 12-month period. Methods: A qualitative explorative approach was used, comprising a purposive sample of 20 young people (11 females and 9 males, ages 15 to 23 years, with app use of 3 to 64 days) from 3 pediatric and 3 adult departments. Participants were interviewed individually using a semistructured interview guide. Data were collected from January to March 2017 and analyzed using thematic analysis. Results: A total of 5 themes were identified: (1) not feeling alone anymore (“we are in this together”); (2) gaining competence by sharing experiences and practical knowledge (“they know what they are talking about”); (3) feeling safer (“it’s just a click away”); (4) breaking the ice by starting to share thoughts and feelings and asking for help (“it is an outstretched hand”); and (5) lack of motivating factors (“done with the app”). Young people reported that YWD promoted self-management by peer-to-peer social support, exchanging messages with health care providers, and sharing YWD with parents. Participants recommended YWD as a supplement to self-management for newly diagnosed young people with T1DM and suggested improvements in app content and functionality. Conclusions: The mHealth app YWD has the potential to support self-management. In particular, peer-to-peer support reduced feelings of loneliness and helped young people to gain knowledge and skills for managing T1DM. A need exists for alternative ways to train health care providers in using YWD and to support collaboration between young people and their parents to further improve young people’s self-management of T1DM. %M 29490897 %R 10.2196/mhealth.8876 %U http://mhealth.jmir.org/2018/2/e43/ %U https://doi.org/10.2196/mhealth.8876 %U http://www.ncbi.nlm.nih.gov/pubmed/29490897 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 6 %N 2 %P e46 %T Feasibility of a Mobile Phone App to Support Recovery From Addiction in China: Secondary Analysis of a Pilot Study %A Han,Hui %A Zhang,Jing Ying %A Hser,Yih-Ing %A Liang,Di %A Li,Xu %A Wang,Shan Shan %A Du,Jiang %A Zhao,Min %+ Collaborative Innovation Center for Brain Science, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, 600 Wan Ping Nan Road, Xu Hui District, Shanghai, 200030, China, 86 18017311220, dujiangdou@163.com %K mHealth %K substance use %K heroin dependence %K amphetamine-type stimulant (ATS) dependence %K mobile app %K China %D 2018 %7 27.02.2018 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Mobile health technologies have been found to improve the self-management of chronic diseases. However, there is limited research regarding their feasibility in supporting recovery from substance use disorders (SUDs) in China. Objective: The objective of this study was to examine the feasibility of a mobile phone-based ecological momentary assessment (EMA) app by testing the concordance of drug use assessed by the EMA, urine testing, and a life experience timeline (LET) assessment. Methods: A total of 75 participants dependent on heroin or amphetamine-type stimulant (ATS) in Shanghai were recruited to participate in a 4-week pilot study. Of the participants, 50 (67% [50/75]) were randomly assigned to the experimental group and 25 (33% [25/75]) were assigned to the control group. The experimental group used mobile health (mHealth) based EMA technology to assess their daily drug use in natural environments and received 2 short health messages each day, whereas the control group only received 2 short health messages each day from the app. Urine tests and LET assessments were conducted each week and a post-intervention survey was administered to both groups. The correlations among the EMA, the LET assessment, and the urine test were investigated. Results: The mean age of the participants was 41.6 (SD 8.0) years, and 71% (53/75) were male. During the 4 weeks of observation, 690 daily EMA survey data were recorded, with a response rate of 49.29% (690/1400). With respect to drug use, the percent of agreement between the EMA and the LET was 66.7%, 79.2%, 72.4%, and 85.8%, respectively, for each of the 4 weeks, whereas the percent of agreement between the EMA and the urine test was 51.2%, 65.1%, 61.9%, and 71.5%, respectively. The post-intervention survey indicated that 46% (32/70) of the participants preferred face-to-face interviews rather than the mHealth app. Conclusions: This study demonstrated poor agreement between the EMA data and the LET and found that the acceptance of mHealth among individuals with SUDs in China was not positive. Hence, greater efforts are needed to improve the feasibility of mHealth in China. %M 29487040 %R 10.2196/mhealth.8388 %U http://mhealth.jmir.org/2018/2/e46/ %U https://doi.org/10.2196/mhealth.8388 %U http://www.ncbi.nlm.nih.gov/pubmed/29487040 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 5 %N 1 %P e15 %T A Mobile Health Platform for Clinical Monitoring in Early Psychosis: Implementation in Community-Based Outpatient Early Psychosis Care %A Kumar,Divya %A Tully,Laura M %A Iosif,Ana-Maria %A Zakskorn,Lauren N %A Nye,Kathleen E %A Zia,Aqsa %A Niendam,Tara Ann %+ Department of Psychiatry and Behavioral Sciences, University of California, Davis, 4701 X Street, Sacramento, CA, 95817, United States, 1 916 734 7927, lmtully@ucdavis.edu %K mHealth %K schizophrenia %K smartphone %K ecological momentary assessment %K experience sampling %D 2018 %7 27.02.2018 %9 Original Paper %J JMIR Ment Health %G English %X Background: A growing body of literature indicates that smartphone technology is a feasible add-on tool in the treatment of individuals with early psychosis (EP) . However, most studies to date have been conducted independent of outpatient care or in a research clinic setting, often with financial incentives to maintain user adherence to the technology. Feasibility of dissemination and implementation of smartphone technology into community mental health centers (CMHCs) has yet to be tested, and whether young adults with EP will use this technology for long periods of time without incentive is unknown. Furthermore, although EP individuals willingly adopt smartphone technology as part of their treatment, it remains unclear whether providers are amenable to integrating smartphone technology into treatment protocols. Objective: This study aimed to establish the feasibility of implementing a smartphone app and affiliated Web-based dashboard in 4 community outpatient EP clinics in Northern California. Methods: EP individuals in 4 clinics downloaded an app on their smartphone and responded to daily surveys regarding mood and symptoms for up to 5 months. Treatment providers at the affiliated clinics viewed survey responses on a secure Web-based dashboard in sessions with their clients and between appointments. EP clients and treatment providers filled out satisfaction surveys at study end regarding usability of the app. Results: Sixty-one EP clients and 20 treatment providers enrolled in the study for up to 5 months. Forty-one EP clients completed the study, and all treatment providers remained in the study for their duration in the clinic. Survey completion for all 61 EP clients was moderate: 40% and 39% for daily and weekly surveys, respectively. Completion rates were slightly higher in the participants who completed the study: 44% and 41% for daily and weekly surveys, respectively. Twenty-seven of 41 (66%) EP clients who completed the study and 11 of 13 (85%) treatment providers who responded to satisfaction surveys reported they would continue to use the app as part of treatment services. Six (15%; 6/41) clients and 3 providers (23%; 3/13) stated that technological glitches impeded their engagement with the platform. Conclusions: EP clients and treatment providers in community-based outpatient clinics are responsive to integrating smartphone technology into treatment services. There were logistical and technical challenges associated with enrolling individuals in CMHCs. To be most effective, implementing smartphone technology in CMHC EP care necessitates adequate technical staff and support for utilization of the platform. %M 29487044 %R 10.2196/mental.8551 %U http://mental.jmir.org/2018/1/e15/ %U https://doi.org/10.2196/mental.8551 %U http://www.ncbi.nlm.nih.gov/pubmed/29487044 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 20 %N 2 %P e45 %T Using Robots at Home to Support Patients With Chronic Obstructive Pulmonary Disease: Pilot Randomized Controlled Trial %A Broadbent,Elizabeth %A Garrett,Jeff %A Jepsen,Nicola %A Li Ogilvie,Vickie %A Ahn,Ho Seok %A Robinson,Hayley %A Peri,Kathryn %A Kerse,Ngaire %A Rouse,Paul %A Pillai,Avinesh %A MacDonald,Bruce %+ Department of Psychological Medicine, Faculty of Medical and Health Sciences, The University of Auckland, 12th floor Auckland Hosptial Support Building, Park Road, Grafton, Auckland, 1142, New Zealand, 64 9 3737599 ext 86756, e.broadbent@auckland.ac.nz %K robotics %K chronic obstructive pulmonary disease %K hospitalization %K medication adherence %K telehealth %K rehabilitation exercise %D 2018 %7 13.02.2018 %9 Original Paper %J J Med Internet Res %G English %X Background: Socially assistive robots are being developed for patients to help manage chronic health conditions such as chronic obstructive pulmonary disease (COPD). Adherence to medication and availability of rehabilitation are suboptimal in this patient group, which increases the risk of hospitalization. Objective: This pilot study aimed to investigate the effectiveness of a robot delivering telehealth care to increase adherence to medication and home rehabilitation, improve quality of life, and reduce hospital readmission compared with a standard care control group. Methods: At discharge from hospital for a COPD admission, 60 patients were randomized to receive a robot at home for 4 months or to a control group. Number of hospitalization days for respiratory admissions over the 4-month study period was the primary outcome. Medication adherence, frequency of rehabilitation exercise, and quality of life were also assessed. Implementation interviews as well as benefit-cost analysis were conducted. Results: Intention-to-treat and per protocol analyses showed no significant differences in the number of respiratory-related hospitalizations between groups. The intervention group was more adherent to their long-acting inhalers (mean number of prescribed puffs taken per day=48.5%) than the control group (mean 29.5%, P=.03, d=0.68) assessed via electronic recording. Self-reported adherence was also higher in the intervention group after controlling for covariates (P=.04). The intervention group increased their rehabilitation exercise frequency compared with the control group (mean difference −4.53, 95% CI −7.16 to −1.92). There were no significant differences in quality of life. Of the 25 patients who had the robot, 19 had favorable attitudes. Conclusions: This pilot study suggests that a homecare robot can improve adherence to medication and increase exercise. Further research is needed with a larger sample size to further investigate effects on hospitalizations after improvements are made to the robots. The robots could be especially useful for patients struggling with adherence. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12615000259549; http://www.anzctr.org.au (Archived by WebCite at  http://www.webcitation.org/6whIjptLS) %M 29439942 %R 10.2196/jmir.8640 %U https://www.jmir.org/2018/2/e45/ %U https://doi.org/10.2196/jmir.8640 %U http://www.ncbi.nlm.nih.gov/pubmed/29439942 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 6 %N 1 %P e30 %T Improving Refill Adherence in Medicare Patients With Tailored and Interactive Mobile Text Messaging: Pilot Study %A Brar Prayaga,Rena %A Jeong,Erwin W %A Feger,Erin %A Noble,Harmony K %A Kmiec,Magdalen %A Prayaga,Ram S %+ mPulse Mobile, Inc, 16530 Ventura Blvd. Suite 500, Encino, CA,, United States, 1 888 678 5735, rena@mpulsemobile.com %K patient activation %K patient engagement %K medication adherence %K refill management %K text messaging %K interactive %K NLP %K Medicare %K disease management %K technology acceptability model %D 2018 %7 30.01.2018 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Nonadherence is a major concern in the management of chronic conditions such as hypertension, cardiovascular disease, and diabetes where patients may discontinue or interrupt their medication for a variety of reasons. Text message reminders have been used to improve adherence. However, few programs or studies have explored the benefits of text messaging with older populations and at scale. In this paper, we present a program design using tailored and interactive text messaging to improve refill rates of partially adherent or nonadherent Medicare members of a large integrated health plan. Objective: The aim of this 3-month program was to gain an understanding of whether tailored interactive text message dialogues could be used to improve medication refills in Medicare patients with one or more chronic diseases. Methods: We used the mPulse Mobile interactive text messaging solution with partially adherent and nonadherent Medicare patients (ie, over age 65 years or younger with disabilities) of Kaiser Permanente Southern California (KP), a large integrated health plan, and compared refill rates of the text messaging group (n=12,272) to a group of partially adherent or nonadherent Medicare patients at KP who did not receive text messages (nontext messaging group, n=76,068). Both groups were exposed to other forms of refill and adherence outreach including phone calls, secure emails, and robo-calls from December 2016 to February 2017. Results: The text messaging group and nontext messaging group were compared using an independent samples t test to test difference in group average of refill rates. There was a significant difference in medication refill rates between the 2 groups, with a 14.07 percentage points higher refill rate in the text messaging group (P<.001). Conclusions: The results showed a strong benefit of using this text messaging solution to improve medication refill rates among Medicare patients. These findings also support using interactive text messaging as a cost-effective, convenient, and user-friendly solution for patient engagement. Program outcomes and insights can be used to enhance the design of future text-based solutions to improve health outcomes and promote adherence and long-term behavior change. %M 29382623 %R 10.2196/mhealth.8930 %U http://mhealth.jmir.org/2018/1/e30/ %U https://doi.org/10.2196/mhealth.8930 %U http://www.ncbi.nlm.nih.gov/pubmed/29382623 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 6 %N 1 %P e23 %T The Impact of mHealth Interventions: Systematic Review of Systematic Reviews %A Marcolino,Milena Soriano %A Oliveira,João Antonio Queiroz %A D'Agostino,Marcelo %A Ribeiro,Antonio Luiz %A Alkmim,Maria Beatriz Moreira %A Novillo-Ortiz,David %+ Pan American Health Organization, 525 23rd St NW, Washington, DC, 20037, United States, 1 2028124726, novillod@paho.org %K telemedicine %K medical informatics %K mobile phones %D 2018 %7 17.01.2018 %9 Review %J JMIR Mhealth Uhealth %G English %X Background: Mobile phone usage has been rapidly increasing worldwide. mHealth could efficiently deliver high-quality health care, but the evidence supporting its current effectiveness is still mixed. Objective: We performed a systematic review of systematic reviews to assess the impact or effectiveness of mobile health (mHealth) interventions in different health conditions and in the processes of health care service delivery. Methods: We used a common search strategy of five major scientific databases, restricting the search by publication date, language, and parameters in methodology and content. Methodological quality was evaluated using the Measurement Tool to Assess Systematic Reviews (AMSTAR) checklist. Results: The searches resulted in a total of 10,689 articles. Of these, 23 systematic reviews (371 studies; more than 79,665 patients) were included. Seventeen reviews included studies performed in low- and middle-income countries. The studies used diverse mHealth interventions, most frequently text messaging (short message service, SMS) applied to different purposes (reminder, alert, education, motivation, prevention). Ten reviews were rated as low quality (AMSTAR score 0-4), seven were rated as moderate quality (AMSTAR score 5-8), and six were categorized as high quality (AMSTAR score 9-11). A beneficial impact of mHealth was observed in chronic disease management, showing improvement in symptoms and peak flow variability in asthma patients, reducing hospitalizations and improving forced expiratory volume in 1 second; improving chronic pulmonary diseases symptoms; improving heart failure symptoms, reducing deaths and hospitalization; improving glycemic control in diabetes patients; improving blood pressure in hypertensive patients; and reducing weight in overweight and obese patients. Studies also showed a positive impact of SMS reminders in improving attendance rates, with a similar impact to phone call reminders at reduced cost, and improved adherence to tuberculosis and human immunodeficiency virus therapy in some scenarios, with evidence of decrease of viral load. Conclusions: Although mHealth is growing in popularity, the evidence for efficacy is still limited. In general, the methodological quality of the studies included in the systematic reviews is low. For some fields, its impact is not evident, the results are mixed, or no long-term studies exist. Exceptions include the moderate quality evidence of improvement in asthma patients, attendance rates, and increased smoking abstinence rates. Most studies were performed in high-income countries, implying that mHealth is still at an early stage of development in low-income countries. %M 29343463 %R 10.2196/mhealth.8873 %U http://mhealth.jmir.org/2018/1/e23/ %U https://doi.org/10.2196/mhealth.8873 %U http://www.ncbi.nlm.nih.gov/pubmed/29343463 %0 Journal Article %@ 2561-9128 %I JMIR Publications %V 1 %N 1 %P e1 %T Accessible Communication Tools for Surgical Site Infection Monitoring and Prevention in Joint Reconstruction: Feasibility Study %A Lu,Keyin %A Chermside-Scabbo,Christopher J %A Marino,Nikolas Evan %A Concepcion,Angela %A Yugawa,Craig %A Aladegbami,Bola %A Paar,Theodora %A St John,Theresa A %A Ross,Will %A Clohisy,John C %A Kirby,John P %+ Department of Surgery, Washington University in Saint Louis, 4901 Forest Park Avenue, St Louis, MO, 63108, United States, 1 (314) 362 1272, kirbyj@wudosis.wustl.edu %K communication tool %K decolonization %K mobile health %K surgical site infection %K automated %K messaging %D 2018 %7 17.01.2018 %9 Original Paper %J JMIR Perioper Med %G English %X Background: The National Surgical Quality Improvement Program logs surgical site infections (SSIs) as the most common cause of unplanned postoperative readmission for a variety of surgical interventions. Hospitals are making significant efforts preoperatively and postoperatively to reduce SSIs and improve care. Telemedicine, defined as using remote technology to implement health care, has the potential to improve outcomes across a wide range of parameters, including reducing SSIs. Objective: The purpose of this study was to assess the feasibility and user satisfaction of two automated messaging systems, EpxDecolonization and EpxWound, to improve perioperative care in a quality improvement project for patients undergoing total joint replacement. Methods: We designed two automated text messaging and calling systems named EpxDecolonization, which reminded patients of their preoperative decolonization protocol, and EpxWound, which monitored pain, wound, and fever status postoperatively. Daily patient responses were recorded and a post-usage survey was sent out to participants to assess satisfaction with the systems. Results: Over the 40-week study period, 638 and 642 patients were enrolled in EpxDecolonization (a preoperative decolonization reminder) and EpxWound (a postoperative surgical site infection telemonitoring system), respectively. Patients could be enrolled in either or both EpxDecolonization and EpxWound, with the default option being dual enrollment. The proportion of sessions responded to was 85.2% for EpxDecolonization and 78.4% for EpxWound. Of the 1280 patients prescribed EpxWound and EpxDecolonization, 821 (64.14%) fully completed the postoperative system satisfaction survey. The median survey score (scale 1-9) was 9 for patient-rated overall care and 8 for whether the telemonitoring systems improved patient communication with providers. The majority of patients (69.0%, 566/821) indicated that the systems sent out an ideal number of messages (not too many, not too few). Conclusions: EpxDecolonization and EpxWound demonstrated high response rates and improved patient-rated communication with providers. These preliminary data suggest that these systems are well tolerated and potentially beneficial to both patients and providers. The systems have the potential to improve both patient satisfaction scores and compliance with preoperative protocols and postoperative wound monitoring. Future efforts will focus on testing the sensitivity and specificity of alerts generated by each system and on demonstrating the ability of these systems to improve clinical quality metrics with more authoritative data. %M 33401369 %R 10.2196/periop.7874 %U http://periop.jmir.org/2018/1/e1/ %U https://doi.org/10.2196/periop.7874 %U http://www.ncbi.nlm.nih.gov/pubmed/33401369 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 6 %N 1 %P e2 %T Importance of Active Participation in Obesity Management Through Mobile Health Care Programs: Substudy of a Randomized Controlled Trial %A Oh,Bumjo %A Yi,Ga-Hye %A Han,Min Kyu %A Kim,Jong Seung %A Lee,Chang Hee %A Cho,Belong %A Kang,Hee Cheol %+ Department of Family Medicine, Seoul Metropolitan Government - Seoul National University Boramae Medical Center, Seoul National University College of Medicine, 20 Boramae-ro 5 gil, Dongjak-gu, Seoul, 07061, Republic Of Korea, 82 2 870 2681, atenae68@nate.com %K physical activity %K mobile health %K metabolic syndrome %K self-report %K adherence %K concordance %D 2018 %7 03.01.2018 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Due to the prevalence of the westernized dietary pattern and lack of physical activity, the numbers of overweight or obese individuals are increasing, resulting in a growing health burden because of various related diseases. A lifestyle modification approach has additional advantages compared with pharmacological therapies or bariatric surgery. In our randomized controlled trial conducted in 2015, we successfully used a ubiquitous health care (SmartCare) service for patients with metabolic syndrome to achieve a significant weight loss effect. Various useful apps have been developed for the SmartCare Service, which involves using a mobile phone to manage chronic diseases, minimizing time and space restrictions. Many studies have demonstrated weight loss effects using a SmartCare service, but limited data are available regarding the effect of active participation in relation to weight loss. Objective: We aimed to assess the weight loss effect achieved after using the SmartCare service in terms of adherence and participation. We divided the intervention group of the previous study according to participation level, and analyzed whether there was a significant difference in the outcome. Methods: We classified participants into 3 groups according to their adherence. Within the intervention group using the SmartCare service, the active group comprised those transmitting anthropometric measurement data using a mobile phone 3 or more times per week or who had a health consultation 5 or more times during a 24-week period. The passive group comprised those who did not adhere to these levels of engagement. The control group comprised those who did not use the SmartCare service. We compared changes in body weight, body mass index (BMI), body fat percentage, waist circumference, and lipid profile among the 3 groups. Results: We identified 422 participants and analyzed 405, excluding 17 who were missing necessary data for analysis. The active group consisted of 116 participants, compared with 80 in the passive group and 209 in the control group (without SmartCare service). There was a statistically significant difference in improvements to body weight, BMI, body fat percentage, and waist circumference among active participants compared with less active participants and the control group (P<.05). However, the lipid profile changes did not differ significantly between groups. Conclusions: The level of participation may be related to improved weight-related outcomes, which may improve health outcomes. To maximize the effectiveness of the SmartCare service, encouraging active participation is important. Trial Registration: Clinicaltrials.gov NCT01344811; https://clinicaltrials.gov/ct2/show/NCT01344811 (Archived by WebCite at http://www.webcitation.org/6alT2MmIB) %M 29298749 %R 10.2196/mhealth.8719 %U http://mhealth.jmir.org/2018/1/e2/ %U https://doi.org/10.2196/mhealth.8719 %U http://www.ncbi.nlm.nih.gov/pubmed/29298749 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 5 %N 12 %P e202 %T Medication Adherence and Technology-Based Interventions for Adolescents With Chronic Health Conditions: A Few Key Considerations %A Badawy,Sherif M %A Thompson,Alexis A %A Kuhns,Lisa M %+ Division of Hematology, Oncology and Stem Cell Transplant, Ann & Robert H Lurie Children's Hospital of Chicago, 225 E Chicago Ave., Box 30, Chicago, IL, 60611, United States, 1 3122274090, sbadawy@luriechildrens.org %K adolescents %K adherence %K compliance %K technology interventions %K mobile apps %K text messaging %D 2017 %7 22.12.2017 %9 Viewpoint %J JMIR Mhealth Uhealth %G English %X The number of children and adolescents with chronic health conditions (CHCs) has doubled over the past two decades. Medication adherence is a key component of disease management within these groups. Low adherence to prescribed medications is a known problem in adolescents with CHCs and is related to health outcomes, including quality of life, disease complications, and mortality. Adolescence is a critical time to create routines and health behaviors that optimize disease self-management and transition to adult care. The mounting interest in the development and use of mobile health tools provides novel opportunities to connect patients, particularly adolescents, with their providers outside of the clinic and to improve health outcomes. There is growing evidence to support the efficacy of technology-based approaches, in particular text-messaging and mobile apps, to improve adherence behavior in adolescents, although cost-effectiveness and long-term health benefits remain unclear. In this short viewpoint article, we review some important considerations for promoting medication adherence in adolescents with CHCs using technology-based approaches. %M 29273573 %R 10.2196/mhealth.8310 %U http://mhealth.jmir.org/2017/12/e202/ %U https://doi.org/10.2196/mhealth.8310 %U http://www.ncbi.nlm.nih.gov/pubmed/29273573 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 19 %N 12 %P e413 %T Two-Way Social Media Messaging in Postoperative Cataract Surgical Patients: Prospective Interventional Study %A Sanguansak,Thuss %A Morley,Katharine E %A Morley,Michael G %A Thinkhamrop,Kavin %A Thuanman,Jaruwan %A Agarwal,Isha %+ Department of Medicine, Massachusetts General Hospital, 108 Parkman St, Boston, MA, 02114, United States, 1 617 726 2707, kemorley@mgh.harvard.edu %K cataract %K social media %K postoperative care %K medication adherence %D 2017 %7 19.12.2017 %9 Original Paper %J J Med Internet Res %G English %X Background: Social media offers a new way to provide education, reminders, and support for patients with a variety of health conditions. Most of these interventions use one-way, provider-patient communication. Incorporating social media tools to improve postoperative (postop) education and follow-up care has only been used in limited situations. Objective: The aim of this study was to determine the feasibility and efficacy of two-way social media messaging to deliver reminders and educational information about postop care to cataract patients. Methods: A total of 98 patients undergoing their first eye cataract surgery were divided into two groups: a no message group receiving usual pre- and postop care and a message group receiving usual care plus messages in a mobile social media format with standardized content and timing. Each patient in the message group received nine messages about hand and face hygiene, medication and postop visit adherence, and links to patient education videos about postop care. Patients could respond to messages as desired. Main outcome measures included medication adherence, postop visit adherence, clinical outcomes, and patients’ subjective assessments of two-way messaging. The number, types, content, and timing of responses by patients to messages were recorded. Results: Medication adherence was better in the message group at postop day 7, with high adherence in 47 patients (96%, 47/49) versus 36 patients (73%, 36/49) in the no message group (P=.004), but no statistically significant differences in medication adherence between the groups were noted at preop and postop day 30. Visit adherence was higher at postop day 30 in the message group (100%, 49/49) versus the no message group (88%, 43/49; P=.03) but was 100% (49/49) in both groups at postop day 1 and 7. Final visual outcomes were similar between groups. A total of 441 standardized messages were sent to the message group. Out of 270 responses generated, 188 (70%) were simple acknowledgments or “thank you,” and 82 (30%) responses were questions that were divided into three general categories: administrative, postop care, and clinical issues. Out of the 82 question responses, 31 (11%) were about administrative issues, 28 (10%) about postop care, and 23 (9%) about clinical symptoms. All the messages about symptoms were triaged by nurses or ophthalmologists and only required reassurance or information. Patients expressed satisfaction with messaging. Conclusions: Two-way social media messaging to deliver postop information to cataract patients is feasible and improves early medication compliance. Further design improvements can streamline work flow to optimize efficiency and patient satisfaction. %M 29258973 %R 10.2196/jmir.8330 %U http://www.jmir.org/2017/12/e413/ %U https://doi.org/10.2196/jmir.8330 %U http://www.ncbi.nlm.nih.gov/pubmed/29258973 %0 Journal Article %@ 2561-1011 %I JMIR Publications %V 1 %N 2 %P e7 %T The Atrial Fibrillation Health Literacy Information Technology System: Pilot Assessment %A Magnani,Jared W %A Schlusser,Courtney L %A Kimani,Everlyne %A Rollman,Bruce L %A Paasche-Orlow,Michael K %A Bickmore,Timothy W %+ Division of Cardiology, Department of Medicine, UPMC Heart and Vascular Institute, University of Pittsburgh, UPMC Presbyterian Hospital, Suite 5-B, 200 Lothrop Street, Pittsburgh, PA, 15213, United States, 1 412 648 6920, magnanij@pitt.edu %K atrial fibrillation %K mHealth %K health-related quality of life %K medication adherence %D 2017 %7 12.12.2017 %9 Original Paper %J JMIR Cardio %G English %X Background: Atrial fibrillation (AF) is a highly prevalent heart rhythm condition that has significant associated morbidity and requires chronic treatment. Mobile health (mHealth) technologies have the potential to enhance multiple aspects of AF care, including education, monitoring of symptoms, and encouraging and tracking medication adherence. We have previously implemented and tested relational agents to improve outcomes in chronic disease and sought to develop a smartphone-based relational agent for improving patient-centered outcomes in AF. Objective: The objective of this study was to pilot a smartphone-based relational agent as preparation for a randomized clinical trial, the Atrial Fibrillation Health Literacy Information Technology Trial (AF-LITT). Methods: We developed the relational agent for use by a smartphone consistent with our prior approaches. We programmed the relational agent as a computer-animated agent to simulate a face-to-face conversation and to serve as a health counselor or coach specific to AF. Relational agent’s dialogue content, informed by a review of literature, focused on patient-centered domains and qualitative interviews with patients with AF, encompassed AF education, common symptoms, adherence challenges, and patient activation. We established that the content was accessible to individuals with limited health or computer literacy. Relational agent content coordinated with use of the smartphone AliveCor Kardia heart rate and rhythm monitor. Participants (N=31) were recruited as a convenience cohort from ambulatory clinical sites and instructed to use the relational agent and Kardia for 30 days. We collected demographic, social, and clinical characteristics and conducted baseline and 30-day assessments of health-related quality of life (HRQoL) with the Atrial Fibrillation Effect on Quality of life (AFEQT) measure; self-reported medication adherence with the Morisky 8-item Medication Adherence Scale (MMAS-8); and patient activation with the Patient Activation Measure (PAM). Results: Participants (mean age 68 [SD 11]; 39% [12/31] women) used the relational agent for an average 17.8 (SD 10.0) days. The mean number of independent log-ins was 19.6 (SD 10.7), with a median of 20 times over 30 days. The mean number of Kardia uses was 26.5 (SD 5.9), and participants using Kardia were in AF for 14.3 (SD 11.0) days. AFEQT scores improved significantly from 64.5 (SD 22.9) at baseline to 76.3 (SD 19.4) units at 30 days (P<.01). We observed marginal but statistically significant improvement in self-reported medication adherence (baseline: 7.3 [SD 0.9], 30 days: 7.7 [SD 0.5]; P=.01). Assessments of acceptability identified that most of the participants found the relational agent useful, informative, and trustworthy. Conclusions: We piloted a 30-day smartphone-based intervention that combined a relational agent with dedicated content for AF alongside Kardia heart rate and rhythm monitoring. Pilot participants had favorable improvements in HRQoL and self-reported medication adherence, as well as positive responses to the intervention. These data will guide a larger, enhanced randomized trial implementing the smartphone relational agent and the Kardia monitor system. %M 29473644 %R 10.2196/cardio.8543 %U http://cardio.jmir.org/2017/2/e7/ %U https://doi.org/10.2196/cardio.8543 %U http://www.ncbi.nlm.nih.gov/pubmed/29473644 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 5 %N 12 %P e184 %T Mobile Health Intervention to Increase Oral Cancer Therapy Adherence in Patients With Chronic Myeloid Leukemia (The REMIND System): Clinical Feasibility and Acceptability Assessment %A Pereira-Salgado,Amanda %A Westwood,Jennifer A %A Russell,Lahiru %A Ugalde,Anna %A Ortlepp,Bronwen %A Seymour,John F %A Butow,Phyllis %A Cavedon,Lawrence %A Ong,Kevin %A Aranda,Sanchia %A Breen,Sibilah %A Kirsa,Suzanne %A Dunlevie,Andrew %A Schofield,Penelope %+ Department of Psychology, School of Health Sciences, Faculty of Health, Arts and Design, Swinburne University of Technology, PO Box 218, Hawthorn, Victoria, 3122, Australia, 61 392144886, pschofield@swin.edu.au %K mobile phone %K neoplasms %K Internet %K medication adherence %D 2017 %7 06.12.2017 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Optimal dosing of oral tyrosine kinase inhibitor therapy is critical to treatment success and survival of patients with chronic myeloid leukemia (CML). Drug intolerance secondary to toxicities and nonadherence are significant factors in treatment failure. Objective: The objective of this study was to develop and pilot-test the clinical feasibility and acceptability of a mobile health system (REMIND) to increase oral drug adherence and patient symptom self-management among people with CML (chronic phase). Methods: A multifaceted intervention was iteratively developed using the intervention development framework by Schofield and Chambers, consisting of defining the patient problem and iteratively refining the intervention. The clinical feasibility and acceptability were examined via patient and intervention nurse interviews, which were audiotaped, transcribed, and deductively content analyzed. Results: The intervention comprised 2 synergistically operating elements: (1) daily medication reminders and routine assessment of side effects with evidence-based self-care advice delivered in real time and (2) question prompt list (QPL) questions and routinely collected individual patient adherence and side effect profile data used to shape nurses’ consultations, which employed motivational interviewing to support adoption of self-management behaviors. A total of 4 consultations and daily alerts and advice were delivered over 10 weeks. In total, 58% (10/17) of patients and 2 nurses participated in the pilot study. Patients reported several benefits of the intervention: help in establishing medication routines, resolution of symptom uncertainty, increased awareness of self-care, and informed decision making. Nurses also endorsed the intervention: it assisted in establishing pill-taking routines and patients developing effective solutions to adherence challenges. Conclusions: The REMIND system with nurse support was usable and acceptable to both patients and nurses. It has the potential to improve adherence and side-effect management and should be further evaluated. %M 29212628 %R 10.2196/mhealth.8349 %U http://mhealth.jmir.org/2017/12/e184/ %U https://doi.org/10.2196/mhealth.8349 %U http://www.ncbi.nlm.nih.gov/pubmed/29212628 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 5 %N 11 %P e179 %T One Drop | Mobile on iPhone and Apple Watch: An Evaluation of HbA1c Improvement Associated With Tracking Self-Care %A Osborn,Chandra Y %A van Ginkel,Joost R %A Marrero,David G %A Rodbard,David %A Huddleston,Brian %A Dachis,Jeff %+ Informed Data Systems Inc, 85 Delancey St, Ste 71, New York, NY, 10002, United States, 1 8604242858, chandra@onedrop.today %K type 1 diabetes %K type 2 diabetes %K mobile health %K mobile phone %K smartwatch %K glycated hemoglobin A1c %K HbA1c %K glycemic control %K self-care behavior %D 2017 %7 29.11.2017 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: The One Drop | Mobile app supports manual and passive (via HealthKit and One Drop’s glucose meter) tracking of self-care and glycated hemoglobin A1c (HbA1c). Objective: We assessed the HbA1c change of a sample of people with type 1 diabetes (T1D) or type 2 diabetes (T2D) using the One Drop | Mobile app on iPhone and Apple Watch, and tested relationships between self-care tracking with the app and HbA1c change. Methods: In June 2017, we identified people with diabetes using the One Drop | Mobile app on iPhone and Apple Watch who entered two HbA1c measurements in the app 60 to 365 days apart. We assessed the relationship between using the app and HbA1c change. Results: Users had T1D (n=65) or T2D (n=191), were 22.7% (58/219) female, with diabetes for a mean 8.34 (SD 8.79) years, and tracked a mean 2176.35 (SD 3430.23) self-care activities between HbA1c entries. There was a significant 1.36% or 14.9 mmol/mol HbA1c reduction (F=62.60, P<.001) from the first (8.72%, 71.8 mmol/mol) to second HbA1c (7.36%, 56.9 mmol/mol) measurement. Tracking carbohydrates was independently associated with greater HbA1c improvement (all P<.01). Conclusions: Using One Drop | Mobile on iPhone and Apple Watch may favorably impact glycemic control. %M 29187344 %R 10.2196/mhealth.8781 %U http://mhealth.jmir.org/2017/11/e179/ %U https://doi.org/10.2196/mhealth.8781 %U http://www.ncbi.nlm.nih.gov/pubmed/29187344 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 1 %N 1 %P e5 %T Implications for Training on Smartphone Medication Reminder App Use by Adults With Chronic Conditions: Pilot Study Applying the Technology Acceptance Model %A Park,Daniel Y %A Goering,Elizabeth M %A Head,Katharine J %A Bartlett Ellis,Rebecca J %+ Department of Communication Studies, Indiana University-Purdue University Indianapolis, 425 University Boulevard, Indianapolis, IN, 46202, United States, 1 317 278 3136, bgoering@iupui.edu %K chronic disease %K education of patients %K medication adherence %K mHealth %K mobile apps %K smartphone %D 2017 %7 10.11.2017 %9 Original Paper %J JMIR Formativ Res %G English %X Background: The majority of middle-aged to older patients with chronic conditions report forgetting to take medications as prescribed. The promotion of patients’ smartphone medication reminder app (SMRA) use shows promise as a feasible and cost-effective way to support their medication adherence. Providing training on SMRA use, guided by the technology acceptance model (TAM), could be a promising intervention to promote patients’ app use. Objective: The aim of this pilot study was to (1) assess the feasibility of an SMRA training session designed to increase patients’ intention to use the app through targeting perceived usefulness of app, perceived ease of app use, and positive subjective norm regarding app use and (2) understand the ways to improve the design and implementation of the training session in a hospital setting. Methods: A two-group design was employed. A total of 11 patients older than 40 years (median=58, SD=9.55) and taking 3 or more prescribed medications took part in the study on one of two different dates as participants in either the training group (n=5) or nontraining group (n=6). The training group received an approximately 2-hour intervention training session designed to target TAM variables regarding one popular SMRA, the Medisafe app. The nontraining group received an approximately 2-hour control training session where the participants individually explored Medisafe app features. Each training session was concluded with a one-time survey and a one-time focus group. Results: Mann-Whitney U tests revealed that the level of perceived ease of use (P=.13) and the level of intention to use an SMRA (P=.33) were higher in the training group (median=7.00, median=6.67, respectively) than in the nontraining group (median=6.25, median=5.83). However, the level of perceived usefulness (U=4.50, Z=−1.99, P=.05) and the level of positive subjective norm (P=.25) were lower in the training group (median=6.50, median=4.29) than in the nontraining group (median=6.92, median=4.50). Focus groups revealed the following participants’ perceptions of SMRA use in the real-world setting that the intervention training session would need to emphasize in targeting perceived usefulness and positive subjective norm: (1) the participants would find an SMRA to be useful if they thought the app could help address specific struggles in medication adherence in their lives and (2) the participants think that their family members (or health care providers) might view positively the participants’ SMRA use in primary care settings (or during routine medical checkups). Conclusions: Intervention training session, guided by TAM, appeared feasible in targeting patients’ perceived ease of use and, thereby, increasing intention to use an SMRA. Emphasizing the real-world utility of SMRA, the training session could better target patients’ perceived usefulness and positive subjective norm that are also important in increasing their intention to use the app. %M 30684397 %R 10.2196/formative.8027 %U http://formative.jmir.org/2017/1/e5/ %U https://doi.org/10.2196/formative.8027 %U http://www.ncbi.nlm.nih.gov/pubmed/30684397 %0 Journal Article %@ 2371-4379 %I JMIR Publications %V 2 %N 2 %P e20 %T Digital Health for Medication Adherence in Adult Diabetes or Hypertension: An Integrative Review %A Conway,Cheryl Moseley %A Kelechi,Teresa J %+ School of Nursing, Western Carolina University, 1 University Way, Cullowhee, NC,, United States, 1 828 778 6019, conway@musc.edu %K digital health %K medication adherence %K Chronic Care Model %K diabetes %K hypertension %D 2017 %7 16.08.2017 %9 Review %J JMIR Diabetes %G English %X Background: Optimal management of chronic diseases, such as type 2 diabetes and hypertension, often include prescription medications. Medication adherence (MA) is one component of self-management. Optimization through digital health—eHealth and mHealth—could enhance patient awareness and/or communication between the patient and provider. Objective: Medication adherence is a major issue that affects 50%-60% of chronically ill adults. Digital health refers to eHealth and mHealth, collectively, and as these technologies become more accessible, remote health delivery is increasingly available as an adjunct to improve medication adherence; communicate with patients and providers; and provide education to patients, families, and communities. The objective of this integrative review was to examine the types of digital health technologies that targeted medication adherence in the adult population with diabetes or hypertension. Methods: An integrative review was conducted using databases within EBSCOhost, PubMed, and Scopus. Eligible studies available as of September 2016 had to be written in English, had to contain digital health interventions to improve medication adherence to prescription medications in adults 18 years or older, and had to focus on diabetes or hypertension. Results: Of the 337 located studies, 13 (3.9%) used a digital health intervention for medication adherence to prescribed medications for diabetes or hypertension and were assessed according to the Chronic Care Model. Conclusions: The 13 studies included in this review found no conclusive evidence of improved medication adherence using digital health interventions such as interactive voice response (IVR), short message service (SMS) text messaging, telemonitoring, and interactive software technology. Among the 13 studies were digital health interventions that foster medication adherence via one-way communication to the patient or two-way communication between the patient and health care provider for adjunct medication adherence strategies. More research is needed to determine which digital health interventions are most beneficial for individuals with diabetes or hypertension. %M 30291093 %R 10.2196/diabetes.8030 %U http://diabetes.jmir.org/2017/2/e20/ %U https://doi.org/10.2196/diabetes.8030 %U http://www.ncbi.nlm.nih.gov/pubmed/30291093 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 5 %N 8 %P e121 %T Developing and Evaluating JIApp: Acceptability and Usability of a Smartphone App System to Improve Self-Management in Young People With Juvenile Idiopathic Arthritis %A Cai,Ran A %A Beste,Dominik %A Chaplin,Hema %A Varakliotis,Socrates %A Suffield,Linda %A Josephs,Francesca %A Sen,Debajit %A Wedderburn,Lucy R %A Ioannou,Yiannakis %A Hailes,Stephen %A Eleftheriou,Despina %+ Arthritis Research UK Centre for Adolescent Rheumatology, University College London, UCL Great Ormond Street Institute of Child Health, 30 Guilford St, London, WC1N 1EH, United Kingdom, 44 0203 108 2420, a.cai@ucl.ac.uk %K juvenile idiopathic arthritis %K self-management %K adolescent %K young adult %K mobile applications %K qualitative research %K smartphone %D 2017 %7 15.08.2017 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Flare-ups in juvenile idiopathic arthritis (JIA) are characterized by joint pain and swelling and often accompanied with fatigue, negative emotions, and reduced participation in activities. To minimize the impact of JIA on the physical and psychosocial development and well-being of young people (YP), it is essential to regularly monitor disease activity and side effects, as well as to support self-management such as adherence to treatment plans and engagement in general health-promoting behaviors. Smartphone technology has the potential to engage YP with their health care through convenient self-monitoring and easy access to information. In addition, having a more accurate summary of self-reported fluctuations in symptoms, behaviors, and psychosocial problems can help both YP and health care professionals (HCPs) better understand the patient’s condition, identify barriers to self-management, and assess treatment effectiveness and additional health care needs. No comprehensive smartphone app has yet been developed in collaboration with YP with JIA, their parents, and HCPs involved in their care. Objectives: The objective of this study was to design, develop, and evaluate the acceptability and usability of JIApp, a self-management smartphone app system for YP with JIA and HCPs. Methods: We used a qualitative, user-centered design approach involving YP, parents, and HCPs from the rheumatology team. The study was conducted in three phases: (1) phase I focused on developing consensus on the features, content, and design of the app; (2) phase II was used for further refining and evaluating the app prototype; and (3) phase III focused on usability testing of the app. The interview transcripts were analyzed using qualitative content analysis. Results: A total of 29 YP (aged 10-23, median age 17) with JIA, 7 parents, and 21 HCPs were interviewed. Major themes identified as the ones that helped inform app development in phase I were: (1) remote monitoring of symptoms, well-being, and activities; (2) treatment adherence; and (3) education and support. During phase II, three more themes emerged that informed further refinement of the app prototype. These included (4) adapting a reward system to motivate end users for using the app; (5) design of the app interface; and (6) clinical practice integration. The usability testing during phase III demonstrated high rates of overall satisfaction and further affirmed the content validity of the app. Conclusions: We present the development and evaluation of a smartphone app to encourage self-management and engagement with health care for YP with JIA. The app was found to have high levels of acceptability and usability among YP and HCPs and has the potential to improve health care and outcomes for this age group. Future feasibility testing in a prospective study will firmly establish the reliability, efficacy, and cost-effectiveness of such an app intervention for patients with arthritis. %M 28811270 %R 10.2196/mhealth.7229 %U http://mhealth.jmir.org/2017/8/e121/ %U https://doi.org/10.2196/mhealth.7229 %U http://www.ncbi.nlm.nih.gov/pubmed/28811270 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 5 %N 8 %P e110 %T The Impact of Text Messaging on Medication Adherence and Exercise Among Postmyocardial Infarction Patients: Randomized Controlled Pilot Trial %A Pandey,Avinash %A Krumme,Alexis A %A Patel,Tejal %A Choudhry,Niteesh K %+ Brigham and Women’s Hospital and Harvard Medical School, 1620 Tremont St Suite 3030, Boston, MA, 02120, United States, 1 617 278 0930, nkchoudhry@bwh.harvard.edu %K medication adherence %K cardiac rehabilitation %K exercise %K randomized controlled trial %D 2017 %7 03.08.2017 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Adherence to evidence-based therapies such as medications and exercise remains poor among patients after a myocardial infarction (MI). Text message reminders have been shown to improve rates of adherence to medication and exercise, but the existing studies have been of short duration. Objective: Two single-center randomized controlled pilot trials were conducted to evaluate the impact of text message reminders over 12 months on adherence to cardiac medications and exercise among patients receiving cardiac rehabilitation after hospitalization for MI. Methods: In the medication adherence trial, 34 patients were randomized to receive usual care alone or usual care plus daily text message reminders delivered at the time of day at which medications were to be taken. In the exercise adherence trial, 50 patients were randomized to receive usual care alone or usual care plus 4 daily text messages reminding them to exercise as directed. Results: The text message reminders led to a mean 14.2 percentage point improvement in self-reported medication adherence over usual care (P<.001, 95% CI 7-21). In the exercise trial, text message reminders resulted in an additional 4.2 days (P=.001, 95% CI 1.9-6.4) and 4.0 hours (P<.001, 95% CI 2.4-5.6) of exercise per month over usual care and a nonsignificant increase of 1.2 metabolic equivalents (METS; P=.06) in exercise capacity as assessed by a BRUCE protocol at 12 months. Conclusions: Text message reminders significantly increased adherence to medication and exercise among post-MI patients receiving care in a structured cardiac rehabilitation program. This technology represents a simple and scalable method to ensure consistent use of evidence-based cardiovascular therapies. Trial Registration: Clinicaltrials.gov NCT02783287; https://clinicaltrials.gov/ct2/show/NCT02783287 (Archived by WebCite at http://www.webcitation.org/6sBnvNb05) %M 28778843 %R 10.2196/mhealth.7144 %U http://mhealth.jmir.org/2017/8/e110/ %U https://doi.org/10.2196/mhealth.7144 %U http://www.ncbi.nlm.nih.gov/pubmed/28778843 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 5 %N 7 %P e100 %T The Relationship Between Individual Characteristics and Interest in Using a Mobile Phone App for HIV Self-Management: Observational Cohort Study of People Living With HIV %A Lucero,Robert James %A Frimpong,Jemima A %A Fehlberg,Elizabeth A %A Bjarnadottir,Ragnhildur I %A Weaver,Michael T %A Cook,Christa %A Modave,Francois %A Rathore,Mobeen H %A Morano,Jamie P %A Ibanez,Gladys %A Cook,Robert L %+ Department of Family, Community, and Health Systems Science, College of Nursing, University of Florida, Health Professions, Nursing, and Pharmacy Complex, 1225 Center Drive, Gainesville, FL,, United States, 1 352 273 6370, rlucero@ufl.edu %K telemedicine %K self-care %K HIV %D 2017 %7 27.07.2017 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: The human immunodeficiency virus (HIV) continues to be a major health issue in the United States, and an estimated 1.2 million people in the United States are living with HIV. As part of Healthy People 2020, the Office of Disease Prevention and Health Promotion has targeted the persistent demographic and geographic disparities in HIV prevalence and management. Preliminary evidence suggests that mobile health technology (smartphone apps) may be a promising way to support HIV self-management among vulnerable populations of people living with HIV (PLWH) who lack access to appropriate health care services. Objective: This study examines the association between individual characteristics of PLWH and level of interest in using a free mobile phone app for HIV self-management. Methods: This study was conducted using cross-sectional survey data collected in the Florida Cohort Study between 2014 and 2016 (N=766). Associations between individual characteristics of PLWH and level of interest in using a free mobile phone app for HIV self-management were examined using bivariate analysis and logistic regression. Results: Overall, 85.5% (655/766) of respondents were interested in using a free mobile phone app that supports HIV self-management. Participants expressed the highest interest in app functions that facilitate communication with health care providers (568/740, 76.8%) or help to identify relevant health care services (556/745 74.6%). Age (OR 0.959, 95% CI 0.936-0.982), education (OR 1.281, 95% CI 1.027-1.598) and disability or inability to work (OR 0.296, 95% CI 0.145-0.606) were all significantly associated with being interested in using a free mobile phone app for HIV self-management. Conclusions: This study indicates that a majority of PLWH are interested in using a free mobile phone app to self-manage their condition. The findings can inform the development of mobile phone apps that support effective HIV self-management. %M 28751298 %R 10.2196/mhealth.7853 %U http://mhealth.jmir.org/2017/7/e100/ %U https://doi.org/10.2196/mhealth.7853 %U http://www.ncbi.nlm.nih.gov/pubmed/28751298 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 5 %N 7 %P e98 %T The Health Buddies App as a Novel Tool to Improve Adherence and Knowledge in Atrial Fibrillation Patients: A Pilot Study %A Desteghe,Lien %A Kluts,Kiki %A Vijgen,Johan %A Koopman,Pieter %A Dilling-Boer,Dagmara %A Schurmans,Joris %A Dendale,Paul %A Heidbuchel,Hein %+ Faculty of Medicine and Life Sciences, Hasselt University, Martelarenlaan 42, Hasselt, 3500, Belgium, 32 11 30 82 26, lien.desteghe@uhasselt.be %K mHealth %K anticoagulants %K medication adherence %K education %K atrial fibrillation %D 2017 %7 19.07.2017 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Atrial fibrillation (AF) constitutes an important risk for stroke, especially in an ageing population. A new app (Health Buddies) was developed as a tool to improve adherence to non-vitamin K antagonist oral anticoagulants (NOACs) in an elderly AF population by providing a virtual contract with their grandchildren, spelling out daily challenges for both. Objective: The aim of this pilot study was to assess the feasibility and usability of the Health Buddies app in AF patients. Methods: Two workshops were conducted to steer app development and to test a first prototype. The feasibility of the finalized app was investigated by assessing the number of eligible AF patients (based on current prescription of NOACs, the presence of grandchildren between 5 and 15 years old, availability of a mobile phone, computer, or tablet), and the proportion of those who were willing to participate. Participants had to use the app for 3 months. The motivation of the patients to use the app was assessed based on the number of logins to the app. Their perception of its usefulness was examined by specific questionnaires. Additionally, the effects on knowledge level about AF and its treatment, and adherence to NOAC intake were investigated. Results: Out of 830 screened AF patients, 410 were taking NOACs and 114 were eligible for inclusion. However, only 3.7% (15/410) of the total NOAC population or 13.2% of the eligible patients (15/114) were willing to participate. The main reasons for not participating were no interest to participate in general or in the concept in particular (29/99, 29%), not feeling comfortable using technology (22/99, 22%), no interest by the grandchildren or their parents (20/99, 20%), or too busy a lifestyle (12/99, 12%). App use significantly decreased towards the end of the study period in both patients (P=.009) and grandchildren (P<.001). NOAC adherence showed a taking adherence and regimen adherence of 88.6% (SD 15.4) and 81.8% (SD 18.7), respectively. Knowledge level increased from 64.6% (SD 14.7) to 70.4% (SD 10.4) after 3 months (P=.09). The app scored positively on clarity, novelty, stimulation, and attractiveness as measured with the user experience questionnaire. Patients evaluated the educational aspect of this app as a capital gain. Conclusions: Only a small proportion of the current AF population seems eligible for the innovative Health Buddies app in its current form. Although the app was positively rated by its users, a large subset of patients was not willing to participate in this study or to use the app. Efforts have to be made to expand the target group in the future. %M 28724512 %R 10.2196/mhealth.7420 %U http://mhealth.jmir.org/2017/7/e98/ %U https://doi.org/10.2196/mhealth.7420 %U http://www.ncbi.nlm.nih.gov/pubmed/28724512 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 6 %N 7 %P e134 %T Comparing Mobile Health Strategies to Improve Medication Adherence for Veterans With Coronary Heart Disease (Mobile4Meds): Protocol for a Mixed-Methods Study %A Park,Linda G %A Collins,Eileen G %A Shim,Janet K %A Whooley,Mary A %+ Department of Veterans Affairs, Community Health Systems, University of California, San Francisco, 2 Koret Way, Box 0608, Room 531A, San Francisco, CA, 94143, United States, 1 415 502 6616, linda.park@ucsf.edu %K text messaging %K mobile application %K mobile health %K cardiovascular disease %K medication %K adherence %D 2017 %7 18.07.2017 %9 Protocol %J JMIR Res Protoc %G English %X Background: Adherence to antiplatelet medications is critical to prevent life threatening complications (ie, stent thrombosis) after percutaneous coronary interventions (PCIs), yet rates of nonadherence range from 21-57% by 12 months. Mobile interventions delivered via text messaging or mobile apps represent a practical and inexpensive strategy to promote behavior change and enhance medication adherence. Objective: The Mobile4Meds study seeks to determine whether text messaging or a mobile app, compared with an educational website control provided to all Veterans, can improve adherence to antiplatelet therapy among patients following acute coronary syndrome (ACS) or PCI. The three aims of the study are to: (1) determine preferences for content and frequency of text messaging to promote medication adherence through focus groups; (2) identify the most patient-centered app that promotes adherence, through a content analysis of all commercially available apps for medication adherence and focus groups centered on usability; and (3) compare adherence to antiplatelet medications in Veterans after ACS/PCI via a randomized clinical trial (RCT). Methods: We will utilize a mixed-methods design that uses focus groups to achieve the first and second aims (N=32). Patients will be followed for 12 months after being randomly assigned to one of three arms: (1) customized text messaging, (2) mobile app, or (3) website-control groups (N=225). Medication adherence will be measured with electronic monitoring devices, pharmacy records, and self-reports. Results: Enrollment for the focus groups is currently in progress. We expect to enroll patients for the RCT in the beginning of 2018. Conclusions: Determining the efficacy of mobile technology using a Veteran-designed protocol to promote medication adherence will have a significant impact on Veteran health and public health, particularly for individuals with chronic diseases that require strict medication adherence. Trial Registration: ClinicalTrials.gov NCT03022669 %M 28720557 %R 10.2196/resprot.7327 %U http://www.researchprotocols.org/2017/7/e134/ %U https://doi.org/10.2196/resprot.7327 %U http://www.ncbi.nlm.nih.gov/pubmed/28720557 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 19 %N 7 %P e245 %T Short Text Messages to Encourage Adherence to Medication and Follow-up for People With Psychosis (Mobile.Net): Randomized Controlled Trial in Finland %A Välimäki,Maritta %A Kannisto,Kati Anneli %A Vahlberg,Tero %A Hätönen,Heli %A Adams,Clive E %+ Department of Nursing Science, Joukahaisenkatu 3-5, University of Turku, 20014, Turku,, Finland, 358 40 5599235, mava@utu.fi %K text messaging %K psychotic disorders %K randomized controlled trial %K medication adherence %D 2017 %7 12.07.2017 %9 Original Paper %J J Med Internet Res %G English %X Background: A text messaging service (short message service [SMS]) has the potential to target large groups of people with long-term illnesses such as serious mental disorders, who may have difficulty with treatment adherence. Robust research on the impact of mobile technology interventions for these patients remains scarce. Objective: The main objective of our study was to investigate the impact of individually tailored short text messages on the rate of psychiatric hospital readmissions, health care service use, and clinical outcomes. In addition, we analyzed treatment costs. Methods: Between September 2011 and November 2012, we randomly assigned 1139 people to a tailored text message intervention (n=569) or usual care (n=570). Participants received semiautomated text messages for up to 12 months or usual care. The primary outcome, based on routinely collected health register data, was patient readmission into a psychiatric hospital during a 12-month follow-up period. Secondary outcomes were related to other service use, coercion, medication, adverse events, satisfaction, social functioning, quality of life, and economic factors (cost analysis). Results: There was 98.24% (1119/1139) follow-up at 12 months. Tailored mobile telephone text messages did not reduce the rate of hospital admissions (242/563, 43.0% of the SMS group vs 216/556, 38.8% of the control group; relative risk 1.11; 95% CI 0.92-1.33; P=.28), time between hospitalizations (mean difference 7.0 days 95% CI –8.0 to 24.0; P=.37), time spent in a psychiatric hospital during the year (mean difference 2.0 days 95% CI –2.0 to 7.0; P=.35), or other service outcomes. People who received text messages were less disabled, based on Global Assessment Scale scores at the time of their readmission, than those who did not receive text messages (odds ratio 0.68; 95% CI 0.47-0.97; P=.04). The costs of treatment were higher for people in the SMS group than in the control group (mean €10,103 vs €9210, respectively, P<.001). Conclusions: High-grade routinely collected data can provide clear outcomes for pragmatic randomized trials. SMS messaging tailored with the input of each individual patient did not decrease the rate of psychiatric hospital visits after the 12 months of follow-up. Although there may have been other, more subtle effects, the results of these were not evident in outcomes of agreed importance to clinicians, policymakers, and patients and their families. Trial Registration: International Standard Randomized Controlled Trial Number (ISRCTN): 27704027; http://www.isrctn.com/ISRCTN27704027 (Archived by WebCite at http://www.webcitation.org/6rVzZrbuz). %M 28701292 %R 10.2196/jmir.7028 %U http://www.jmir.org/2017/7/e245/ %U https://doi.org/10.2196/jmir.7028 %U http://www.ncbi.nlm.nih.gov/pubmed/28701292 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 19 %N 7 %P e246 %T Effectiveness of Digital Medicines to Improve Clinical Outcomes in Patients with Uncontrolled Hypertension and Type 2 Diabetes: Prospective, Open-Label, Cluster-Randomized Pilot Clinical Trial %A Frias,Juan %A Virdi,Naunihal %A Raja,Praveen %A Kim,Yoona %A Savage,George %A Osterberg,Lars %+ Proteus Digital Health, 2600 Bridge Parkway, Redwood City, CA, 94065, United States, 1 4158285009, nvirdi@proteus.com %K digital medicine %K hypertension %K type 2 diabetes %K patient engagement, medication adherence %K therapeutic inertia %D 2017 %7 11.07.2017 %9 Original Paper %J J Med Internet Res %G English %X Background: Hypertension and type 2 diabetes mellitus are major modifiable risk factors for cardiac, cerebrovascular, and kidney diseases. Reasons for poor disease control include nonadherence, lack of patient engagement, and therapeutic inertia. Objective: The aim of this study was to assess the impact on clinic-measured blood pressure (BP) and glycated hemoglobin (HbA1c) using a digital medicine offering (DMO) that measures medication ingestion adherence, physical activity, and rest using digital medicines (medication taken with ingestible sensor), wearable sensor patches, and a mobile device app. Methods: Participants with elevated systolic BP (SBP ≥140 mm Hg) and HbA1c (≥7%) failing antihypertensive (≥2 medications) and oral diabetes therapy were enrolled in this three-arm, 12-week, cluster-randomized study. Participants used DMO (includes digital medicines, the wearable sensor patch, and the mobile device app) for 4 or 12 weeks or received usual care based on site randomization. Providers in the DMO arms could review the DMO data via a Web portal. In all three arms, providers were instructed to make medical decisions (medication titration, adherence counseling, education, and lifestyle coaching) on all available clinical information at each visit. Primary outcome was change in SBP at week 4. Other outcomes included change in SBP and HbA1c at week 12, and low-density lipoprotein cholesterol (LDL-C) and diastolic blood pressure (DBP) at weeks 4 and 12, as well as proportion of patients at BP goal (<140/90 mm Hg) at weeks 4 and 12, medical decisions, and medication adherence patterns. Results: Final analysis included 109 participants (12 sites; age: mean 58.7, SD years; female: 49.5%, 54/109; Hispanic: 45.9%, 50/109; income ≤ US $20,000: 56.9%, 62/109; and ≤ high school education: 52.3%, 57/109). The DMO groups had 80 participants (7 sites) and usual care had 29 participants (5 sites). At week 4, DMO resulted in a statistically greater SBP reduction than usual care (mean –21.8, SE 1.5 mm Hg vs mean –12.7, SE 2.8 mmHg; mean difference –9.1, 95% CI –14.0 to –3.3 mm Hg) and maintained a greater reduction at week 12. The DMO groups had greater reductions in HbA1c, DBP, and LDL-C, and a greater proportion of participants at BP goal at weeks 4 and 12 compared with usual care. The DMO groups also received more therapeutic interventions than usual care. Medication adherence was ≥80% while using the DMO. The most common adverse event was a self-limited rash at the wearable sensor site (12%, 10/82). Conclusions: For patients failing hypertension and diabetes oral therapy, this DMO, which provides dose-by-dose feedback on medication ingestion adherence, can help lower BP, HbA1c, and LDL-C, and promote patient engagement and provider decision making. Trial Registration: Clinicaltrials.gov NCT02827630; https://clinicaltrials.gov/show/NCT02827630 (Archived by WebCite at http://www.webcitation.org/6rL8dW2VF) %M 28698169 %R 10.2196/jmir.7833 %U http://www.jmir.org/2017/7/e246/ %U https://doi.org/10.2196/jmir.7833 %U http://www.ncbi.nlm.nih.gov/pubmed/28698169 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 5 %N 6 %P e76 %T Direct Adherence Measurement Using an Ingestible Sensor Compared With Self-Reporting in High-Risk Cardiovascular Disease Patients Who Knew They Were Being Measured: A Prospective Intervention %A Thompson,David %A Mackay,Teresa %A Matthews,Maria %A Edwards,Judith %A Peters,Nicholas S %A Connolly,Susan B %+ National Heart and Lung Institute, Imperial College London, 4th Floor Imperial Centre for Translational and Experimental Medicine, Du Cane Road, London, W12 0NN, United Kingdom, 44 2075941880, n.peters@imperial.ac.uk %K cardiac prevention and rehabilitation %K adherence %K mHealth %K remote monitoring %K cardiovascular diseases %K primary prevention %K medication adherence %K telemedicine %D 2017 %7 12.06.2017 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Use of appropriate cardioprotective medication is a cornerstone of cardiovascular disease prevention, but less-than-optimal patient adherence is common. Thus, strategies for improving adherence are recommended to adopt a multifaceted approach. Objective: The objective of our study was to test a system comprising a biodegradable, ingestible sensor for direct measurement of medication ingestion in a group of patients at elevated cardiovascular risk attending a cardiac prevention and rehabilitation program. Methods: In this prospective intervention trial in a single group of 21 patients running from April 2014 to June 2015, we measured adherence by self-report and adherence determined objectively by the system. The sensor emits a signal when it encounters the acidic environment of the stomach, detectable by an externally worn patch and linked software app. Longitudinal adherence data in the form of daily progress charts for sensed dosing events as compared with scheduled dosing are visible to patients on their tablet computer’s medication dosing app, thus providing patients with continuous medication adherence feedback. We sought feedback on patient acceptability by questionnaire assessment. Participants used the system for the 12-week period of their cardiac prevention and rehabilitation program. Results: Only 1 patient at initial assessment and 1 patient at end-of-program assessment reported often missing medication. The remaining patients reported never missing medication or had missing data. Only 12 (57%) of patients overall achieved system-determined adherence of 80% or more, and 3 patients had scores below 40%. Participants reported high levels of acceptability. Conclusions: This integrated system was well tolerated in a group of 21 patients over an appreciable time frame. Its ability to measure adherence reveals the sizeable disconnect between patient self-reported adherence and actual medication taking and has promising potential for clinical use as a tool to encourage better medication-taking behavior due to its ability to provide continuous patient-level feedback. %M 28606895 %R 10.2196/mhealth.6998 %U http://mhealth.jmir.org/2017/6/e76/ %U https://doi.org/10.2196/mhealth.6998 %U http://www.ncbi.nlm.nih.gov/pubmed/28606895 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 5 %N 5 %P e66 %T Text Messaging and Mobile Phone Apps as Interventions to Improve Adherence in Adolescents With Chronic Health Conditions: A Systematic Review %A Badawy,Sherif M %A Barrera,Leonardo %A Sinno,Mohamad G %A Kaviany,Saara %A O’Dwyer,Linda C %A Kuhns,Lisa M %+ Ann & Robert H. Lurie Children's Hospital of Chicago, Department of Pediatrics, Division of Hematology, Oncology and Stem Cell Transplant, Northwestern University Feinberg School of Medicine, 225 E Chicago Ave, Box 30, Chicago, IL, 60611, United States, 1 3122274836, sbadawy@luriechildrens.org %K adolescents %K medication adherence %K chronic health conditions %K chronic medical conditions %K text messaging %K mobile phone apps %K smartphone apps %K smartphone applications %D 2017 %7 15.05.2017 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: The number of adolescents with chronic health conditions (CHCs) continues to increase. Medication nonadherence is a global challenge among adolescents across chronic conditions and is associated with poor health outcomes. While there has been growing interest in the use of mHealth technology to improve medication adherence among adolescents with CHCs, particularly text messaging and mobile phone apps, there has been no prior systematic review of their efficacy. Objective: The purpose of this review was to systematically evaluate the most recent evidence for the efficacy of text messaging and mobile phone apps as interventions to promote medication adherence among adolescents with CHCs. Methods: PubMed, Embase, CENTRAL, PsycINFO, Web of Science, Google Scholar, and additional databases were searched from 1995 until November 2015. An additional hand search of related themes in the Journal of Medical Internet Research was also conducted. The Preferred Reporting Results of Systematic Reviews and Meta-Analyses guidelines were followed. Two reviewers independently screened titles/abstracts, assessed full-text articles, extracted data from included articles, and assessed their quality using Grades of Recommendation, Assessment, Development, and Evaluation criteria. Included studies were described in original research articles that targeted adherence in adolescents with CHCs (12-24 years-old). Results: Of the 1423 records examined, 15 met predefined criteria: text messaging (n=12) and mobile phone apps (n=3). Most studies were performed in the United States (11/15, 73%), were randomized-controlled trials (8/15, 53%), had a sample size <50 (11/15, 73%), and included adherence self-report and/or biomarkers (9/15, 60%). Only four studies were designed based on a theoretical framework. Approaches for text messaging and mobile phone app interventions varied across studies. Seven articles (7/15, 47%) reported significant improvement in adherence with moderate to large standardized mean differences. Most of the included studies were of low or moderate quality. Studies varied in sample size, methods of adherence assessment, and definition of adherence, which prohibited performing a meta-analysis. Conclusions: The use of text messaging and mobile phone app interventions to improve medication adherence among adolescents with CHCs has shown promising feasibility and acceptability, and there is modest evidence to support the efficacy of these interventions. Further evaluation of short- and long-term efficacy and cost-effectiveness of these interventions is warranted given the early and evolving state of the science. %M 28506955 %R 10.2196/mhealth.7798 %U http://mhealth.jmir.org/2017/5/e66/ %U https://doi.org/10.2196/mhealth.7798 %U http://www.ncbi.nlm.nih.gov/pubmed/28506955 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 6 %N 5 %P e87 %T EpxMedTracking: Feasibility Evaluation of an SMS-Based Medication Adherence Tracking System in Community Practice %A Tricarico,Christopher %A Peters,Robert %A Som,Avik %A Javaherian,Kavon %A Ross,Will %+ Washington University in St. Louis School of Medicine, Washington University School of Medicine, Campus Box 8023, St. Louis, MO,, United States, 1 314 362 6854, rossw@wustl.edu %K medication adherence %K eHealth %K text messaging %D 2017 %7 15.05.2017 %9 Original Paper %J JMIR Res Protoc %G English %X Background: Medication adherence remains a difficult problem to both assess and improve in patients. It is a multifactorial problem that goes beyond the commonly cited reason of forgetfulness. To date, eHealth (also known as mHealth and telehealth) interventions to improve medication adherence have largely been successful in improving adherence. However, interventions to date have used time- and cost-intensive strategies or focused solely on medication reminding, leaving much room for improvement in using a modality as flexible as eHealth. Objective: Our objective was to develop and implement a fully automated short message service (SMS)-based medication adherence system, EpxMedTracking, that reminds patients to take their medications, explores reasons for missed doses, and alerts providers to help address problems of medication adherence in real time. Methods: EpxMedTracking is a fully automated bidirectional SMS-based messaging system with provider involvement that was developed and implemented through Epharmix, Inc. Researchers analyzed 11 weeks of de-identified data from patients cared for by multiple provider groups in routine community practice for feasibility and functionality. Patients included were those in the care of a provider purchasing the EpxMedTracking tool from Epharmix and were enrolled from a clinic by their providers. The primary outcomes assessed were the rate of engagement with the system, reasons for missing doses, and self-reported medication adherence. Results: Of the 25 patients studied over the 11 weeks, 3 never responded and subsequently opted out or were deleted by their provider. No other patients opted out or were deleted during the study period. Across the 11 weeks of the study period, the overall weekly engagement rate was 85.9%. There were 109 total reported missed doses including “I forgot” at 33 events (30.3%), “I felt better” at 29 events (26.6%), “out of meds” at 20 events (18.4%), “I felt sick” at 19 events (17.4%), and “other” at 3 events (2.8%). We also noted an increase in self-reported medication adherence in patients using the EpxMedTracking system. Conclusions: EpxMedTracking is an effective tool for tracking self-reported medication adherence over time. It uniquely identifies actionable reasons for missing doses for subsequent provider intervention in real time based on patient feedback. Patients enrolled on EpxMedTracking also self-report higher rates of medication adherence over time while on the system. %M 28506954 %R 10.2196/resprot.7223 %U http://www.researchprotocols.org/2017/5/e87/ %U https://doi.org/10.2196/resprot.7223 %U http://www.ncbi.nlm.nih.gov/pubmed/28506954 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 6 %N 4 %P e62 %T Mobile Application to Promote Adherence to Oral Chemotherapy and Symptom Management: A Protocol for Design and Development %A Fishbein,Joel Nathan %A Nisotel,Lauren Ellen %A MacDonald,James John %A Amoyal Pensak,Nicole %A Jacobs,Jamie Michele %A Flanagan,Clare %A Jethwani,Kamal %A Greer,Joseph Andrew %+ Center for Psychiatric Oncology and Behavioral Sciences, Massachusetts General Hospital and Harvard Medical School, 55 Fruit St, Boston, MA,, United States, 1 617 643 2143, jgreer2@mgh.harvard.edu %K telemedicine %K neoplasms %K mobile apps %K medication adherence %K self-administration %K antineoplastic agents %K ambulatory monitoring %K mHealth %K software design %D 2017 %7 20.04.2017 %9 Protocol %J JMIR Res Protoc %G English %X Background: Oral chemotherapy is increasingly used in place of traditional intravenous chemotherapy to treat patients with cancer. While oral chemotherapy includes benefits such as ease of administration, convenience, and minimization of invasive infusions, patients receive less oversight, support, and symptom monitoring from clinicians. Additionally, adherence is a well-documented challenge for patients with cancer prescribed oral chemotherapy regimens. With the ever-growing presence of smartphones and potential for efficacious behavioral intervention technology, we created a mobile health intervention for medication and symptom management. Objective: The objective of this study was to develop and evaluate the usability and acceptability of a smartphone app to support adherence to oral chemotherapy and symptom management in patients with cancer. Methods: We used a 5-step development model to create a comprehensive mobile app with theoretically informed content. The research and technical development team worked together to develop and iteratively test the app. In addition to the research team, key stakeholders including patients and family members, oncology clinicians, health care representatives, and practice administrators contributed to the content refinement of the intervention. Patient and family members also participated in alpha and beta testing of the final prototype to assess usability and acceptability before we began the randomized controlled trial. Results: We incorporated app components based on the stakeholder feedback we received in focus groups and alpha and beta testing. App components included medication reminders, self-reporting of medication adherence and symptoms, an education library including nutritional information, Fitbit integration, social networking resources, and individually tailored symptom management feedback. We are conducting a randomized controlled trial to determine the effectiveness of the app in improving adherence to oral chemotherapy, quality of life, and burden of symptoms and side effects. At every stage in this trial, we are engaging stakeholders to solicit feedback on our progress and next steps. Conclusions: To our knowledge, we are the first to describe the development of an app designed for people taking oral chemotherapy. The app addresses many concerns with oral chemotherapy, such as medication adherence and symptom management. Soliciting feedback from stakeholders with broad perspectives and expertise ensured that the app was acceptable and potentially beneficial for patients, caregivers, and clinicians. In our development process, we instantiated 7 of the 8 best practices proposed in a recent review of mobile health app development. Our process demonstrated the importance of effective communication between research groups and technical teams, as well as meticulous planning of technical specifications before development begins. Future efforts should consider incorporating other proven strategies in software, such as gamification, to bolster the impact of mobile health apps. Forthcoming results from our randomized controlled trial will provide key data on the effectiveness of this app in improving medication adherence and symptom management. Trial Registration: ClinicalTrials.gov NCT02157519; https://clinicaltrials.gov/ct2/show/NCT02157519 (Archived by WebCite at http://www.webcitation.org/6prj3xfKA) %M 28428158 %R 10.2196/resprot.6198 %U http://www.researchprotocols.org/2017/4/e62/ %U https://doi.org/10.2196/resprot.6198 %U http://www.ncbi.nlm.nih.gov/pubmed/28428158 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 5 %N 4 %P e45 %T Assessing the Medication Adherence App Marketplace From the Health Professional and Consumer Vantage Points %A Dayer,Lindsey E %A Shilling,Rebecca %A Van Valkenburg,Madalyn %A Martin,Bradley C %A Gubbins,Paul O %A Hadden,Kristie %A Heldenbrand,Seth %+ Department of Pharmacy Practice, University of Arkansas for Medical Sciences College of Pharmacy, 4301 W Markham, Little Rock, AR, 72205, United States, 1 501 526 4211, ledayer@uams.edu %K smartphone %K apps %K adherence %K medication %K health literacy %D 2017 %7 19.04.2017 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Nonadherence produces considerable health consequences and economic burden to patients and payers. One approach to improve medication nonadherence that has gained interest in recent years is the use of smartphone adherence apps. The development of smartphone adherence apps has increased rapidly since 2012; however, literature evaluating the clinical app and effectiveness of smartphone adherence apps to improve medication adherence is generally lacking. Objective: The aims of this study were to (1) provide an updated evaluation and comparison of medication adherence apps in the marketplace by assessing the features, functionality, and health literacy (HL) of the highest-ranking adherence apps and (2) indirectly measure the validity of our rating methodology by determining the relationship between our app evaluations and Web-based consumer ratings. Methods: Two independent reviewers assessed the features and functionality using a 4-domain rating tool of all adherence apps identified based on developer claims. The same reviewers downloaded and tested the 100 highest-ranking apps including an additional domain for assessment of HL. Pearson product correlations were estimated between the consumer ratings and our domain and total scores. Results: A total of 824 adherence apps were identified; of these, 645 unique apps were evaluated after applying exclusion criteria. The median initial score based on descriptions was 14 (max of 68; range 0-60). As a result, 100 of the highest-scoring unique apps underwent user testing. The median overall user-tested score was 31.5 (max of 73; range 0-60). The majority of the user tested the adherence apps that underwent user testing reported a consumer rating score in their respective online marketplace. The mean consumer rating was 3.93 (SD 0.84). The total user-tested score was positively correlated with consumer ratings (r=.1969, P=.04). Conclusions: More adherence apps are available in the Web-based marketplace, and the quality of these apps varies considerably. Consumer ratings are positively but weakly correlated with user-testing scores suggesting that our rating tool has some validity but that consumers and clinicians may assess adherence app quality differently. %M 28428169 %R 10.2196/mhealth.6582 %U http://mhealth.jmir.org/2017/4/e45/ %U https://doi.org/10.2196/mhealth.6582 %U http://www.ncbi.nlm.nih.gov/pubmed/28428169 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 5 %N 4 %P e50 %T Texting and Mobile Phone App Interventions for Improving Adherence to Preventive Behavior in Adolescents: A Systematic Review %A Badawy,Sherif M %A Kuhns,Lisa M %+ Ann & Robert H. Lurie Children's Hospital of Chicago, Department of Pediatrics, Division of Hematology, Oncology, and Stem Cell Transplant, Northwestern University Feinberg School of Medicine, 225 E, Chicago Ave, Box #30, Chicago, IL, 60611, United States, 1 312 227 4836, sbadawy@luriechildrens.org %K adolescent %K text messaging %K smartphone %K mobile phone %K mobile applications %K medication adherence %K behavior %K prevention %D 2017 %7 19.04.2017 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Many preventable behaviors contribute to adolescent mortality and morbidity. Non-adherence to preventive measures represents a challenge and has been associated with worse health outcomes in this population. The widespread use of electronic communication technologies by adolescents, particularly the use of text messaging (short message service, SMS) and mobile phones, presents new opportunities to intervene on risk and preventive risk behavior, but little is known about their efficacy. Objective: This study aimed to systematically evaluate evidence for the efficacy of text messaging and mobile phone app interventions to improve adherence to preventive behavior among adolescents and describe intervention approaches to inform intervention development. Methods: This review covers literature published between 1995 and 2015. Searches included PubMed, Embase, CENTRAL, PsycINFO, CINAHL, INSPEC, Web of Science, Google Scholar, and additional databases. The search strategy sought articles on text messaging and mobile phone apps combined with adherence or compliance, and adolescents and youth. An additional hand search of related themes in the Journal of Medical Internet Research was also conducted. Two reviewers independently screened titles and abstracts, assessed full-text articles, and extracted data from articles that met inclusion criteria. Included studies reflect original research—experimental or preexperimental designs with text messaging or mobile phone app interventions—targeting adherence to preventive behavior among adolescents (12-24 years old). The preferred reporting items of systematic reviews and meta-analyses (PRISMA) guidelines were followed for reporting results, and findings were critically appraised against the Oxford Centre for Evidence-based Medicine criteria. Results: Of 1454 records, 19 met inclusion criteria, including text messaging (n=15) and mobile phone apps (n=4). Studies targeted clinic attendance, contraceptive use, oral health, physical activity and weight management, sun protection, human papillomavirus (HPV) vaccination, smoking cessation, and sexual health. Most studies were performed in the United States (47%, 9/19), included younger adolescents (63%, 12/19), and had sample size <100 (63%, 12/19). Although most studies were randomized controlled trials (RCTs; 58%, 11/19), only 5 followed an intent-to-treat analysis. Only 6 of 19 studies (32%) incorporated a theoretical framework in their design. Most studies reported good feasibility with high acceptability and satisfaction. About half of the included studies (42%, 8/19) demonstrated significant improvement in preventive behavior with moderate standardized mean differences. As early efforts in this field to establish feasibility and initial efficacy, most studies were low to moderate in quality. Studies varied in sample size and methods of preventive behavior adherence or outcome assessment, which prohibited performing a meta-analysis. Conclusions: Despite the promising feasibility and acceptability of text messaging and mobile phone apps in improving preventive behavior among adolescents, overall findings were modest in terms of efficacy. Further research evaluating the efficacy, effectiveness, and cost-effectiveness of these intervention approaches in promoting preventive behavior among adolescents is needed. %M 28428157 %R 10.2196/mhealth.6837 %U http://mhealth.jmir.org/2017/4/e50/ %U https://doi.org/10.2196/mhealth.6837 %U http://www.ncbi.nlm.nih.gov/pubmed/28428157 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 19 %N 4 %P e113 %T Young People’s Preferences for an Asthma Self-Management App Highlight Psychological Needs: A Participatory Study %A Peters,Dorian %A Davis,Sharon %A Calvo,Rafael Alejandro %A Sawyer,Susan M %A Smith,Lorraine %A Foster,Juliet M %+ School of Electrical and Information Engineering, Faculty of Engineering, University of Sydney, Bldg J03, Electrical Engineering, Maze Crescent, Sydney, 2006, Australia, 61 0289015604, dorian.peters@sydney.edu.au %K asthma %K mobile applications %K quality of life %K mental health %K adolescents %K chronic disease %K mhealth %K participatory design %D 2017 %7 11.04.2017 %9 Original Paper %J J Med Internet Res %G English %X Background: Although the prevalence of mental illness among young people with asthma is known to be twice the rate of the wider population, none of the asthma apps reported have acknowledged or attempted to include psychological support features. This is perhaps because user involvement in the development of asthma apps has been scarce. User involvement, facilitated by participatory design methods, can begin to address these issues while contributing insights to our understanding of the psychological experience associated with asthma and how technology might improve quality of life. Objective: The goal of this participatory user research study was to explore the experience, needs, and ideas of young people with asthma while allowing them to define requirements for an asthma app that would be engaging and effective at improving their well-being. Methods: Young people aged 15-24 years with doctor-diagnosed asthma were invited to participate in a participatory workshop and to complete a workbook designed to elicit their thoughts and ideas about living with asthma, technology use, and the design of an app. Participants generated a number of artifacts (including collages, concept maps, and paper prototypes) designed to reify their ideas, tacit knowledge, and experience. Results: A total of 20 participants (mean age 17.8 years; 60%, 12/20 female) representing a range from inadequately to well-controlled asthma completed a workbook and 13 of these also took part in a workshop (four workshops were held in total), resulting in 102 participant-generated artifacts. Theoretical thematic analysis resulted in a set of personal needs, feature ideas, and app characteristics considered relevant by young people for an asthma support app. The data revealed that psychological factors such as anxiety, and impediments to autonomy, competence, and relatedness (as consistent with self-determination theory [SDT]), were considered major influences on quality of life by young people with asthma. Furthermore, the incorporation of features pertaining to psychological experience was particularly valued by participants. Conclusions: In addition to practical features for asthma management, an app for young people with asthma should include support for the mental health factors associated with lived experience (ie, anxiety, lack of autonomy, and social disconnectedness). We show how support for these factors can be translated into design features of an app for asthma. In addition to informing the development of asthma-support technologies for young people, these findings could have implications for technologies designed to support people with chronic illness more generally. %M 28400353 %R 10.2196/jmir.6994 %U http://www.jmir.org/2017/4/e113/ %U https://doi.org/10.2196/jmir.6994 %U http://www.ncbi.nlm.nih.gov/pubmed/28400353 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 6 %N 3 %P e48 %T Automated Adherence Reminders for High Risk Children With Asthma: A Research Protocol %A Adams,Sarah A %A Leach,Michelle Chan %A Feudtner,Chris %A Miller,Victoria A %A Kenyon,Chén Collin %+ The Children's Hospital of Philadelphia, PolicyLab and Center for Pediatric Clinical Effectiveness, 15th floor, Rm 1509, 3401 Civic Center Blvd, CHOP North, Philadelphia, PA, 19104, United States, 1 (267) 426 6339, kenyonc@email.chop.edu %K asthma %K pediatrics %K child %K child, preschool %K adolescent %K metered dose inhalers %K medication adherence %K text messaging %K pilot projects %K randomized controlled trial %K clinical protocols %D 2017 %7 27.03.2017 %9 Protocol %J JMIR Res Protoc %G English %X Background: The use of inhaled corticosteroid (ICS) medications has been shown to improve asthma control and reduce asthma-related morbidity and mortality. Two recent randomized trials demonstrated dramatic improvements in ICS adherence by monitoring adherence with electronic sensors and providing automated reminders to participants to take their ICS medications. Given their lower levels of adherence and higher levels of asthma-related emergency department (ED) visits, hospitalizations, and death, urban minority populations could potentially benefit greatly from these types of interventions. Objective: The principal objective of this study will be to evaluate the feasibility, acceptability, and limited efficacy of a text message (short message service, SMS) reminder intervention to enhance ICS adherence in an urban minority population of children with asthma. We will also assess trajectories of ICS adherence in the 2 months following asthma hospitalization. Methods: Participants will include 40 children aged 2-13 years, who are currently admitted to the Children’s Hospital of Philadelphia (CHOP) for asthma, and their parent or legal guardian. Participants will be assigned to intervention and control arms using a 1:1 randomization scheme. The intervention arm will receive daily text message reminders for a 30-day intervention phase following hospitalization. This will be followed by a 30-day follow-up phase, in which all participants may choose whether or not to receive the text messages. Feasibility will be assessed by measuring (1) retention of the participants through the study phases and (2) perceived usefulness, acceptability, and preferences regarding the intervention components. Limited efficacy outcomes will include percent adherence to prescribed ICS regimen measured using Propeller Health sensors and change in parent-reported asthma control. We will perform an exploratory analysis to assess for discrete trajectories of adherence using group-based trajectory modeling (GBTM). Results: Study enrollment began in December 2015 and the intervention and follow-up phases are ongoing. Results of the data analysis are expected to be available by December 2016. Conclusions: This study will add to the literature by providing foundational feasibility data on which elements of a mobile health text-message reminder intervention may need to be modified to suit the needs and constraints of high-risk urban minority populations. Trial Registration: Clinicaltrials.gov NCT02615743; https://www.clinicaltrials.gov/ct2/show/study/NCT02615743 (Archived with WebCite at http://www.webcitation.org/6ji59rAXN) %M 28347975 %R 10.2196/resprot.6674 %U http://www.researchprotocols.org/2017/3/e48/ %U https://doi.org/10.2196/resprot.6674 %U http://www.ncbi.nlm.nih.gov/pubmed/28347975 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 5 %N 3 %P e27 %T Development and Testing of a Mobile Phone App for Self-Monitoring of Calcium Intake in Young Women %A Tay,Ilona %A Garland,Suzanne %A Gorelik,Alexandra %A Wark,John Dennis %+ Royal Melbourne Hospital, Bone and Mineral Medicine, Royal Parade, Parkville, VIC, 3052, Australia, 61 3 83445201, jdwark@unimelb.edu.au %K behavior therapy %K cell phones %K health behavior %K primary prevention %K self care %K telemedicine %D 2017 %7 07.03.2017 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Interventions to prevent osteoporosis by increasing dairy intake or physical activity in young women have been limited to increasing osteoporosis knowledge and awareness. However, findings have shown that this does not always lead to a change in behaviors. Self-monitoring using mobile devices in behavioral interventions has yielded significant and positive outcomes. Yet, to our knowledge, mobile self-monitoring has not been used as an intervention strategy to increase calcium intake, particularly in young women, for better bone health outcomes. Objective: As development and testing of mobile app–based interventions requires a sequence of steps, our study focused on testing the acceptability and usability of Calci-app, a dietary app to self-monitor calcium consumption, before it is used in a behavioral change intervention in young women aged 18-25 years. Methods: Calci-app development followed 4 steps: (1) conceptualization, (2) development and pretesting, (3) pilot testing, and (4) mixed methods evaluation. Results: We present the development process of Calci-app and evaluation of the acceptability and usability of the app in young women. Overall, 78% (31/40) of study participants completed the 5-day food record with high compliance levels (defined as more than 3 days of full or partial completion). There was a significant reduction in the proportion of participants completing all meal entries over the 5 days (P=.01). Participants generally found Calci-app easy and convenient to use, but it was time-consuming and they expressed a lack of motivation to use the app. Conclusions: We present a detailed description of the development process of Calci-app and an evaluation of its usability and acceptability to self-monitor dietary calcium intake. The findings from this preliminary study demonstrated acceptable use of Calci-app to self-monitor calcium consumption. However, for regular and long-term use the self-monitoring function in Calci-app could be expanded to allow participants to view their total daily calcium intake compared with the recommended daily intake. Additionally, to facilitate sustainable lifestyle behavior modifications, a combination of various behavior change techniques should be considered, such as education, goal setting, and advice to participants based on their stage of change. The feedback on barriers and facilitators from testing Calci-app will be used to design a bone health mHealth intervention to modify risky lifestyle behaviors in young women for better bone health outcomes. %M 28270379 %R 10.2196/mhealth.5717 %U http://mhealth.jmir.org/2017/3/e27/ %U https://doi.org/10.2196/mhealth.5717 %U http://www.ncbi.nlm.nih.gov/pubmed/28270379 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 19 %N 2 %P e46 %T Factors Associated With Dropout During Recruitment and Follow-Up Periods of a mHealth-Based Randomized Controlled Trial for Mobile.Net to Encourage Treatment Adherence for People With Serious Mental Health Problems %A Kannisto,Kati Anneli %A Korhonen,Joonas %A Adams,Clive E %A Koivunen,Marita Hannele %A Vahlberg,Tero %A Välimäki,Maritta Anneli %+ Department of Nursing Science, University of Turku, Joukahaisenkatu 3-5, Turku, FI-20014, Finland, 358 505312652, kaankan@utu.fi %K text messaging %K mobile health %K antipsychotics %K mental health %K psychiatric services %K methodological study %D 2017 %7 21.02.2017 %9 Original Paper %J J Med Internet Res %G English %X Background: Clinical trials are the gold standard of evidence-based practice. Still many papers inadequately report methodology in randomized controlled trials (RCTs), particularly for mHealth interventions for people with serious mental health problems. To ensure robust enough evidence, it is important to understand which study phases are the most vulnerable in the field of mental health care. Objective: We mapped the recruitment and the trial follow-up periods of participants to provide a picture of the dropout predictors from a mHealth-based trial. As an example, we used a mHealth-based multicenter RCT, titled “Mobile.Net,” targeted at people with serious mental health problems. Methods: Recruitment and follow-up processes of the Mobile.Net trial were monitored and analyzed. Recruitment outcomes were recorded as screened, eligible, consent not asked, refused, and enrolled. Patient engagement was recorded as follow-up outcomes: (1) attrition during short message service (SMS) text message intervention and (2) attrition during the 12-month follow-up period. Multiple regression analysis was used to identify which demographic factors were related to recruitment and retention. Results: We recruited 1139 patients during a 15-month period. Of 11,530 people screened, 36.31% (n=4186) were eligible. This eligible group tended to be significantly younger (mean 39.2, SD 13.2 years, P<.001) and more often women (2103/4181, 50.30%) than those who were not eligible (age: mean 43.7, SD 14.6 years; women: 3633/6514, 55.78%). At the point when potential participants were asked to give consent, a further 2278 refused. Those who refused were a little older (mean 40.2, SD 13.9 years) than those who agreed to participate (mean 38.3, SD 12.5 years; t1842=3.2, P<.001). We measured the outcomes after 12 months of the SMS text message intervention. Attrition from the SMS text message intervention was 4.8% (27/563). The patient dropout rate after 12 months was 0.36% (4/1123), as discovered from the register data. In all, 3.12% (35/1123) of the participants withdrew from the trial. However, dropout rates from the patient survey (either by paper or telephone interview) were 52.45% (589/1123) and 27.8% (155/558), respectively. Almost all participants (536/563, 95.2%) tolerated the intervention, but those who discontinued were more often women (21/27, 78%; P=.009). Finally, participants’ age (P<.001), gender (P<.001), vocational education (P=.04), and employment status (P<.001) seemed to predict their risk of dropping out from the postal survey. Conclusions: Patient recruitment and engagement in the 12-month follow-up conducted with a postal survey were the most vulnerable phases in the SMS text message-based trial. People with serious mental health problems may need extra support during the recruitment process and in engaging them in SMS text message-based trials to ensure robust enough evidence for mental health care. ClinicalTrial: International Standard Randomized Controlled Trial Number (ISRCTN): 27704027; http://www.isrctn.com/ISRCTN27704027 (Archived by WebCite at http://www.webcitation.org/6oHcU2SFp) %M 28223262 %R 10.2196/jmir.6417 %U http://www.jmir.org/2017/2/e46/ %U https://doi.org/10.2196/jmir.6417 %U http://www.ncbi.nlm.nih.gov/pubmed/28223262 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 5 %N 2 %P e18 %T Use of a Novel Artificial Intelligence Platform on Mobile Devices to Assess Dosing Compliance in a Phase 2 Clinical Trial in Subjects With Schizophrenia %A Bain,Earle E %A Shafner,Laura %A Walling,David P %A Othman,Ahmed A %A Chuang-Stein,Christy %A Hinkle,John %A Hanina,Adam %+ AiCure, LLC, 19 West 24th Street, 11th Fl., New York, NY, 10010, United States, 1 800 570 0448, laura.shafner@aicure.com %K medication adherence %K artificial intelligence %K clinical trials as topic %D 2017 %7 21.02.2017 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Accurately monitoring and collecting drug adherence data can allow for better understanding and interpretation of the outcomes of clinical trials. Most clinical trials use a combination of pill counts and self-reported data to measure drug adherence, despite the drawbacks of relying on these types of indirect measures. It is assumed that doses are taken, but the exact timing of these events is often incomplete and imprecise. Objective: The objective of this pilot study was to evaluate the use of a novel artificial intelligence (AI) platform (AiCure) on mobile devices for measuring medication adherence, compared with modified directly observed therapy (mDOT) in a substudy of a Phase 2 trial of the α7 nicotinic receptor agonist (ABT-126) in subjects with schizophrenia. Methods: AI platform generated adherence measures were compared with adherence inferred from drug concentration measurements. Results: The mean cumulative pharmacokinetic adherence over 24 weeks was 89.7% (standard deviation [SD] 24.92) for subjects receiving ABT-126 who were monitored using the AI platform, compared with 71.9% (SD 39.81) for subjects receiving ABT-126 who were monitored by mDOT. The difference was 17.9% (95% CI -2 to 37.7; P=.08). Conclusions: Using drug levels, this substudy demonstrates the potential of AI platforms to increase adherence, rapidly detect nonadherence, and predict future nonadherence. Subjects monitored using the AI platform demonstrated a percentage change in adherence of 25% over the mDOT group. Subjects were able to use the technology successfully for up to 6 months in an ambulatory setting with early termination rates that are comparable to subjects outside of the substudy. Trial Registration: ClinicalTrials.gov NCT01655680 https://clinicaltrials.gov/ct2/show/NCT01655680?term=NCT01655680 %M 28223265 %R 10.2196/mhealth.7030 %U http://mhealth.jmir.org/2017/2/e18/ %U https://doi.org/10.2196/mhealth.7030 %U http://www.ncbi.nlm.nih.gov/pubmed/28223265 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 4 %N 4 %P e136 %T Patient-Facing Mobile Apps to Treat High-Need, High-Cost Populations: A Scoping Review %A Singh,Karandeep %A Drouin,Kaitlin %A Newmark,Lisa P %A Filkins,Malina %A Silvers,Elizabeth %A Bain,Paul A %A Zulman,Donna M %A Lee,Jae-Ho %A Rozenblum,Ronen %A Pabo,Erika %A Landman,Adam %A Klinger,Elissa V %A Bates,David W %+ Departments of Learning Health Sciences and Internal Medicine, University of Michigan Medical School, 1161H NIB, 300 N Ingalls St, Ann Arbor, MI, 48109-5403, United States, 1 734 936 1649, kdpsingh@umich.edu %K review %K mobile apps %K mHealth %K chronic disease %K self-management %D 2016 %7 19.12.2016 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Self-management is essential to caring for high-need, high-cost (HNHC) populations. Advances in mobile phone technology coupled with increased availability and adoption of health-focused mobile apps have made self-management more achievable, but the extent and quality of the literature supporting their use is not well defined. Objective: The purpose of this review was to assess the breadth, quality, bias, and types of outcomes measured in the literature supporting the use of apps targeting HNHC populations. Methods: Data sources included articles in PubMed and MEDLINE (National Center for Biotechnology Information), EMBASE (Elsevier), the Cochrane Central Register of Controlled Trials (EBSCO), Web of Science (Thomson Reuters), and the NTIS (National Technical Information Service) Bibliographic Database (EBSCO) published since 2008. We selected studies involving use of patient-facing iOS or Android mobile health apps. Extraction was performed by 1 reviewer; 40 randomly selected articles were evaluated by 2 reviewers to assess agreement. Results: Our final analysis included 175 studies. The populations most commonly targeted by apps included patients with obesity, physical handicaps, diabetes, older age, and dementia. Only 30.3% (53/175) of the apps studied in the reviewed literature were identifiable and available to the public through app stores. Many of the studies were cross-sectional analyses (42.9%, 75/175), small (median number of participants=31, interquartile range 11.0-207.2, maximum 11,690), or performed by an app’s developers (61.1%, 107/175). Of the 175 studies, only 36 (20.6%, 36/175) studies evaluated a clinical outcome. Conclusions: Most apps described in the literature could not be located on the iOS or Android app stores, and existing research does not robustly evaluate the potential of mobile apps. Whereas apps may be useful in patients with chronic conditions, data do not support this yet. Although we had 2-3 reviewers to screen and assess abstract eligibility, only 1 reviewer abstracted the data. This is one limitation of our study. With respect to the 40 articles (22.9%, 40/175) that were assigned to 2 reviewers (of which 3 articles were excluded), inter-rater agreement was significant on the majority of items (17 of 30) but fair-to-moderate on others. %M 27993761 %R 10.2196/mhealth.6445 %U http://mhealth.jmir.org/2016/4/e136/ %U https://doi.org/10.2196/mhealth.6445 %U http://www.ncbi.nlm.nih.gov/pubmed/27993761 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 4 %N 4 %P e132 %T Mobile Phone Apps to Improve Medication Adherence: A Systematic Stepwise Process to Identify High-Quality Apps %A Santo,Karla %A Richtering,Sarah S %A Chalmers,John %A Thiagalingam,Aravinda %A Chow,Clara K %A Redfern,Julie %+ The George Institute for Global Health, University of Sydney, Level 10, King George V Building, 83-117 Missenden Rd, Camperdown, NSW, Sydney, 2050, Australia, 61 280524620, ksanto@georgeinstitute.org.au %K medication adherence %K medication compliance %K mobile phone %K smartphone %K mobile apps %K mobile applications %D 2016 %7 02.12.2016 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: There are a growing number of mobile phone apps available to support people in taking their medications and to improve medication adherence. However, little is known about how these apps differ in terms of features, quality, and effectiveness. Objective: We aimed to systematically review the medication reminder apps available in the Australian iTunes store and Google Play to assess their features and their quality in order to identify high-quality apps. Methods: This review was conducted in a similar manner to a systematic review by using a stepwise approach that included (1) a search strategy; (2) eligibility assessment; (3) app selection process through an initial screening of all retrieved apps and full app review of the included apps; (4) data extraction using a predefined set of features considered important or desirable in medication reminder apps; (5) analysis by classifying the apps as basic and advanced medication reminder apps and scoring and ranking them; and (6) a quality assessment by using the Mobile App Rating Scale (MARS), a reliable tool to assess mobile health apps. Results: We identified 272 medication reminder apps, of which 152 were found only in Google Play, 87 only in iTunes, and 33 in both app stores. Apps found in Google Play had more customer reviews, higher star ratings, and lower cost compared with apps in iTunes. Only 109 apps were available for free and 124 were recently updated in 2015 or 2016. Overall, the median number of features per app was 3.0 (interquartile range 4.0) and only 18 apps had ≥9 of the 17 desirable features. The most common features were flexible scheduling that was present in 56.3% (153/272) of the included apps, medication tracking history in 54.8% (149/272), snooze option in 34.9% (95/272), and visual aids in 32.4% (88/272). We classified 54.8% (149/272) of the included apps as advanced medication reminder apps and 45.2% (123/272) as basic medication reminder apps. The advanced apps had a higher number of features per app compared with the basic apps. Using the MARS instrument, we were able to identify high-quality apps that were rated as being very interesting and entertaining, highly interactive and customizable, intuitive, and easy to use and to navigate as well as having a high level of visual appeal and good-quality information. Conclusions: Many medication reminder apps are available in the app stores; however, the majority of them did not have many of the desirable features and were, therefore, considered low quality. Through a systematic stepwise process, we were able to identify high-quality apps to be tested in a future study that will provide evidence on the use of medication reminder apps to improve medication adherence. %M 27913373 %R 10.2196/mhealth.6742 %U http://mhealth.jmir.org/2016/4/e132/ %U https://doi.org/10.2196/mhealth.6742 %U http://www.ncbi.nlm.nih.gov/pubmed/27913373 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 18 %N 11 %P e292 %T Self-Monitoring Utilization Patterns Among Individuals in an Incentivized Program for Healthy Behaviors %A Kim,Ju Young %A Wineinger,Nathan E %A Taitel,Michael %A Radin,Jennifer M %A Akinbosoye,Osayi %A Jiang,Jenny %A Nikzad,Nima %A Orr,Gregory %A Topol,Eric %A Steinhubl,Steve %+ Department of Digital Health, Scripps Translational Science Institute, 3344 North Torrey Pines Court, Suite 300, La Jolla, CA, 92037, United States, 1 858 554 5757, steinhub@scripps.edu %K health behavior %K mobile health %K mobile apps %K reward %K self blood pressure monitoring %K blood glucose self-monitoring %D 2016 %7 17.11.2016 %9 Original Paper %J J Med Internet Res %G English %X Background: The advent of digital technology has enabled individuals to track meaningful biometric data about themselves. This novel capability has spurred nontraditional health care organizations to develop systems that aid users in managing their health. One of the most prolific systems is Walgreens Balance Rewards for healthy choices (BRhc) program, an incentivized, Web-based self-monitoring program. Objective: This study was performed to evaluate health data self-tracking characteristics of individuals enrolled in the Walgreens’ BRhc program, including the impact of manual versus automatic data entries through a supported device or apps. Methods: We obtained activity tracking data from a total of 455,341 BRhc users during 2014. Upon identifying users with sufficient follow-up data, we explored temporal trends in user participation. Results: Thirty-four percent of users quit participating after a single entry of an activity. Among users who tracked at least two activities on different dates, the median length of participating was 8 weeks, with an average of 5.8 activities entered per week. Furthermore, users who participated for at least twenty weeks (28.3% of users; 33,078/116,621) consistently entered 8 to 9 activities per week. The majority of users (77%; 243,774/315,744) recorded activities through manual data entry alone. However, individuals who entered activities automatically through supported devices or apps participated roughly four times longer than their manual activity-entering counterparts (average 20 and 5 weeks, respectively; P<.001). Conclusions: This study provides insights into the utilization patterns of individuals participating in an incentivized, Web-based self-monitoring program. Our results suggest automated health tracking could significantly improve long-term health engagement. %M 27856407 %R 10.2196/jmir.6371 %U http://www.jmir.org/2016/11/e292/ %U https://doi.org/10.2196/jmir.6371 %U http://www.ncbi.nlm.nih.gov/pubmed/27856407 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 4 %N 4 %P e116 %T Engaging Gatekeeper-Stakeholders in Development of a Mobile Health Intervention to Improve Medication Adherence Among African American and Pacific Islander Elderly Patients With Hypertension %A Yazdanshenas,Hamed %A Bazargan,Mohsen %A Jones,Loretta %A Vawer,May %A Seto,Todd B %A Farooq,Summer %A Taira,Deborah A %+ College of Medicine, Departments of Family Medicine and Orthopedic Surgery, Charles R Drew University of Medicine and Science/University of California, Los Angeles (UCLA), 1748 East, LSRN Bldg, # N150, 118th St, Los Angeles, CA, 90059, United States, 1 3233573452, Yazdanshenas@ucla.edu %K health %K technology %K elderly %K minority %K hypertension %K mHealth %D 2016 %7 26.10.2016 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Approximately 70 million people in the United States have hypertension. Although antihypertensive therapy can reduce the morbidity and mortality associated with hypertension, often patients do not take their medication as prescribed. Objective: The goal of this study was to better understand issues affecting the acceptability and usability of mobile health technology (mHealth) to improve medication adherence for elderly African American and Native Hawaiian and Pacific Islander patients with hypertension. Methods: In-depth interviews were conducted with 20 gatekeeper-stakeholders using targeted open-ended questions. Interviews were deidentified, transcribed, organized, and coded manually by two independent coders. Analysis of patient interviews used largely a deductive approach because the targeted open-ended interview questions were designed to explore issues specific to the design and acceptability of a mHealth intervention for seniors. Results: A number of similar themes regarding elements of a successful intervention emerged from our two groups of African American and Native Hawaiian and Pacific Islander gatekeeper-stakeholders. First was the need to teach participants both about the importance of adherence to antihypertensive medications. Second, was the use of mobile phones for messaging and patients need to be able to access ongoing technical support. Third, messaging needs to be short and simple, but personalized, and to come from someone the participant trusts and with whom they have a connection. There were some differences between groups. For instance, there was a strong sentiment among the African American group that the church be involved and that the intervention begin with group workshops, whereas the Native Hawaiian and Pacific Islander group seemed to believe that the teaching could occur on a one-to-one basis with the health care provider. Conclusions: Information from our gatekeeper-stakeholder (key informant) interviews suggests that the design of a mHealth intervention to improve adherence to antihypertensives among the elderly could be very similar for African Americans and Native Hawaiian and Pacific Islanders. The main difference might be in the way in which the program is initiated (possibly through church-based workshops for African Americans and by individual providers for Native Hawaiian and Pacific Islanders). Another difference might be who sends the messages with African Americans wanting someone outside the health care system, but Native Hawaiian and Pacific Islanders preferring a provider. %M 27784651 %R 10.2196/mhealth.5905 %U http://mhealth.jmir.org/2016/4/e116/ %U https://doi.org/10.2196/mhealth.5905 %U http://www.ncbi.nlm.nih.gov/pubmed/27784651 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 4 %N 4 %P e121 %T Economic Evaluation of Text-Messaging and Smartphone-Based Interventions to Improve Medication Adherence in Adolescents with Chronic Health Conditions: A Systematic Review %A Badawy,Sherif M %A Kuhns,Lisa M %+ Ann and Robert H Lurie Children's Hospital of Chicago, Department of Pediatrics, Division of Hematology, Oncology, and Stem Cell Transplant, Northwestern University Feinberg School of Medicine, 225 E Chicago Ave, Box 30, Chicago, IL,, United States, 1 312 227 4836, sbadawy@luriechildrens.org %K adolescent %K text messaging %K smartphone %K medication adherence %K chronic disease %K cost-benefit analysis %D 2016 %7 25.10.2016 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: The rate of chronic health conditions (CHCs) in children and adolescents has doubled in the past 20 years, with increased health care costs. Technology-based interventions have demonstrated efficacy to improving medication adherence. However, data to support the cost effectiveness of these interventions are lacking. Objective: The objective of this study is to conduct an economic evaluation of text-messaging and smartphone-based interventions that focus on improving medication adherence in adolescents with CHCs. Methods: Searches included PubMed MEDLINE, Embase, Cochrane Central Register of Controlled Trials, Cumulative Index to Nursing and Allied Health Literature, PsycINFO, Web of Science, and Inspec. Eligibility criteria included age (12-24 years old), original articles, outcomes for medication adherence, and economic outcomes. Results: Our search identified 1118 unique articles that were independently screened. A total of 156 articles met inclusion criteria and were then examined independently with full-text review. A total of 15 articles met most criteria but lacked economic outcomes such as cost effectiveness or cost-utility data. No articles met all predefined criteria to be included for final review. Only 4 articles (text messaging [n=3], electronic directly observed therapy [n=1]) described interventions with possible future cost-saving but no formal economic evaluation. Conclusions: The evidence to support the cost effectiveness of text-messaging and smartphone-based interventions in improving medication adherence in adolescents with CHCs is insufficient. This lack of research highlights the need for comprehensive economic evaluation of such interventions to better understand their role in cost-savings while improving medication adherence and health outcomes. Economic evaluation of technology-based interventions can contribute to more evidence-based assessment of the scalability, sustainability, and benefits of broader investment of such technology tools in adolescents with CHCs. %M 27780795 %R 10.2196/mhealth.6425 %U http://mhealth.jmir.org/2016/4/e121/ %U https://doi.org/10.2196/mhealth.6425 %U http://www.ncbi.nlm.nih.gov/pubmed/27780795 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 4 %N 3 %P e111 %T Mobile Sensing and Support for People With Depression: A Pilot Trial in the Wild %A Wahle,Fabian %A Kowatsch,Tobias %A Fleisch,Elgar %A Rufer,Michael %A Weidt,Steffi %+ University of St Gallen, Institute of Technology Management, Dufourstrasse 40a, Büro 1-236, St Gallen, 9000, Switzerland, 41 712247244, tobias.kowatsch@unisg.ch %K depression %K mHealth %K  activities of daily living %K classification %K context awareness %K cognitive behavioral therapy %D 2016 %7 21.09.2016 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Depression is a burdensome, recurring mental health disorder with high prevalence. Even in developed countries, patients have to wait for several months to receive treatment. In many parts of the world there is only one mental health professional for over 200 people. Smartphones are ubiquitous and have a large complement of sensors that can potentially be useful in monitoring behavioral patterns that might be indicative of depressive symptoms and providing context-sensitive intervention support. Objective: The objective of this study is 2-fold, first to explore the detection of daily-life behavior based on sensor information to identify subjects with a clinically meaningful depression level, second to explore the potential of context sensitive intervention delivery to provide in-situ support for people with depressive symptoms. Methods: A total of 126 adults (age 20-57) were recruited to use the smartphone app Mobile Sensing and Support (MOSS), collecting context-sensitive sensor information and providing just-in-time interventions derived from cognitive behavior therapy. Real-time learning-systems were deployed to adapt to each subject’s preferences to optimize recommendations with respect to time, location, and personal preference. Biweekly, participants were asked to complete a self-reported depression survey (PHQ-9) to track symptom progression. Wilcoxon tests were conducted to compare scores before and after intervention. Correlation analysis was used to test the relationship between adherence and change in PHQ-9. One hundred twenty features were constructed based on smartphone usage and sensors including accelerometer, Wifi, and global positioning systems (GPS). Machine-learning models used these features to infer behavior and context for PHQ-9 level prediction and tailored intervention delivery. Results: A total of 36 subjects used MOSS for ≥2 weeks. For subjects with clinical depression (PHQ-9≥11) at baseline and adherence ≥8 weeks (n=12), a significant drop in PHQ-9 was observed (P=.01). This group showed a negative trend between adherence and change in PHQ-9 scores (rho=−.498, P=.099). Binary classification performance for biweekly PHQ-9 samples (n=143), with a cutoff of PHQ-9≥11, based on Random Forest and Support Vector Machine leave-one-out cross validation resulted in 60.1% and 59.1% accuracy, respectively. Conclusions: Proxies for social and physical behavior derived from smartphone sensor data was successfully deployed to deliver context-sensitive and personalized interventions to people with depressive symptoms. Subjects who used the app for an extended period of time showed significant reduction in self-reported symptom severity. Nonlinear classification models trained on features extracted from smartphone sensor data including Wifi, accelerometer, GPS, and phone use, demonstrated a proof of concept for the detection of depression superior to random classification. While findings of effectiveness must be reproduced in a RCT to proof causation, they pave the way for a new generation of digital health interventions leveraging smartphone sensors to provide context sensitive information for in-situ support and unobtrusive monitoring of critical mental health states. %M 27655245 %R 10.2196/mhealth.5960 %U http://mhealth.jmir.org/2016/3/e111/ %U https://doi.org/10.2196/mhealth.5960 %U http://www.ncbi.nlm.nih.gov/pubmed/27655245 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 5 %N 3 %P e174 %T Evaluation of a Behavioral Mobile Phone App Intervention for the Self-Management of Type 2 Diabetes: Randomized Controlled Trial Protocol %A Goyal,Shivani %A Lewis,Gary %A Yu,Catherine %A Rotondi,Michael %A Seto,Emily %A Cafazzo,Joseph A %+ Centre for Global eHealth Innovation, Techna Institute, University Health Network, 4th Floor, 190 Elizabeth Street, Toronto, ON, M5G2C4, Canada, 1 6479793309, shiv_go@icloud.com %K diabetes mellitus %K type 2 %K telemedicine %K evaluation %K self-care %K randomized controlled trial %K mobile applications %K motivation %K blood glucose %D 2016 %7 19.08.2016 %9 Protocol %J JMIR Res Protoc %G English %X Background: Patients with type 2 diabetes mellitus (T2DM) struggle with the management of their condition due to difficulty relating lifestyle behaviors with glycemic control. While self-monitoring of blood glucose (SMBG) has proven to be effective for those treated with insulin, it has been shown to be less beneficial for those only treated with oral medications or lifestyle modification. We hypothesized that the effective self-management of non-insulin treated T2DM requires a behavioral intervention that empowers patients with the ability to self-monitor, understand the impact of lifestyle behaviors on glycemic control, and adjust their self-care based on contextualized SMBG data. Objective: The primary objective of this randomized controlled trial (RCT) is to determine the impact of bant2, an evidence-based, patient-centered, behavioral mobile app intervention, on the self-management of T2DM. Our second postulation is that automated feedback delivered through the mobile app will be as effective, less resource intensive, and more scalable than interventions involving additional health care provider feedback. Methods: This study is a 12-month, prospective, multicenter RCT in which 150 participants will be randomly assigned to one of two groups: the control group will receive current standard of care, and the intervention group will receive the mobile phone app system in addition to standard of care. The primary outcome measure is change in glycated hemoglobin A1c from baseline to 12 months. Results: The first patient was enrolled on July 28, 2015, and we anticipate completing this study by September, 2018. Conclusions: This RCT is one of the first to evaluate an evidence-based mobile app that focuses on facilitating lifestyle behavior change driven by contextualized and structured SMBG. The results of this trial will provide insights regarding the usage of mobile tools and consumer-grade devices for diabetes self-care, the economic model of using incentives to motivate behavior change, and the consumption of test strips when following a rigorously structured approach for SMBG. Trial Registration: ClinicalTrials.gov NCT02370719; https://clinicaltrials.gov/ct2/show/NCT02370719 (Archived at http://www.webcitation.org/6jpyjfVRs) %M 27542325 %R 10.2196/resprot.5959 %U http://www.researchprotocols.org/2016/3/e174/ %U https://doi.org/10.2196/resprot.5959 %U http://www.ncbi.nlm.nih.gov/pubmed/27542325 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 5 %N 3 %P e170 %T Protocol for a Randomized Controlled Trial Evaluating Mobile Text Messaging to Promote Retention and Adherence to Antiretroviral Therapy for People Living With HIV in Burkina Faso %A Wagner,Natascha %A Ouedraogo,Denis %A Artavia-Mora,Luis %A Bedi,Arjun %A Thiombiano,Boundia Alexandre %+ International Institute of Social Studies, Erasmus University Rotterdam, Kortenaerkade 12, The Hage, 2518AX, Netherlands, 31 0704260 ext 574, wagner@iss.nl %K HIV %K PLHIV %K mHealth %K SMS %K RCT %K developing countries %D 2016 %7 17.08.2016 %9 Protocol %J JMIR Res Protoc %G English %X Background: Retention in care and adherence to antiretroviral therapy (ART) among people living with human immunodeficiency virus (PLHIV) is a critical challenge in many African countries including Burkina Faso. Delivering text messaging (short message service, SMS) interventions through mobile phones may help facilitate health service delivery and improve patient health. Despite this potential, no evaluations have been delivered for national scale settings to demonstrate the impact of mobile health (mHealth) for PLHIV. Objectives: This study aims to test the impact of SMS text messaging reminders for PLHIV in Burkina Faso, who are under ART. The evaluation identifies whether patients who receive SMS text messages are more likely to (1) retain in care (measured as a dichotomous variable), (2) adhere to antiretroviral regimens (measured as the number of doses missed in the past 7 days), and (3) experience slower disease progression (measured with T-lymphocytes cells). The second objective is to assess its effects on the frequency of health center visits, physical and psychosocial health, nutrition and whether the type of message (text vs image) and frequency (weekly vs semiweekly) have differential impacts including the possibility of message fatigue over time. Methods: This 24-month, wide-scale intervention implements a randomized controlled trial (RCT) to evaluate the impact of four variants of a mHealth intervention versus a control group. Our sample comprises adult patients (>15 years of age) undergoing antiretroviral therapy with access to mobile phone services. Multivariate regression analysis will be used to analyze the effect of the intervention on the study population. Data collection is done at baseline and three follow-up waves 6, 12, and 24 months after the intervention starts. Results: The targeted 3800 patients were recruited between February 2015 and May 2015. But political uncertainty delayed the launch of the intervention until October 2015. Data analysis has not yet started. The first follow-up data collection started in April 2016. To the best of our knowledge, this is the first research that explores the effects of mobile message reminders using a wide-spread sample across an entire nation over a 2-year horizon, especially in a Francophone African country. Conclusions: We hypothesize that the interventions have a positive impact on retention in care and adherence to ART schemes and that a more sluggish disease progression will be observed in the short run. However, these benefits may fade out in the long run. The study expects to advance the research on how long mHealth interventions remain effective and when fatigue sets in the context of wide-scale interventions. This information will be useful in designing future wide-scale mHealth interventions in developing countries. %M 27535717 %R 10.2196/resprot.5823 %U http://www.researchprotocols.org/2016/3/e170/ %U https://doi.org/10.2196/resprot.5823 %U http://www.ncbi.nlm.nih.gov/pubmed/27535717 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 4 %N 3 %P e83 %T An Evidence-Based Antimicrobial Stewardship Smartphone App for Hospital Outpatients: Survey-based Needs Assessment Among Patients %A Micallef,Christianne %A McLeod,Monsey %A Castro-Sánchez,Enrique %A Gharbi,Myriam %A Charani,Esmita %A Moore,Luke SP %A Gilchrist,Mark %A Husson,Fran %A Costelloe,Ceire %A Holmes,Alison H %+ National Institute for Health Research (NIHR) Health Protection Research Unit in Healthcare Associated Infection and Antimicrobial Resistance, Imperial College, Hammersmith Campus, London W12 0NN, United Kingdom, 44 0203 313 2732, c.micallef@imperial.ac.uk %K mobile electronic devices %K mHealth %K mobile health %K antimicrobial resistance %K patient involvement %D 2016 %7 06.07.2016 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Current advances in modern technology have enabled the development and utilization of electronic medical software apps for both mobile and desktop computing devices. A range of apps on a large variety of clinical conditions for patients and the public are available, but very few target antimicrobials or infections. Objective: We sought to explore the use of different antimicrobial information resources with a focus on electronic platforms, including apps for portable devices, by outpatients at two large, geographically distinct National Health Service (NHS) teaching hospital trusts in England. We wanted to determine whether there is demand for an evidence-based app for patients, to garner their perceptions around infections/antimicrobial prescribing, and to describe patients’ experiences of their interactions with health care professionals in relation to this topic. Methods: A cross-sectional survey design was used to investigate aspects of antimicrobial prescribing and electronic devices experienced by patients at four hospitals in London and a teaching hospital in the East of England. Results: A total of 99 surveys were completed and analyzed. A total of 82% (80/98) of respondents had recently been prescribed antimicrobials; 87% (85/98) of respondents were prescribed an antimicrobial by a hospital doctor or through their general practitioner (GP) in primary care. Respondents wanted information on the etiology (42/65, 65%) and prevention and/or management (32/65, 49%) of their infections, with the infections reported being upper and lower respiratory tract, urinary tract, oral, and skin and soft tissue infections. All patients (92/92, 100%) desired specific information on the antimicrobial prescribed. Approximately half (52/95, 55%) stated it was “fine” for doctors to use a mobile phone/tablet computer during the consultation while 13% (12/95) did not support the idea of doctors accessing health care information in this way. Although only 30% (27/89) of respondents reported on the use of health care apps, 95% (81/85) offered information regarding aspects of antimicrobials or infections that could be provided through a tailored app for patients. Analysis of the comments revealed the following main global themes: knowledge, technology, and patient experience. Conclusions: The majority of respondents in our study wanted to have specific etiological and/or infection management advice. All required antimicrobial-related information. Also, most supported the use of electronic resources of information, including apps, by their doctors. While a minority of people currently use health apps, many feel that apps could be used to provide additional support/information related to infections and appropriate use of antimicrobials. In addition, we found that there is a need for health care professionals to engage with patients and help address common misconceptions around the generation of antimicrobial resistance. %M 27383743 %R 10.2196/mhealth.5243 %U http://mhealth.jmir.org/2016/3/e83/ %U https://doi.org/10.2196/mhealth.5243 %U http://www.ncbi.nlm.nih.gov/pubmed/27383743 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 5 %N 2 %P e131 %T A Cognitive Behavioral Therapy–Based Text Messaging Intervention Versus Medical Management for HIV-Infected Substance Users: Study Protocol for a Pilot Randomized Trial %A Glasner-Edwards,Suzette %A Patrick,Kevin %A Ybarra,Michele L %A Reback,Cathy J %A Rawson,Richard A %A Chokron Garneau,Helene %A Chavez,Kathryn %A Venegas,Alexandra %+ Integrated Substance Abuse Programs, Semel Institute for Neuroscience and Human Behavior, University of California Los Angeles, 11075 Santa Monica Blvd, Suite 200, Los Angeles, CA,, United States, 1 310 267 5206, sglasner@ucla.edu %K SMS %K medication adherence %K HIV %K relapse prevention %K text messaging %K CBT %K ART %D 2016 %7 24.06.2016 %9 Protocol %J JMIR Res Protoc %G English %X Background: Evidence-based psychosocial interventions for addictions and related conditions such as cognitive behavioral therapy (CBT) are underutilized. Obstacles to implementation of CBT in clinical settings include limited availability of quality training, supervision, and certification in CBT for clinicians; high rates of clinician turnover and high caseloads; and limited qualifications of the workforce to facilitate CBT expertise. Objective: Mobile phone–based delivery of CBT, if demonstrated to be feasible and effective, could be transformative in broadening its application and improving the quality of addiction treatment. No experimental interventions that deliver CBT targeting both drug use and medication adherence using text messaging have been previously reported; as such, the objective of this study is to develop and test an SMS-based treatment program for HIV-positive adults with comorbid substance use disorders. Methods: With user input, we developed a 12-week CBT-based text messaging intervention (TXT-CBT) targeting antiretroviral (ART) adherence, risk behaviors, and drug use in a population of HIV-infected substance users. Results: The intervention has been developed and is presently being tested in a pilot randomized clinical trial. Results will be reported later this year. Conclusions: This investigation will yield valuable knowledge about the utility of a cost-effective, readily deployable text messaging behavioral intervention for HIV-infected drug users. %M 27341852 %R 10.2196/resprot.5407 %U http://www.researchprotocols.org/2016/2/e131/ %U https://doi.org/10.2196/resprot.5407 %U http://www.ncbi.nlm.nih.gov/pubmed/27341852 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 18 %N 6 %P e116 %T The Influence of Wireless Self-Monitoring Program on the Relationship Between Patient Activation and Health Behaviors, Medication Adherence, and Blood Pressure Levels in Hypertensive Patients: A Substudy of a Randomized Controlled Trial %A Kim,Ju Young %A Wineinger,Nathan. E %A Steinhubl,Steven. R %+ Digital medicine, Scripps Translational Science Institute, 3344 North Torrey Pines Court, Suite 300, La Jolla, CA, 92037, United States, 1 858 554 5708, steinhub@scripps.edu %K patient participation %K blood pressure self-monitoring %K wireless technology %K telemedicine %K health behavior %K medication adherence %D 2016 %7 22.06.2016 %9 Original Paper %J J Med Internet Res %G English %X Background: Active engagement in the management of hypertension is important in improving self-management behaviors and clinical outcomes. Mobile phone technology using wireless monitoring tools are now widely available to help individuals monitor their blood pressure, but little is known about the conditions under which such technology can effect positive behavior changes or clinical outcomes. Objective: To study the influence of wireless self-monitoring program and patient activation measures on health behaviors, medication adherence, and blood pressure levels as well as control of blood pressure in hypertensive patients. Methods: We examined a subset of 95 hypertensive participants from a 6-month randomized controlled trial designed to determine the utility of a wireless self-monitoring program (n=52 monitoring program, n=43 control), which consisted of a blood pressure monitoring device connected with a mobile phone, reminders for self-monitoring, a Web-based disease management program, and a mobile app for monitoring and education, compared with the control group receiving a standard disease management program. Study participants provided measures of patient activation, health behaviors including smoking, drinking, and exercise, medication adherence, and blood pressure levels. We assessed the influence of wireless self-monitoring as a moderator of the relationship between patient activation and health behaviors, medication adherence, and control of blood pressure. Results: Improvements in patient activation were associated with improvements in cigarette smoking (beta=−0.46, P<.001) and blood pressure control (beta=0.04, P=.02). This relationship was further strengthened in reducing cigarettes (beta=−0.60, P<.001), alcohol drinking (beta=−0.26, P=.01), and systolic (beta=−0.27, P=.02) and diastolic blood pressure (beta=−0.34, P=.007) at 6 months among individuals participating in the wireless self-monitoring program. No differences were observed with respect to medication adherence. Conclusions: Participation in a wireless self-monitoring program provides individuals motivated to improve their health management with an added benefit above and beyond that of motivation alone. Hypertensive individuals eager to change health behaviors are excellent candidates for mobile health self-monitoring.. Trial Registration: ClinicalTrials.gov NCT01975428, https://clinicaltrials.gov/ct2/show/NCT01975428 (Archived by WebCite at http://www.webcitation.org/6iSO5OgOG) %M 27334418 %R 10.2196/jmir.5429 %U http://www.jmir.org/2016/6/e116/ %U https://doi.org/10.2196/jmir.5429 %U http://www.ncbi.nlm.nih.gov/pubmed/27334418 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 18 %N 6 %P e122 %T A Web-Based and Mobile Health Social Support Intervention to Promote Adherence to Inhaled Asthma Medications: Randomized Controlled Trial %A Koufopoulos,Justin T %A Conner,Mark T %A Gardner,Peter H %A Kellar,Ian %+ School of Psychology, Faculty of Medicine and Health, University of Leeds, Lifton Place, Leeds, LS2 9JT, United Kingdom, 44 (0)1133437242, i.kellar@leeds.ac.uk %K Internet %K telemedicine %K social support %K asthma %K adherence %K attrition %K engagement %K randomized controlled trial %K online community %K social health network %D 2016 %7 13.06.2016 %9 Original Paper %J J Med Internet Res %G English %X Background: Online communities hold great potential as interventions for health, particularly for the management of chronic illness. The social support that online communities can provide has been associated with positive treatment outcomes, including medication adherence. There are few studies that have attempted to assess whether membership of an online community improves health outcomes using rigorous designs. Objective: Our objective was to conduct a rigorous proof-of-concept randomized controlled trial of an online community intervention for improving adherence to asthma medicine. Methods: This 9-week intervention included a sample of asthmatic adults from the United Kingdom who were prescribed an inhaled corticosteroid preventer. Participants were recruited via email and randomized to either an “online community” or “no online community” (diary) condition. After each instance of preventer use, participants (N=216) were required to report the number of doses of medication taken in a short post. Those randomized to the online community condition (n=99) could read the posts of other community members, reply, and create their own posts. Participants randomized to the no online community condition (n=117) also posted their medication use, but could not read others’ posts. The main outcome measures were self-reported medication adherence at baseline and follow-up (9 weeks postbaseline) and an objective measure of adherence to the intervention (visits to site). Results: In all, 103 participants completed the study (intervention: 37.8%, 39/99; control: 62.2%, 64/117). MANCOVA of self-reported adherence to asthma preventer medicine at follow-up was not significantly different between conditions in either intention-to-treat (P=.92) or per-protocol (P=.68) analysis. Site use was generally higher in the control compared to intervention conditions. Conclusions: Joining an online community did not improve adherence to preventer medication for asthma patients. Without the encouragement of greater community support or more components to sustain engagement over time, the current findings do not support the use of an online community to improve adherence. ClinicalTrial: International Standard Randomized Controlled Trial Number (ISRCTN): 29399269; http://www.isrctn.com/ISRCTN29399269/29399269 (Archived by WebCite at http://www.webcitation.org/6fUbEuVoT) %M 27298211 %R 10.2196/jmir.4963 %U http://www.jmir.org/2016/6/e122/ %U https://doi.org/10.2196/jmir.4963 %U http://www.ncbi.nlm.nih.gov/pubmed/27298211 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 18 %N 5 %P e121 %T Acceptability of Interventions Delivered Online and Through Mobile Phones for People Who Experience Severe Mental Health Problems: A Systematic Review %A Berry,Natalie %A Lobban,Fiona %A Emsley,Richard %A Bucci,Sandra %+ School of Psychological Sciences, Faculty of Medical and Human Sciences, University of Manchester, Room S42, Zochonis Building, Brunswick Street, Manchester, M13 9PL, United Kingdom, 44 16130 ext 60428, natalie.berry@manchester.ac.uk %K mHealth %K eHealth %K severe mental health %K psychosis %K bipolar disorder %K personality disorder %K severe mental health problems (SMI) %K acceptability %D 2016 %7 31.05.2016 %9 Original Paper %J J Med Internet Res %G English %X Background: Psychological interventions are recommended for people with severe mental health problems (SMI). However, barriers exist in the provision of these services and access is limited. Therefore, researchers are beginning to develop and deliver interventions online and via mobile phones. Previous research has indicated that interventions delivered in this format are acceptable for people with SMI. However, a comprehensive systematic review is needed to investigate the acceptability of online and mobile phone-delivered interventions for SMI in depth. Objective: This systematic review aimed to 1) identify the hypothetical acceptability (acceptability prior to or without the delivery of an intervention) and actual acceptability (acceptability where an intervention was delivered) of online and mobile phone-delivered interventions for SMI, 2) investigate the impact of factors such as demographic and clinical characteristics on acceptability, and 3) identify common participant views in qualitative studies that pinpoint factors influencing acceptability. Methods: We conducted a systematic search of the databases PubMed, Embase, PsycINFO, CINAHL, and Web of Science in April 2015, which yielded a total of 8017 search results, with 49 studies meeting the full inclusion criteria. Studies were included if they measured acceptability through participant views, module completion rates, or intervention use. Studies delivering interventions were included if the delivery method was online or via mobile phones. Results: The hypothetical acceptability of online and mobile phone-delivered interventions for SMI was relatively low, while actual acceptability tended to be high. Hypothetical acceptability was higher for interventions delivered via text messages than by emails. The majority of studies that assessed the impact of demographic characteristics on acceptability reported no significant relationships between the two. Additionally, actual acceptability was higher when participants were provided remote online support. Common qualitative factors relating to acceptability were safety and privacy concerns, the importance of an engaging and appealing delivery format, the inclusion of peer support, computer and mobile phone literacy, technical issues, and concerns about the impact of psychological state on intervention use. Conclusions: This systematic review provides an in-depth focus on the acceptability of online and mobile phone-delivered interventions for SMI and identified the need for further research in this area. Based on the results from this review, we recommend that researchers measure both hypothetical and actual acceptability to identify whether initial perceptions of online and mobile phone-delivered interventions change after access. In addition, more focus is needed on the potential impact of demographic and clinical characteristics on acceptability. The review also identified issues with module completion rates and intervention use as measures of acceptability. We therefore advise researchers to obtain qualitative reports of acceptability throughout each phase of intervention development and testing. Further implications and opportunities for future research are discussed. %M 27245693 %R 10.2196/jmir.5250 %U http://www.jmir.org/2016/5/e121/ %U https://doi.org/10.2196/jmir.5250 %U http://www.ncbi.nlm.nih.gov/pubmed/27245693 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 18 %N 4 %P e91 %T A Remote Medication Monitoring System for Chronic Heart Failure Patients to Reduce Readmissions: A Two-Arm Randomized Pilot Study %A Hale,Timothy M %A Jethwani,Kamal %A Kandola,Manjinder Singh %A Saldana,Fidencio %A Kvedar,Joseph C %+ Partners Healthcare, Connected Health, 25 New Chardon Street Suite 300, Boston, MA,, United States, 1 617 643 9852, tmhale@mgh.harvard.edu %K heart failure %K telemonitoring %K telehealth %K self-management %K self-care %K complex medication regimens %K medication management %K medication adherence %K hospitalization length of stay %K ED visits %D 2016 %7 6.5.2016 %9 Original Paper %J J Med Internet Res %G English %X Background: Heart failure (HF) is a chronic condition affecting nearly 5.7 million Americans and is a leading cause of morbidity and mortality. With an aging population, the cost associated with managing HF is expected to more than double from US $31 billion in 2012 to US $70 billion by 2030. Readmission rates for HF patients are high—25% are readmitted at 30 days and nearly 50% at 6 months. Low medication adherence contributes to poor HF management and higher readmission rates. Remote telehealth monitoring programs aimed at improved medication management and adherence may improve HF management and reduce readmissions. Objective: The primary goal of this randomized controlled pilot study is to compare the MedSentry remote medication monitoring system versus usual care in older HF adult patients who recently completed a HF telemonitoring program. We hypothesized that remote medication monitoring would be associated with fewer unplanned hospitalizations and emergency department (ED) visits, increased medication adherence, and improved health-related quality of life (HRQoL) compared to usual care. Methods: Participants were randomized to usual care or use of the remote medication monitoring system for 90 days. Twenty-nine participants were enrolled and the final analytic sample consisted of 25 participants. Participants completed questionnaires at enrollment and closeout to gather data on medication adherence, health status, and HRQoL. Electronic medical records were reviewed for data on baseline classification of heart function and the number of unplanned hospitalizations and ED visits during the study period. Results: Use of the medication monitoring system was associated with an 80% reduction in the risk of all-cause hospitalization and a significant decrease in the number of all-cause hospitalization length of stay in the intervention arm compared to usual care. Objective device data indicated high adherence rates (95%-99%) among intervention group participants despite finding no significant difference in self-reported adherence between study arms. The intervention group had poorer heart function and HRQoL at baseline, and HRQoL declined significantly in the intervention group compared to controls. Conclusions: The MedSentry medication monitoring system is a promising technology that merits continued development and evaluation. The MedSentry medication monitoring system may be useful both as a standalone system for patients with complex medication regimens or used to complement existing HF telemonitoring interventions. We found significant reductions in risk of all-cause hospitalization and the number of all-cause length of stay in the intervention group compared to controls. Although HRQoL deteriorated significantly in the intervention group, this may have been due to the poorer HF-functioning at baseline in the intervention group compared to controls. Telehealth medication adherence technologies, such as the MedSentry medication monitoring system, are a promising method to improve patient self-management,the quality of patient care, and reduce health care utilization and expenditure for patients with HF and other chronic diseases that require complex medication regimens. Trial Registration: ClinicalTrials.gov NCT01814696; https://clinicaltrials.gov/ct2/show/study/NCT01814696 (Archived by WebCite® at http://www.webcitation.org/6giqAVhno) %M 27154462 %R 10.2196/jmir.5256 %U http://www.jmir.org/2016/4/e91/ %U https://doi.org/10.2196/jmir.5256 %U http://www.ncbi.nlm.nih.gov/pubmed/27154462 %0 Journal Article %@ 2291-5222 %I JMIR Publications Inc. %V 4 %N 2 %P e48 %T Creating Effective Mobile Phone Apps to Optimize Antiretroviral Therapy Adherence: Perspectives From Stimulant-Using HIV-Positive Men Who Have Sex With Men %A Horvath,Keith J %A Alemu,Dawit %A Danh,Thu %A Baker,Jason V %A Carrico,Adam W %+ Division of Epidemiology and Community Health, School of Public Health, University of Minnesota, WBOB, Suite 300, 1300 South 2nd Street, Minneapolis, MN, 55454, United States, 1 612 626 1799, horva018@umn.edu %K smartphone apps %K technology adoption and use %K men who have sex with men %K stimulant drug use %K HIV %D 2016 %7 15.04.2016 %9 Original Paper %J JMIR mHealth uHealth %G English %X Background: The use of stimulant drugs among men who have sex with men (MSM) with human immunodeficiency virus (HIV) is associated with decreased odds of antiretroviral therapy (ART) adherence and elevated risk of forward HIV transmission. Advancing tailored and innovative mobile phone–based ART adherence app interventions for stimulant-using HIV-positive MSM requires greater understanding of their needs and preferences in this emerging area. Objective: The purpose of this study is to (1) assess reasons that stimulant-using HIV-positive MSM download and sustain their use of mobile phone apps in general, and (2) obtain feedback on features and functions that these men prefer in a mobile phone app to optimize their ART adherence. Methods: Focus groups were conducted with stimulant-using HIV-positive MSM (24-57 years of age; mostly non-Hispanic white; 42% once a week or more frequent stimulant drug use) in San Francisco and Minneapolis. Our aim was to explore the mobile phone app features and functions that they considered when deciding to download and sustain their use of general apps over time, as well as specific features and functions that they would like to see incorporated into an ART adherence mobile app. Focus groups were audiorecorded and transcribed verbatim. Thematic analysis was applied to transcripts using line-by-line open coding and organizing codes into meaningful themes. Results: Men reported that they currently had a variety of health and wellness, social media and networking, gaming and entertainment, and utility apps on their mobile phones. Downloading apps to their mobile phones was influenced by the cost of the app, recommendations by a trusted source, and the time it takes to download. In addition, downloading and sustained use of apps was more likely to occur when men had control over most features of the app and apps were perceived to be useful, engaging, secure, and credible. Participants suggested that ART adherence mobile phone apps include social networking features, connections to local resources and their medical chart, and breaking HIV news and updates. Although some men expressed concerns about daily self-monitoring of HIV medication doses, many appreciated receiving a summary of their medication adherence over time and suggested that feedback about missed doses be delivered in an encouraging and humorous manner. Conclusions: In this study, we were able to recruit a relatively high proportion (42%) of HIV-positive MSM reporting weekly or more stimulant use. These results suggest critical design elements that may need to be considered during development of ART adherence-related mobile phone apps for this, and possibly other, high-risk groups. In particular, finding the optimal balance of security, engagement, usefulness, control capabilities, and credibility will be critical to sustained used of HIV treatment apps. %M 27084049 %R 10.2196/mhealth.5287 %U http://mhealth.jmir.org/2016/2/e48/ %U https://doi.org/10.2196/mhealth.5287 %U http://www.ncbi.nlm.nih.gov/pubmed/27084049 %0 Journal Article %@ 2291-5222 %I JMIR Publications Inc. %V 4 %N 2 %P e34 %T Characterization of Apps and Other e-Tools for Medication Use: Insights Into Possible Benefits and Risks %A van Kerkhof,Linda Wilhelmina Maria %A van der Laar,Catharina Walthera Egbertha %A de Jong,Charlie %A Weda,Marjolein %A Hegger,Ingrid %+ National Institute for Public Health and the Environment (RIVM), Centre for Health Protection, PO Box 1, Bilthoven, 3720 BA, Netherlands, 31 302748688, linda.van.kerkhof@rivm.nl %K mobile apps %K drugs %K eHealth %K mHealth %K medication use %D 2016 %7 06.04.2016 %9 Original Paper %J JMIR mHealth uHealth %G English %X Background: In the past years, an enormous increase in the number of available health-related applications (apps) has occurred, from approximately 5800 in 2011 to over 23,000 in 2013, in the iTunes store. However, little is still known regarding the use, possible effectiveness, and risks of these applications. In this study, we focused on apps and other e-tools related to medicine use. A large subset of the general population uses medicines and might benefit from tools that aid in the use of medicine. Objective: The aim of the present study was to gain more insight into the characteristics, possible risks, and possible benefits of health apps and e-tools related to medication use. Methods: We first made an inventory of apps and other e-tools for medication use (n=116). Tools were coded by two independent researchers, based on the information available in the app stores and websites. Subsequently, for one type of often downloaded apps (aimed at people with diabetes), we investigated users’ experiences using an online questionnaire. Results: Results of the inventory show that many apps for medication use are available and that they mainly offer simple functionalities. In line with this, the most experienced benefit by users of apps for regulating blood glucose levels in the online questionnaire was “information quick and conveniently available”. Other often experienced benefits were improving health and self-reliance. Results of the inventory show that a minority of the apps for medication use has potentially high risks and for many of the apps it is unclear whether and how personal data are stored. In contrast, online questionnaire among users of apps for blood glucose regulation indicates that they hardly ever experience problems or doubts considering reliability and/or privacy. Although, respondents do mention to experience disadvantages of use due to incomplete apps and apps with poor ease of use. Respondents not using app(s) indicate that they might use them in the future if reliability of the apps and instructions on how to use them are more clear. Conclusions: This study shows that for apps and e-tools related to medicine use a small subset of tools might involve relatively high risks. For the large group of nonmedical devices apps, risks are lower, but risks lie in the enormous availability and low levels of regulation. In addition, both users and nonusers indicated that overall quality of apps (ease of use, completeness, good functionalities) is an issue. Considering that important benefits (eg, improving health and self-reliance) are experienced by many of the respondents using apps for regulating blood glucose levels, improving reliability and quality of apps is likely to have many profits. In addition, creating better awareness regarding the existence and how to use apps will likely improve proper use by more people, enhancing the profits of these tools. %M 27052946 %R 10.2196/mhealth.4149 %U http://mhealth.jmir.org/2016/2/e34/ %U https://doi.org/10.2196/mhealth.4149 %U http://www.ncbi.nlm.nih.gov/pubmed/27052946 %0 Journal Article %@ 2369-2960 %I JMIR Publications %V 2 %N 1 %P e15 %T Why do Patients Forget to Take Immunosuppression Medications and Miss Appointments: Can a Mobile Phone App Help? %A Israni,Ajay %A Dean,Carl %A Kasel,Brian %A Berndt,Lisa %A Wildebush,Winston %A Wang,C Jason %+ Hennepin County Medical Center, Department of Medicine, 701 Park Ave, Minneapolis, MN, 55415, United States, 1 612 873 6987, isran001@umn.edu %K adherence %K immunosuppressive medications %K appointments %K mobile phone %D 2016 %7 04.04.2016 %9 Original Paper %J JMIR Public Health Surveill %G English %X Background: Kidney transplant recipients must adhere to their immunosuppressive medication regimen. However, non-adherence remains a major problem. Objective: The aim of this paper is to determine how kidney transplant recipients remember to take their medications, and assess their perception and beliefs about adherence to immunosuppressive medications and barriers to medication adherence. In addition, we aim to assess perception and beliefs about willingness to use a hypothetical, mobile phone app to improve adherence. Methods: We conducted a qualitative study that included an average of three home or workplace visits of kidney transplant recipients (N=16) from a single urban transplant center. Results: The qualitative study revealed that transplant recipients understood the importance of taking their immunosuppressive medications and this motivated them to take their medications. The visits showed that most participants have incorporated medication use into their daily lives and that any minor deviation from daily routines could result in non-adherence. Participants also reported other barriers to adherence. All participants were interested in using an app to remind them to take their medication; however, they reported potential barriers to using the app. Conclusions: Although kidney transplant recipients understood the importance of medication adherence, there were significant barriers to maintaining adherence. Participants also reported interest in using a mobile phone app. %M 27227150 %R 10.2196/publichealth.5285 %U http://publichealth.jmir.org/2016/1/e15/ %U https://doi.org/10.2196/publichealth.5285 %U http://www.ncbi.nlm.nih.gov/pubmed/27227150 %0 Journal Article %@ 2291-5222 %I JMIR Publications Inc. %V 4 %N 1 %P e31 %T Developing mHealth Remote Monitoring Technology for Attention Deficit Hyperactivity Disorder: A Qualitative Study Eliciting User Priorities and Needs %A Simons,Lucy %A Valentine,Althea Z %A Falconer,Caroline J %A Groom,Madeleine %A Daley,David %A Craven,Michael P %A Young,Zoe %A Hall,Charlotte %A Hollis,Chris %+ Division of Psychiatry and Applied Psychology, School of Medicine, University of Nottingham, Institute of Mental Health, Triumph Road, Nottingham, NG7 2TU, United Kingdom, 44 +1158231294, chris.hollis@nottingham.ac.uk %K attention deficit hyperactivity disorder %K mHealth %K eMental Health %K remote monitoring technology %K mental health services %K qualitative methods %K feasibility testing %K user requirements %D 2016 %7 23.03.2016 %9 Original Paper %J JMIR mHealth uHealth %G English %X Background: Guidelines in the United Kingdom recommend that medication titration for attention deficit hyperactivity disorder (ADHD) should be completed within 4-6 weeks and include regular reviews. However, most clinicians think that weekly clinic contact is infeasible, and audits have shown that this timeline is rarely achieved. Thus, a more effective monitoring and review system is needed; remote monitoring technology (RMT) may be one way to improve current practice. However, little is known about whether patients with ADHD, their families, and clinicians would be interested in using RMT. Objective: To explore patients’, parents’, and health care professionals’ views and attitudes toward using digital technology for remote monitoring during titration for ADHD. Methods: This was a qualitative study, and data were collected through 11 focus groups with adults and young people with ADHD, parents of children with ADHD, and health care professionals (N=59). Results: All participant groups were positive about using RMT in the treatment of ADHD, but they were also aware of barriers to its use, especially around access to technology and integrating RMT into clinical care. They identified that RMT had the most potential for use in the ongoing management and support of ADHD, rather than during the distinct titration period. Participants identified features of RMT that could improve the quality of consultations and support greater self-management. Conclusions: RMT has the potential to augment support and care for ADHD, but it needs to go beyond the titration period and offer more to patients and families than monitoring through outcome measures. Developing and evaluating an mHealth app that incorporates the key features identified by end users is required. %M 27009498 %R 10.2196/mhealth.5009 %U http://mhealth.jmir.org/2016/1/e31/ %U https://doi.org/10.2196/mhealth.5009 %U http://www.ncbi.nlm.nih.gov/pubmed/27009498 %0 Journal Article %@ 2291-5222 %I JMIR Publications Inc. %V 4 %N 1 %P e12 %T A Mobile App for Hypertension Management Based on Clinical Practice Guidelines: Development and Deployment %A Kang,Hannah %A Park,Hyeoun-Ae %+ Systems Biomedical Informatics Research Center, College of Nursing, Seoul National University, 103 Daehak-ro, Jongno-gu, Seoul, , Republic Of Korea, 82 2 740 8827, hapark@snu.ac.kr %K mobile health %K clinical practice guideline %K hypertension %K self-management %D 2016 %7 02.02.2016 %9 Original Paper %J JMIR mHealth uHealth %G English %X Background: Hypertension is a chronic and lifestyle-related disease that requires continuous preventive care. Although there are many evidence-based clinical practice guidelines (CPGs) for hypertension management, applying them to daily management can be difficult for patients with hypertension. A mobile app, based on CPGs, could help patients with hypertension manage their disease. Objective: To develop a mobile app for hypertension management based on CPGs and evaluate its effectiveness in patients with hypertension with respect to perceived usefulness, user satisfaction, and medication adherence. Methods: The hypertension management app (HMA) was developed according to the Web-Roadmap methodology, which includes planning, analysis, design, implementation, and evaluation phases. The HMA was provided to individuals (N=38) with hypertension. Medication adherence was measured before and after using the HMA for 4 weeks. The perceived usefulness and user satisfaction were surveyed in the patients who completed the medication adherence survey. Results: Of the 38 study participants, 29 (76%) participated in medical adherence assessment. Medication adherence, as measured by the Modified Morisky Scale, was significantly improved in these patients after they had used the HMA (P=.001). The perceived usefulness score was 3.7 out of 5. The user satisfaction scores, with respect to using the HMA for blood pressure recording, medication recording, data sending, alerting, recommending, and educating about medication were 4.3, 3.8, 3.1, 3.2, 3.4, and 3.8 out of 5, respectively, in the 19 patients. Conclusions: This study showed that a mobile app for hypertension management based on CPGs is effective at improving medication adherence. %M 26839283 %R 10.2196/mhealth.4966 %U http://mhealth.jmir.org/2016/1/e12/ %U https://doi.org/10.2196/mhealth.4966 %U http://www.ncbi.nlm.nih.gov/pubmed/26839283 %0 Journal Article %@ 2291-5222 %I JMIR Publications Inc. %V 3 %N 4 %P e108 %T Let Visuals Tell the Story: Medication Adherence in Patients with Type II Diabetes Captured by a Novel Ingestion Sensor Platform %A Browne,Sara H %A Behzadi,Yashar %A Littlewort,Gwen %+ University of California, San Diego, School of Medicine, 9500 Gilman Drive, Mail Code 0640, La Jolla, CA, 92093-0640, United States, 1 858 822 6563, shbrowne@ucsd.edu %K ingestion sensor platform %K data visualization %K time domain methods %K medication adherence %K patient self-management %D 2015 %7 31.12.2015 %9 Original Paper %J JMIR mHealth uHealth %G English %X Background: Chronic diseases such as diabetes require high levels of medication adherence and patient self-management for optimal health outcomes. A novel sensing platform, Digital Health Feedback System (Proteus Digital Health, Redwood City, CA), can for the first time detect medication ingestion events and physiological measures simultaneously, using an edible sensor, personal monitor patch, and paired mobile device. The Digital Health Feedback System (DHFS) generates a large amount of data. Visual analytics of this rich dataset may provide insights into longitudinal patterns of medication adherence in the natural setting and potential relationships between medication adherence and physiological measures that were previously unknown. Objective: Our aim was to use modern methods of visual analytics to represent continuous and discrete data from the DHFS, plotting multiple different data types simultaneously to evaluate the potential of the DHFS to capture longitudinal patterns of medication-taking behavior and self-management in individual patients with type II diabetes. Methods: Visualizations were generated using time domain methods of oral metformin medication adherence and physiological data obtained by the DHFS use in 5 patients with type II diabetes over 37-42 days. The DHFS captured at-home metformin adherence, heart rate, activity, and sleep/rest. A mobile glucose monitor captured glucose testing and level (mg/dl). Algorithms were developed to analyze data over varying time periods: across the entire study, daily, and weekly. Following visualization analysis, correlations between sleep/rest and medication ingestion were calculated across all subjects. Results: A total of 197 subject days, encompassing 141,840 data events were analyzed. Individual continuous patch use varied between 87-98%. On average, the cohort took 78% (SD 12) of prescribed medication and took 77% (SD 26) within the prescribed ±2-hour time window. Average activity levels per subjects ranged from 4000-12,000 steps per day. The combination of activity level and heart rate indicated different levels of cardiovascular fitness between subjects. Visualizations over the entire study captured the longitudinal pattern of missed doses (the majority of which took place in the evening), the timing of ingestions in individual subjects, and the range of medication ingestion timing, which varied from 1.5-2.4 hours (Subject 3) to 11 hours (Subject 2). Individual morning self-management patterns over the study period were obtained by combining the times of waking, metformin ingestion, and glucose measurement. Visualizations combining multiple data streams over a 24-hour period captured patterns of broad daily events: when subjects rose in the morning, tested their blood glucose, took their medications, went to bed, hours of sleep/rest, and level of activity during the day. Visualizations identified highly consistent daily patterns in Subject 3, the most adherent participant. Erratic daily patterns including sleep/rest were demonstrated in Subject 2, the least adherent subject. Correlation between sleep /rest and medication ingestion in each individual subject was evaluated. Subjects 2 and 4 showed correlation between amount of sleep/rest over a 24-hour period and medication-taking the following day (Subject 2: r=.47, P<.02; Subject 4: r=.35, P<.05). With Subject 2, sleep/rest disruptions during the night were highly correlated (r=.47, P<.009) with missing doses the following day. Conclusions: Visualizations integrating medication ingestion and physiological data from the DHFS over varying time intervals captured detailed individual longitudinal patterns of medication adherence and self-management in the natural setting. Visualizing multiple data streams simultaneously, providing a data-rich representation, revealed information that would not have been shown by plotting data streams individually. Such analyses provided data far beyond traditional adherence summary statistics and may form the foundation of future personalized predictive interventions to drive longitudinal adherence and support optimal self-management in chronic diseases such as diabetes. %M 26721413 %R 10.2196/mhealth.4292 %U http://mhealth.jmir.org/2015/4/e108/ %U https://doi.org/10.2196/mhealth.4292 %U http://www.ncbi.nlm.nih.gov/pubmed/26721413 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 17 %N 6 %P e142 %T A Mobile Health Intervention Supporting Heart Failure Patients and Their Informal Caregivers: A Randomized Comparative Effectiveness Trial %A Piette,John D %A Striplin,Dana %A Marinec,Nicolle %A Chen,Jenny %A Trivedi,Ranak B %A Aron,David C %A Fisher,Lawrence %A Aikens,James E %+ Center for Clinical Management Research and Center for Managing Chronic Disease, VA Ann Arbor Healthcare System and University of Michigan School of Public Health, 1415 Washington Heights, SPH-1, Ann Arbor, MI, 48109, United States, 1 734 763 1457, jpiette@umich.edu %K telehealth %K mobile health %K heart failure %K disease management %K self-management %D 2015 %7 10.06.2015 %9 Original Paper %J J Med Internet Res %G English %X Background: Mobile health (mHealth) interventions may improve heart failure (HF) self-care, but standard models do not address informal caregivers’ needs for information about the patient’s status or how the caregiver can help. Objective: We evaluated mHealth support for caregivers of HF patients over and above the impact of a standard mHealth approach. Methods: We identified 331 HF patients from Department of Veterans Affairs outpatient clinics. All patients identified a “CarePartner” outside their household. Patients randomized to “standard mHealth” (n=165) received 12 months of weekly interactive voice response (IVR) calls including questions about their health and self-management. Based on patients’ responses, they received tailored self-management advice, and their clinical team received structured fax alerts regarding serious health concerns. Patients randomized to “mHealth+CP” (n=166) received an identical intervention, but with automated emails sent to their CarePartner after each IVR call, including feedback about the patient’s status and suggestions for how the CarePartner could support disease care. Self-care and symptoms were measured via 6- and 12-month telephone surveys with a research associate. Self-care and symptom data also were collected through the weekly IVR assessments. Results: Participants were on average 67.8 years of age, 99% were male (329/331), 77% where white (255/331), and 59% were married (195/331). During 15,709 call-weeks of attempted IVR assessments, patients completed 90% of their calls with no difference in completion rates between arms. At both endpoints, composite quality of life scores were similar across arms. However, more mHealth+CP patients reported taking medications as prescribed at 6 months (8.8% more, 95% CI 1.2-16.5, P=.02) and 12 months (13.8% more, CI 3.7-23.8, P<.01), and 10.2% more mHealth+CP patients reported talking with their CarePartner at least twice per week at the 6-month follow-up (P=.048). mHealth+CP patients were less likely to report negative emotions during those interactions at both endpoints (both P<.05), were consistently more likely to report taking medications as prescribed during weekly IVR assessments, and also were less likely to report breathing problems or weight gains (all P<.05). Among patients with more depressive symptoms at enrollment, those randomized to mHealth+CP were more likely than standard mHealth patients to report excellent or very good general health during weekly IVR calls. Conclusions: Compared to a relatively intensive model of IVR monitoring, self-management assistance, and clinician alerts, a model including automated feedback to an informal caregiver outside the household improved HF patients’ medication adherence and caregiver communication. mHealth+CP may also decrease patients’ risk of HF exacerbations related to shortness of breath and sudden weight gains. mHealth+CP may improve quality of life among patients with greater depressive symptoms. Weekly health and self-care monitoring via mHealth tools may identify intervention effects in mHealth trials that go undetected using typical, infrequent retrospective surveys. Trial Registration: ClinicalTrials.gov NCT00555360; https://clinicaltrials.gov/ct2/show/NCT00555360 (Archived by WebCite at http://www.webcitation.org/6Z4Tsk78B). %M 26063161 %R 10.2196/jmir.4550 %U http://www.jmir.org/2015/6/e142/ %U https://doi.org/10.2196/jmir.4550 %U http://www.ncbi.nlm.nih.gov/pubmed/26063161 %0 Journal Article %@ 1929-0748 %I JMIR Publications Inc. %V 4 %N 2 %P e40 %T Mobile Phone and Tablet Apps to Support Young People’s Management of Their Physical Long-Term Conditions: A Systematic Review Protocol %A Majeed-Ariss,Rabiya %A Hall,Andrew G %A McDonagh,Janet %A Fallon,Deborah %A Swallow,Veronica %+ School of Healthcare, Faculty of Medicine and Health, University of Leeds, Baines Wing, Leeds, LS2 9JT, United Kingdom, 44 0113 243 1751, v.m.swallow@leeds.ac.uk %K mobile app %K mobile phone %K protocol %K smartphone %K tablets %K young people %K long-term conditions %K chronic conditions %K management %K systematic review %D 2015 %7 07.04.2015 %9 Protocol %J JMIR Res Protoc %G English %X Background: The prevalence of long-term or chronic conditions that limit activity and reduce quality of life in young people aged 10-24 years is rising. This group has distinct health care needs and requires tailored support strategies to facilitate increasing personal responsibility for the management of their condition wherever possible, as they mature. Mobile phone and tablet mobile technologies featuring software program apps are already well used by young people for social networking or gaming. They have also been utilized in health care to support personal condition management, using condition-specific and patient-tailored software. Such apps have much potential, and there is an emerging body of literature on their use in a health context making this review timely. Objective: The objective of this paper is to develop a systematic review protocol focused on identifying and assessing the effectiveness of mobile phone and tablet apps that support young people’s management of their chronic conditions. Methods: The search strategy will include a combination of standardized indexed search terms and free-text terms related to the key concepts of young people; long-term conditions and mobile technology. Peer-reviewed journal articles published from 2003 that meet the inclusion and exclusion criteria will be identified through searching the generated hits from 5 bibliographical databases. Two independent reviewers will screen the titles and abstracts to determine which articles focus on testing interventions identified as a mobile phone or tablet apps, and that have been designed and delivered to support the management of long-term conditions in young people aged 10-24 years. Data extraction and quality assessment tools will be used to facilitate consistent analysis and synthesis. It is anticipated that several studies will meet the selection criteria but that these are likely to be heterogeneous in terms of study design, reported outcomes, follow-up times, participants’ age, and health condition. Sub-group analyses will be undertaken and where possible meta-analyses will take place. Results: This review will synthesize available knowledge surrounding tablet and mobile phone apps that support management of long term physical health conditions in young people. The findings will be synthesized to determine which elements of the technologies were most effective for this population. Conclusions: This systematic review aims to synthesize existing literature in order to generate findings that will facilitate the development of an app intervention. The review will form the first phase of development and evaluation of a complex intervention as recommended by the United Kingdom Medical Research Council. The knowledge gained from the review will be verified in subsequent phases, which will include primary qualitative work with health professionals and young people with long term conditions as research participants. Young people living with long-term conditions will be involved as co-researchers and consumer advisors in all subsequent phases to develop and evaluate an app to support the management of long-term physical health conditions. Trial Registration: PROSPERO International prospective register of systematic reviews: CRD42014015418; http://www.crd.york.ac.uk/PROSPERO/display_record.asp?ID=CRD42014015418#.VRqCpTpnL8E (Archived by Webcite at http://www.webcitation.org/6XREcWqQY). %M 25854293 %R 10.2196/resprot.4159 %U http://www.researchprotocols.org/2015/2/e40/ %U https://doi.org/10.2196/resprot.4159 %U http://www.ncbi.nlm.nih.gov/pubmed/25854293 %0 Journal Article %@ 1929-0748 %I JMIR Publications Inc. %V 4 %N 1 %P e31 %T The Mobile Insulin Titration Intervention (MITI) for Insulin Glargine Titration in an Urban, Low-Income Population: Randomized Controlled Trial Protocol %A Levy,Natalie %A Moynihan,Victoria %A Nilo,Annielyn %A Singer,Karyn %A Bernik,Lidia S %A Etiebet,Mary-Ann %A Fang,Yixin %A Cho,James %A Natarajan,Sundar %+ Division of General Internal Medicine and Clinical Innovation, Department of Medicine, New York University School of Medicine, Bellevue CD building, 630, 462 First Ave, New York, NY, 10016, United States, 1 646 501 0691, Victoria.Ramsay@nyumc.org %K patient care management %K delivery of care %K health care disparities %K telemedicine %K remote consultation %D 2015 %7 13.03.2015 %9 Protocol %J JMIR Res Protoc %G English %X Background: Patients on insulin glargine typically visit a clinician to obtain advice on how to adjust their insulin dose. These multiple clinic visits can be costly and time-consuming, particularly for low-income patients. It may be feasible to achieve insulin titration through text messages and phone calls with patients instead of face-to-face clinic visits. Objective: The objectives of this study are to (1) evaluate if the Mobile Insulin Titration Intervention (MITI) is clinically effective by helping patients reach their optimal dose of insulin glargine, (2) determine if the intervention is feasible within the setting and population, (3) assess patient satisfaction with the intervention, and (4) measure the costs associated with this intervention. Methods: This is a pilot study evaluating an approach to insulin titration using text messages and phone calls among patients with insulin-dependent type 2 diabetes in the outpatient medical clinic of Bellevue Hospital Center, a safety-net hospital in New York City. Patients will be randomized in a 1:1 ratio to either the MITI arm (texting/phone call intervention) or the usual-care arm (in-person clinic visits). Using a Web-based platform, weekday text messages will be sent to patients in the MITI arm, asking them to text back their fasting blood glucose values. In addition to daily reviews for alarm values, a clinician will rereview the texted values weekly, consult our physician-approved titration algorithm, and call the patients with advice on how to adjust their insulin dose. The primary outcome will be whether or not a patient reaches his/her optimal dose of insulin glargine within 12 weeks. Results: Recruitment for this study occurred between June 2013 and December 2014. We are continuing to collect intervention and follow-up data from our patients who are currently enrolled. The results of our data analysis are expected to be available in 2015. Conclusions: This study explores the use of widely-available text messaging and voice technologies for insulin titration. We aim to show that remote insulin titration is clinically effective, feasible, satisfactory, and cost saving for low-income patients in a busy, urban clinic. Trial Registration: Trial Registration: Clinicaltrials.gov NCT01879579; http://clinicaltrials.gov/ct2/show/NCT01879579 (Archived by WebCite at http://www.webcitation.org/6WUEgjZUO). %M 25794243 %R 10.2196/resprot.4206 %U http://www.researchprotocols.org/2015/1/e31/ %U https://doi.org/10.2196/resprot.4206 %U http://www.ncbi.nlm.nih.gov/pubmed/25794243 %0 Journal Article %@ 1929-0748 %I JMIR Publications Inc. %V 4 %N 1 %P e33 %T Clinical Effect Size of an Educational Intervention in the Home and Compliance With Mobile Phone-Based Reminders for People Who Suffer From Stroke: Protocol of a Randomized Controlled Trial %A Merchán-Baeza,Jose Antonio %A Gonzalez-Sanchez,Manuel %A Cuesta-Vargas,Antonio %+ Universidad de Malaga, C/ Arquitecto Francisco Peñalosa, Ampliación Campus Teatinos, Malaga, 29071, Spain, Malaga, 29071, Spain, 34 951 952 823, acuesta.var@gmail.com %K stroke %K ADL %K environment %K patient adherence %K mobile apps %K mobile health %D 2015 %7 10.03.2015 %9 Protocol %J JMIR Res Protoc %G English %X Background: Stroke is the third-leading cause of death and the leading cause of long-term neurological disability in the world. Cognitive, communication, and physical weakness combined with environmental changes frequently cause changes in the roles, routines, and daily occupations of stroke sufferers. Educational intervention combines didactic and interactive intervention, which combines the best choices for teaching new behaviors since it involves the active participation of the patient in learning. Nowadays, there are many types of interventions or means to increase adherence to treatment. Objective: The aim of this study is to enable patients who have suffered stroke and been discharged to their homes to improve the performance of the activities of daily living (ADL) in their home environment, based on advice given by the therapist. A secondary aim is that these patients continue the treatment through a reminder app installed on their mobile phones. Methods: This study is a clinical randomized controlled trial. The total sample will consist of 80 adults who have suffered a stroke with moderate severity and who have been discharged to their homes in the 3 months prior to recruitment to the study. The following tests and scales will be used to measure the outcome variables: Barthel Index, the Functional Independence Measure, the Mini-Mental State Examination, the Canadian Neurological Scale, the Stroke Impact Scale-16, the Trunk Control Test, the Modified Rankin Scale, the Multidimensional Scale of Perceived Social Support, the Quality of Life Scale for Stroke, the Functional Reach Test, the Romberg Test, the Time Up and Go test, the Timed-Stands Test, a portable dynamometer, and a sociodemographic questionnaire. Descriptive analyses will include mean, standard deviation, and 95% confidence intervals of the values for each variable. The Kolmogov-Smirnov (KS) test and a 2x2 mixed-model analysis of variance (ANOVA) will be used. Intergroup effect sizes will be calculated (Cohen’s d). Results: Currently, the study is in the recruitment phase and implementation of the intervention has begun. The authors anticipate that during 2015 the following processes should be completed: recruitment, intervention, and data collection. It is expected that the analysis of all data and the first results should be available in early-to-mid 2016. Conclusions: An educational intervention based on therapeutic home advice and a reminder app has been developed by the authors with the intention that patients who have suffered stroke perform the ADL more easily and use their affected limbs more actively in the ADL. The use of reminders via mobile phone is proposed as an innovative tool to increase treatment adherence in this population. Trial Registration: ClinicalTrials.gov NCT01980641; https://clinicaltrials.gov/ct2/show/NCT01980641 (Archived by WebCite at http://www.webcitation.org/6WRWFmY6U). %M 25757808 %R 10.2196/resprot.4034 %U http://www.researchprotocols.org/2015/1/e33/ %U https://doi.org/10.2196/resprot.4034 %U http://www.ncbi.nlm.nih.gov/pubmed/25757808 %0 Journal Article %@ 2291-5222 %I JMIR Publications Inc. %V 3 %N 1 %P e21 %T Qualitative Evaluation of a Text Messaging Intervention to Support Patients With Active Tuberculosis: Implementation Considerations %A Iribarren,Sarah J %A Sward,Katherine A %A Beck,Susan L %A Pearce,Patricia F %A Thurston,Diana %A Chirico,Cristina %+ School of Nursing, Columbia University, 617 West 168th Street, New York, NY, 10032, United States, 1 212 342 0689, si2277@cumc.columbia.edu %K mHealth %K tuberculosis %K sociotechnical evaluation %K text messaging %D 2015 %7 27.02.2015 %9 Original Paper %J JMIR mHealth uHealth %G English %X Background: Tuberculosis (TB) remains a major global public health problem and mobile health (mHealth) interventions have been identified as a modality to improve TB outcomes. TextTB, an interactive text-based intervention to promote adherence with TB medication, was pilot-tested in Argentina with results supporting the implementation of trials at a larger scale. Objective: The objective of this research was to understand issues encountered during pilot-testing in order to inform future implementation in a larger-scale trial. Methods: A descriptive, observational qualitative design guided by a sociotechnical framework was used. The setting was a clinic within a public pulmonary-specialized hospital in Argentina. Data were collected through workflow observation over 115 days, text messages (n=2286), review of the study log, and stakeholder input. Emerging issues were categorized as organizational, human, technical, or sociotechnical considerations. Results: Issues related to the intervention included workflow issues (eg, human, training, security), technical challenges (eg, data errors, platform shortcomings), and message delivery issues (eg, unintentional sending of multiple messages, auto-confirmation problems). System/contextual issues included variable mobile network coverage, electrical and Internet outages, and medication shortages. Conclusions: Intervention challenges were largely manageable during pilot-testing, but need to be addressed systematically before proceeding with a larger-scale trial. Potential solutions are outlined. Findings may help others considering implementing an mHealth intervention to anticipate and mitigate certain challenges. Although some of the issues may be context dependent, other issues such as electrical/Internet outages and limited resources are not unique issues to our setting. Release of new software versions did not result in solutions for certain issues, as specific features used were removed. Therefore, other software options will need to be considered before expanding into a larger-scale endeavor. Improved automation of some features will be necessary, however, a goal will be to retain the intervention capability to be interactive, user friendly, and patient focused. Continued collaboration with stakeholders will be required to conduct further research and to understand how such an mHealth intervention can be effectively integrated into larger health systems. %M 25802968 %R 10.2196/mhealth.3971 %U http://mhealth.jmir.org/2015/1/e21/ %U https://doi.org/10.2196/mhealth.3971 %U http://www.ncbi.nlm.nih.gov/pubmed/25802968 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 17 %N 2 %P e52 %T Impact of mHealth Chronic Disease Management on Treatment Adherence and Patient Outcomes: A Systematic Review %A Hamine,Saee %A Gerth-Guyette,Emily %A Faulx,Dunia %A Green,Beverly B %A Ginsburg,Amy Sarah %+ PATH, 2201 Westlake Ave #200, Seattle, WA, 98121, United States, 1 206 285 3500, egerthguyette@path.org %K telemedicine %K mHealth %K mobile health %K patient compliance %K patient adherence %K chronic disease %K diabetes mellitus %K cardiovascular diseases %K lung diseases %D 2015 %7 24.02.2015 %9 Original Paper %J J Med Internet Res %G English %X Background: Adherence to chronic disease management is critical to achieving improved health outcomes, quality of life, and cost-effective health care. As the burden of chronic diseases continues to grow globally, so does the impact of non-adherence. Mobile technologies are increasingly being used in health care and public health practice (mHealth) for patient communication, monitoring, and education, and to facilitate adherence to chronic diseases management. Objective: We conducted a systematic review of the literature to evaluate the effectiveness of mHealth in supporting the adherence of patients to chronic diseases management (“mAdherence”), and the usability, feasibility, and acceptability of mAdherence tools and platforms in chronic disease management among patients and health care providers. Methods: We searched PubMed, Embase, and EBSCO databases for studies that assessed the role of mAdherence in chronic disease management of diabetes mellitus, cardiovascular disease, and chronic lung diseases from 1980 through May 2014. Outcomes of interest included effect of mHealth on patient adherence to chronic diseases management, disease-specific clinical outcomes after intervention, and the usability, feasibility, and acceptability of mAdherence tools and platforms in chronic disease management among target end-users. Results: In all, 107 articles met all inclusion criteria. Short message service was the most commonly used mAdherence tool in 40.2% (43/107) of studies. Usability, feasibility, and acceptability or patient preferences for mAdherence interventions were assessed in 57.9% (62/107) of studies and found to be generally high. A total of 27 studies employed randomized controlled trial (RCT) methods to assess impact on adherence behaviors, and significant improvements were observed in 15 of those studies (56%). Of the 41 RCTs that measured effects on disease-specific clinical outcomes, significant improvements between groups were reported in 16 studies (39%). Conclusions: There is potential for mHealth tools to better facilitate adherence to chronic disease management, but the evidence supporting its current effectiveness is mixed. Further research should focus on understanding and improving how mHealth tools can overcome specific barriers to adherence. %M 25803266 %R 10.2196/jmir.3951 %U http://www.jmir.org/2015/2/e52/ %U https://doi.org/10.2196/jmir.3951 %U http://www.ncbi.nlm.nih.gov/pubmed/25803266 %0 Journal Article %@ 1929-0748 %I JMIR Publications Inc. %V 4 %N 1 %P e11 %T Scaled-Up Mobile Phone Intervention for HIV Care and Treatment: Protocol for a Facility Randomized Controlled Trial %A L'Engle,Kelly L %A Green,Kimberly %A Succop,Stacey M %A Laar,Amos %A Wambugu,Samuel %+ FHI 360, Social and Behavioral Health Sciences, 359 Blackwell Streeet, Suite 200, Durham, NC, 27701, United States, 1 919 544 7040 ext 11528, klengle@fhi360.org %K implementation science %K mobile phones %K mHealth %K HIV %K AIDS %K HIV care and treatment %K cluster-RCT %K Ghana %D 2015 %7 23.01.2015 %9 Protocol %J JMIR Res Protoc %G English %X Background: Adherence to prevention, care, and treatment recommendations among people living with HIV (PLHIV) is a critical challenge. Yet good clinical outcomes depend on consistent, high adherence to antiretroviral therapy (ART) regimens. Mobile phones offer a promising means to improve patient adherence and health outcomes. However, limited information exists on the impact that mobile phones for health (mHealth) programs have on ART adherence or the behavior change processes through which such interventions may improve patient health, particularly among ongoing clients enrolled in large public sector HIV service delivery programs and key populations such as men who have sex with men (MSM) and female sex workers (FSW). Objective: Our aim is to evaluate an mHealth intervention where text message reminders are used as supportive tools for health providers and as motivators and reminders for ART clients to adhere to treatment and remain linked to care in Ghana. Using an implementation science framework, we seek to: (1) evaluate mHealth intervention effects on patient adherence and health outcomes, (2) examine the delivery of the mHealth intervention for improving HIV care and treatment, and (3) assess the cost-effectiveness of the mHealth intervention. Methods: The 36-month study will use a facility cluster randomized controlled design (intervention vs standard of care) for evaluating the impact of mHealth on HIV care and treatment. Specifically, we will look at ART adherence, HIV viral load, retention in care, and condom use at 6 and 12-month follow-up. In addition, participant adoption and satisfaction with the program will be measured. This robust methodology will be complemented by qualitative interviews to obtain feedback on the motivational qualities of the program and benefits and challenges of delivery, especially for key populations. Cost-effectiveness will be assessed using incremental cost-effectiveness ratios, with health effects expressed in terms of viral load suppression and costs of resources used for the intervention. Results: This study and protocol was fully funded, but it was terminated prior to review from ethics boards and study implementation. Conclusions: This cluster-RCT would have provided insights into the health effects, motivational qualities, and cost-effectiveness of mHealth interventions for PLHIV in public sector settings. We are seeking funding from alternate sources to implement the trial. %M 25650838 %R 10.2196/resprot.3659 %U http://www.researchprotocols.org/2015/1/e11/ %U https://doi.org/10.2196/resprot.3659 %U http://www.ncbi.nlm.nih.gov/pubmed/25650838 %0 Journal Article %@ 2291-5222 %I JMIR Publications Inc. %V 3 %N 1 %P e5 %T Don’t Forget the Doctor: Gastroenterologists’ Preferences on the Development of mHealth Tools for Inflammatory Bowel Disease %A van Mierlo,Trevor %A Fournier,Rachel %A Fedorak,Richard %+ Evolution Health Systems Inc., 1266 Queen Street West, Suite 8, Toronto, ON, M6K1L3, Canada, 1 416 644 8476, tvanmierlo@evolutionhs.com %K mHealth %K adherence %K concordance %K compliance %K shared decision making %K therapeutic alliance %K gastroenterology %K IBD %K ulcerative colitis %D 2015 %7 21.01.2015 %9 Original Paper %J JMIR mHealth uHealth %G English %X Background: Inflammatory bowel disease (IBD) encompasses a number of disorders of the gastrointestinal tract. Treatment for IBD is lifelong and complex, and the majority of IBD patients seek information on the Internet. However, research has found existing digital resources to be of questionable quality and that patients find content lacking. Gastroenterologists are frontline sources of information for North American IBD patients, but their opinions and preferences for digital content, design, and utility have not been investigated. The purpose of this study is to systematically explore gastroenterologists’ perceptions of, and design preferences for, mHealth tools. Objective: Our goal was to critically assess these issues and elicit expert feedback by seeking consensus with Canadian gastroenterologists. Methods: Using a qualitative approach, a closed meeting with 7 gastroenterologists was audio recorded and field notes taken. To synthesize results, an anonymous questionnaire was collected at the end of the session. Participant-led discussion themes included methodological approaches to non-adherence, concordance, patient-centricity, and attributes of digital tools that would be actively supported and promoted. Results: Survey results indicated that 4 of the 7 gastroenterologists had experienced patients bringing digital resources to a visit, but 5 found digital patient resources to be inaccurate or irrelevant. All participants agreed that digital tools were of increasing importance and could be leveraged to aid in consultations and save time. When asked to assess digital attributes that they would be confident to refer patients to, all seven indicated that the inclusion of evidence-based facts were of greatest importance. Patient peer-support networks were deemed an asset but only if closely monitored by experts. When asked about interventions, nearly all (6/7) preferred tools that addressed a mix of compliance and concordance, and only one supported the development of tools that focused on compliance. Participants confirmed that they would actively refer patients and other physicians to digital resources. However, while a number of digital IBD tools exist, gastroenterologists would be reluctant to endorse them. Conclusions: Gastroenterologists appear eager to use digital resources that they believe benefit the physician-patient relationship, but despite the trend of patient-centric tools that focus on concordance (shared decision making and enlightened communication between patients and their health care providers), they would prefer digital tools that highlight compliance (patient following orders). This concordance gap highlights an issue of disparity in digital health: patients may not use tools that physicians promote, and physicians may not endorse tools that patients will use. Further research investigating the concordance gap, and tensions between physician preferences and patient needs, is required. %M 25608628 %R 10.2196/mhealth.3987 %U http://mhealth.jmir.org/2015/1/e5/ %U https://doi.org/10.2196/mhealth.3987 %U http://www.ncbi.nlm.nih.gov/pubmed/25608628 %0 Journal Article %@ 1929-0748 %I JMIR Publications Inc. %V 4 %N 1 %P e1 %T Text Messaging to Improve Hypertension Medication Adherence in African Americans: BPMED Intervention Development and Study Protocol %A Buis,Lorraine R %A Artinian,Nancy T %A Schwiebert,Loren %A Yarandi,Hossein %A Levy,Phillip D %+ University of Michigan, Department of Family Medicine, 1018 Fuller St., Ann Arbor, MI, 48104, United States, 1 734 998 7120, buisl@umich.edu %K mobile phone %K text messaging %K hypertension %K blood pressure %K African Americans %K medication adherence %K mobile health %D 2015 %7 02.01.2015 %9 Protocol %J JMIR Res Protoc %G English %X Background: Hypertension (HTN) is a major public health concern in the United States, with almost 78 million Americans age 20 years and over suffering from the condition. Moreover, HTN is a key risk factor for health disease and stroke. African Americans disproportionately shoulder the burdens of HTN, with greater prevalence, disease severity, earlier onset, and more HTN-related complications than age-matched whites. Medication adherence for the treatment of HTN is poor, with estimates indicating that only about half of hypertensive patients are adherent to prescribed medication regimens. Although no single intervention for improving medication adherence has emerged as superior to others, text message medication reminders have the potential to help improve medication adherence in African Americans with uncontrolled HTN as mobile phone adoption is very high in this population. Objective: The purpose of this two-phased study was to develop (Phase I) and test in a randomized controlled trial (RCT) (Phase II) a text message system, BPMED, to improve the quality of medication management through increasing medication adherence in African Americans with uncontrolled HTN. Methods: In Phase I, we recruited 16 target end-users from a primary care clinic, to assist in the development of BPMED through participating in one of three focus groups. Focus groups sought to gain patient perspectives on HTN, medication adherence, mobile phone use, and the use of text messaging to support medication adherence. Potential intervention designs were presented to participants, and feedback on the designs was solicited. In Phase II, we conducted two pilot RCTs to determine the feasibility, acceptability, and preliminary efficacy of BPMED in primary care and emergency department settings. Both pilot studies recruited approximately 60 participants, who were randomized equally between usual care and the BPMED intervention. Results: Although data collection is now complete, data analysis from the two pilot RCTs is still ongoing and results are expected in 2015. Conclusions: This study was designed to determine preliminary feasibility and acceptability of our approach among African Americans with uncontrolled HTN in primary care and emergency department settings. Results from these studies are of great interest as little work has been done to document the use of text message medication reminders to improve HTN-related outcomes, particularly within underserved urban minorities. Trial Registration: Clinicaltrials.gov NCT01465217; https://clinicaltrials.gov/ct2/show/NCT01465217 (Archived by WebCite at http://www.webcitation.org/6V0tto0lZ). %M 25565680 %R 10.2196/resprot.4040 %U http://www.researchprotocols.org/2015/1/e1/ %U https://doi.org/10.2196/resprot.4040 %U http://www.ncbi.nlm.nih.gov/pubmed/25565680 %0 Journal Article %@ 1929-0748 %I JMIR Publications Inc. %V 3 %N 4 %P e79 %T Improving Outcomes in Cancer Patients on Oral Anti-Cancer Medications Using a Novel Mobile Phone-Based Intervention: Study Design of a Randomized Controlled Trial %A Agboola,Stephen %A Flanagan,Clare %A Searl,Meghan %A Elfiky,Aymen %A Kvedar,Joseph %A Jethwani,Kamal %+ Partners Healthcare Center for Connected Health, 25 New Chardon St., Suite 300, Boston, MA, 02114, United States, 1 617 643 0291, sagboola@partners.org %K cancer %K oral anti-cancer medication %K mobile application %K randomized controlled trial %K self-care %K mHealth %K medication adherence %D 2014 %7 23.12.2014 %9 Protocol %J JMIR Res Protoc %G English %X Background: The widespread and increasing use of oral anti-cancer medications has been ushered in by a rapidly increasing understanding of cancer pathophysiology. Furthermore, their popular ease of administration and potential cost savings has highlighted their central position in the health care system as a whole. These facts have heightened appreciation of the unique challenges associated with the use of oral anti-cancer medications; especially in the long-term use of these medications and the associated side effects that may impede optimal adherence to their use. Therefore, we developed ChemOtheRapy Assistant, CORA, a personalized mobile phone–based self-management application to help cancer patients on oral anti-cancer medications. Objective: Our objective is to evaluate the effect of CORA on adherence to oral anti-cancer medications and other clinically relevant outcomes in the management of patients with renal and prostate cancer. Methods: The study will be implemented as a 2-parallel group randomized controlled trial in 104 patients with renal or prostate cancer on oral anti-cancer medications over a 3-month study period. The intervention group will use CORA in addition to usual care for self-management while the control group will continue care as usual. Medication adherence will be measured objectively by a Medication Event Monitoring System device and is defined as the percentage of prescribed doses taken. We will also assess the effect of the intervention on cancer-related symptoms measured by the MD Anderson Symptom Inventory and unplanned hospital utilizations. Other outcomes that will be measured at study start, midpoint, and endpoint are health-related quality of life, cancer-related fatigue, and anxiety. Group differences in medication adherence will be examined by t tests or by non-parametric Mann-Whitney tests if the data are not normally distributed. Logistic regression will be used to identify potential predictors of adherence. Results: We expect to have results for this study before the end of 2016. Conclusions: This novel mobile phone–enabled, multimodal self-management and educational intervention could lead to improvements in clinical outcomes and serve as a foundation for future mHealth research in improving outcomes for patients on oral anti-cancer medications. %M 25537463 %R 10.2196/resprot.4041 %U http://www.researchprotocols.org/2014/4/e79/ %U https://doi.org/10.2196/resprot.4041 %U http://www.ncbi.nlm.nih.gov/pubmed/25537463 %0 Journal Article %@ 2291-5222 %I JMIR Publications Inc. %V 2 %N 4 %P e44 %T User Preferences and Design Recommendations for an mHealth App to Promote Cystic Fibrosis Self-Management %A Hilliard,Marisa E %A Hahn,Amy %A Ridge,Alana K %A Eakin,Michelle N %A Riekert,Kristin A %+ Johns Hopkins University School of Medicine, Department of Medicine, 5501 Hopkins Bayview Circle, Asthma and Allergy Center 3B.37, Baltimore, MD, 21224, United States, 1 410 550 7755, kriekert@jhmi.edu %K cystic fibrosis %K qualitative research %K mobile health %D 2014 %7 24.10.2014 %9 Original Paper %J JMIR mHealth uHealth %G English %X Background: mHealth apps hold potential to provide automated, tailored support for treatment adherence among individuals with chronic medical conditions. Yet relatively little empirical research has guided app development and end users are infrequently involved in designing the app features or functions that would best suit their needs. Self-management apps may be particularly useful for people with chronic conditions like cystic fibrosis (CF) that have complex, demanding regimens. Objective: The aim of this mixed-methods study was to involve individuals with CF in guiding the development of engaging, effective, user-friendly adherence promotion apps that meet their preferences and self-management needs. Methods: Adults with CF (n=16, aged 21-48 years, 50% male) provided quantitative data via a secure Web survey and qualitative data via semi-structured telephone interviews regarding previous experiences using apps in general and for health, and preferred and unwanted features of potential future apps to support CF self-management. Results: Participants were smartphone users who reported sending or receiving text messages (93%, 14/15) or emails (80%, 12/15) on their smartphone or device every day, and 87% (13/15) said it would be somewhat or very hard to give up their smartphone. Approximately one-half (53%, 8/15) reported having health apps, all diet/weight-related, yet many reported that existing nutrition apps were not well-suited for CF management. Participants wanted apps to support CF self-management with characteristics such as having multiple rather than single functions (eg, simple alarms), being specific to CF, and minimizing user burden. Common themes for desired CF app features were having information at one’s fingertips, automation of disease management activities such as pharmacy refills, integration with smartphones’ technological capabilities, enhancing communication with health care team, and facilitating socialization within the CF community. Opinions were mixed regarding gamification and earning rewards or prizes. Participants emphasized the need for customization options to meet individual preferences and disease management goals. Conclusions: Unique capabilities of emerging smartphone technologies (eg, social networking integration, movement and location detection, integrated sensors, or electronic monitors) make many of these requests possible. Involving end users in all stages of mHealth app development and collaborating with technology experts and the health care system may result in apps that maintain engagement, improve integration and automation, and ultimately impact self-management and health outcomes. %M 25344616 %R 10.2196/mhealth.3599 %U http://mhealth.jmir.org/2014/4/e44/ %U https://doi.org/10.2196/mhealth.3599 %U http://www.ncbi.nlm.nih.gov/pubmed/25344616 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 16 %N 10 %P e222 %T Use of Mobile Phone Text Message Reminders in Health Care Services: A Narrative Literature Review %A Kannisto,Kati Anneli %A Koivunen,Marita Hannele %A Välimäki,Maritta Anneli %+ Department of Nursing Science, University of Turku, Lemminkäisenkatu 1, Turku, 20014, Finland, 358 50 5312652, kaankan@utu.fi %K text messaging %K short message service %K cellular phone %K reminder system %K review %D 2014 %7 17.10.2014 %9 Original Paper %J J Med Internet Res %G English %X Background: Mobile text messages are a widely recognized communication method in societies, as the global penetration of the technology approaches 100% worldwide. Systematic knowledge is still lacking on how the mobile telephone text messaging (short message service, SMS) has been used in health care services. Objective: This study aims to review the literature on the use of mobile phone text message reminders in health care. Methods: We conducted a systematic literature review of studies on mobile telephone text message reminders. The data sources used were PubMed (MEDLINE), CINAHL, Proquest Databases/ PsycINFO, EMBASE, Cochrane Library, Scopus, and hand searching since 2003. Studies reporting the use of SMS intended to remind patients in health services were included. Given the heterogeneity in the studies, descriptive characteristics, purpose of the study, response rates, description of the intervention, dose and timing, instruments, outcome measures, and outcome data from the studies were synthesized using a narrative approach. Results: From 911 initial citations, 60 studies were included in the review. The studies reported a variety of use for SMS. Mobile telephone text message reminders were used as the only intervention in 73% (44/60) of the studies, and in 27% (16/60) of the remaining studies, SMS was connected to another comprehensive health intervention system. SMS reminders were sent to different patient groups: patients with HIV/AIDS (15%, 9/60) and diabetes (13%, 8/60) being the most common groups. The response rates of the studies varied from 22-100%. Typically, the text message reminders were sent daily. The time before the specific intervention to be rendered varied from 10 minutes (eg, medication taken) to 2 weeks (eg, scheduled appointment). A wide range of different evaluation methods and outcomes were used to assess the impact of SMS varying from existing databases (eg, attendance rate based on medical records), questionnaires, and physiological measures. About three quarters of the studies (77%, 46/60) reported improved outcomes: adherence to medication or to treatment reportedly improved in 40% (24/60) of the studies, appointment attendance in 18% (11/60) of the studies, and non-attendance rates decreased in 18% (11/60) of the studies. Other positive impacts were decreased amount of missed medication doses, more positive attitudes towards medication, and reductions in treatment interruptions. Conclusions: We can conclude that although SMS reminders are used with different patient groups in health care, SMS is less systematically studied with randomized controlled trial study design. Although the amount of evidence for SMS application recommendations is still limited, having 77% (46/60) of the studies showing improved outcomes may indicate its use in health care settings. However, more well-conducted SMS studies are still needed. %M 25326646 %R 10.2196/jmir.3442 %U http://www.jmir.org/2014/10/e222/ %U https://doi.org/10.2196/jmir.3442 %U http://www.ncbi.nlm.nih.gov/pubmed/25326646 %0 Journal Article %@ 2291-5222 %I JMIR Publications Inc. %V 2 %N 1 %P e11 %T Evaluating User Perceptions of Mobile Medication Management Applications With Older Adults: A Usability Study %A Grindrod,Kelly Anne %A Li,Melissa %A Gates,Allison %+ School of Pharmacy, Faculty of Science, University of Waterloo, 200 University Avenue, Waterloo, ON, N2L3G1, Canada, 1 519 888 4567 ext 21358, kgrindrod@uwaterloo.ca %K medication therapy management %K medication adherence %K mHealth %K mobile health %D 2014 %7 14.03.2014 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Medication nonadherence has a significant impact on the health and wellbeing of individuals with chronic disease. Several mobile medication management applications are available to help users track, remember, and read about their medication therapy. Objective: The objective of this study was to explore the usability and usefulness of existing medication management applications for older adults. Methods: We recruited 35 participants aged 50 and over to participate in a 2-hour usability session. The average age ranged from 52-78 years (mean 67 years) and 71% (25/35) of participants were female. Each participant was provided with an iPad loaded with four medication management applications: MyMedRec, DrugHub, Pillboxie, and PocketPharmacist. These applications were evaluated using the 10 item System Usability Scale (SUS) and visual analog scale. An investigator-moderated 30-minute discussion followed, and was recorded. We used a grounded theory (GT) approach to analyze qualitative data. Results: When assessing mobile medication management applications, participants struggled to think of a need for the applications in their own lives. Many were satisfied with their current management system and proposed future use only if cognition and health declined. Most participants felt capable of using the applications after a period of time and training, but were frustrated by their initial experiences with the applications. The early experiences of participants highlighted the benefits of linear navigation and clear wording (eg, “undo” vs “cancel”) when designing for older users. While there was no order effect, participants attributed their poor performance to the order in which they tried the applications. They also described being a part of a technology generation that did not encounter the computer until adulthood. Of the four applications, PocketPharmacist was found to be the least usable with a score of 42/100 (P<.0001) though it offered a drug interaction feature that was among the favorite features of participants. The usability scores for MyMedRec (56/100), DrugHub (57/100), and Pillboxie (52/100) were not significantly different and participants preferred MyMedRec and DrugHub for their simple, linear interfaces. Conclusions: With training, adults aged 50 and over can be capable and interested in using mHealth applications for their medication management. However, in order to adopt such technology, they must find a need that their current medication management system cannot fill. Interface diversity and multimodal reminder methods should be considered to increase usability for older adults. Lastly, regulation or the involvement of older adults in development may help to alleviate generation bias and mistrust for applications. %M 25099993 %R 10.2196/mhealth.3048 %U http://mhealth.jmir.org/2014/1/e11/ %U https://doi.org/10.2196/mhealth.3048 %U http://www.ncbi.nlm.nih.gov/pubmed/25099993 %0 Journal Article %@ 14388871 %I JMIR Publications Inc. %V 15 %N 7 %P e141 %T Assessing Adolescent Asthma Symptoms and Adherence Using Mobile Phones %A Mulvaney,Shelagh A %A Ho,Yun-Xian %A Cala,Cather M %A Chen,Qingxia %A Nian,Hui %A Patterson,Barron L %A Johnson,Kevin B %+ School of Nursing, Vanderbilt University School of Medicine, 461 21st Ave, Nashville, TN, 37240, United States, 1 615 322 1198, shelagh.mulvaney@vanderbilt.edu %K asthma %K adherence %K mobile technology %K adolescent %K assessment %D 2013 %7 17.07.2013 %9 Original Paper %J J Med Internet Res %G English %X Background: Self-report is the most common method of measuring medication adherence but is influenced by recall error and response bias, and it typically does not provide insight into the causes of poor adherence. Ecological momentary assessment (EMA) of health behaviors using mobile phones offers a promising alternative to assessing adherence and collecting related data that can be clinically useful for adherence problem solving. Objective: To determine the feasibility of using EMA via mobile phones to assess adolescent asthma medication adherence and identify contextual characteristics of adherence decision making. Methods: We utilized a descriptive and correlational study design to explore a mobile method of symptom and adherence assessment using an interactive voice response system. Adolescents aged 12-18 years with a diagnosis of asthma and prescribed inhalers were recruited from an academic medical center. A survey including barriers to mobile phone use, the Illness Management Survey, and the Pediatric Asthma Quality of Life Questionnaire were administered at baseline. Quantitative and qualitative assessment of asthma symptoms and adherence were conducted with daily calls to mobile phones for 1 month. The Asthma Control Test (ACT) was administered at 2 study time points: baseline and 1 month after baseline. Results: The sample consisted of 53 adolescents who were primarily African American (34/53, 64%) and female (31/53, 58%) with incomes US$40K/year or lower (29/53, 55%). The majority of adolescents (37/53, 70%) reported that they carried their phones with them everywhere, but only 47% (25/53) were able to use their mobile phone at school. Adolescents responded to an average of 20.1 (SD 8.1) of the 30 daily calls received (67%). Response frequency declined during the last week of the month (b=-0.29, P<.001) and was related to EMA-reported levels of rescue inhaler adherence (r= 0.33, P=.035). Using EMA, adolescents reported an average of 0.63 (SD 1.2) asthma symptoms per day and used a rescue inhaler an average of 70% of the time (SD 35%) when they experienced symptoms. About half (26/49, 53%) of the instances of nonadherence took place in the presence of friends. The EMA-measured adherence to rescue inhaler use correlated appropriately with asthma control as measured by the ACT (r=-0.33, P=.034). Conclusions: Mobile phones provided a feasible method to assess asthma symptoms and adherence in adolescents. The EMA method was consistent with the ACT, a widely established measure of asthma control, and results provided valuable insights regarding the context of adherence decision making that could be used clinically for problem solving or as feedback to adolescents in a mobile or Web-based support system. %M 23864345 %R 10.2196/jmir.2413 %U http://www.jmir.org/2013/7/e141/ %U https://doi.org/10.2196/jmir.2413 %U http://www.ncbi.nlm.nih.gov/pubmed/23864345 %0 Journal Article %@ 2291-5222 %I JMIR Publications Inc. %V 1 %N 2 %P e10 %T iMHere: A Novel mHealth System for Supporting Self-Care in Management of Complex and Chronic Conditions %A Parmanto,Bambang %A Pramana,Gede %A Yu,Daihua Xie %A Fairman,Andrea D %A Dicianno,Brad E %A McCue,Michael P %+ Department of Health Information Management, School of Health & Rehabilitation Sciences, University of Pittsburgh, 6026 Forbes Tower, University of Pittsburgh, Pittsburgh, PA, PA 15243, United States, 1 412 383 6649, parmanto@pitt.edu %K mobile health %K mhealth %K self-care %K clinician-directed self-care %K self-management %K telehealth %K telemedicine %K smartphone %K chronic disease management %K spina bifida %K patient-clinician communications %D 2013 %7 11.07.2013 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Individuals with chronic conditions are vulnerable to secondary complications that can be prevented with adherence to self-care routines. They benefit most from receiving effective treatments beyond acute care, usually in the form of regular follow-up and self-care support in their living environments. One such population is individuals with spina bifida (SB), the most common permanently disabling birth defect in the United States. A Wellness Program at the University of Pittsburgh in which wellness coordinators supervise the care of individuals with chronic disease has produced remarkably improved outcomes. However, time constraints and travel costs have limited its scale. Mobile telehealth service delivery is a potential solution for improving access to care for a larger population. Objective: The project’s goal was to develop and implement a novel mHealth system to support complex self-care tasks, continuous adherence to regimens, monitoring of adherence, and secure two-way communications between patients and clinicians. Methods: We developed and implemented a novel architecture of mHealth system called iMHere (iMobile Health and Rehabilitation) consisting of smartphone apps, a clinician portal, and a two-way communication protocol connecting the two. The process of implementing iMHere consisted of: (1) requirement analysis to identify clinically important functions that need to be supported, (2) design and development of the apps and the clinician portal, (3) development of efficient real-time bi-directional data exchange between the apps and the clinician portal, (4) usability studies on patients, and (5) implementation of the mHealth system in a clinical service delivery. Results: There were 9 app features identified as relevant, and 5 apps were considered priority. There were 5 app features designed and developed to address the following issues: medication, skin care, bladder self-catheterization, bowel management, and mental health. The apps were designed to support a patient’s self-care tasks, send adherence data to the clinician portal, and receive personalized regimens from the portal. The Web-based portal was designed for clinicians to monitor patients’ conditions and to support self-care regimens. The two-way communication protocol was developed to facilitate secure and efficient data exchange between the apps and the portal. The 3 phases of usability study discovered usability issues in the areas of self-care workflow, navigation and interface, and communications between the apps and the portal. The system was used by 14 patients in the first 6 months of the clinical implementation, with 1 drop out due to having a poor wireless connection. The apps have been highly utilized consistently by patients, even those addressing complex issues such as medication and skincare. The patterns of utilization showed an increase in use in the first month, followed by a plateau. Conclusions: The system was capable of supporting self-care and adherence to regimen, monitoring adherence, supporting clinician engagement with patients, and has been highly utilized. %M 25100682 %R 10.2196/mhealth.2391 %U http://mhealth.jmir.org/2013/2/e10/ %U https://doi.org/10.2196/mhealth.2391 %U http://www.ncbi.nlm.nih.gov/pubmed/25100682 %0 Journal Article %@ 1929-0748 %I JMIR Publications Inc. %V 1 %N 2 %P e8 %T Mobile.net: Mobile Telephone Text Messages to Encourage Adherence to Medication and to Follow up With People With Psychosis: Methods and Protocol for a Multicenter Randomized Controlled Two-Armed Trial %A Välimäki,Maritta %A Hätönen,Heli %A Adams,Clive E %+ Department of Nursing Science, University of Turku and Southwest Hospital District, Lemminkäisenkatu 1, University of Turku, 20014, Finland, 358 406890546, mava@utu.fi %K Adherence %K text messages %K psychosis %D 2012 %7 02.08.2012 %9 Protocol %J JMIR Res Protoc %G English %X Background: Schizophrenia is a high-cost, chronic, serious mental illness. There is a clear need to improve treatments and expand access to care for persons with schizophrenia, but simple, tailored interventions are missing. Objective: To evaluate the impact of tailored mobile telephone text messages to encourage adherence to medication and to follow up with people with psychosis at 12 months. Methods: Mobile.Net is a pragmatic randomized trial with inpatient psychiatric wards allocated to two parallel arms. The trial will include 24 sites and 45 psychiatric hospital wards providing inpatient care in Finland. The participants will be adult patients aged 18–65 years, of either sex, with antipsychotic medication (Anatomical Therapeutic Chemical classification 2011) on discharge from a psychiatric hospital, who have a mobile phone, are able to use the Finnish language, and are able to give written informed consent to participate in the study. The intervention group will receive semiautomatic system (short message service [SMS]) messages after they have been discharged from the psychiatric hospital. Patients will choose the form, content, timing, and frequency of the SMS messages related to their medication, keeping appointments, and other daily care. SMS messages will continue to the end of the study period (12 months) or until participants no longer want to receive the messages. Patients will be encouraged to contact researchers if they feel that they need to adjust the message in any way. At all times, both groups will receive usual care at the discretion of their team (psychiatry and nursing). The primary outcomes are service use and healthy days by 12 months based on routine data (admission to a psychiatric hospital, time to next hospitalization, time in hospital during this year, and healthy days). The secondary outcomes are service use, coercive measures, medication, adverse events, satisfaction with care, the intervention, and the trial, social functioning, and economic factors. Data will be collected 12 months after baseline. The outcomes are based on the national health registers and patients’ subjective evaluations. The primary analysis will be by intention-to-treat. Trial Registration: International Standard Randomised Controlled Trial Number (ISRCTN): 27704027; http://www.controlled-trials.com/ISRCTN27704027 (Archived by WebCite at http://www.webcitation.org/69FkM4vcq) %M 23611874 %R 10.2196/resprot.2136 %U http://www.researchprotocols.org/2012/2/e8/ %U https://doi.org/10.2196/resprot.2136 %U http://www.ncbi.nlm.nih.gov/pubmed/23611874