@Article{info:doi/10.2196/64208, author="Liao, Wan-Chuen and Angus, Fiona and Conley, Jane and Chen, Li-Chia", title="The Efficacy of Digital Interventions on Adherence to Oral Systemic Anticancer Therapy Among Patients With Cancer: Systematic Review and Meta-Analysis", journal="JMIR Cancer", year="2025", month="Apr", day="16", volume="11", pages="e64208", keywords="efficacy", keywords="digital interventions", keywords="oral systemic anticancer therapy", keywords="medication adherence", keywords="cancer", keywords="oral", keywords="patients with cancer", keywords="therapy", keywords="systematic review", keywords="meta-analysis", keywords="care plans", keywords="medication", keywords="treatments", keywords="mobile app", keywords="mobile applications", keywords="mHealth", keywords="multimedia platforms", keywords="digital technology", keywords="self-reported", keywords="mobile phone", abstract="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 (I{\texttwosuperior}=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 ", doi="10.2196/64208", url="https://cancer.jmir.org/2025/1/e64208" } @Article{info:doi/10.2196/53144, author="Paneerselvam, Sritheran Ganesh and Lua, Lin Pei and Chooi, Han Wen and Rehman, Ur Inayat and Goh, Wen Khang and Ming, Chiau Long", title="Effectiveness of Mobile Apps in Improving Medication Adherence Among Chronic Kidney Disease Patients: Systematic Review", journal="J Med Internet Res", year="2025", month="Apr", day="16", volume="27", pages="e53144", keywords="mobile applications", keywords="medication adherence", keywords="chronic kidney disease", keywords="health outcomes", keywords="mobile health", keywords="mhealth", keywords="digital health", keywords="kidney disease", keywords="patient education", keywords="medication monitoring", keywords="e-medication", keywords="electronic medication", abstract="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. ", doi="10.2196/53144", url="https://www.jmir.org/2025/1/e53144" } @Article{info:doi/10.2196/55846, author="Abdullah, Nailah Nik and Tang, Jia and Fetrati, Hemad and Kaukiah, Binti Nor Fadhilah and Saharudin, Bin Sahrin and Yong, Sim Vee and Yen, How Chia", title="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", journal="JMIR Cardio", year="2025", month="Apr", day="10", volume="9", pages="e55846", keywords="heart failure", keywords="medication adherence", keywords="self-monitoring", keywords="chatbot", keywords="conversational agent", keywords="Wizard of Oz", keywords="digital health", abstract="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. ", doi="10.2196/55846", url="https://cardio.jmir.org/2025/1/e55846" } @Article{info:doi/10.2196/60758, author="Caballero Mateos, Irene and Morales Portillo, Crist{\'o}bal and Lainez L{\'o}pez, Mar{\'i}a and Vilches-Arenas, {\'A}ngel", title="Efficacy of a Digital Educational Intervention for Patients With Type 2 Diabetes Mellitus: Multicenter, Randomized, Prospective, 6-Month Follow-Up Study", journal="J Med Internet Res", year="2025", month="Apr", day="10", volume="27", pages="e60758", keywords="body composition", keywords="type 2 diabetes mellitus", keywords="digital", keywords="metabolic control", keywords="social networks", keywords="satisfaction", keywords="telemedicine", abstract="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\%; $\chi$21=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 ", doi="10.2196/60758", url="https://www.jmir.org/2025/1/e60758" } @Article{info:doi/10.2196/65668, author="Han, Seunghoon and Song, Jihong and Han, Sungpil and Choi, Suein and Lim, Jonghyuk and Oh, Yeob Byeong and Shin, Dongoh", title="Participant Adherence in Repeated-Dose Clinical Studies Using Video-Based Observation: Retrospective Data Analysis", journal="JMIR Mhealth Uhealth", year="2025", month="Apr", day="7", volume="13", pages="e65668", keywords="adherence", keywords="mobile health", keywords="self-administration", keywords="repeated-dose clinical trials", keywords="video-based monitoring", keywords="mobile phone", abstract="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. ", doi="10.2196/65668", url="https://mhealth.jmir.org/2025/1/e65668" } @Article{info:doi/10.2196/65268, author="Wang, Honghong and Qin, Ziqi and Li, Yixuan and Duan, Yuqiong and Lu, Qiaoyue and Xiao, Xueling", title="Effect of a WeChat-Based Hybrid Intervention on the Adaptation Outcomes of People Living With HIV/AIDS: Pilot Randomized Controlled Trial", journal="J Med Internet Res", year="2025", month="Apr", day="3", volume="27", pages="e65268", keywords="HIV/AIDS", keywords="quality of life", keywords="acceptance of illness", keywords="mental health", keywords="randomized controlled trial", keywords="mobile phone", abstract="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 ($\beta$ 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 ", doi="10.2196/65268", url="https://www.jmir.org/2025/1/e65268", url="http://www.ncbi.nlm.nih.gov/pubmed/39988931" } @Article{info:doi/10.2196/58837, author="Flo, L. Gayle and Alzate Aguirre, Mateo and Gochanour, R. Benjamin and Hynes, J. Kristin and Scott, G. Christopher and Fink, L. Angela and M Arruda-Olson, Adelaide", title="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", journal="JMIR Cardio", year="2025", month="Mar", day="28", volume="9", pages="e58837", keywords="coronary disease", keywords="follow-up studies", keywords="lipids", keywords="myocardial infarction", keywords="statins", abstract="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. ", doi="10.2196/58837", url="https://cardio.jmir.org/2025/1/e58837" } @Article{info:doi/10.2196/59953, author="Gicquelais, E. Rachel and Conway, Caitlin and Vjorn, Olivia and Genz, Andrew and Kirk, Gregory and Westergaard, Ryan", title="Mobile Health Tool to Capture Social Determinants of Health and Their Impact on HIV Treatment Outcomes Among People Who Use Drugs: Pilot Feasibility Study", journal="JMIR Form Res", year="2025", month="Mar", day="26", volume="9", pages="e59953", keywords="HIV", keywords="drug use", keywords="social determinants of health", keywords="mobile health", keywords="mHealth", keywords="smartphone", abstract="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. ", doi="10.2196/59953", url="https://formative.jmir.org/2025/1/e59953" } @Article{info:doi/10.2196/67246, author="Zhou, Xu-Hua and Chen, Hui and Yang, Weiwei and Wang, Li and Chen, Lin and Zhu, Ying and Zhang, Yingjun and Shi, Mei and Zhang, Qin", title="Efficacy of eHealth Interventions for Hemodialysis Patients: Systematic Review and Meta-Analysis", journal="J Med Internet Res", year="2025", month="Mar", day="26", volume="27", pages="e67246", keywords="hemodialysis", keywords="eHealth interventions", keywords="quality of life", keywords="treatment adherence", keywords="anxiety", keywords="depression", keywords="meta-analysis", keywords="kidney", keywords="systematic review", keywords="kidney diseases", keywords="kidney function", keywords="chronic diseases", abstract="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 ", doi="10.2196/67246", url="https://www.jmir.org/2025/1/e67246" } @Article{info:doi/10.2196/69204, author="Du, ShanShan and Zhao, Yining", title="Enhancing Digital Health Interventions for Medication Adherence: Considerations for Broader Applicability and Long-Term Impact", journal="J Med Internet Res", year="2025", month="Mar", day="14", volume="27", pages="e69204", keywords="mobile apps", keywords="digital health", keywords="atrial fibrillation", keywords="anticoagulants", keywords="medication adherence", keywords="mobile phone", doi="10.2196/69204", url="https://www.jmir.org/2025/1/e69204" } @Article{info:doi/10.2196/59780, author="Dos Santos, Cristina Fabiana and Brin, Maeve and Tanner, R. Mary and Galindo, A. Carla and Schnall, Rebecca", title="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", journal="JMIR Hum Factors", year="2025", month="Feb", day="28", volume="12", pages="e59780", keywords="HIV prevention", keywords="data visualization", keywords="patient-reported health information", keywords="mHealth", keywords="digital health", keywords="usability", keywords="human immunodeficiency virus", keywords="preexposure prophylaxis", keywords="men who have sex with men", keywords="apps", keywords="HIV", keywords="PrEP", abstract="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. ", doi="10.2196/59780", url="https://humanfactors.jmir.org/2025/1/e59780" } @Article{info:doi/10.2196/58341, author="Reilly, Rachel and McKetin, Rebecca and Barzi, Federica and Degan, Tayla and Ezard, Nadine and Conigrave, Katherine and Butt, Julia and Roe, Yvette and Wand, Handan and Quinn, Brendan and Longbottom, Wade and Treloar, Carla and Dunlop, Adrian and Ward, James", title="Web-Based Application for Reducing Methamphetamine Use Among Aboriginal and Torres Strait Islander People: Randomized Waitlist Controlled Trial", journal="J Med Internet Res", year="2025", month="Feb", day="28", volume="27", pages="e58341", keywords="methamphetamine", keywords="Aboriginal and Torres Strait Islander Health", keywords="web-based intervention", keywords="randomised controlled trial", keywords="therapeutic program", keywords="methamphetamine use", keywords="substance use", keywords="digital interventions", keywords="treatment", keywords="psychosocial wellbeing", keywords="effectiveness", keywords="app", keywords="psychosocial distress", keywords="mobile phone", abstract="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 ", doi="10.2196/58341", url="https://www.jmir.org/2025/1/e58341", url="http://www.ncbi.nlm.nih.gov/pubmed/40053754" } @Article{info:doi/10.2196/65302, author="Dang, Ha Thu and Wickramasinghe, Nilmini and Jayaraman, Prakash Prem and Burbury, Kate and Alexander, Marliese and Whitechurch, Ashley and Dyer, Mitchell and Quinn, Stephen and Forkan, Mohammad Abdur Rahim and Schofield, Penelope", title="Digital Solution to Support Medication Adherence and Self-Management in Patients with Cancer (SAMSON): Pilot Randomized Controlled Trial", journal="JMIR Form Res", year="2025", month="Feb", day="19", volume="9", pages="e65302", keywords="home-based cancer treatment", keywords="smartphone app", keywords="oral chemotherapy", keywords="patient safety", keywords="SAMSON", keywords="mobile phone", keywords="digital solution", keywords="medication adherence", keywords="self-management", keywords="cancer", keywords="randomized controlled trial", keywords="RCT", keywords="pilot study", keywords="oncology", keywords="mobile health", keywords="mHealth", keywords="quality of life", keywords="eHealth", abstract="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 ", doi="10.2196/65302", url="https://formative.jmir.org/2025/1/e65302", url="http://www.ncbi.nlm.nih.gov/pubmed/39969972" } @Article{info:doi/10.2196/60256, author="Lunde, Pernille and Bye, Asta and Grimsmo, Jostein and Pripp, Hugo Are and Ritschel, Vibeke and Jarstad, Even and Nilsson, Blakstad Birgitta", title="Effects of Individualized Follow-Up With an App Postcardiac Rehabilitation: Five-Year Follow-Up of a Randomized Controlled Trial", journal="J Med Internet Res", year="2025", month="Feb", day="13", volume="27", pages="e60256", keywords="mHealth", keywords="cardiac rehabilitation", keywords="mobile phone app", keywords="smartphone", keywords="lifestyle", abstract="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) ", doi="10.2196/60256", url="https://www.jmir.org/2025/1/e60256" } @Article{info:doi/10.2196/56737, author="Xiao, Jian and Li, Mengyao and Cai, Ruwen and Huang, Hangxing and Yu, Huimin and Huang, Ling and Li, Jingyang and Yu, Ting and Zhang, Jiani and Cheng, Shuqiao", title="Smart Pharmaceutical Monitoring System With Personalized Medication Schedules and Self-Management Programs for Patients With Diabetes: Development and Evaluation Study", journal="J Med Internet Res", year="2025", month="Feb", day="11", volume="27", pages="e56737", keywords="pharmaceutical services", keywords="diabetes", keywords="self-management", keywords="intelligent medication scheduling system", keywords="drug database", keywords="GPT-4", abstract="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. ", doi="10.2196/56737", url="https://www.jmir.org/2025/1/e56737" } @Article{info:doi/10.2196/65141, author="Hossain, Rubana Sheikh and Samant, N. Akanksha and Balsamo, C. Briana and Hawley, E. Chelsea and Zanchelli, C. Michael and Zhu, Carolyn and Venegas, D. Maria and Robertson, Marina and McCullough, B. Megan and Beizer, L. Judith and Boockvar, S. Kenneth and Siu, L. Albert and Moo, R. Lauren and Hung, W. William", title="Effect of Medication Management at Home via Pharmacist-Led Home Televisits: Protocol for a Cluster Randomized Controlled Trial", journal="JMIR Res Protoc", year="2025", month="Feb", day="5", volume="14", pages="e65141", keywords="older adults", keywords="medication management", keywords="televisit", keywords="polypharmacy", keywords="adverse drug reaction", abstract="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 ", doi="10.2196/65141", url="https://www.researchprotocols.org/2025/1/e65141" } @Article{info:doi/10.2196/58938, author="Fraterman, Itske and Sacchi, Lucia and Mallo, Henk and Tibollo, Valentina and Glaser, Catherina Savannah Lucia and Medlock, Stephanie and Cornet, Ronald and Gabetta, Matteo and Hisko, Vitali and Khadakou, Vadzim and Barkan, Ella and Del Campo, Laura and Glasspool, David and Kogan, Alexandra and Lanzola, Giordano and Leizer, Roy and Ottaviano, Manuel and Peleg, Mor and ?niata?a, Konrad and Lisowska, Aneta and Wilk, Szymon and Parimbelli, Enea and Quaglini, Silvana and Rizzo, Mimma and Locati, Deborah Laura and Boekhout, Annelies and van de Poll-Franse, V. Lonneke and Wilgenhof, Sofie", title="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", journal="JMIR Cancer", year="2025", month="Jan", day="30", volume="11", pages="e58938", keywords="eHealth", keywords="melanoma", keywords="cancer", keywords="fatigue", keywords="quality of life", keywords="intervention", keywords="pilot study", keywords="exploratory", keywords="health-related", keywords="interventions", keywords="symptom", keywords="monitoring", keywords="well-being", keywords="immunotherapy", keywords="immune-related", keywords="immune-checkpoint inhibitor", keywords="patient", keywords="feasibility", keywords="smartphone", keywords="app", keywords="smartwatch", keywords="linear regression model", keywords="mobile phone", abstract="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 ($\beta$=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 ", doi="10.2196/58938", url="https://cancer.jmir.org/2025/1/e58938" } @Article{info:doi/10.2196/57540, author="Del Moral Trinidad, Eduardo Luis and Andrade Villanueva, Federico Jaime and Mart{\'i}nez Ayala, Pedro and Cabrera Silva, Ismael Rodolfo and Herrera Godina, Guadalupe Melva and Gonz{\'a}lez-Hern{\'a}ndez, Alicia Luz", title="Effectiveness of an mHealth Intervention With Short Text Messages to Promote Treatment Adherence Among HIV-Positive Mexican Adults: Randomized Controlled Trial", journal="JMIR Mhealth Uhealth", year="2025", month="Jan", day="28", volume="13", pages="e57540", keywords="HIV", keywords="treatment adherence", keywords="mobile health", keywords="mHealth", keywords="mHealth intervention", keywords="randomized clinical trial", keywords="text messages", keywords="eHealth intervention", keywords="sexual health", keywords="randomized controlled trial", keywords="RCT", abstract="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/$\mu$L vs 290 cells/$\mu$L; 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 ", doi="10.2196/57540", url="https://mhealth.jmir.org/2025/1/e57540" } @Article{info:doi/10.2196/50828, author="Bugnon, Benjamin and Bosisio, Francesca and Kaufmann, Alain and Bonnabry, Pascal and Geissbuhler, Antoine and von Plessen, Christian", title="Value Propositions for Digital Shared Medication Plans to Boost Patient--Health Care Professional Partnerships: Co-Design Study", journal="J Particip Med", year="2025", month="Jan", day="28", volume="17", pages="e50828", keywords="digital shared medication plan", keywords="medication records", keywords="medication list", keywords="e-medication", keywords="interoperability", keywords="electronic patient records", keywords="patient involvement", keywords="partnership", keywords="coproduction", keywords="medication safety", abstract="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. ", doi="10.2196/50828", url="https://jopm.jmir.org/2025/1/e50828" } @Article{info:doi/10.2196/50693, author="Ehrler, Frederic and Gschwind, Liliane and Hagberg, Hamdi and Meyer, Philippe and Blondon, Katherine", title="A Medication Management App (Smart-Meds) for Patients After an Acute Coronary Syndrome: Pilot Pre-Post Mixed Methods Study", journal="JMIR Cardio", year="2025", month="Jan", day="23", volume="9", pages="e50693", keywords="medication adherence", keywords="gamified app", keywords="narration", keywords="acute coronary syndrome", keywords="beliefs about medication", keywords="self-reported adherence", keywords="pilot study", keywords="usability evaluation", keywords="storytelling component", abstract="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. ", doi="10.2196/50693", url="https://cardio.jmir.org/2025/1/e50693" } @Article{info:doi/10.2196/60326, author="Kirkham, M. Aidan and Fergusson, A. Dean and Presseau, Justin and McIsaac, I. Daniel and Shorr, Risa and Roberts, J. Derek", title="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", journal="JMIR Res Protoc", year="2025", month="Jan", day="16", volume="14", pages="e60326", keywords="coronary artery disease", keywords="cerebrovascular disease", keywords="peripheral artery disease", keywords="polyvascular disease", keywords="underprescription", keywords="nonadherence", keywords="implementation strategy", keywords="adherence-supporting strategy", keywords="statins", keywords="antiplatelets", keywords="antihypertensives", keywords="guideline-recommended medications", keywords="implementation", keywords="atherosclerosis", keywords="patient adherence", keywords="RCT", keywords="randomized controlled trials", keywords="PRISMA", abstract="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 ", doi="10.2196/60326", url="https://www.researchprotocols.org/2025/1/e60326" } @Article{info:doi/10.2196/57991, author="Sekandi, Nabbuye Juliet and Buregyeya, Esther and Zalwango, Sarah and Nakkonde, Damalie and Kaggwa, Patrick and Quach, Thu Trang Ho and Asiimwe, David and Atuyambe, Lynn and Dobbin, Kevin", title="Effectiveness of a Mobile Health Intervention (DOT Selfie) in Increasing Treatment Adherence Monitoring and Support for Patients With Tuberculosis in Uganda: Randomized Controlled Trial", journal="JMIR Mhealth Uhealth", year="2025", month="Jan", day="16", volume="13", pages="e57991", keywords="tuberculosis", keywords="digital adherence technologies", keywords="video-observed treatment", keywords="video directly observed treatment", keywords="directly observed therapy", keywords="adherence", keywords="mHealth", keywords="Uganda", keywords="Africa", abstract="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 ", doi="10.2196/57991", url="https://mhealth.jmir.org/2025/1/e57991", url="http://www.ncbi.nlm.nih.gov/pubmed/39715573" } @Article{info:doi/10.2196/53971, author="Hoeppner, B. Bettina and Siegel, R. Kaitlyn and Futter, E. Allison and Finley-Abboud, Diadora and Williamson, C. Alivia and Kahler, W. Christopher and Park, R. Elyse and Hoeppner, S. Susanne", title="Smoking Cessation Smartphone App for Nondaily Smoking With Telephone Onboarding: Proof-of-Concept Randomized Controlled Trial", journal="JMIR Mhealth Uhealth", year="2025", month="Jan", day="15", volume="13", pages="e53971", keywords="mobile health", keywords="mHealth", keywords="smoking cessation", keywords="nondaily smoking", keywords="smartphone", keywords="smoking", keywords="positive psychology", keywords="mobile phone", abstract="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 ", doi="10.2196/53971", url="https://mhealth.jmir.org/2025/1/e53971" } @Article{info:doi/10.2196/63653, author="Hartch, Christa and Dietrich, S. Mary and Lancaster, Jeanette B. and Mulvaney, A. Shelagh and Stolldorf, P. Deonni", title="Satisfaction and Usability of a Commercially Available Medication Adherence App (Medisafe) Among Medically Underserved Patients With Chronic Illnesses: Survey Study", journal="JMIR Hum Factors", year="2025", month="Jan", day="7", volume="12", pages="e63653", keywords="medication adherence", keywords="mHealth", keywords="mobile phone", keywords="app", keywords="medically underserved", keywords="chronic disease", keywords="satisfaction", keywords="usage", keywords="health disparities", abstract="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 ", doi="10.2196/63653", url="https://humanfactors.jmir.org/2025/1/e63653" } @Article{info:doi/10.2196/57458, author="Gon{\c{c}}alves, Ana and Sim{\~o}es, Augusto Pedro and Sousa-Pinto, Bernardo and Taveira-Gomes, Tiago", title="Use of Extrinsic Motivators to Improve the BMI of Obese or Overweight Adolescents: Systematic Review", journal="J Med Internet Res", year="2024", month="Dec", day="30", volume="26", pages="e57458", keywords="adolescents", keywords="obesity", keywords="overweight", keywords="extrinsic motivators", keywords="body mass index", abstract="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. ", doi="10.2196/57458", url="https://www.jmir.org/2024/1/e57458", url="http://www.ncbi.nlm.nih.gov/pubmed/39576963" } @Article{info:doi/10.2196/57774, author="Mi, Z. Ranran and Yang, Fan Ellie and Tahk, Alexander and Tarfa, Adati and Cotter, M. Lynne and Lu, Linqi and Yang, Sijia and Gustafson Sr, H. David and Westergaard, Ryan and Shah, Dhavan", title="mHealth Engagement for Antiretroviral Medication Adherence Among People With HIV and Substance Use Disorders: Observational Study", journal="J Med Internet Res", year="2024", month="Dec", day="20", volume="26", pages="e57774", keywords="information and communication technologies", keywords="ICTs", keywords="mHealth", keywords="medication adherence", keywords="HIV care", keywords="antiretroviral therapy", keywords="substance use", keywords="social support", keywords="patient management", keywords="health disparities", keywords="information technology", keywords="communication technology", keywords="mobile health", keywords="app", keywords="clinic", keywords="United States", keywords="participants", keywords="mobile phone", abstract="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. ", doi="10.2196/57774", url="https://www.jmir.org/2024/1/e57774" } @Article{info:doi/10.2196/58920, author="Lin, Bing and Li, Jiayan and Liu, Jiaxiu and He, Wei and Pan, Haiying and Zhong, Xiaoni", title="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", journal="JMIR Mhealth Uhealth", year="2024", month="Dec", day="12", volume="12", pages="e58920", keywords="preexposure prophylaxis", keywords="adherence", keywords="trajectory analysis", keywords="men who have sex with men", keywords="mHealth", keywords="mobile health", keywords="mHealth intervention", keywords="decision tree", abstract="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 ", doi="10.2196/58920", url="https://mhealth.jmir.org/2024/1/e58920" } @Article{info:doi/10.2196/56763, author="Zheng, Yaguang and Adhikari, Samrachana and Li, Xiyue and Zhao, Yunan and Mukhopadhyay, Amrita and Hamo, E. Carine and Stokes, Tyrel and Blecker, Saul", title="Association Between Video-Based Telemedicine Visits and Medication Adherence Among Patients With Heart Failure: Retrospective Cross-Sectional Study", journal="JMIR Cardio", year="2024", month="Dec", day="5", volume="8", pages="e56763", keywords="telemedicine", keywords="medication adherence", keywords="heart failure", keywords="systolic dysfunction", keywords="medical therapy", keywords="telehealth", keywords="remote monitoring", keywords="self-management", abstract="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. ", doi="10.2196/56763", url="https://cardio.jmir.org/2024/1/e56763" } @Article{info:doi/10.2196/57652, author="Iino, Haru and Kizaki, Hayato and Imai, Shungo and Hori, Satoko", title="Medication Management Initiatives Using Wearable Devices: Scoping Review", journal="JMIR Hum Factors", year="2024", month="Nov", day="27", volume="11", pages="e57652", keywords="medication adherence", keywords="scoping review", keywords="database search", keywords="integrated medication management", keywords="drug", keywords="pharmacy", keywords="pharmacology", keywords="pharmacotherapy", keywords="pharmaceutics", keywords="medication", keywords="adherence", keywords="wearable", keywords="synthesis", keywords="review methods", keywords="digital health", abstract="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. ", doi="10.2196/57652", url="https://humanfactors.jmir.org/2024/1/e57652" } @Article{info:doi/10.2196/52266, author="Matsumura, Koichiro and Nakagomi, Atsushi and Yagi, Eijiro and Yamada, Nobuhiro and Funauchi, Yohei and Kakehi, Kazuyoshi and Yoshida, Ayano and Kawamura, Takayuki and Ueno, Masafumi and Nakazawa, Gaku and Tabuchi, Takahiro", title="Impact of an mHealth App (Kencom) on Patients With Untreated Hypertension Initiating Antihypertensive Medications: Real-World Cohort Study", journal="JMIR Cardio", year="2024", month="Nov", day="26", volume="8", pages="e52266", keywords="untreated hypertension", keywords="mobile health app", keywords="antihypertensive medication", keywords="cardiovascular disease", keywords="mHealth", abstract="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. ", doi="10.2196/52266", url="https://cardio.jmir.org/2024/1/e52266" } @Article{info:doi/10.2196/51424, author="Sheehan, M. Diana and Gwanzura, Tendai and Ibarra, Cynthia and Ramirez-Ortiz, Daisy and Swendeman, Dallas and Duncan, T. Dustin and Mu{\~n}oz-Laboy, Miguel and Devieux, G. Jessy and Trepka, Jo Mary", title="Psychometric Properties of Measuring Antiretroviral Therapy Adherence Among Young Latino Sexual Minority Men With HIV: Ecological Momentary Assessment and Electronic Pill Dispenser Study", journal="Online J Public Health Inform", year="2024", month="Nov", day="21", volume="16", pages="e51424", keywords="human immunodeficiency virus", keywords="HIV", keywords="MSM", keywords="sexual minority", keywords="antiretroviral therapy", keywords="Latino", keywords="Hispanic", keywords="adherence", keywords="psychometric", keywords="ecological momentary assessment", keywords="electronic pill dispenser", keywords="validity", keywords="acceptability", keywords="compliance", keywords="medication dispenser", keywords="reminder", keywords="alert", keywords="digital health", keywords="young adult", abstract="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. ", doi="10.2196/51424", url="https://ojphi.jmir.org/2024/1/e51424" } @Article{info:doi/10.2196/65010, author="Yoon, Minjae and Lee, Hyun Ji and Kim, In-Cheol and Lee, Ju-Hee and Kim, Mi-Na and Kim, Hack-Lyoung and Lee, Sunki and Kim, Jai In and Choi, Seonghoon and Park, Sung-Ji and Hur, Taeho and Hussain, Musarrat and Lee, Sungyoung and Choi, Dong-Ju", title="Smartphone App for Improving Self-Awareness of Adherence to Edoxaban Treatment in Patients With Atrial Fibrillation (ADHERE-App Trial): Randomized Controlled Trial", journal="J Med Internet Res", year="2024", month="Nov", day="21", volume="26", pages="e65010", keywords="mobile apps", keywords="digital health", keywords="atrial fibrillation", keywords="anticoagulants", keywords="medication adherence", keywords="mobile phone", abstract="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 ", doi="10.2196/65010", url="https://www.jmir.org/2024/1/e65010", url="http://www.ncbi.nlm.nih.gov/pubmed/39570659" } @Article{info:doi/10.2196/60787, author="Wang, Tzu and Huang, Yen-Ming and Chan, Hsun-Yu", title="Exploration of Features of Mobile Applications for Medication Adherence in Asia: Narrative Review", journal="J Med Internet Res", year="2024", month="Nov", day="8", volume="26", pages="e60787", keywords="Asia", keywords="adherence", keywords="application", keywords="feature", keywords="medication", keywords="mobile", abstract="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. ", doi="10.2196/60787", url="https://www.jmir.org/2024/1/e60787" } @Article{info:doi/10.2196/56437, author="Reilly, D. Erin and Kelly, M. Megan and Grigorian, L. Hannah and Waring, E. Molly and Quigley, S. Karen and Hogan, P. Timothy and Heapy, A. Alicia and Drebing, E. Charles and Volonte, Matias and Kathawalla, Ummul-Kiram and Robins, E. Hannah and Bernice, Katarina and Bickmore, Timothy", title="Virtual Coach--Guided Online Acceptance and Commitment Therapy for Chronic Pain: Pilot Feasibility Randomized Controlled Trial", journal="JMIR Form Res", year="2024", month="Nov", day="8", volume="8", pages="e56437", keywords="chronic pain", keywords="randomized controlled trial", keywords="usability", keywords="acceptance and commitment therapy", keywords="embodied conversational agent", keywords="veterans", abstract="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 ", doi="10.2196/56437", url="https://formative.jmir.org/2024/1/e56437" } @Article{info:doi/10.2196/48696, author="Nowels, Aideen Molly and McDarby, Meghan and Brody, Lilla and Kleiman, Evan and Sagui Henson, Sara and Castro Sweet, Cynthia and Kozlov, Elissa", title="Predictors of Engagement in Multiple Modalities of Digital Mental Health Treatments: Longitudinal Study", journal="J Med Internet Res", year="2024", month="Nov", day="7", volume="26", pages="e48696", keywords="digital health", keywords="mental health", keywords="health care benefit", keywords="prediction", keywords="technology", keywords="digital mental health", keywords="employer-based", keywords="teletherapy", keywords="coaching", keywords="utilization", keywords="mobile phone", abstract="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. ", doi="10.2196/48696", url="https://www.jmir.org/2024/1/e48696" } @Article{info:doi/10.2196/60961, author="Pimenta, Cristina M. and Torres, Silva Thiago and Hoagland, Brenda and Cohen, Mirian and Mann, Gruber Claudio and Jalil, M. Cristina and Carvalheira, Eduardo and Freitas, Lucilene and Fernandes, Nilo and Castanheira, Debora and Benedetti, Marcos and Moreira, Julio and Simpson, Keila and Trefiglio, Roberta and O'Malley, Gabrielle and Veloso, G. Valdilea and Grinsztejn, Beatriz", title="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", journal="JMIR Public Health Surveill", year="2024", month="Oct", day="24", volume="10", pages="e60961", keywords="pre-exposure prophylaxis", keywords="PrEP", keywords="implementation", keywords="public health system", keywords="cabotegravir", keywords="HIV prevention", keywords="Latin America", keywords="long-acting PrEP", abstract="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. ", doi="10.2196/60961", url="https://publichealth.jmir.org/2024/1/e60961", url="http://www.ncbi.nlm.nih.gov/pubmed/39446416" } @Article{info:doi/10.2196/63456, author="Ashimwe, Aimerence and Davoody, Nadia", title="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", journal="JMIR Med Inform", year="2024", month="Oct", day="23", volume="12", pages="e63456", keywords="eHealth", keywords="telemedicine", keywords="mobile health", keywords="mHealth", keywords="medication management", keywords="home care", keywords="family caregivers", keywords="mobile phone", abstract="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. ", doi="10.2196/63456", url="https://medinform.jmir.org/2024/1/e63456" } @Article{info:doi/10.2196/53819, author="Horvath, J. Keith and Lammert, Sara and Erickson, Darin and Amico, Rivet K. and Talan, J. Ali and Shalhav, Ore and Sun, J. Christina and Rendina, Jonathon H.", title="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", journal="J Med Internet Res", year="2024", month="Sep", day="30", volume="26", pages="e53819", keywords="HIV", keywords="antiretroviral therapy", keywords="ART", keywords="mobile health", keywords="mHealth", keywords="intervention", keywords="men who have sex with men", abstract="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/$\mu$L). 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 ", doi="10.2196/53819", url="https://www.jmir.org/2024/1/e53819" } @Article{info:doi/10.2196/50508, author="Eaton, Cyd and Vallejo, Natalie and McDonald, Xiomara and Wu, Jasmine and Rodr{\'i}guez, Rosa and Muthusamy, Nishanth and Mathioudakis, Nestoras and Riekert, A. Kristin", title="User Engagement With mHealth Interventions to Promote Treatment Adherence and Self-Management in People With Chronic Health Conditions: Systematic Review", journal="J Med Internet Res", year="2024", month="Sep", day="24", volume="26", pages="e50508", keywords="mobile health", keywords="mHealth", keywords="digital health", keywords="treatment adherence", keywords="self-management", keywords="user engagement", keywords="chronic health conditions", keywords="mobile phone", abstract="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 ", doi="10.2196/50508", url="https://www.jmir.org/2024/1/e50508", url="http://www.ncbi.nlm.nih.gov/pubmed/39316431" } @Article{info:doi/10.2196/53793, author="Singh, Ankita and Chakraborty, Shayok and He, Zhe and Pang, Yuanying and Zhang, Shenghao and Subedi, Ronast and Lustria, Liza Mia and Charness, Neil and Boot, Walter", title="Predicting Adherence to Computer-Based Cognitive Training Programs Among Older Adults: Study of Domain Adaptation and Deep Learning", journal="JMIR Aging", year="2024", month="Sep", day="16", volume="7", pages="e53793", keywords="domain adaptation", keywords="adherence", keywords="cognitive training", keywords="deep neural networks", keywords="early detection of cognitive decline", abstract="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. ", doi="10.2196/53793", url="https://aging.jmir.org/2024/1/e53793" } @Article{info:doi/10.2196/59013, author="Goeldner, Moritz and Gehder, Sara", title="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", journal="J Med Internet Res", year="2024", month="Aug", day="29", volume="26", pages="e59013", keywords="digital health application", keywords="DiGA", keywords="data-driven analysis", keywords="clinical evidence", keywords="health economics", keywords="positive care effect", keywords="medical benefit", keywords="patient-relevant structural and procedural improvements", keywords="pSVV", keywords="digital health care act", abstract="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 f{\"u}r 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 {\texteuro}200 to {\texteuro}700 ({\texteuro}1=US \$1.07), averaging at a median of {\texteuro}514 for a 3-month DiGA prescription. Following negotiations or arbitration board decisions, prices typically see a 50\% reduction, settling at a median of {\texteuro}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. ", doi="10.2196/59013", url="https://www.jmir.org/2024/1/e59013" } @Article{info:doi/10.2196/56960, author="Rothman, Brian and Slomkowski, Mary and Speier, Austin and Rush, John A. and Trivedi, H. Madhukar and Lawson, Erica and Fahmy, Michael and Carpenter, Daniel and Chen, Dalei and Forbes, Ainslie", title="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", journal="JMIR Res Protoc", year="2024", month="Aug", day="20", volume="13", pages="e56960", keywords="adherence", keywords="digital placebo", keywords="sham control", keywords="cognitive-emotional training", keywords="Emotional Faces Memory Task", keywords="mobile phone", abstract="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-{\AA}sberg 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-{\AA}sberg 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 ", doi="10.2196/56960", url="https://www.researchprotocols.org/2024/1/e56960" } @Article{info:doi/10.2196/53355, author="Chen, Tingting and Zhao, Wenbo and Pei, Qianqian and Chen, Yanru and Yin, Jinmei and Zhang, Min and Wang, Cheng and Zheng, Jing", title="Efficacy of a Web-Based Home Blood Pressure Monitoring Program in Improving Predialysis Blood Pressure Control Among Patients Undergoing Hemodialysis: Randomized Controlled Trial", journal="JMIR Mhealth Uhealth", year="2024", month="Aug", day="9", volume="12", pages="e53355", keywords="hemodialysis", keywords="hypertension", keywords="home blood pressure monitoring", keywords="eHealth", keywords="randomized controlled trial", abstract="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; $\chi$22=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; $\beta$=?6.09, 95 \% CI ?10.94 to ?1.24, P=.01) and the predialysis diastolic BP (t163=3.20, P=.002; $\beta$=?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 ", doi="10.2196/53355", url="https://mhealth.jmir.org/2024/1/e53355" } @Article{info:doi/10.2196/57058, author="Sassone, Biagio and Fuca', Giuseppe and Pedaci, Mario and Lugli, Roberta and Bertagnin, Enrico and Virzi', Santo and Bovina, Manuela and Pasanisi, Giovanni and Mandini, Simona and Myers, Jonathan and Tolomeo, Paolo", title="Analysis of Demographic and Socioeconomic Factors Influencing Adherence to a Web-Based Intervention Among Patients After Acute Coronary Syndrome: Prospective Observational Cohort Study", journal="JMIR Cardio", year="2024", month="Aug", day="2", volume="8", pages="e57058", keywords="telemedicine", keywords="digital literacy", keywords="digital health", keywords="acute coronary syndrome", keywords="older age", keywords="caregiver", keywords="socioeconomic", keywords="educational", keywords="mobile phone", abstract="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. ", doi="10.2196/57058", url="https://cardio.jmir.org/2024/1/e57058", url="http://www.ncbi.nlm.nih.gov/pubmed/38912920" } @Article{info:doi/10.2196/55421, author="Cruz-Cobo, Celia and Bernal-Jim{\'e}nez, {\'A}ngeles Mar{\'i}a and Calle, Germ{\'a}n and Gheorghe, Luciana Livia and Guti{\'e}rrez-Barrios, Alejandro and Ca{\~n}adas, Dolores and Tur, A. Josep and V{\'a}zquez-Garc{\'i}a, Rafael and Santi-Cano, Jos{\'e} Mar{\'i}a", title="Efficacy of a Mobile Health App (eMOTIVA) Regarding Compliance With Cardiac Rehabilitation Guidelines in Patients With Coronary Artery Disease: Randomized Controlled Clinical Trial", journal="JMIR Mhealth Uhealth", year="2024", month="Jul", day="25", volume="12", pages="e55421", keywords="coronary event", keywords="coronary heart disease", keywords="eHealth", keywords="lifestyle", keywords="mHealth", keywords="mobile health", abstract="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 ", doi="10.2196/55421", url="https://mhealth.jmir.org/2024/1/e55421" } @Article{info:doi/10.2196/54117, author="Leung, Lam Chung and Alacapa, Jason and Tasca, Gon{\c{c}}alves Bianca and Villanueva, Daniel Andre and Masulit, Saniata and Ignacio, Louie Marvin and Uy, Nicole Kathleen and Pell, Christopher and van Kalmthout, Kristian and Powers, Rachel and Fielding, Katherine and Jerene, Degu", title="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", journal="JMIR Hum Factors", year="2024", month="Jul", day="23", volume="11", pages="e54117", keywords="tuberculosis", keywords="digital adherence technologies", keywords="implementation", keywords="acceptability", keywords="qualitative research", keywords="Philippines", keywords="digital health", keywords="tuberculosis treatment", keywords="support strategy", keywords="support", keywords="medication adherence", keywords="health care workers", keywords="interview", keywords="interviews", keywords="user", keywords="user privacy", keywords="privacy", keywords="digital adherence", abstract="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. ", doi="10.2196/54117", url="https://humanfactors.jmir.org/2024/1/e54117" } @Article{info:doi/10.2196/58013, author="Miao, Yiqun and Luo, Yuan and Zhao, Yuhan and Liu, Mingxuan and Wang, Huiying and Wu, Ying", title="Effectiveness of eHealth Interventions in Improving Medication Adherence Among Patients With Cardiovascular Disease: Systematic Review and Meta-Analysis", journal="J Med Internet Res", year="2024", month="Jul", day="15", volume="26", pages="e58013", keywords="eHealth", keywords="medication adherence", keywords="heart", keywords="cardiovascular", keywords="adherence", keywords="cardiology", keywords="digital health", keywords="cardiovascular diseases", keywords="network meta-analysis", keywords="synthesis", keywords="syntheses", keywords="review methods", keywords="review methodology", keywords="search", keywords="searches", keywords="searching", keywords="systematic", keywords="meta-analysis", keywords="meta-analyses", keywords="drug", keywords="drugs", keywords="pharmacy", keywords="pharmacies", keywords="pharmacology", keywords="pharmacotherapy", keywords="pharmaceutic", keywords="pharmaceutics", keywords="pharmaceuticals", keywords="pharmaceutical", keywords="medication", keywords="medications", abstract="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/ ", doi="10.2196/58013", url="https://www.jmir.org/2024/1/e58013" } @Article{info:doi/10.2196/53607, author="Chan, Wing Colette Sze and Kan, Pui Mandy Ming and Wong, Ching Arkers Kwan", title="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", journal="J Med Internet Res", year="2024", month="Jun", day="20", volume="26", pages="e53607", keywords="wearable monitoring device", keywords="older adults", keywords="adherence", keywords="systematic review", keywords="healthy aging", keywords="peer support", keywords="professional help", keywords="support", keywords="peers", keywords="peer", keywords="professionals", keywords="wearable", keywords="monitoring devices", keywords="monitoring device", keywords="community-dwelling", keywords="older adult", keywords="aging", keywords="elderly", abstract="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. ", doi="10.2196/53607", url="https://www.jmir.org/2024/1/e53607", url="http://www.ncbi.nlm.nih.gov/pubmed/38900546" } @Article{info:doi/10.2196/50248, author="Arshed, Muhammad and Mahmud, Aidalina and Minhat, Sakdiah Halimatus and Lim, Ying Poh and Zakar, Rubeena", title="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", journal="JMIR Mhealth Uhealth", year="2024", month="Jun", day="19", volume="12", pages="e50248", keywords="mobile health", keywords="mHealth", keywords="intervention", keywords="medication adherence", keywords="hypertension", keywords="low- to middle-income country", keywords="effectiveness", keywords="randomized controlled trial", keywords="Pakistan", keywords="drug adherence", keywords="tool", keywords="mHealth module", keywords="self-efficacy", keywords="systolic blood pressure", keywords="feedback", abstract="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 ", doi="10.2196/50248", url="https://mhealth.jmir.org/2024/1/e50248" } @Article{info:doi/10.2196/56003, author="Ulm, Clayton and Chen, Sixia and Fleshman, Brianna and Benson, Lizbeth and Kendzor, E. Darla and Frank-Pearce, Summer and Neil, M. Jordan and Vidrine, Damon and De La Torre, Irene and Businelle, S. Michael", title="Smartphone-Based Survey and Message Compliance in Adults Initially Unready to Quit Smoking: Secondary Analysis of a Randomized Controlled Trial", journal="JMIR Form Res", year="2024", month="Jun", day="7", volume="8", pages="e56003", keywords="just-in-time adaptive intervention", keywords="tailored messaging", keywords="smoking cessation", keywords="mobile health", keywords="survey compliance", keywords="phase-based model", keywords="smoking", keywords="smoker", keywords="survey", keywords="smokers", keywords="messaging", keywords="smartphone", keywords="efficacy", keywords="pilot randomized controlled trial", keywords="adult smokers", keywords="linear regression", keywords="age", keywords="intervention engagement", keywords="engagement", abstract="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 ", doi="10.2196/56003", url="https://formative.jmir.org/2024/1/e56003", url="http://www.ncbi.nlm.nih.gov/pubmed/38848557" } @Article{info:doi/10.2196/53784, author="Klein, R. Morgan and Darnall, D. Beth and You, S. Dokyoung", title="Feasibility of Web-Based Single-Session Empowered Relief in Patients With Chronic Pain Taking Methadone or Buprenorphine: Protocol for a Single-Arm Trial", journal="JMIR Res Protoc", year="2024", month="Jun", day="6", volume="13", pages="e53784", keywords="chronic pain", keywords="opioid use disorder", keywords="methadone", keywords="buprenorphine", keywords="behavioral medicine", keywords="telehealth", keywords="psychology", abstract="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 ", doi="10.2196/53784", url="https://www.researchprotocols.org/2024/1/e53784", url="http://www.ncbi.nlm.nih.gov/pubmed/38843513" } @Article{info:doi/10.2196/55918, author="Hurtado, Lidia and Gonzalez Concepcion, Melinda and Flix-Valle, Aida and Ruiz-Romeo, Marina and Gonzalez-Rodriguez, Sonia and Pe{\~n}a, Marta and Paviglianiti, Annalisa and Pera Jambrina, Angeles Maria and Sureda, Anna and Ochoa-Arnedo, Cristian and Mussetti, Alberto", title="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", journal="JMIR Form Res", year="2024", month="Jun", day="4", volume="8", pages="e55918", keywords="hematology", keywords="hematopoietic cell transplantation", keywords="telemedicine", keywords="wearables", keywords="chimeric antigen receptor T", keywords="CART", keywords="wearable", keywords="hematopoietic", keywords="transplantation", keywords="transplant", keywords="pilot study", keywords="hematological", keywords="HCT", keywords="telehealth", keywords="therapy", keywords="device", keywords="quality of life", keywords="digital health", keywords="smartphone", keywords="app", keywords="patient", keywords="teenager", keywords="youth", keywords="noninterventional", abstract="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. ", doi="10.2196/55918", url="https://formative.jmir.org/2024/1/e55918", url="http://www.ncbi.nlm.nih.gov/pubmed/38833696" } @Article{info:doi/10.2196/53411, author="Kumwichar, Ponlagrit and Prappre, Tagoon and Chongsuvivatwong, Virasakdi", title="Tuberculosis Treatment Compliance Under Smartphone-Based Video-Observed Therapy Versus Community-Based Directly Observed Therapy: Cluster Randomized Controlled Trial", journal="JMIR Mhealth Uhealth", year="2024", month="Jun", day="3", volume="12", pages="e53411", keywords="video-enhanced therapy", keywords="tuberculosis", keywords="health care system", keywords="observed therapy", keywords="treatment compliance", keywords="lung disease", keywords="randomized trial", keywords="digital health", keywords="telehealth", keywords="telemedicine", keywords="mobile phone", abstract="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 ", doi="10.2196/53411", url="https://mhealth.jmir.org/2024/1/e53411", url="http://www.ncbi.nlm.nih.gov/pubmed/38830205" } @Article{info:doi/10.2196/47996, author="Musiimenta, Angella and Tumuhimbise, Wilson and Atukunda, Esther and Mugaba, Aaron and Linnemayr, Sebastian and Haberer, Jessica", title="Digital Adherence Technologies Linked to Mobile Money Incentives for Medication Adherence Among People Living With Tuberculosis: Mixed Methods Feasibility and Acceptability Study", journal="JMIR Hum Factors", year="2024", month="May", day="31", volume="11", pages="e47996", keywords="digital adherence technologies", keywords="real-time monitoring", keywords="SMS text message reminders", keywords="mobile money", keywords="financial incentives", keywords="tuberculosis", keywords="medication adherence", keywords="user-centered approach", abstract="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. ", doi="10.2196/47996", url="https://humanfactors.jmir.org/2024/1/e47996", url="http://www.ncbi.nlm.nih.gov/pubmed/38819905" } @Article{info:doi/10.2196/51013, author="Bandiera, Carole and Pasquier, J{\'e}r{\^o}me and Locatelli, Isabella and Schneider, P. Marie", title="Using a Semiautomated Procedure (CleanADHdata.R Script) to Clean Electronic Adherence Monitoring Data: Tutorial", journal="JMIR Form Res", year="2024", month="May", day="22", volume="8", pages="e51013", keywords="medication adherence", keywords="digital technology", keywords="digital pharmacy", keywords="electronic adherence monitoring", keywords="data management", keywords="data cleaning", keywords="research methodology", keywords="algorithms", keywords="R", keywords="semiautomated", keywords="code", keywords="coding", keywords="computer science", keywords="computer programming", keywords="medications", keywords="computer script", abstract="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 ($\Delta$+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. ", doi="10.2196/51013", url="https://formative.jmir.org/2024/1/e51013", url="http://www.ncbi.nlm.nih.gov/pubmed/38776539" } @Article{info:doi/10.2196/50851, author="Tran, Steven and Smith, Lorraine and Carter, Stephen", title="Understanding Patient Perspectives on the Use of Gamification and Incentives in mHealth Apps to Improve Medication Adherence: Qualitative Study", journal="JMIR Mhealth Uhealth", year="2024", month="May", day="14", volume="12", pages="e50851", keywords="qualitative", keywords="patient", keywords="perspectives", keywords="gamification", keywords="incentives", keywords="mobile app", keywords="mobile health", keywords="mHealth", keywords="medication adherence", keywords="mobile phone", abstract="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. ", doi="10.2196/50851", url="https://mhealth.jmir.org/2024/1/e50851", url="http://www.ncbi.nlm.nih.gov/pubmed/38743461" } @Article{info:doi/10.2196/51526, author="Ruksakulpiwat, Suebsarn and Phianhasin, Lalipat and Benjasirisan, Chitchanok and Ding, Kedong and Ajibade, Anuoluwapo and Kumar, Ayanesh and Stewart, Cassie", title="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", journal="JMIR Mhealth Uhealth", year="2024", month="May", day="6", volume="12", pages="e51526", keywords="ChatGPT", keywords="systematic reviews", keywords="medication adherence", keywords="mobile health", keywords="mHealth", keywords="ischemic stroke", keywords="mobile phone", abstract="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. ", doi="10.2196/51526", url="https://mhealth.jmir.org/2024/1/e51526", url="http://www.ncbi.nlm.nih.gov/pubmed/38710069" } @Article{info:doi/10.2196/53596, author="Browne, Sara and Umlauf, Anya and Moore, J. David and Benson, A. Constance and Vaida, Florin", title="User Experience of Persons Using Ingestible Sensor--Enabled Pre-Exposure Prophylaxis to Prevent HIV Infection: Cross-Sectional Survey Study", journal="JMIR Mhealth Uhealth", year="2024", month="May", day="3", volume="12", pages="e53596", keywords="ingestible sensor", keywords="sensor", keywords="sensors", keywords="oral", keywords="UX", keywords="user experience", keywords="HIV prevention", keywords="medication adherence", keywords="HIV", keywords="prevention", keywords="prophylaxis", keywords="STI", keywords="STD", keywords="sexually transmitted", keywords="sexual transmission", keywords="drug", keywords="drugs", keywords="pharmacy", keywords="pharmacies", keywords="pharmacology", keywords="pharmacotherapy", keywords="pharmaceutic", keywords="pharmaceutics", keywords="pharmaceuticals", keywords="pharmaceutical", keywords="medication", keywords="medications", keywords="adherence", keywords="compliance", keywords="sexually transmitted infection", keywords="sexually transmitted disease", abstract="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 ", doi="10.2196/53596", url="https://mhealth.jmir.org/2024/1/e53596" } @Article{info:doi/10.2196/49024, author="Eaton, K. Cyd and McWilliams, Emma and Yablon, Dana and Kesim, Irem and Ge, Renee and Mirus, Karissa and Sconiers, Takeera and Donkoh, Alfred and Lawrence, Melanie and George, Cynthia and Morrison, Leigh Mary and Muther, Emily and Oates, R. Gabriela and Sathe, Meghana and Sawicki, S. Gregory and Snell, Carolyn and Riekert, Kristin", title="Cross-Cutting mHealth Behavior Change Techniques to Support Treatment Adherence and Self-Management of Complex Medical Conditions: Systematic Review", journal="JMIR Mhealth Uhealth", year="2024", month="May", day="1", volume="12", pages="e49024", keywords="cystic fibrosis", keywords="mobile health", keywords="technology", keywords="self-management", keywords="patient adherence", keywords="behavior intervention", keywords="mHealth intervention", keywords="systematic review", keywords="evaluation of mHealth", keywords="treatment adherence", keywords="mHealth", abstract="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 ", doi="10.2196/49024", url="https://mhealth.jmir.org/2024/1/e49024" } @Article{info:doi/10.2196/44463, author="Liu, Zhuo and Sun, Xin and Guo, Zhen-Ni and Sun, Ye and Yang, Yi and Yan, Xiuli", title="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", journal="JMIR Mhealth Uhealth", year="2024", month="Apr", day="24", volume="12", pages="e44463", keywords="health belief model", keywords="health education", keywords="secondary prevention", keywords="stroke", keywords="medication adherence", keywords="patient education", keywords="web-based education", keywords="digital intervention", keywords="promotion", keywords="stroke patients", keywords="ischemic", keywords="prevention", keywords="quasi-experimental study", keywords="education", keywords="control group", keywords="health management", keywords="management", keywords="systolic blood pressure", keywords="blood pressure", keywords="effectiveness", abstract="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 $\beta$ ?3.94; P=.02), LDL-C (adjusted $\beta$ ?0.21; P=.008), and HbA1c (adjusted $\beta$ ?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 ", doi="10.2196/44463", url="https://mhealth.jmir.org/2024/1/e44463" } @Article{info:doi/10.2196/49512, author="Tate, D. Allan and Fertig, R. Angela and de Brito, N. Junia and Ellis, M. {\'E}milie and Carr, Patrick Christopher and Trofholz, Amanda and Berge, M. Jerica", title="Momentary Factors and Study Characteristics Associated With Participant Burden and Protocol Adherence: Ecological Momentary Assessment", journal="JMIR Form Res", year="2024", month="Apr", day="24", volume="8", pages="e49512", keywords="adherence", keywords="burden", keywords="data quality", keywords="ecological momentary assessment", keywords="mental health", keywords="mHealth", keywords="mobile health", keywords="participant adherence", keywords="public health", keywords="stress", keywords="study design", keywords="survey burden", keywords="survey", abstract="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 ($\beta$=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. ", doi="10.2196/49512", url="https://formative.jmir.org/2024/1/e49512", url="http://www.ncbi.nlm.nih.gov/pubmed/38656787" } @Article{info:doi/10.2196/54833, author="Polus, Manria and Keikhosrokiani, Pantea and Korhonen, Olli and Behutiye, Woubshet and Isomursu, Minna", title="Impact of Digital Interventions on the Treatment Burden of Patients With Chronic Conditions: Protocol for a Systematic Review", journal="JMIR Res Protoc", year="2024", month="Apr", day="23", volume="13", pages="e54833", keywords="chronic illness", keywords="treatment burden", keywords="eHealth", keywords="mHealth", keywords="digital health", keywords="mobile health", abstract="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 ", doi="10.2196/54833", url="https://www.researchprotocols.org/2024/1/e54833", url="http://www.ncbi.nlm.nih.gov/pubmed/38652531" } @Article{info:doi/10.2196/48756, author="Bernal-Jim{\'e}nez, {\'A}ngeles Mar{\'i}a and Calle, German and Guti{\'e}rrez Barrios, Alejandro and Gheorghe, Luciana Livia and Cruz-Cobo, Celia and Trujillo-Garrido, Nuria and Rodr{\'i}guez-Mart{\'i}n, Amelia and Tur, A. Josep and V{\'a}zquez-Garc{\'i}a, Rafael and Santi-Cano, Jos{\'e} Mar{\'i}a", title="Effectiveness of an Interactive mHealth App (EVITE) in Improving Lifestyle After a Coronary Event: Randomized Controlled Trial", journal="JMIR Mhealth Uhealth", year="2024", month="Apr", day="22", volume="12", pages="e48756", keywords="coronary artery disease", keywords="healthy lifestyle", keywords="mHealth", keywords="mobile health", keywords="percutaneous coronary intervention", keywords="randomized controlled trial", keywords="secondary prevention", keywords="therapeutic adherence", abstract="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 ", doi="10.2196/48756", url="https://mhealth.jmir.org/2024/1/e48756", url="http://www.ncbi.nlm.nih.gov/pubmed/38648103" } @Article{info:doi/10.2196/53006, author="Sun, Ting and Xu, Xuejie and Ding, Zenghui and Xie, Hui and Ma, Linlin and Zhang, Jing and Xia, Yuxin and Zhang, Guoli and Ma, Zuchang", title="Development of a Health Behavioral Digital Intervention for Patients With Hypertension Based on an Intelligent Health Promotion System and WeChat: Randomized Controlled Trial", journal="JMIR Mhealth Uhealth", year="2024", month="Apr", day="5", volume="12", pages="e53006", keywords="adherence", keywords="hypertension", keywords="health behavior", keywords="mHealth", keywords="digital health", abstract="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 ", doi="10.2196/53006", url="https://mhealth.jmir.org/2024/1/e53006", url="http://www.ncbi.nlm.nih.gov/pubmed/38578692" } @Article{info:doi/10.2196/54866, author="To{\"i}go, Mickael and Marc, Julie and Hayot, Maurice and Moulis, Lionel and Carbonnel, Francois", title="Quality Assessment of Smartphone Medication Management Apps in France: Systematic Search", journal="JMIR Mhealth Uhealth", year="2024", month="Mar", day="18", volume="12", pages="e54866", keywords="medication adherence", keywords="mobile apps", keywords="telemedicine", keywords="reminder system", keywords="behavioral therapy", keywords="mHealth", keywords="mobile health", keywords="app", keywords="apps", keywords="applications", keywords="smartphone apps", keywords="medication", keywords="medications", keywords="adherence", keywords="search", keywords="searches", keywords="searching", keywords="systematic", keywords="App Store", keywords="Google Play", keywords="French", keywords="reminder", keywords="reminders", keywords="MARS", keywords="quality", keywords="Mobile App Rating Scale", keywords="mobile phone", abstract="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 m{\'e}dicaments (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. ", doi="10.2196/54866", url="https://mhealth.jmir.org/2024/1/e54866", url="http://www.ncbi.nlm.nih.gov/pubmed/38498042" } @Article{info:doi/10.2196/54635, author="Nabunya, Proscovia and Cavazos-Rehg, Patricia and Mugisha, James and Kasson, Erin and Namuyaba, Imelda Olive and Najjuuko, Claire and Nsubuga, Edward and Filiatreau, M. Lindsey and Mwebembezi, Abel and Ssewamala, M. Fred", title="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", journal="JMIR Res Protoc", year="2024", month="Mar", day="8", volume="13", pages="e54635", keywords="depression", keywords="adherence", keywords="mHealth", keywords="cognitive behavioral therapy", keywords="antiretroviral therapy", keywords="youth living with HIV", keywords="Uganda", abstract="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 ", doi="10.2196/54635", url="https://www.researchprotocols.org/2024/1/e54635", url="http://www.ncbi.nlm.nih.gov/pubmed/38457202" } @Article{info:doi/10.2196/50528, author="Ni, Chenxu and Wang, Yi-fu and Zhang, Yun-ting and Yuan, Min and Xu, Qing and Shen, Fu-ming and Li, Dong-Jie and Huang, Fang", title="A Mobile Applet for Assessing Medication Adherence and Managing Adverse Drug Reactions Among Patients With Cancer: Usability and Utility Study", journal="JMIR Form Res", year="2024", month="Feb", day="29", volume="8", pages="e50528", keywords="WeChat applet", keywords="usability testing", keywords="utility testing", keywords="cancer patients", keywords="patients", keywords="cancer", keywords="qualitative study", abstract="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. ", doi="10.2196/50528", url="https://formative.jmir.org/2024/1/e50528", url="http://www.ncbi.nlm.nih.gov/pubmed/38421700" } @Article{info:doi/10.2196/48971, author="Chai, R. Peter and Kaithamattam, J. Jenson and Chung, Michelle and Tom, J. Jeremiah and Goodman, R. Georgia and Hasdianda, Adrian Mohammad and Carnes, Christopher Tony and Vaduganathan, Muthiah and Scirica, M. Benjamin and Schnipper, L. Jeffrey", title="Formative Perceptions of a Digital Pill System to Measure Adherence to Heart Failure Pharmacotherapy: Mixed Methods Study", journal="JMIR Cardio", year="2024", month="Feb", day="15", volume="8", pages="e48971", keywords="behavioral interventions", keywords="cardiac treatment", keywords="digital pill system", keywords="heart failure medication", keywords="heart failure", keywords="ingestible sensors", keywords="medication adherence", abstract="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. ", doi="10.2196/48971", url="https://cardio.jmir.org/2024/1/e48971", url="http://www.ncbi.nlm.nih.gov/pubmed/38358783" } @Article{info:doi/10.2196/52573, author="Liu, Peng and Wang, Lingmeng and Wang, Fuzhi", title="Evaluation of Chinese HIV Mobile Apps by Researchers and Patients With HIV: Quality Evaluation Study", journal="JMIR Mhealth Uhealth", year="2024", month="Jan", day="26", volume="12", pages="e52573", keywords="HIV", keywords="mobile app", keywords="evaluation", keywords="mobile phone", abstract="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. ", doi="10.2196/52573", url="https://mhealth.jmir.org/2024/1/e52573", url="http://www.ncbi.nlm.nih.gov/pubmed/38277215" } @Article{info:doi/10.2196/47295, author="Robinson, Billy and Proimos, Eleni and Zou, Daniel and Gong, Enying and Oldenburg, Brian and See, Katharine", title="Functionality and Quality of Asthma mHealth Apps and Their Consistency With International Guidelines: Structured Search and Evaluation", journal="JMIR Mhealth Uhealth", year="2024", month="Jan", day="10", volume="12", pages="e47295", keywords="asthma", keywords="mobile health", keywords="mHealth", keywords="app", keywords="mobile", keywords="chronic disease", keywords="systematic review", keywords="smartphone", keywords="review methodology", keywords="respiratory", keywords="compliance", keywords="guideline", keywords="guidelines", keywords="review of apps", keywords="evaluation", keywords="quality", keywords="best practices", keywords="apps", keywords="mobile phone", abstract="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 ", doi="10.2196/47295", url="https://mhealth.jmir.org/2024/1/e47295", url="http://www.ncbi.nlm.nih.gov/pubmed/38198204" } @Article{info:doi/10.2196/49302, author="B{\'e}jar, Mar{\'i}a Luis and Mesa-Rodr{\'i}guez, Pedro and Garc{\'i}a-Perea, Dolores Mar{\'i}a", title="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", journal="JMIR Mhealth Uhealth", year="2024", month="Jan", day="8", volume="12", pages="e49302", keywords="primary care professionals", keywords="Mediterranean diet", keywords="smartphone applications", keywords="smartphone apps", keywords="health promotion", keywords="Mediterranean diet adherence", keywords="food group", abstract="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 ", doi="10.2196/49302", url="https://mhealth.jmir.org/2024/1/e49302", url="http://www.ncbi.nlm.nih.gov/pubmed/38190226" } @Article{info:doi/10.2196/48716, author="Wu, Ying and Wang, Xiaohui and Zhou, Mengyao and Huang, Zhuoer and Liu, Lijuan and Cong, Li", title="Application of eHealth Tools in Anticoagulation Management After Cardiac Valve Replacement: Scoping Review Coupled With Bibliometric Analysis", journal="JMIR Mhealth Uhealth", year="2024", month="Jan", day="5", volume="12", pages="e48716", keywords="eHealth tool", keywords="cardiac valve replacement", keywords="anticoagulation management", keywords="scoping review", keywords="bibliometrics analysis", keywords="rehabilitation", abstract="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. ", doi="10.2196/48716", url="https://mhealth.jmir.org/2024/1/e48716", url="http://www.ncbi.nlm.nih.gov/pubmed/38180783" } @Article{info:doi/10.2196/52697, author="Bhagavathula, Srikanth Akshaya and Aldhaleei, Ali Wafa and Atey, Mehari Tesfay and Assefa, Solomon and Tesfaye, Wubshet", title="Efficacy of eHealth Technologies on Medication Adherence in Patients With Acute Coronary Syndrome: Systematic Review and Meta-Analysis", journal="JMIR Cardio", year="2023", month="Dec", day="19", volume="7", pages="e52697", keywords="medication adherence", keywords="eHealth", keywords="secondary prevention", keywords="acute coronary syndrome", keywords="heart disease", keywords="text messaging", keywords="mobile app", keywords="cardiology", keywords="cardioprotective", keywords="prevention", keywords="efficacy", keywords="statins", abstract="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 $\beta$-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 $\beta$-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. ", doi="10.2196/52697", url="https://cardio.jmir.org/2023/1/e52697", url="http://www.ncbi.nlm.nih.gov/pubmed/38113072" } @Article{info:doi/10.2196/50990, author="Faisal, Sadaf and Samoth, Devine and Aslam, Yusra and Patel, Hawa and Park, SooMin and Baby, Bincy and Patel, Tejal", title="Key Features of Smart Medication Adherence Products: Updated Scoping Review", journal="JMIR Aging", year="2023", month="Dec", day="19", volume="6", pages="e50990", keywords="technology", keywords="medication", keywords="aging", keywords="adherence", keywords="smart medication", keywords="digital technology", keywords="self-management", keywords="older adult", keywords="mobile health", keywords="mHealth", keywords="apps", keywords="digital health", keywords="geriatrics", keywords="older adults", keywords="mHealth app", keywords="application", keywords="management", keywords="scoping review", keywords="medication adherence", keywords="consumer", keywords="use", keywords="mobile phone", abstract="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. ", doi="10.2196/50990", url="https://aging.jmir.org/2023/1/e50990", url="http://www.ncbi.nlm.nih.gov/pubmed/38113067" } @Article{info:doi/10.2196/49352, author="Kreniske, Philip and Namuyaba, Imelda Olive and Kasumba, Robert and Namatovu, Phionah and Ssewamala, Fred and Wingood, Gina and Wei, Ying and Ybarra, L. Michele and Oloya, Charlotte and Tindyebwa, Costella and Ntulo, Christina and Mujune, Vincent and Chang, W. Larry and Mellins, A. Claude and Santelli, S. John", title="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", journal="JMIR Res Protoc", year="2023", month="Dec", day="19", volume="12", pages="e49352", keywords="adolescence", keywords="PrEP", keywords="pre-exposure prophylaxis", keywords="HIV", keywords="mental health", keywords="substance use", keywords="sexual health", keywords="mobile phones", keywords="randomized controlled trial", keywords="adaptation", keywords="Uganda", abstract="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 ", doi="10.2196/49352", url="https://www.researchprotocols.org/2023/1/e49352", url="http://www.ncbi.nlm.nih.gov/pubmed/38113102" } @Article{info:doi/10.2196/50806, author="Chen, Hwa Huan and Hsu, Tien Hsin and Lin, Chao Pei and Chen, Chin-Yin and Hsieh, Fen Hsiu and Ko, Hung Chih", title="Efficacy of a Smartphone App in Enhancing Medication Adherence and Accuracy in Individuals With Schizophrenia During the COVID-19 Pandemic: Randomized Controlled Trial", journal="JMIR Ment Health", year="2023", month="Dec", day="14", volume="10", pages="e50806", keywords="cognitive functions", keywords="medication adherence", keywords="psychiatric symptoms", keywords="schizophrenia", keywords="smartphone app", abstract="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 ", doi="10.2196/50806", url="https://mental.jmir.org/2023/1/e50806", url="http://www.ncbi.nlm.nih.gov/pubmed/38096017" } @Article{info:doi/10.2196/50579, author="Hartch, E. Christa and Dietrich, S. Mary and Stolldorf, P. Deonni", title="Effect of a Medication Adherence Mobile Phone App on Medically Underserved Patients with Chronic Illness: Preliminary Efficacy Study", journal="JMIR Form Res", year="2023", month="Dec", day="11", volume="7", pages="e50579", keywords="medication adherence", keywords="medication self-efficacy", keywords="mobile phone applications", keywords="medically underserved populations", keywords="mHealth", keywords="mobile health", keywords="app", keywords="apps", keywords="applications", keywords="underserved", keywords="adherence", keywords="survey", keywords="surveys", keywords="chronic illness", abstract="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. ", doi="10.2196/50579", url="https://formative.jmir.org/2023/1/e50579", url="http://www.ncbi.nlm.nih.gov/pubmed/38079192" } @Article{info:doi/10.2196/51277, author="Turvey, Carolyn and Fuhrmeister, Lindsey and Klein, Dawn and McCoy, Kimberly and Moeckli, Jane and Stewart Steffensmeier, R. Kenda and Suiter, Natalie and Van Tiem, Jen", title="Secure Messaging Intervention in Patients Starting New Antidepressant to Promote Adherence: Pilot Randomized Controlled Trial", journal="JMIR Form Res", year="2023", month="Dec", day="8", volume="7", pages="e51277", keywords="depression", keywords="text messaging", keywords="medication adherence", keywords="medication", keywords="medications", keywords="adherence", keywords="antidepressant", keywords="antidepressants", keywords="depressive", keywords="text message", keywords="text messages", keywords="messaging", keywords="SMS", keywords="veteran", keywords="veterans", keywords="military", keywords="randomized controlled trial", keywords="RCT", keywords="controlled trials", keywords="mental health", keywords="psychiatry", keywords="mobile phone", abstract="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 ", doi="10.2196/51277", url="https://formative.jmir.org/2023/1/e51277", url="http://www.ncbi.nlm.nih.gov/pubmed/38064267" } @Article{info:doi/10.2196/46830, author="Adu, Kofi Medard and Dias, Luz Raquel da and Agyapong, Belinda and Eboreime, Ejemai and Sapara, O. Adegboyega and Lawal, A. Mobolaji and Chew, Corina and Diamond Frost, Karen and Li, Daniel and Flynn, Michael and Hassan, Sameh and Saleh, Ahmed and Sridharan, Sanjana and White, Matt and Agyapong, IO Vincent", title="Repetitive Transcranial Magnetic Stimulation With and Without Text4Support for the Treatment of Resistant Depression: Protocol for a Patient-Centered Multicenter Randomized Controlled Pilot Trial", journal="JMIR Res Protoc", year="2023", month="Dec", day="7", volume="12", pages="e46830", keywords="repetitive transcranial magnetic stimulation", keywords="treatment-resistant depression", keywords="cognitive behavioral therapy", keywords="Text4Support", keywords="text messaging", keywords="major depressive disorder", abstract="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 ", doi="10.2196/46830", url="https://www.researchprotocols.org/2023/1/e46830", url="http://www.ncbi.nlm.nih.gov/pubmed/38060308" } @Article{info:doi/10.2196/45947, author="Harper, C. Rosie and Sheppard, Sally and Stewart, Carly and Clark, J. Carol", title="Exploring Adherence to Pelvic Floor Muscle Training in Women Using Mobile Apps: Scoping Review", journal="JMIR Mhealth Uhealth", year="2023", month="Nov", day="30", volume="11", pages="e45947", keywords="adherence", keywords="behavior change", keywords="mHealth", keywords="mobile apps", keywords="pelvic floor muscle training", keywords="women", abstract="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. ", doi="10.2196/45947", url="https://mhealth.jmir.org/2023/1/e45947", url="http://www.ncbi.nlm.nih.gov/pubmed/38032694" } @Article{info:doi/10.2196/48843, author="Hamlin, Matilda and Holm{\'e}n, Joacim and Wentz, Elisabet and Aiff, Harald and Ali, Lilas and Steingrimsson, Steinn", title="Patient Experience of Digitalized Follow-up of Antidepressant Treatment in Psychiatric Outpatient Care: Qualitative Analysis", journal="JMIR Ment Health", year="2023", month="Oct", day="11", volume="10", pages="e48843", keywords="major depressive disorder", keywords="digital psychiatry", keywords="mobile app", keywords="adherence", keywords="antidepressant", keywords="antidepressants", keywords="depressive", keywords="depression", keywords="mHealth", keywords="mobile health", keywords="app", keywords="apps", keywords="application", keywords="applications", keywords="experience", keywords="interview", keywords="interviews", keywords="medication", keywords="prescribe", keywords="prescription", keywords="dose", abstract="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. ", doi="10.2196/48843", url="https://mental.jmir.org/2023/1/e48843", url="http://www.ncbi.nlm.nih.gov/pubmed/37819697" } @Article{info:doi/10.2196/49252, author="Fraterman, Itske and Wollersheim, M. Barbara and Tibollo, Valentina and Glaser, Catherina Savannah Lucia and Medlock, Stephanie and Cornet, Ronald and Gabetta, Matteo and Gisko, Vitali and Barkan, Ella and di Flora, Nicola and Glasspool, David and Kogan, Alexandra and Lanzola, Giordano and Leizer, Roy and Mallo, Henk and Ottaviano, Manuel and Peleg, Mor and van de Poll-Franse, V. Lonneke and Veggiotti, Nicole and ?niata?a, Konrad and Wilk, Szymon and Parimbelli, Enea and Quaglini, Silvana and Rizzo, Mimma and Locati, Deborah Laura and Boekhout, Annelies and Sacchi, Lucia and Wilgenhof, Sofie", title="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", journal="JMIR Res Protoc", year="2023", month="Oct", day="11", volume="12", pages="e49252", keywords="eHealth", keywords="melanoma", keywords="fatigue", keywords="quality of life", keywords="intervention", keywords="pilot study", keywords="QoL", keywords="cancer", keywords="oncology", keywords="HRQoL", keywords="symptom", keywords="symptoms", keywords="monitoring", keywords="adoption", keywords="acceptance", keywords="patient education", keywords="digital health", keywords="immune checkpoint inhibitors", keywords="immunotherapy", abstract="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 ", doi="10.2196/49252", url="https://www.researchprotocols.org/2023/1/e49252", url="http://www.ncbi.nlm.nih.gov/pubmed/37819691" } @Article{info:doi/10.2196/47137, author="Mulawa, I. Marta and Hoare, Jacqueline and Knippler, T. Elizabeth and Mtukushe, Bulelwa and Matiwane, Mluleki and Muessig, E. Kathryn and Al-Mujtaba, Maryam and Wilkinson, Harper T. and Platt, Alyssa and Egger, R. Joseph and Hightow-Weidman, B. Lisa", title="MASI, a Smartphone App to Improve Treatment Adherence Among South African Adolescents and Young Adults With HIV: Protocol for a Pilot Randomized Controlled Trial", journal="JMIR Res Protoc", year="2023", month="Sep", day="19", volume="12", pages="e47137", keywords="HIV", keywords="adherence", keywords="mHealth", keywords="digital health", keywords="smartphone", keywords="adolescents and young adults", keywords="youths", keywords="South Africa", keywords="social support", keywords="randomized", keywords="controlled trial", keywords="pilot", keywords="antiretroviral therapy", keywords="sexually transmitted", keywords="app", keywords="apps", keywords="mobile phone", abstract="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 ", doi="10.2196/47137", url="https://www.researchprotocols.org/2023/1/e47137", url="http://www.ncbi.nlm.nih.gov/pubmed/37725409" } @Article{info:doi/10.2196/45986, author="Edwards, Colin and Borton, Rebecca and Ross, Anita and Molloy, Fiona", title="A Bespoke Electronic Health Journal for Monitoring Response to Botulinum Toxin in Treatment of Cervical Dystonia: Open-Label Observational Study of User Experience", journal="JMIR Form Res", year="2023", month="Aug", day="23", volume="7", pages="e45986", keywords="cervical dystonia", keywords="electronic health journal", keywords="user experience", keywords="user acceptance testing", keywords="botulinum toxin", keywords="diary", keywords="acceptability", keywords="user testing", keywords="symptom control", keywords="spasm", keywords="muscle pain", keywords="spasmodic torticollis", abstract="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. ", doi="10.2196/45986", url="https://formative.jmir.org/2023/1/e45986", url="http://www.ncbi.nlm.nih.gov/pubmed/37610807" } @Article{info:doi/10.2196/44297, author="Rai, Amneet and Riddle, Mark and Mishra, Rajendra and Nguyen, Nhien and Valine, Kelly and Fenney, Megan", title="Use of a Smartphone-Based Medication Adherence Platform to Improve Outcomes in Uncontrolled Type 2 Diabetes Among Veterans: Prospective Case-Crossover Study", journal="JMIR Diabetes", year="2023", month="Aug", day="10", volume="8", pages="e44297", keywords="application", keywords="biguanide", keywords="blood glucose", keywords="case-crossover", keywords="diabetes management", keywords="diabetes", keywords="diabetic", keywords="digital health intervention", keywords="epidemiology", keywords="glucose monitoring", keywords="glucose", keywords="HbgA1c", keywords="hemoglobin A1c", keywords="hemoglobin", keywords="hyperlipidemia", keywords="hypertension", keywords="interquartile range", keywords="IQR", keywords="MAS", keywords="Medication Adherence Scores", keywords="medication adherence", keywords="mobile health intervention", keywords="mobile phone", keywords="odds ratio", keywords="paired t test", keywords="quasi experimental", keywords="SEAMS", keywords="Self-Efficacy for Appropriate Medication Use Scale", keywords="smartphone", keywords="sulfonylurea", keywords="T2DM", keywords="Type 2 Diabetes Mellitus", keywords="veteran", abstract="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. ", doi="10.2196/44297", url="https://diabetes.jmir.org/2023/1/e44297", url="http://www.ncbi.nlm.nih.gov/pubmed/37561555" } @Article{info:doi/10.2196/47018, author="Ngah, Emerencia Yayah and Raoufi, Ghazal and Amirkhani, Maral and Esmaeili, Ashkan and Nikooifard, Rasa and Ghaemi Mood, Shidrokh and Rahmanian, Ava and Boltena, Tadesse Minyahil and Aga, Eresso and Neogi, Ujjwal and Ikomey Mondinde, George and El-Khatib, Ziad", title="Testing the Impact of Phone Texting Reminders for Children's Immunization Appointments in Rural Cameroon: Protocol for a Nonrandomized Controlled Trial", journal="JMIR Res Protoc", year="2023", month="Aug", day="9", volume="12", pages="e47018", keywords="immunization", keywords="children", keywords="Cameroon", keywords="digital health", keywords="global health", keywords="nonrandomized controlled trial", keywords="child vaccination", abstract="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 ", doi="10.2196/47018", url="https://www.researchprotocols.org/2023/1/e47018", url="http://www.ncbi.nlm.nih.gov/pubmed/37556178" } @Article{info:doi/10.2196/46533, author="Pandey, Avinash and D'Souza, Michelle Marie and Pandey, Shekhar Amritanshu and Mir, Hassan", title="A Web-Based Application for Risk Stratification and Optimization in Patients With Cardiovascular Disease: Pilot Study", journal="JMIR Cardio", year="2023", month="Aug", day="3", volume="7", pages="e46533", keywords="atherosclerotic cardiovascular disease", keywords="guideline-directed medical therapy", keywords="mHealth", keywords="mobile health", keywords="risk stratification", keywords="secondary prevention", keywords="web application", abstract="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. ", doi="10.2196/46533", url="https://cardio.jmir.org/2023/1/e46533", url="http://www.ncbi.nlm.nih.gov/pubmed/37535400" } @Article{info:doi/10.2196/47516, author="Hallgren, A. Kevin and Duncan, H. Mark and Iles-Shih, D. Matthew and Cohn, B. Eliza and McCabe, J. Connor and Chang, M. Yanni and Saxon, J. Andrew", title="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", journal="JMIR Form Res", year="2023", month="Jul", day="6", volume="7", pages="e47516", keywords="contingency management", keywords="methamphetamine use disorder", keywords="mobile health", keywords="mHealth", keywords="mobile phone", abstract="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. ", doi="10.2196/47516", url="https://formative.jmir.org/2023/1/e47516", url="http://www.ncbi.nlm.nih.gov/pubmed/37410529" } @Article{info:doi/10.2196/40173, author="Biehl, T. Jacob and Patel, Ravi and Lee, J. Adam", title="Toward the Design of Sensing-Based Medication Adherence Aids That Support Individualized Activities of Daily Living: Survey and Interviews With Patients and Providers", journal="JMIR Hum Factors", year="2023", month="Jul", day="4", volume="10", pages="e40173", keywords="sensing", keywords="medication adherence", keywords="active intervention", keywords="self-management", keywords="patient care", keywords="medication", keywords="qualitative study", keywords="successful intervention", keywords="patient support", abstract="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. ", doi="10.2196/40173", url="https://humanfactors.jmir.org/2023/1/e40173", url="http://www.ncbi.nlm.nih.gov/pubmed/37402141" } @Article{info:doi/10.2196/45414, author="Egilsson, Erlendur and Bjarnason, Ragnar and Njardvik, Urdur", title="Usage and Daily Attrition of a Smartphone-Based Health Behavior Intervention: Randomized Controlled Trial", journal="JMIR Mhealth Uhealth", year="2023", month="Jun", day="26", volume="11", pages="e45414", keywords="mHealth intervention", keywords="mobile health", keywords="adolescent", keywords="attrition", keywords="mental health", keywords="physical activity", abstract="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\%; $\chi$21=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; $\chi$21=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 ", doi="10.2196/45414", url="https://mhealth.jmir.org/2023/1/e45414", url="http://www.ncbi.nlm.nih.gov/pubmed/37358888" } @Article{info:doi/10.2196/45254, author="Lauvsnes, Forsmo Anders Dahlen and Hansen, Ivar Tor and Ankill, {\O}iungen Sebastian and Bae, Won Sang and Gr{\aa}we, W. Rolf and Braund, A. Taylor and Larsen, Mark and Langaas, Mette", title="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", journal="JMIR Form Res", year="2023", month="Jun", day="23", volume="7", pages="e45254", keywords="executive functioning", keywords="substance use disorder", keywords="ecological momentary assessment", keywords="clinical inference", keywords="substance use", keywords="pilot study", keywords="mood", keywords="mental health", keywords="neurocognitive functioning", keywords="smartphone use", keywords="mobile sensor", keywords="sensor", keywords="decision support", keywords="mobile phone", abstract="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. ", doi="10.2196/45254", url="https://formative.jmir.org/2023/1/e45254", url="http://www.ncbi.nlm.nih.gov/pubmed/37351934" } @Article{info:doi/10.2196/43527, author="Suzuki, Mai and Yamanaka, Kou and Fukushima, Shinichi and Ogawa, Mayu and Nagaiwa, Yuki and Naito, Toshio", title="A Mobile Medication Support App and Its Impact on People Living With HIV: 12-Week User Experience and Medication Compliance Pilot Study", journal="JMIR Form Res", year="2023", month="Jun", day="22", volume="7", pages="e43527", keywords="human immunodeficiency virus", keywords="HIV", keywords="acquired immunodeficiency syndrome", keywords="mobile health", keywords="mHealth", keywords="medication compliance", keywords="satisfaction survey", abstract="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. ", doi="10.2196/43527", url="https://formative.jmir.org/2023/1/e43527", url="http://www.ncbi.nlm.nih.gov/pubmed/37021843" } @Article{info:doi/10.2196/47575, author="Mulawa, I. Marta and Mtukushe, Bulelwa and Knippler, T. Elizabeth and Matiwane, Mluleki and Al-Mujtaba, Maryam and Muessig, E. Kathryn and Hoare, Jacqueline and Hightow-Weidman, B. Lisa", title="Supporting Adolescents With HIV in South Africa Through an Adherence-Supporting App: Mixed Methods Beta-Testing Study", journal="JMIR Form Res", year="2023", month="Jun", day="1", volume="7", pages="e47575", keywords="adolescents", keywords="HIV", keywords="adherence", keywords="mHealth", keywords="mobile health", keywords="technology", keywords="smartphone app", keywords="health app", keywords="beta testing", keywords="implementation", keywords="digital health intervention", keywords="usability", keywords="HIV treatment", abstract="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. ", doi="10.2196/47575", url="https://formative.jmir.org/2023/1/e47575", url="http://www.ncbi.nlm.nih.gov/pubmed/37261883" } @Article{info:doi/10.2196/42978, author="Yoon, Ho Chang and Nolan, Imogen and Humphrey, Gayl and Duffy, J. Eamon and Thomas, G. Mark and Ritchie, R. Stephen", title="Long-Term Impact of a Smartphone App on Prescriber Adherence to Antibiotic Guidelines for Adult Patients With Community-Acquired Pneumonia: Interrupted Time-Series Study", journal="J Med Internet Res", year="2023", month="May", day="2", volume="25", pages="e42978", keywords="app", keywords="antimicrobial stewardship", keywords="antibiotic adherence", keywords="community", keywords="pneumonia", keywords="smartphone", keywords="mobile health", keywords="mHealth", keywords="antibiotic", keywords="behavior", keywords="adults", keywords="diagnosis", keywords="pulmonary", keywords="patient", abstract="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. ", doi="10.2196/42978", url="https://www.jmir.org/2023/1/e42978", url="http://www.ncbi.nlm.nih.gov/pubmed/37129941" } @Article{info:doi/10.2196/45856, author="Marcos Anton, Gemma and Puig Llobet, Montserrat and Lluch Canut, Teresa and Sanchez Ortega, Aurelia Maria and Piazuelo Pont, Merc{\`e} and Moreno-Arroyo, M{\textordfeminine}Carmen", title="mHealth to Improve Experience, Adherence to Pharmacological Treatment, and Positive Mental Health in Patients Diagnosed With Femur Fractures: Protocol for a Quasi-Experimental Study", journal="JMIR Res Protoc", year="2023", month="Apr", day="28", volume="12", pages="e45856", keywords="education", keywords="patient experience", keywords="medication adherence", keywords="mental health", keywords="nurse", keywords="mHealth", keywords="mobile health", keywords="protocol", keywords="prognosis", keywords="pharmacological treatment", keywords="femur fracture", keywords="femur", keywords="diagnosis", keywords="quality of care", keywords="care", keywords="psychological", keywords="efficacy", keywords="training", keywords="pathology", abstract="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 ", doi="10.2196/45856", url="https://www.researchprotocols.org/2023/1/e45856", url="http://www.ncbi.nlm.nih.gov/pubmed/37115614" } @Article{info:doi/10.2196/39930, author="Stecher, Chad and Cloonan, Sara and Linnemayr, Sebastian and Huberty, Jennifer", title="Combining Behavioral Economics--Based Incentives With the Anchoring Strategy: Protocol for a Randomized Controlled Trial", journal="JMIR Res Protoc", year="2023", month="Apr", day="28", volume="12", pages="e39930", keywords="habits", keywords="mindfulness meditation", keywords="mobile apps", keywords="mobile health", keywords="mHealth", keywords="adherence", keywords="meditation", keywords="mindfulness", keywords="intervention", keywords="apps", keywords="smartphone apps", keywords="stress", keywords="management", keywords="mobile phone", abstract="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 ", doi="10.2196/39930", url="https://www.researchprotocols.org/2023/1/e39930", url="http://www.ncbi.nlm.nih.gov/pubmed/37115610" } @Article{info:doi/10.2196/40437, author="Smith, L. Crystal and Keever, Abigail and Bowden, Theresa and Olson, Katie and Rodin, Nicole and McDonell, G. Michael and Roll, M. John and Smoody, Gillian and LeBrun, Jeff and Miguel, QC Andre and McPherson, M. Sterling", title="Patient Feedback on a Mobile Medication Adherence App for Buprenorphine and Naloxone: Closed and Open-Ended Survey on Feasibility and Acceptability", journal="JMIR Form Res", year="2023", month="Apr", day="19", volume="7", pages="e40437", keywords="opioids", keywords="mobile technology", keywords="medication adherence", keywords="buprenorphine", keywords="naloxone", keywords="opioid use disorder", keywords="opioid agonist therapy", keywords="medication-assisted treatment", keywords="medications for opioid use disorder", keywords="opioid", keywords="opioid use", keywords="well-being", keywords="quality of life", keywords="clinic", keywords="technology", keywords="medication", keywords="remote", keywords="coaching", keywords="tracking", keywords="stress", keywords="incentive", keywords="tool", keywords="mobile phone", abstract="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. ", doi="10.2196/40437", url="https://formative.jmir.org/2023/1/e40437", url="http://www.ncbi.nlm.nih.gov/pubmed/37074780" } @Article{info:doi/10.2196/45301, author="Musiimenta, Angella and Tumuhimbise, Wilson and Atukunda, Esther and Mugaba, Aaron and Linnemayr, Sebastian and Haberer, Jessica", title="Digital Adherence Technologies and Mobile Money Incentives for Management of Tuberculosis Medication Among People Living With Tuberculosis: Mixed Methods Formative Study", journal="JMIR Form Res", year="2023", month="Apr", day="12", volume="7", pages="e45301", keywords="digital adherence technologies", keywords="real-time monitoring", keywords="SMS reminders", keywords="mobile money", keywords="financial incentives", keywords="tuberculosis", keywords="medication adherence", keywords="user-centered approach", keywords="mobile wallet", keywords="support medication", keywords="mobile phone", abstract="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 ", doi="10.2196/45301", url="https://formative.jmir.org/2023/1/e45301", url="http://www.ncbi.nlm.nih.gov/pubmed/37043263" } @Article{info:doi/10.2196/35112, author="Faber, S. Jasper and Poot, C. Charlotte and Dekkers, Tessa and Romero Herrera, Natalia and Chavannes, H. Niels and Meijer, Eline and Visch, T. V.", title="Developing a Digital Medication Adherence Intervention for and With Patients With Asthma and Low Health Literacy: Protocol for a Participatory Design Approach", journal="JMIR Form Res", year="2023", month="Apr", day="12", volume="7", pages="e35112", keywords="participatory design", keywords="low health literacy", keywords="eHealth", keywords="medication adherence", keywords="asthma", keywords="mHealth", keywords="health literacy", keywords="participatory medicine", keywords="health care", keywords="medication", abstract="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. ", doi="10.2196/35112", url="https://formative.jmir.org/2023/1/e35112", url="http://www.ncbi.nlm.nih.gov/pubmed/37043260" } @Article{info:doi/10.2196/43507, author="Topp, Robert and Greenstein, Jay and Etnoyer-Slaski, Jena", title="The Effect of a Mobile Health App on Treatment Adherence and Revenue at Physical Health Clinics: Retrospective Record Review", journal="JMIR Rehabil Assist Technol", year="2023", month="Mar", day="28", volume="10", pages="e43507", keywords="physical health", keywords="completion of therapy", keywords="phone app", keywords="clinic charges and payments", keywords="payment", keywords="cost", keywords="physiotherapy", keywords="physical therapy", keywords="adherence", keywords="attrition", keywords="mobile phone", keywords="reminder", keywords="mobile health", keywords="mHealth", keywords="health app", keywords="mobile app", abstract="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. ", doi="10.2196/43507", url="https://rehab.jmir.org/2023/1/e43507", url="http://www.ncbi.nlm.nih.gov/pubmed/36889337" } @Article{info:doi/10.2196/40595, author="Seki, Tomotsugu and Aki, Morio and Furukawa, A. Toshi and Kawashima, Hirotsugu and Miki, Tomotaka and Sawaki, Yujin and Ando, Takaaki and Katsuragi, Kentaro and Kawashima, Takahiko and Ueno, Senkei and Miyagi, Takashi and Noma, Shun'ichi and Tanaka, Shiro and Kawakami, Koji", title="Electronic Health Record--Nested Reminders for Serum Lithium Level Monitoring in Patients With Mood Disorder: Randomized Controlled Trial", journal="J Med Internet Res", year="2023", month="Mar", day="22", volume="25", pages="e40595", keywords="electronic health record", keywords="lithium", keywords="mood disorders", keywords="randomized controlled trial", keywords="quality of health care", abstract="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 ", doi="10.2196/40595", url="https://www.jmir.org/2023/1/e40595", url="http://www.ncbi.nlm.nih.gov/pubmed/36947138" } @Article{info:doi/10.2196/35045, author="Emery, Joanne and Huang, Yue and Naughton, Felix and Cooper, Sue and McDaid, Lisa and Dickinson, Anne and Clark, Miranda and Kinahan-Goodwin, Darren and Thomson, Ross and Phillips, Lucy and Lewis, Sarah and Coleman, Tim", title="Comparison of a Daily Smartphone App and Retrospective Questionnaire Measures of Adherence to Nicotine Replacement Therapy Among Pregnant Women: Observational Study", journal="JMIR Form Res", year="2023", month="Mar", day="7", volume="7", pages="e35045", keywords="smoking cessation", keywords="pregnancy", keywords="nicotine replacement therapy", keywords="treatment adherence measurement", keywords="smartphone app", keywords="questionnaires", keywords="ecological momentary assessment", keywords="mHealth", keywords="mobile health", keywords="smoking", keywords="nicotine", abstract="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 {\textsterling}25 ({\textasciitilde}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. ", doi="10.2196/35045", url="https://formative.jmir.org/2023/1/e35045", url="http://www.ncbi.nlm.nih.gov/pubmed/36881452" } @Article{info:doi/10.2196/34958, author="O'Connor, Antonia and Sharrad, Kelsey and King, Charmaine and Carson-Chahhoud, Kristin", title="An Augmented Reality Technology to Provide Demonstrative Inhaler Technique Education for Patients With Asthma: Interview Study Among Patients, Health Professionals, and Key Community Stakeholders", journal="JMIR Form Res", year="2023", month="Mar", day="2", volume="7", pages="e34958", keywords="augmented reality", keywords="asthma", keywords="disease management", keywords="smartphone", keywords="inhaler technique", keywords="mobile phone", abstract="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. ", doi="10.2196/34958", url="https://formative.jmir.org/2023/1/e34958", url="http://www.ncbi.nlm.nih.gov/pubmed/36862496" } @Article{info:doi/10.2196/43019, author="Clement, Edwards Meredith and Lovett, Aish and Caldwell, Sylvia and Beckford, Jeremy and Hilgart, Michelle and Corneli, Amy and Flickinger, Tabor and Dillingham, Rebecca and Ingersoll, Karen", title="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", journal="JMIR Form Res", year="2023", month="Feb", day="27", volume="7", pages="e43019", keywords="pre-exposure prophylaxis", keywords="HIV", keywords="mobile apps", keywords="mobile phone", abstract="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. ", doi="10.2196/43019", url="https://formative.jmir.org/2023/1/e43019", url="http://www.ncbi.nlm.nih.gov/pubmed/36848209" } @Article{info:doi/10.2196/42691, author="Jones, Joyce and McKenzie-White, Jane and Saxton, Ronald and Grieb, M. Suzanne and Nonyane, Bareng and Graham, Cadeesha and Cano, Anthony and Johnson, Sheridan and Childs, Lanisha and Greenbaum, Adena and Flynn, Colin and Pearlowitz, Marcia and Celano, Shivaun and Chang, W. Larry and Page, R. Kathleen", title="Leveraging mHealth and Patient Supporters for African Americans' and Latinxs' Engagement in HIV Care (LEAN): Protocol for a Randomized, Controlled, Effectiveness-Implementation Trial", journal="JMIR Res Protoc", year="2023", month="Feb", day="14", volume="12", pages="e42691", keywords="mHealth", keywords="HIV linkage to care", keywords="HIV virologic suppression", keywords="HIV continuum of care", keywords="adherence", keywords="implementation", abstract="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 ", doi="10.2196/42691", url="https://www.researchprotocols.org/2023/1/e42691", url="http://www.ncbi.nlm.nih.gov/pubmed/36787165" } @Article{info:doi/10.2196/40504, author="van Eijck, C. Sander and Janssen, M. Daan and van der Steen, C. Maria and Delvaux, G. Eugenie J. L. and Hendriks, E. Johannes G. and Janssen, A. Rob P.", title="Digital Health Applications to Establish a Remote Diagnosis of Orthopedic Knee Disorders: Scoping Review", journal="J Med Internet Res", year="2023", month="Feb", day="9", volume="25", pages="e40504", keywords="orthopedic surgery", keywords="eHealth", keywords="digital health", keywords="mobile health", keywords="mHealth", keywords="telemedicine", keywords="artificial intelligence", keywords="diagnosis", keywords="remote patient management", keywords="musculoskeletal system", keywords="knee", keywords="mobile phone", abstract="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. ", doi="10.2196/40504", url="https://www.jmir.org/2023/1/e40504", url="http://www.ncbi.nlm.nih.gov/pubmed/36566450" } @Article{info:doi/10.2196/42799, author="Sun, Liang and Qu, Mengbing and Chen, Bing and Li, Chuancang and Fan, Haohao and Zhao, Yang", title="Effectiveness of mHealth on Adherence to Antiretroviral Therapy in Patients Living With HIV: Meta-analysis of Randomized Controlled Trials", journal="JMIR Mhealth Uhealth", year="2023", month="Jan", day="23", volume="11", pages="e42799", keywords="HIV", keywords="mHealth", keywords="antiretroviral therapy", keywords="meta-analysis", abstract="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 ", doi="10.2196/42799", url="https://mhealth.jmir.org/2023/1/e42799", url="http://www.ncbi.nlm.nih.gov/pubmed/36689267" } @Article{info:doi/10.2196/41735, author="Donovan, Gemma and Hall, Nicola and Smith, Felicity and Ling, Jonathan and Wilkes, Scott", title="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", journal="JMIR Form Res", year="2022", month="Dec", day="21", volume="6", number="12", pages="e41735", keywords="medication adherence", keywords="text messaging", keywords="human-centered design", keywords="complex interventions", keywords="community pharmacy", abstract="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. ", doi="10.2196/41735", url="https://formative.jmir.org/2022/12/e41735", url="http://www.ncbi.nlm.nih.gov/pubmed/36542458" } @Article{info:doi/10.2196/42941, author="Wu, Dezhi and Lowry, Benjamin Paul and Zhang, Dongsong and Tao, Youyou", title="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", journal="J Med Internet Res", year="2022", month="Dec", day="20", volume="24", number="12", pages="e42941", keywords="mobile health", keywords="mHealth", keywords="trust", keywords="patient adherence", keywords="mobile patient education system", keywords="MPES", keywords="patient-physician communication", keywords="theory of planned behavior", keywords="TPB", keywords="patient-centered care", keywords="mobile phone", abstract="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. ", doi="10.2196/42941", url="https://www.jmir.org/2022/12/e42941", url="http://www.ncbi.nlm.nih.gov/pubmed/36538351" } @Article{info:doi/10.2196/40382, author="Axelrad, Jordan and Long, Millie and Horst, Sara and Afzali, Anita and Sapir, Tamar and Fajardo, Kristina and De Felice, Kara and Sandler, Robert and Cross, Raymond", title="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", journal="JMIR Res Protoc", year="2022", month="Dec", day="15", volume="11", number="12", pages="e40382", keywords="remote therapy monitoring", keywords="connected health", keywords="patient engagement", keywords="Crohn disease", keywords="ulcerative colitis", keywords="inflammatory bowel disease", keywords="mobile phone", abstract="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 ", doi="10.2196/40382", url="https://www.researchprotocols.org/2022/12/e40382", url="http://www.ncbi.nlm.nih.gov/pubmed/36520519" } @Article{info:doi/10.2196/36829, author="Kajubi, Phoebe and Parkes-Ratanshi, Rosalind and Twimukye, Adelline and Bwanika Naggirinya, Agnes and Nabaggala, Sarah Maria and Kiragga, Agnes and Castelnuovo, Barbara and King, Rachel", title="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", journal="JMIR Form Res", year="2022", month="Dec", day="6", volume="6", number="12", pages="e36829", keywords="mobile health", keywords="mHealth", keywords="mobile communication technologies", keywords="people living with HIV", keywords="antiretroviral therapy", keywords="quality of life", keywords="Uganda", abstract="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 ", doi="10.2196/36829", url="https://formative.jmir.org/2022/12/e36829", url="http://www.ncbi.nlm.nih.gov/pubmed/36472904" } @Article{info:doi/10.2196/39489, author="Pfammatter, Fidler Angela and Hughes, Olivia Bonnie and Tucker, Becky and Whitmore, Harry and Spring, Bonnie and Tasali, Esra", title="The Development of a Novel mHealth Tool for Obstructive Sleep Apnea: Tracking Continuous Positive Airway Pressure Adherence as a Percentage of Time in Bed", journal="J Med Internet Res", year="2022", month="Dec", day="5", volume="24", number="12", pages="e39489", keywords="obstructive sleep apnea", keywords="continuous positive airway pressure", keywords="CPAP adherence", keywords="weight loss", keywords="lifestyle", abstract="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. ", doi="10.2196/39489", url="https://www.jmir.org/2022/12/e39489", url="http://www.ncbi.nlm.nih.gov/pubmed/36469406" } @Article{info:doi/10.2196/39047, author="Richey, G. Anabel and Kovacs, Ildiko and Browne, Sara", title="Use of an Ingestible, Sensor-Based Digital Adherence System to Strengthen the Therapeutic Relationship in Serious Mental Illness", journal="JMIR Ment Health", year="2022", month="Dec", day="2", volume="9", number="12", pages="e39047", keywords="patient-physician relationship", keywords="ingestible sensor", keywords="mental health", keywords="serious mental illness", keywords="antipsychotic", keywords="medication adherence", keywords="digital adherence", keywords="therapy", keywords="digital intervention", keywords="digital mental health", doi="10.2196/39047", url="https://mental.jmir.org/2022/12/e39047", url="http://www.ncbi.nlm.nih.gov/pubmed/36459392" } @Article{info:doi/10.2196/26925, author="Khusial, Rishi and van Koppen, Sophia and Honkoop, Persijn and Rijssenbeek-Nouwens, Lucia and Fieten, Berthine Karin and Keij, Sascha and Drijver-Messelink, Marieke and Sont, Jacob", title="Patients' and Health Care Providers' Perceptions on mHealth Use After High-Altitude Climate Therapy for Severe Asthma: Mixed Methods Study", journal="JMIR Form Res", year="2022", month="Nov", day="22", volume="6", number="11", pages="e26925", keywords="eHealth", keywords="mobile health", keywords="mHealth", keywords="asthma", keywords="self-management", keywords="home monitoring", keywords="mobile phone", abstract="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. ", doi="10.2196/26925", url="https://formative.jmir.org/2022/11/e26925", url="http://www.ncbi.nlm.nih.gov/pubmed/36413384" } @Article{info:doi/10.2196/36766, author="Vilasi, Antonio and Panuccio, Antonio Vincenzo and Morante, Salvatore and Villa, Antonino and Versace, Carmela Maria and Mezzatesta, Sabrina and Mercuri, Sergio and Inguanta, Rosalinda and Aiello, Giuseppe and Cutrupi, Demetrio and Puglisi, Rossella and Capria, Salvatore and Li Vigni, Maurizio and Tripepi, Giovanni and Torino, Claudia", title="Monitoring Risk Factors and Improving Adherence to Therapy in Patients With Chronic Kidney Disease (Smit-CKD Project): Pilot Observational Study", journal="JMIR Bioinform Biotech", year="2022", month="Nov", day="15", volume="3", number="1", pages="e36766", keywords="SMIT-CKD", keywords="mHealth", keywords="eHealth", keywords="CKD", keywords="therapy adherence", keywords="risk factor", keywords="kidney", keywords="adherence", keywords="integrated system", keywords="health app", keywords="monitoring", keywords="cardiology", keywords="cardiac", keywords="renal", keywords="chronic kidney disease", keywords="cardiovascular", keywords="mobile health", keywords="mobile app", abstract="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. ", doi="10.2196/36766", url="https://bioinform.jmir.org/2022/1/e36766" } @Article{info:doi/10.2196/42376, author="Hallgren, A. Kevin", title="Remotely Assessing Mechanisms of Behavioral Change in Community Substance Use Disorder Treatment to Facilitate Measurement-Informed Care: Pilot Longitudinal Questionnaire Study", journal="JMIR Form Res", year="2022", month="Nov", day="7", volume="6", number="11", pages="e42376", keywords="addiction", keywords="clinical pilot", keywords="measurement-based care", keywords="mechanisms of change", keywords="mobile health", keywords="mHealth", keywords="mobile phone", abstract="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. ", doi="10.2196/42376", url="https://formative.jmir.org/2022/11/e42376", url="http://www.ncbi.nlm.nih.gov/pubmed/36342773" } @Article{info:doi/10.2196/25879, author="Rumi, Gabriele and Canonica, Walter G. and Foster, M. Juliet and Chavannes, H. Niels and Valenti, Giuseppe and Contiguglia, Rosario and Rapsomaniki, Eleni and Kocks, H. Janwillem W. and De Brasi, Dario and Braido, Fulvio", title="Digital Coaching Using Smart Inhaler Technology to Improve Asthma Management in Patients With Asthma in Italy: Community-Based Study", journal="JMIR Mhealth Uhealth", year="2022", month="Nov", day="2", volume="10", number="11", pages="e25879", keywords="asthma control", keywords="asthma management", keywords="connected devices", keywords="digital health", keywords="eHealth", keywords="inhalers", keywords="maintenance and reliever therapy", keywords="mobile phone", abstract="Background: Reliance on short-acting $\beta$-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. ", doi="10.2196/25879", url="https://mhealth.jmir.org/2022/11/e25879", url="http://www.ncbi.nlm.nih.gov/pubmed/36322120" } @Article{info:doi/10.2196/38048, author="Isakadze, Nino and Molello, Nancy and MacFarlane, Zane and Gao, Yumin and Spaulding, M. Erin and Commodore Mensah, Yvonne and Marvel, A. Francoise and Khoury, Shireen and Marine, E. Joseph and Michos, D. Erin and Spragg, David and Berger, D. Ronald and Calkins, Hugh and Cooper, A. Lisa and Martin, S. Seth", title="The Virtual Inclusive Digital Health Intervention Design to Promote Health Equity (iDesign) Framework for Atrial Fibrillation: Co-design and Development Study", journal="JMIR Hum Factors", year="2022", month="Oct", day="31", volume="9", number="4", pages="e38048", keywords="atrial fibrillation", keywords="digital health intervention", keywords="human-centered design", keywords="health equity", keywords="smartphone", keywords="mobile application", keywords="cardiac", keywords="cardiology", keywords="virtual meeting", keywords="virtual health", keywords="medication adherence", abstract="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. ", doi="10.2196/38048", url="https://humanfactors.jmir.org/2022/4/e38048", url="http://www.ncbi.nlm.nih.gov/pubmed/36315217" } @Article{info:doi/10.2196/42216, author="Stecher, Chad and Ghai, Ishita and Lunkuse, Lillian and Wabukala, Peter and Odiit, Mary and Nakanwagi, Agnes and Linnemayr, Sebastian", title="Incentives and Reminders to Improve Long-term Medication Adherence (INMIND): Protocol for a Pilot Randomized Controlled Trial", journal="JMIR Res Protoc", year="2022", month="Oct", day="31", volume="11", number="10", pages="e42216", keywords="medication adherence", keywords="HIV", keywords="antiretroviral therapy", keywords="habit formation", keywords="routines", keywords="behavioral economics", abstract="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 ", doi="10.2196/42216", url="https://www.researchprotocols.org/2022/10/e42216", url="http://www.ncbi.nlm.nih.gov/pubmed/36315224" } @Article{info:doi/10.2196/38690, author="Venkatraman, Vishal and Kirsch, P. Elayna and Luo, Emily and Kunte, Sameer and Ponder, Madison and Gellad, F. Ziad and Liu, Beiyu and Lee, Hui-Jie and Jung, Sin-Ho and Haglund, M. Michael and Lad, P. Shivanand", title="Outcomes With a Mobile Digital Health Platform for Patients Undergoing Spine Surgery: Retrospective Analysis", journal="JMIR Perioper Med", year="2022", month="Oct", day="26", volume="5", number="1", pages="e38690", keywords="digital health", keywords="spine surgery", keywords="surgical outcomes", keywords="mobile health", keywords="mobile application", keywords="surgery", keywords="postoperative", keywords="mobile app", keywords="mHealth", keywords="recovery", abstract="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. ", doi="10.2196/38690", url="https://periop.jmir.org/2022/1/e38690", url="http://www.ncbi.nlm.nih.gov/pubmed/36287589" } @Article{info:doi/10.2196/38501, author="Song, Yuqing and Reifsnider, Elizabeth and Chen, Yanling and Wang, Ying and Chen, Hong", title="The Impact of a Theory-Based mHealth Intervention on Disease Knowledge, Self-efficacy, and Exercise Adherence Among Ankylosing Spondylitis Patients: Randomized Controlled Trial", journal="J Med Internet Res", year="2022", month="Oct", day="20", volume="24", number="10", pages="e38501", keywords="rheumatic disease", keywords="health belief model", keywords="mobile health", keywords="patient education", keywords="WeChat", abstract="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 ", doi="10.2196/38501", url="https://www.jmir.org/2022/10/e38501", url="http://www.ncbi.nlm.nih.gov/pubmed/36264605" } @Article{info:doi/10.2196/35039, author="Lim, Lin Su and Tay, Juan Melissa Hui and Ong, Wen Kai and Johal, Jolyn and Yap, Ven Qai and Chan, Huak Yiong and Yeo, Ning Genevieve Kai and Khoo, Meng Chin and Yaxley, Alison", title="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", journal="JMIR Diabetes", year="2022", month="Sep", day="30", volume="7", number="3", pages="e35039", keywords="engagement", keywords="diabetes", keywords="prediabetes", keywords="mobile health", keywords="mHealth", keywords="mobile apps", keywords="weight loss", keywords="glycemic control", keywords="glycated hemoglobin", keywords="HbA1c change", keywords="mobile phone", abstract="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 ", doi="10.2196/35039", url="https://diabetes.jmir.org/2022/3/e35039", url="http://www.ncbi.nlm.nih.gov/pubmed/36178718" } @Article{info:doi/10.2196/37868, author="Step, M. Mary and McMillen Smith, Jennifer and Lewis, A. Steven and Avery, K. Ann", title="Using the Positive Peers Mobile App to Improve Clinical Outcomes for Young People With HIV: Prospective Observational Cohort Comparison", journal="JMIR Mhealth Uhealth", year="2022", month="Sep", day="28", volume="10", number="9", pages="e37868", keywords="mobile health", keywords="mHealth", keywords="HIV", keywords="Positive Peers", keywords="retention in care", keywords="re-engagement in care", keywords="viral suppression", abstract="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. ", doi="10.2196/37868", url="https://mhealth.jmir.org/2022/9/e37868", url="http://www.ncbi.nlm.nih.gov/pubmed/36170001" } @Article{info:doi/10.2196/33247, author="Aguiar, Maria and Trujillo, Maria and Chaves, Deisy and {\'A}lvarez, Roberto and Epelde, Gorka", title="mHealth Apps Using Behavior Change Techniques to Self-report Data: Systematic Review", journal="JMIR Mhealth Uhealth", year="2022", month="Sep", day="9", volume="10", number="9", pages="e33247", keywords="mobile health", keywords="mHealth", keywords="behavior change techniques", keywords="adherence", keywords="app", keywords="mobile health interventions", keywords="behavior", abstract="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. ", doi="10.2196/33247", url="https://mhealth.jmir.org/2022/9/e33247", url="http://www.ncbi.nlm.nih.gov/pubmed/36083606" } @Article{info:doi/10.2196/37163, author="O'Connor, Cara and Leyritana, Katerina and Doyle, M. Aoife and Birdthistle, Isolde and Lewis, J. James and Gill, Randeep and Salva{\~n}a, Maurice Edsel", title="Delivering an mHealth Adherence Support Intervention for Patients With HIV: Mixed Methods Process Evaluation of the Philippines Connect for Life Study", journal="JMIR Form Res", year="2022", month="Aug", day="12", volume="6", number="8", pages="e37163", keywords="mobile health", keywords="mHealth", keywords="adherence", keywords="HIV", keywords="antiretroviral therapy", keywords="process evaluation", keywords="Philippines", keywords="men who have sex with men", keywords="MSM", keywords="mobile phone", abstract="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. ", doi="10.2196/37163", url="https://formative.jmir.org/2022/8/e37163", url="http://www.ncbi.nlm.nih.gov/pubmed/35969425" } @Article{info:doi/10.2196/37936, author="Lin, Bing and Liu, Jiaxiu and He, Wei and Pan, Haiying and Ma, Yingjie and Zhong, Xiaoni", title="Effect of a Reminder System on Pre-exposure Prophylaxis Adherence in Men Who Have Sex With Men: Prospective Cohort Study Based on WeChat Intervention", journal="J Med Internet Res", year="2022", month="Aug", day="11", volume="24", number="8", pages="e37936", keywords="pre-exposure prophylaxis (PrEP)", keywords="adherence", keywords="reminder system", keywords="men who have sex with men (MSM)", keywords="WeChat", keywords="oral PrEP", keywords="HIV prevention", keywords="MSM", keywords="reminder", keywords="message", abstract="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 ", doi="10.2196/37936", url="https://www.jmir.org/2022/8/e37936", url="http://www.ncbi.nlm.nih.gov/pubmed/35969436" } @Article{info:doi/10.2196/38247, author="Bachina, Preetham and Lippincott, Kirk Christopher and Perry, Allison and Munk, Elizabeth and Maltas, Gina and Bohr, Rebecca and Rock, Bryan Robert and Shah, Maunank", title="Programmatic Adoption and Implementation of Video-Observed Therapy in Minnesota: Prospective Observational Cohort Study", journal="JMIR Form Res", year="2022", month="Aug", day="5", volume="6", number="8", pages="e38247", keywords="video directly observed therapy", keywords="vDOT", keywords="mobile health", keywords="mHealth", keywords="tuberculosis", keywords="medication adherence", keywords="telemedicine", keywords="treatment", keywords="telehealth", keywords="observed therapy", keywords="COVID-19", keywords="primary outcome", keywords="treatment adherence", keywords="technology adoption", keywords="virtual health", abstract="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. ", doi="10.2196/38247", url="https://formative.jmir.org/2022/8/e38247", url="http://www.ncbi.nlm.nih.gov/pubmed/35834671" } @Article{info:doi/10.2196/39098, author="Skeens, Micah and Sezgin, Emre and Stevens, Jack and Landier, Wendy and Pai, Ahna and Gerhardt, Cynthia", title="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", journal="JMIR Res Protoc", year="2022", month="Jul", day="21", volume="11", number="7", pages="e39098", keywords="medication adherence", keywords="digital health", keywords="mHealth", keywords="pediatrics", keywords="app", keywords="bone marrow transplant", keywords="adherence", keywords="usability", keywords="feasibility", keywords="caregivers", keywords="children", keywords="hematopoietic stem cell transplant", keywords="HSCT", abstract="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 ", doi="10.2196/39098", url="https://www.researchprotocols.org/2022/7/e39098", url="http://www.ncbi.nlm.nih.gov/pubmed/35862184" } @Article{info:doi/10.2196/38796, author="Kumwichar, Ponlagrit and Chongsuvivatwong, Virasakdi and Prappre, Tagoon", title="Tuberculosis Treatment Compliance Under Smartphone-Based Video-Observed Therapy Versus Community-Based Directly Observed Therapy: Protocol for a Cluster Randomized Controlled Trial", journal="JMIR Res Protoc", year="2022", month="Jul", day="8", volume="11", number="7", pages="e38796", keywords="VOT", keywords="VDOT", keywords="video-enhanced therapy", keywords="tuberculosis", keywords="health care system", keywords="observed therapy", keywords="video-observed therapy", keywords="treatment compliance", keywords="lung disease", keywords="randomized trial", keywords="digital health", keywords="telehealth", keywords="telemedicine", abstract="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 ", doi="10.2196/38796", url="https://www.researchprotocols.org/2022/7/e38796", url="http://www.ncbi.nlm.nih.gov/pubmed/35802403" } @Article{info:doi/10.2196/33264, author="Islam, Shariful Sheikh Mohammed and Mishra, Vinaytosh and Siddiqui, Umer Muhammad and Moses, Chandir Jeban and Adibi, Sasan and Nguyen, Lemai and Wickramasinghe, Nilmini", title="Smartphone Apps for Diabetes Medication Adherence: Systematic Review", journal="JMIR Diabetes", year="2022", month="Jun", day="21", volume="7", number="2", pages="e33264", keywords="smartphones", keywords="digital health", keywords="diabetes", keywords="medication adherence", keywords="applications", keywords="apps", keywords="mHealth", keywords="mobile health", keywords="task-technology fit", abstract="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. ", doi="10.2196/33264", url="https://diabetes.jmir.org/2022/2/e33264", url="http://www.ncbi.nlm.nih.gov/pubmed/35727613" } @Article{info:doi/10.2196/31491, author="Dramburg, Stephanie and Perna, Serena and Di Fraia, Marco and Tripodi, Salvatore and Arasi, Stefania and Castelli, Sveva and Villalta, Danilo and Buzzulini, Francesca and Sfika, Ifigenia and Villella, Valeria and Potapova, Ekaterina and Brighetti, Antonia Maria and Travaglini, Alessandro and Verardo, Pierluigi and Pelosi, Simone and Matricardi, Maria Paolo", title="Validation Parameters of Patient-Generated Data for Digitally Recorded Allergic Rhinitis Symptom and Medication Scores in the @IT.2020 Project: Exploratory Study", journal="JMIR Mhealth Uhealth", year="2022", month="Jun", day="3", volume="10", number="6", pages="e31491", keywords="allergic rhinitis", keywords="symptom scores", keywords="patient-generated data", keywords="patient-reported outcomes", keywords="mHealth", keywords="mobile health", keywords="health applications", keywords="allergies", keywords="allergy monitor", keywords="digital health", keywords="medication scores", abstract="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. ", doi="10.2196/31491", url="https://mhealth.jmir.org/2022/6/e31491", url="http://www.ncbi.nlm.nih.gov/pubmed/35657659" } @Article{info:doi/10.2196/34906, author="Patel, Tejal and Ivo, Jessica and Pitre, Teresa and Faisal, Sadaf and Antunes, Kristen and Oda, Kasumi", title="An In-Home Medication Dispensing System to Support Medication Adherence for Patients With Chronic Conditions in the Community Setting: Prospective Observational Pilot Study", journal="JMIR Form Res", year="2022", month="May", day="19", volume="6", number="5", pages="e34906", keywords="smart", keywords="medication adherence", keywords="usability", keywords="geriatric", keywords="in-home", keywords="community", keywords="chronic diseases", keywords="medication dispensing", keywords="eHealth", keywords="platform", keywords="self management", keywords="support tool", keywords="chronic disease", keywords="caregiver", keywords="satisfaction", abstract="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. ", doi="10.2196/34906", url="https://formative.jmir.org/2022/5/e34906", url="http://www.ncbi.nlm.nih.gov/pubmed/35587371" } @Article{info:doi/10.2196/36845, author="Daniels, Joseph and Peters, H. Remco P. and Medina-Marino, Andrew and Bongo, Cikizwa and Stephenson, Rob", title="A Skills-Based HIV Serostatus Disclosure Intervention for Sexual Minority Men in South Africa: Protocol for Intervention Adaptation and a Pilot Randomized Controlled Trial", journal="JMIR Res Protoc", year="2022", month="May", day="16", volume="11", number="5", pages="e36845", keywords="gay", keywords="bisexual", keywords="men who have sex with men", keywords="HIV intervention adaptation", keywords="videoconference delivery", keywords="HIV", keywords="public health", keywords="mobile phone", abstract="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 ", doi="10.2196/36845", url="https://www.researchprotocols.org/2022/5/e36845", url="http://www.ncbi.nlm.nih.gov/pubmed/35576574" } @Article{info:doi/10.2196/37124, author="Jose, K. Nisha and Vaz, Clint and Chai, R. Peter and Rodrigues, Rashmi", title="The Acceptability of Adherence Support via Mobile Phones for Antituberculosis Treatment in South India: Exploratory Study", journal="JMIR Form Res", year="2022", month="May", day="13", volume="6", number="5", pages="e37124", keywords="adherence", keywords="tuberculosis", keywords="antitubercular therapy", keywords="mHealth", keywords="mobile health", keywords="digital health", keywords="South India", keywords="technology acceptance", keywords="health intervention", abstract="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. ", doi="10.2196/37124", url="https://formative.jmir.org/2022/5/e37124", url="http://www.ncbi.nlm.nih.gov/pubmed/35560021" } @Article{info:doi/10.2196/36114, author="Morcillo-Mu{\~n}oz, Yolanda and S{\'a}nchez-Guarnido, Jos{\'e} Antonio and Calz{\'o}n-Fern{\'a}ndez, Silvia and Baena-Parejo, Isabel", title="Multimodal Chronic Pain Therapy for Adults via Smartphone: Randomized Controlled Clinical Trial", journal="J Med Internet Res", year="2022", month="May", day="11", volume="24", number="5", pages="e36114", keywords="chronic pain", keywords="eHealth", keywords="multimodal intervention", keywords="catastrophizing", keywords="self-management", keywords="mHealth", keywords="mobile phone", keywords="randomized controlled trials", abstract="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 ", doi="10.2196/36114", url="https://www.jmir.org/2022/5/e36114", url="http://www.ncbi.nlm.nih.gov/pubmed/35373" } @Article{info:doi/10.2196/37946, author="Baptist, Alan and Gibson-Scipio, Wanda and Carcone, Idalski April and Ghosh, Samiran and Jacques-Tiura, J. Angela and Hall, Amy and MacDonell, Kolmodin Karen", title="Asthma and Technology in Emerging African American Adults (The ATHENA Project): Protocol for a Trial Using the Multiphase Optimization Strategy Framework", journal="JMIR Res Protoc", year="2022", month="May", day="10", volume="11", number="5", pages="e37946", keywords="African American emerging adults", keywords="asthma management", keywords="mHealth", keywords="mobile health", keywords="motivational interviewing", keywords="asthma control", keywords="physical activity", abstract="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 ", doi="10.2196/37946", url="https://www.researchprotocols.org/2022/5/e37946", url="http://www.ncbi.nlm.nih.gov/pubmed/35536642" } @Article{info:doi/10.2196/30058, author="Bartlett, Kiera Yvonne and Farmer, Andrew and Newhouse, Nikki and Miles, Lisa and Kenning, Cassandra and French, P. David", title="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", journal="JMIR Form Res", year="2022", month="Apr", day="29", volume="6", number="4", pages="e30058", keywords="medication adherence", keywords="type 2 diabetes mellitus", keywords="behavior change techniques", keywords="text messaging", keywords="feasibility studies", keywords="diabetes", keywords="medication", keywords="digital health", abstract="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 ", doi="10.2196/30058", url="https://formative.jmir.org/2022/4/e30058", url="http://www.ncbi.nlm.nih.gov/pubmed/35486430" } @Article{info:doi/10.2196/32169, author="Gudala, Meghana and Ross, Trail Mary Ellen and Mogalla, Sunitha and Lyons, Mandi and Ramaswamy, Padmavathy and Roberts, Kirk", title="Benefits of, Barriers to, and Needs for an Artificial Intelligence--Powered Medication Information Voice Chatbot for Older Adults: Interview Study With Geriatrics Experts", journal="JMIR Aging", year="2022", month="Apr", day="28", volume="5", number="2", pages="e32169", keywords="medication information", keywords="chatbot", keywords="older adults", keywords="technology capabilities", keywords="mobile phone", abstract="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. ", doi="10.2196/32169", url="https://aging.jmir.org/2022/2/e32169", url="http://www.ncbi.nlm.nih.gov/pubmed/35482367" } @Article{info:doi/10.2196/25561, author="Kawichai, Surinda and Songtaweesin, Natalie Wipaporn and Wongharn, Prissana and Phanuphak, Nittaya and Cressey, R. Tim and Moonwong, Juthamanee and Vasinonta, Anuchit and Saisaengjan, Chutima and Chinbunchorn, Tanat and Puthanakit, Thanyawee", title="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", journal="JMIR Mhealth Uhealth", year="2022", month="Apr", day="21", volume="10", number="4", pages="e25561", keywords="mHealth", keywords="PrEP adherence", keywords="adolescents", keywords="men who have sex with men", keywords="transgender women", keywords="mobile phone", abstract="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 ", doi="10.2196/25561", url="https://mhealth.jmir.org/2022/4/e25561", url="http://www.ncbi.nlm.nih.gov/pubmed/35451976" } @Article{info:doi/10.2196/32702, author="Giebel, Denk Godwin and Speckemeier, Christian and Abels, Carina and B{\"o}rchers, Kirstin and Wasem, J{\"u}rgen and Blase, Nikola and Neusser, Silke", title="Problems and Barriers Related to the Use of Digital Health Applications: Protocol for a Scoping Review", journal="JMIR Res Protoc", year="2022", month="Apr", day="21", volume="11", number="4", pages="e32702", keywords="digital health application", keywords="DHA", keywords="mHealth, problems, barriers, scoping review", keywords="mobile health", keywords="health insurance", keywords="electronic database", keywords="health database", keywords="mHealth app", abstract="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 ", doi="10.2196/32702", url="https://www.researchprotocols.org/2022/4/e32702", url="http://www.ncbi.nlm.nih.gov/pubmed/35451979" } @Article{info:doi/10.2196/33628, author="Cai, Yiyuan and Gong, Wenjie and He, Wenjun and He, Hua and Hughes, P. James and Simoni, Jane and Xiao, Shuiyuan and Gloyd, Stephen and Lin, Meijuan and Deng, Xinlei and Liang, Zichao and Dai, Bofeng and Liao, Jing and Hao, Yuantao and Xu, Roman Dong", title="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", journal="JMIR Mhealth Uhealth", year="2022", month="Apr", day="19", volume="10", number="4", pages="e33628", keywords="medication adherence", keywords="mobile texting", keywords="lay health worker", keywords="resource-poor community", keywords="primary health care", keywords="quality of care", keywords="mHealth", keywords="schizophrenia", keywords="maintenance", keywords="residual effect", keywords="mental health", keywords="patient outcomes", abstract="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. ", doi="10.2196/33628", url="https://mhealth.jmir.org/2022/4/e33628", url="http://www.ncbi.nlm.nih.gov/pubmed/35438649" } @Article{info:doi/10.2196/31040, author="Kulh{\'a}nek, Adam and Lukavska, Katerina and Gabrhel{\'i}k, Roman and Nov{\'a}k, Daniel and Burda, V{\'a}clav and Prokop, Jind?ich and Holter, S. Marianne T. and Brendryen, H{\aa}var", title="Comparing Reminders Sent via SMS Text Messaging and Email for Improving Adherence to an Electronic Health Program: Randomized Controlled Trial", journal="JMIR Mhealth Uhealth", year="2022", month="Mar", day="18", volume="10", number="3", pages="e31040", keywords="eHealth", keywords="randomized controlled trial", keywords="adherence", keywords="reminders", keywords="SMS text messaging", keywords="email", keywords="smoking cessation", keywords="text message", abstract="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; $\chi$21=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 ", doi="10.2196/31040", url="https://mhealth.jmir.org/2022/3/e31040", url="http://www.ncbi.nlm.nih.gov/pubmed/35302945" } @Article{info:doi/10.2196/27588, author="Mujcic, Ajla and Blankers, Matthijs and Boon, Brigitte and Verdonck-de Leeuw, M. Irma and Smit, Filip and van Laar, Margriet and Engels, Rutger", title="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", journal="J Med Internet Res", year="2022", month="Mar", day="17", volume="24", number="3", pages="e27588", keywords="smoking cessation", keywords="cancer survivors", keywords="effectiveness", keywords="cost-effectiveness", keywords="eHealth", abstract="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 ", doi="10.2196/27588", url="https://www.jmir.org/2022/3/e27588", url="http://www.ncbi.nlm.nih.gov/pubmed/35297777" } @Article{info:doi/10.2196/31972, author="Limmroth, Volker and Bayer-Gersmann, Kirsten and Mueller, Christian and Sch{\"u}rks, Markus", title="Ascertaining Medication Use and Patient-Reported Outcomes via an App and Exploring Gamification in Patients With Multiple Sclerosis Treated With Interferon $\beta$-1b: Observational Study", journal="JMIR Form Res", year="2022", month="Mar", day="14", volume="6", number="3", pages="e31972", keywords="digital observational study", keywords="BETACONNECT", keywords="app", keywords="interferon $\beta$-1b", keywords="multiple sclerosis", keywords="medication adherence", keywords="medication compliance", keywords="medication persistence", keywords="health-related quality of life", keywords="gamification", keywords="mobile phone", abstract="Background: The BETACONNECT autoinjector and myBETAapp app were designed to support patients with multiple sclerosis receiving interferon $\beta$-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 $\beta$-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. ", doi="10.2196/31972", url="https://formative.jmir.org/2022/3/e31972", url="http://www.ncbi.nlm.nih.gov/pubmed/35285806" } @Article{info:doi/10.2196/35157, author="Mason, Madilyn and Cho, Youmin and Rayo, Jessica and Gong, Yang and Harris, Marcelline and Jiang, Yun", title="Technologies for Medication Adherence Monitoring and Technology Assessment Criteria: Narrative Review", journal="JMIR Mhealth Uhealth", year="2022", month="Mar", day="10", volume="10", number="3", pages="e35157", keywords="medication adherence", keywords="technology assessment", keywords="remote sensing technology", keywords="telemedicine", abstract="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. ", doi="10.2196/35157", url="https://mhealth.jmir.org/2022/3/e35157", url="http://www.ncbi.nlm.nih.gov/pubmed/35266873" } @Article{info:doi/10.2196/27202, author="Ni, Zhao and Wu, Bei and Yang, Qing and Yan, L. Lijing and Liu, Changqing and Shaw, J. Ryan", title="An mHealth Intervention to Improve Medication Adherence and Health Outcomes Among Patients With Coronary Heart Disease: Randomized Controlled Trial", journal="J Med Internet Res", year="2022", month="Mar", day="9", volume="24", number="3", pages="e27202", keywords="mHealth", keywords="medication adherence", keywords="coronary disease", keywords="blood pressure", keywords="China", keywords="randomized controlled trial", abstract="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 ", doi="10.2196/27202", url="https://www.jmir.org/2022/3/e27202", url="http://www.ncbi.nlm.nih.gov/pubmed/35262490" } @Article{info:doi/10.2196/28332, author="Ranjit, S. Yerina and Krishnan, Archana and Ghosh, Debarchana and Cravero, Claire and Zhou, Xin and Altice, L. Frederick", title="mHealth Intervention to Improve Treatment Outcomes Among People With HIV Who Use Cocaine: Protocol for a Pilot Randomized Controlled Trial", journal="JMIR Res Protoc", year="2022", month="Mar", day="7", volume="11", number="3", pages="e28332", keywords="smart pillbox", keywords="smartphone", keywords="mHealth intervention", keywords="people with HIV", keywords="cocaine use", keywords="antiretroviral therapy", keywords="description of feasibility and acceptability", keywords="mobile phone", abstract="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 ", doi="10.2196/28332", url="https://www.researchprotocols.org/2022/3/e28332", url="http://www.ncbi.nlm.nih.gov/pubmed/35254270" } @Article{info:doi/10.2196/29415, author="Cao, Weidan and Milks, Wesley M. and Liu, Xiaofu and Gregory, E. Megan and Addison, Daniel and Zhang, Ping and Li, Lang", title="mHealth Interventions for Self-management of Hypertension: Framework and Systematic Review on Engagement, Interactivity, and Tailoring", journal="JMIR Mhealth Uhealth", year="2022", month="Mar", day="2", volume="10", number="3", pages="e29415", keywords="mHealth", keywords="mobile app", keywords="digital behavior change", keywords="interventions", keywords="systematic review", keywords="hypertension", keywords="engagement", keywords="interactivity", keywords="tailoring", keywords="mobile phone", abstract="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. ", doi="10.2196/29415", url="https://mhealth.jmir.org/2022/3/e29415", url="http://www.ncbi.nlm.nih.gov/pubmed/35234655" } @Article{info:doi/10.2196/33062, author="Ridho, Abdurahman and Alfian, D. Sofa and van Boven, M. Job F. and Levita, Jutti and Yalcin, Aki Esin and Le, Ly and Alffenaar, Jan-Willem and Hak, Eelko and Abdulah, Rizky and Pradipta, S. Ivan", title="Digital Health Technologies to Improve Medication Adherence and Treatment Outcomes in Patients With Tuberculosis: Systematic Review of Randomized Controlled Trials", journal="J Med Internet Res", year="2022", month="Feb", day="23", volume="24", number="2", pages="e33062", keywords="tuberculosis", keywords="intervention", keywords="eHealth", keywords="medication adherence technology", keywords="nonadherence", keywords="digital health", keywords="systematic review", keywords="treatment outcomes", abstract="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. ", doi="10.2196/33062", url="https://www.jmir.org/2022/2/e33062", url="http://www.ncbi.nlm.nih.gov/pubmed/35195534" } @Article{info:doi/10.2196/30671, author="Tran, Steven and Smith, Lorraine and El-Den, Sarira and Carter, Stephen", title="The Use of Gamification and Incentives in Mobile Health Apps to Improve Medication Adherence: Scoping Review", journal="JMIR Mhealth Uhealth", year="2022", month="Feb", day="21", volume="10", number="2", pages="e30671", keywords="gamification", keywords="incentives", keywords="mobile application", keywords="mHealth", keywords="medication adherence", keywords="mobile phone", abstract="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. ", doi="10.2196/30671", url="https://mhealth.jmir.org/2022/2/e30671", url="http://www.ncbi.nlm.nih.gov/pubmed/35188475" } @Article{info:doi/10.2196/25597, author="Chevance, Astrid and Fortel, Axel and Jouannin, Adeline and Denis, Faustine and Mamzer, Marie-France and Ravaud, Philippe and Sidorkiewicz, Stephanie", title="Acceptability of and Willingness to Take Digital Pills by Patients, the Public, and Health Care Professionals: Qualitative Content Analysis of a Large Online Survey", journal="J Med Internet Res", year="2022", month="Feb", day="18", volume="24", number="2", pages="e25597", keywords="acceptability", keywords="health technology assessment", keywords="clinical effectiveness research", keywords="ethics", keywords="digital pill", keywords="digital health", keywords="digital therapeutics", keywords="ingestible sensor", keywords="adherence", abstract="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. ", doi="10.2196/25597", url="https://www.jmir.org/2022/2/e25597", url="http://www.ncbi.nlm.nih.gov/pubmed/35179509" } @Article{info:doi/10.2196/31570, author="Pouls, PH Bart and Bekker, L. Charlotte and van Dulmen, Sandra and Vriezekolk, E. Johanna and van den Bemt, JF Bart", title="A Serious Puzzle Game to Enhance Adherence to Antirheumatic Drugs in Patients With Rheumatoid Arthritis: Systematic Development Using Intervention Mapping", journal="JMIR Serious Games", year="2022", month="Feb", day="18", volume="10", number="1", pages="e31570", keywords="medication adherence", keywords="serious game", keywords="eHealth", keywords="rheumatoid arthritis", keywords="intervention mapping", keywords="intervention development", abstract="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. ", doi="10.2196/31570", url="https://games.jmir.org/2022/1/e31570", url="http://www.ncbi.nlm.nih.gov/pubmed/35179510" } @Article{info:doi/10.2196/33603, author="Carpenter, A. Chelsea and Eastman, Abraham and Ross, M. Kathryn", title="Consistency With and Disengagement From Self-monitoring of Weight, Dietary Intake, and Physical Activity in a Technology-Based Weight Loss Program: Exploratory Study", journal="JMIR Form Res", year="2022", month="Feb", day="18", volume="6", number="2", pages="e33603", keywords="self-monitoring", keywords="adherence", keywords="weight loss", keywords="digital tools", keywords="mobile phone", abstract="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. ", doi="10.2196/33603", url="https://formative.jmir.org/2022/2/e33603", url="http://www.ncbi.nlm.nih.gov/pubmed/35179513" } @Article{info:doi/10.2196/32946, author="Morken, Margreta Ingvild and Storm, Marianne and S{\o}reide, Arne Jon and Urstad, Hjorthaug Kristin and Karlsen, Bj{\o}rg and Huseb{\o}, Lunde Anne Marie", title="Posthospitalization Follow-Up of Patients With Heart Failure Using eHealth Solutions: Restricted Systematic Review", journal="J Med Internet Res", year="2022", month="Feb", day="15", volume="24", number="2", pages="e32946", keywords="adherence", keywords="eHealth", keywords="heart failure", keywords="posthospitalization follow-up", keywords="patient outcome", keywords="review", abstract="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. ", doi="10.2196/32946", url="https://www.jmir.org/2022/2/e32946", url="http://www.ncbi.nlm.nih.gov/pubmed/35166680" } @Article{info:doi/10.2196/29393, author="Sheshadri, Ajay and Makhnoon, Sukh and Alousi, M. Amin and Bashoura, Lara and Andrade, Rene and Miller, J. Christopher and Stolar, R. Karen and Arain, Hasan Muhammad and Noor, Laila and Balagani, Amulya and Jain, Akash and Blanco, David and Ortiz, Abel and Taylor, S. Michael and Stenzler, Alex and Mehta, Rohtesh and Popat, R. Uday and Hosing, Chitra and Ost, E. David and Champlin, E. Richard and Dickey, F. Burton and Peterson, K. Susan", title="Home-Based Spirometry Telemonitoring After Allogeneic Hematopoietic Cell Transplantation: Mixed Methods Evaluation of Acceptability and Usability", journal="JMIR Form Res", year="2022", month="Feb", day="7", volume="6", number="2", pages="e29393", keywords="allogeneic hematopoietic cell transplantation", keywords="home-based spirometry", keywords="acceptability", keywords="usability", keywords="mixed methods evaluation", keywords="patient perspectives", keywords="spirometry", keywords="feasibility", keywords="mHealth", keywords="home-based", keywords="remote care", keywords="respirology", keywords="pulmonary medicine", keywords="mobile phone", abstract="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. ", doi="10.2196/29393", url="https://formative.jmir.org/2022/2/e29393", url="http://www.ncbi.nlm.nih.gov/pubmed/35129455" } @Article{info:doi/10.2196/30811, author="O'Connor, Cara and Leyritana, Katerina and Doyle, M. Aoife and Lewis, J. James and Gill, Randeep and Salva{\~n}a, Maurice Edsel", title="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", journal="JMIR Form Res", year="2022", month="Feb", day="3", volume="6", number="2", pages="e30811", keywords="mHealth", keywords="adherence", keywords="HIV", keywords="antiretroviral therapy", keywords="intervention development", keywords="mobile phone", abstract="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. ", doi="10.2196/30811", url="https://formative.jmir.org/2022/2/e30811", url="http://www.ncbi.nlm.nih.gov/pubmed/35113030" } @Article{info:doi/10.2196/32626, author="Assefi, Aria and van Dommelen, Paula and Arnaud, Lilian and Otero, Carlos and Fernandez-Luque, Luis and Koledova, Ekaterina and Calliari, Eduardo Luis", title="Adherence to Growth Hormone Treatment Using a Connected Device in Latin America: Real-World Exploratory Descriptive Analysis Study", journal="JMIR Mhealth Uhealth", year="2022", month="Jan", day="20", volume="10", number="1", pages="e32626", keywords="adherence", keywords="connected device", keywords="growth", keywords="growth disorders", keywords="growth hormone", keywords="electronic injection device", keywords="real-world data", keywords="disorder", keywords="therapy", keywords="treatment", keywords="children", keywords="outcome", abstract="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. ", doi="10.2196/32626", url="https://mhealth.jmir.org/2022/1/e32626", url="http://www.ncbi.nlm.nih.gov/pubmed/35049518" } @Article{info:doi/10.2196/24174, author="Rivers, T. John and Smith, Carla and Smith, Ian and Cameron, James", title="The Impact of a Mobile App on Participation in Cardiac Rehabilitation and Understanding Barriers to Success: Comparative Cohort Study", journal="JMIR Cardio", year="2022", month="Jan", day="17", volume="6", number="1", pages="e24174", keywords="cardiac rehabilitation", keywords="digital health", keywords="smartphone app", keywords="Cardihab", keywords="participation rates", keywords="rehabilitation", keywords="cardiology", keywords="heart", keywords="app", keywords="barrier", abstract="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. ", doi="10.2196/24174", url="https://cardio.jmir.org/2022/1/e24174", url="http://www.ncbi.nlm.nih.gov/pubmed/35037891" } @Article{info:doi/10.2196/34885, author="Torres, Silva Thiago and Jalil, Moreira Emilia and Coelho, Esteves Lara and Bezerra, Barros Daniel Rodrigues and Jalil, Moreira Cristina and Hoagland, Brenda and Cardoso, Wagner Sandra and Arayasirikul, Sean and Veloso, Gon{\c{c}}alves Valdilea and Wilson, C. Erin and McFarland, Willi and Grinsztejn, Beatriz", title="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", journal="JMIR Res Protoc", year="2022", month="Jan", day="13", volume="11", number="1", pages="e34885", keywords="sexual and gender minorities", keywords="young MSM", keywords="Brazil", keywords="HIV prevention", keywords="technology-based adherence intervention", keywords="HIV", abstract="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 ", doi="10.2196/34885", url="https://www.researchprotocols.org/2022/1/e34885", url="http://www.ncbi.nlm.nih.gov/pubmed/35023848" } @Article{info:doi/10.2196/27192, author="Oh, Woo Sang and Kim, Kyoung-Kon and Kim, Soo Sung and Park, Kyung Su and Park, Sangshin", title="Effect of an Integrative Mobile Health Intervention in Patients With Hypertension and Diabetes: Crossover Study", journal="JMIR Mhealth Uhealth", year="2022", month="Jan", day="11", volume="10", number="1", pages="e27192", keywords="diabetes mellitus type 2", keywords="obesity", keywords="hypertension", keywords="mHealth", keywords="mobile phone", abstract="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. ", doi="10.2196/27192", url="https://mhealth.jmir.org/2022/1/e27192", url="http://www.ncbi.nlm.nih.gov/pubmed/35014961" } @Article{info:doi/10.2196/30807, author="Senoo, Keitaro and Miki, Tomonori and Ohkura, Takashi and Iwakoshi, Hibiki and Nishimura, Tetsuro and Shiraishi, Hirokazu and Teramukai, Satoshi and Matoba, Satoaki", title="A Smartphone App to Improve Oral Anticoagulation Adherence in Patients With Atrial Fibrillation: Prospective Observational Study", journal="JMIR Mhealth Uhealth", year="2022", month="Jan", day="7", volume="10", number="1", pages="e30807", keywords="atrial fibrillation", keywords="smartphone app", keywords="anticoagulants", keywords="drug adherence", keywords="education", keywords="patient involvement", abstract="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. ", doi="10.2196/30807", url="https://mhealth.jmir.org/2022/1/e30807", url="http://www.ncbi.nlm.nih.gov/pubmed/34894626" } @Article{info:doi/10.2196/31852, author="Krishna, Meenakshi and Sybil, Deborah and Shrivastava, Kumar Priyanshu and Premchandani, Shubhangi and Kumar, Himanshu and Kumar, Pintu", title="An Innovative App (ExoDont) for Postoperative Care of Patients After Tooth Extraction: Prototype Development and Testing Study", journal="JMIR Perioper Med", year="2021", month="Dec", day="31", volume="4", number="2", pages="e31852", keywords="ExoDont", keywords="Android app", keywords="teledentistry", keywords="mHealth", keywords="tooth extraction", keywords="postoperative", keywords="dentistry", keywords="dentist", keywords="teeth", keywords="dental surgery", keywords="oral surgery", abstract="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. ", doi="10.2196/31852", url="https://periop.jmir.org/2021/2/e31852", url="http://www.ncbi.nlm.nih.gov/pubmed/34982720" } @Article{info:doi/10.2196/31890, author="Elzinga, O. Willem and Prins, Samantha and Borghans, M. Laura G. J. and Gal, Pim and Vargas, A. Gabriel and Groeneveld, J. Geert and Doll, J. Robert", title="Detection of Clenbuterol-Induced Changes in Heart Rate Using At-Home Recorded Smartwatch Data: Randomized Controlled Trial", journal="JMIR Form Res", year="2021", month="Dec", day="30", volume="5", number="12", pages="e31890", keywords="photoplethysmography", keywords="smartwatch", keywords="wearable", keywords="at-home", keywords="heart rate", keywords="RCT", keywords="wearable device", keywords="digital health", keywords="cardiovascular", keywords="cardiology", keywords="sensors", keywords="heart rate sensor", keywords="smart technology", abstract="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 ", doi="10.2196/31890", url="https://formative.jmir.org/2021/12/e31890", url="http://www.ncbi.nlm.nih.gov/pubmed/34967757" } @Article{info:doi/10.2196/26356, author="Wynn, S. Chelsea and Catallozzi, Marina and Kolff, A. Chelsea and Holleran, Stephen and Meyer, Dodi and Ramakrishnan, Rajasekhar and Stockwell, S. Melissa", title="Personalized Reminders for Immunization Using Short Messaging Systems to Improve Human Papillomavirus Vaccination Series Completion: Parallel-Group Randomized Trial", journal="JMIR Mhealth Uhealth", year="2021", month="Dec", day="27", volume="9", number="12", pages="e26356", keywords="text messaging", keywords="mobile reminders", keywords="human papillomavirus", keywords="adolescent", keywords="text reminders", keywords="vaccine completion", keywords="vaccine decision-making", keywords="vaccine education", keywords="transtheoretical model", keywords="mobile phone", keywords="smartphone", keywords="mHealth", keywords="mobile health", keywords="minority health", abstract="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 ", doi="10.2196/26356", url="https://mhealth.jmir.org/2021/12/e26356", url="http://www.ncbi.nlm.nih.gov/pubmed/34958306" } @Article{info:doi/10.2196/22672, author="Doyle, Julie and Murphy, Emma and Gavin, Shane and Pascale, Alessandra and Deparis, St{\'e}phane and Tommasi, Pierpaolo and Smith, Suzanne and Hannigan, Caoimhe and Sillevis Smitt, Myriam and van Leeuwen, Cora and Lastra, Julia and Galvin, Mary and McAleer, Patricia and Tompkins, Lorraine and Jacobs, An and M Marques, Marta and Medina Maestro, Jaime and Boyle, Gordon and Dinsmore, John", title="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", journal="J Med Internet Res", year="2021", month="Dec", day="15", volume="23", number="12", pages="e22672", keywords="digital health", keywords="aging", keywords="multimorbidity", keywords="chronic disease", keywords="self-management", keywords="integrated care", keywords="longitudinal study", keywords="engagement", keywords="usability", keywords="mobile phone", abstract="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 ", doi="10.2196/22672", url="https://www.jmir.org/2021/12/e22672", url="http://www.ncbi.nlm.nih.gov/pubmed/34914612" } @Article{info:doi/10.2196/22125, author="Dinsmore, John and Hannigan, Caoimhe and Smith, Suzanne and Murphy, Emma and Kuiper, L. Janneke M. and O'Byrne, Emma and Galvin, Mary and Jacobs, An and Sillevis Smitt, Myriam and van Leeuwen, Cora and McAleer, Patricia and Tompkins, Lorraine and Brady, Anne-Marie and McCarron, Mary and Doyle, Julie", title="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", journal="JMIR Res Protoc", year="2021", month="Dec", day="15", volume="10", number="12", pages="e22125", keywords="multimorbidity", keywords="digital health", keywords="chronic disease", keywords="self-management", keywords="older adults", keywords="integrated care", keywords="behaviour change", keywords="mobile phone", keywords="smart phone", keywords="smart device", abstract="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 ", doi="10.2196/22125", url="https://www.researchprotocols.org/2021/12/e22125", url="http://www.ncbi.nlm.nih.gov/pubmed/34914613" } @Article{info:doi/10.2196/29197, author="Markossian, W. Talar and Boyda, Jason and Taylor, Jennifer and Etingen, Bella and Modave, Fran{\c{c}}ois and Price, Ron and Kramer, J. Holly", title="A Mobile App to Support Self-management of Chronic Kidney Disease: Development Study", journal="JMIR Hum Factors", year="2021", month="Dec", day="15", volume="8", number="4", pages="e29197", keywords="chronic kidney disease", keywords="mobile app", keywords="self-management", keywords="mHealth", keywords="mobile apps", keywords="digital health", keywords="kidney disease", keywords="smartphone", abstract="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. ", doi="10.2196/29197", url="https://humanfactors.jmir.org/2021/4/e29197", url="http://www.ncbi.nlm.nih.gov/pubmed/34914614" } @Article{info:doi/10.2196/17839, author="Chatterjee, Pothik and Beck, M. Adam and Brager, Levenson Jenna Ashley and Durand, J. Daniel and D'Adamo, R. Christopher", title="The Effect of an Automated Mobile Patient Engagement Application on Emergency Department Revisits: Prospective Observational Study", journal="JMIR Form Res", year="2021", month="Dec", day="13", volume="5", number="12", pages="e17839", keywords="patient engagement", keywords="value-based care", keywords="digital health", keywords="mobile app", keywords="automation", keywords="readmission", keywords="revisit", keywords="emergency department", abstract="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. ", doi="10.2196/17839", url="https://formative.jmir.org/2021/12/e17839", url="http://www.ncbi.nlm.nih.gov/pubmed/34898451" } @Article{info:doi/10.2196/22557, author="Ghorbani, Banafsheh and Jackson, C. Alun and Noorchenarboo, Mohammad and Mandegar, H. Mohammad and Sharifi, Farshad and Mirmoghtadaie, Zohrehsadat and Bahramnezhad, Fatemeh", title="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", journal="J Med Internet Res", year="2021", month="Dec", day="10", volume="23", number="12", pages="e22557", keywords="teach back", keywords="gamification", keywords="treatment regimen", keywords="coronary artery bypass graft", keywords="patient training", abstract="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 ", doi="10.2196/22557", url="https://www.jmir.org/2021/12/e22557", url="http://www.ncbi.nlm.nih.gov/pubmed/34890346" } @Article{info:doi/10.2196/25129, author="Bezabih, Mequanint Alemitu and Gerling, Kathrin and Abebe, Workeabeba and Abeele, Vanden Vero", title="Behavioral Theories and Motivational Features Underlying eHealth Interventions for Adolescent Antiretroviral Adherence: Systematic Review", journal="JMIR Mhealth Uhealth", year="2021", month="Dec", day="10", volume="9", number="12", pages="e25129", keywords="HIV", keywords="adolescents", keywords="ART adherence", keywords="eHealth", keywords="health theories", keywords="behavior change techniques", keywords="motivational design principles", abstract="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. ", doi="10.2196/25129", url="https://mhealth.jmir.org/2021/12/e25129", url="http://www.ncbi.nlm.nih.gov/pubmed/34890353" } @Article{info:doi/10.2196/30762, author="Lee, W. Austin and Kenfield, A. Stacey and Wang, Y. Elizabeth and Enriquez, Anthony and Oni-Orisan, Akinyemi and Steinman, A. Michael and Sim, Ida and Breyer, N. Benjamin and Bauer, R. Scott", title="Tracking Lower Urinary Tract Symptoms and Tamsulosin Side Effects Among Older Men Using a Mobile App (PERSONAL): Feasibility and Usability Study", journal="JMIR Form Res", year="2021", month="Dec", day="10", volume="5", number="12", pages="e30762", keywords="LUTS", keywords="tamsulosin", keywords="mobile", keywords="app", keywords="mobile phone", abstract="Background: Continuous $\alpha$1a-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. ", doi="10.2196/30762", url="https://formative.jmir.org/2021/12/e30762", url="http://www.ncbi.nlm.nih.gov/pubmed/34889745" } @Article{info:doi/10.2196/32842, author="Carlozzi, E. Noelle and Choi, Won Sung and Wu, Zhenke and Miner, A. Jennifer and Lyden, K. Angela and Graves, Christopher and Wang, Jitao and Sen, Srijan", title="An App-Based Just-in-Time Adaptive Self-management Intervention for Care Partners (CareQOL): Protocol for a Pilot Trial", journal="JMIR Res Protoc", year="2021", month="Dec", day="9", volume="10", number="12", pages="e32842", keywords="caregivers", keywords="quality of life", keywords="spinal cord injuries", keywords="Huntington disease", keywords="hematopoietic stem cell transplantation", keywords="feasibility studies", keywords="self-management", keywords="mobile apps", keywords="outcome assessment", keywords="mobile phone", abstract="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 ", doi="10.2196/32842", url="https://www.researchprotocols.org/2021/12/e32842", url="http://www.ncbi.nlm.nih.gov/pubmed/34889775" } @Article{info:doi/10.2196/29563, author="Moshontz, Hannah and Colmenares, J. Alejandra and Fronk, E. Gaylen and Sant'Ana, J. Sarah and Wyant, Kendra and Wanta, E. Susan and Maus, Adam and Gustafson Jr, H. David and Shah, Dhavan and Curtin, J. John", title="Prospective Prediction of Lapses in Opioid Use Disorder: Protocol for a Personal Sensing Study", journal="JMIR Res Protoc", year="2021", month="Dec", day="7", volume="10", number="12", pages="e29563", keywords="digital therapeutics", keywords="risk prediction", keywords="opioid lapse", keywords="mobile phone", abstract="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 ", doi="10.2196/29563", url="https://www.researchprotocols.org/2021/12/e29563", url="http://www.ncbi.nlm.nih.gov/pubmed/34559061" } @Article{info:doi/10.2196/28242, author="Bughin, Fran{\c{c}}ois and Bui, Gaspard and Ayoub, Bronia and Blervaque, Leo and Saey, Didier and Avignon, Antoine and Brun, Fr{\'e}d{\'e}ric Jean and Molinari, Nicolas and Pomies, Pascal and Mercier, Jacques and Gouzi, Fares and Hayot, Maurice", title="Impact of a Mobile Telerehabilitation Solution on Metabolic Health Outcomes and Rehabilitation Adherence in Patients With Obesity: Randomized Controlled Trial", journal="JMIR Mhealth Uhealth", year="2021", month="Dec", day="6", volume="9", number="12", pages="e28242", keywords="telerehabilitation", keywords="mHealth", keywords="rehabilitation", keywords="obesity", keywords="mobile phone", abstract="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/m{\texttwosuperior}) 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 {\texttimes} 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 ", doi="10.2196/28242", url="https://mhealth.jmir.org/2021/12/e28242", url="http://www.ncbi.nlm.nih.gov/pubmed/34874887" } @Article{info:doi/10.2196/33568, author="Goldstein, P. Stephanie and Zhang, Fengqing and Klasnja, Predrag and Hoover, Adam and Wing, R. Rena and Thomas, Graham John", title="Optimizing a Just-in-Time Adaptive Intervention to Improve Dietary Adherence in Behavioral Obesity Treatment: Protocol for a Microrandomized Trial", journal="JMIR Res Protoc", year="2021", month="Dec", day="6", volume="10", number="12", pages="e33568", keywords="obesity", keywords="weight loss", keywords="dietary adherence", keywords="just-in-time adaptive intervention", keywords="microrandomized trial", keywords="mobile phone", abstract="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 ", doi="10.2196/33568", url="https://www.researchprotocols.org/2021/12/e33568", url="http://www.ncbi.nlm.nih.gov/pubmed/34874892" } @Article{info:doi/10.2196/31213, author="Greenstein, Jay and Topp, Robert and Etnoyer-Slaski, Jena and Staelgraeve, Michael and McNulty, John", title="Effect of a Mobile Health App on Adherence to Physical Health Treatment: Retrospective Analysis", journal="JMIR Rehabil Assist Technol", year="2021", month="Dec", day="2", volume="8", number="4", pages="e31213", keywords="adherence", keywords="self-discharge", keywords="phone app", keywords="physical therapy", keywords="chiropractor", keywords="mobile phone", abstract="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. ", doi="10.2196/31213", url="https://rehab.jmir.org/2021/4/e31213", url="http://www.ncbi.nlm.nih.gov/pubmed/34655468" } @Article{info:doi/10.2196/29758, author="McCarthy, Marie and Zhang, Lili and Monacelli, Greta and Ward, Tomas", title="Using Methods From Computational Decision-making to Predict Nonadherence to Fitness Goals: Protocol for an Observational Study", journal="JMIR Res Protoc", year="2021", month="Nov", day="26", volume="10", number="11", pages="e29758", keywords="decision-making games", keywords="computational psychology", keywords="fitness goals", keywords="advanced analytics", keywords="mobile app", keywords="computational modeling", keywords="fitness tracker", keywords="mobile phone", abstract="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 ", doi="10.2196/29758", url="https://www.researchprotocols.org/2021/11/e29758", url="http://www.ncbi.nlm.nih.gov/pubmed/34842557" } @Article{info:doi/10.2196/23359, author="Carlin, Thomas and Soulard, Julie and Aubourg, Timoth{\'e}e and Knitza, Johannes and Vuillerme, Nicolas", title="Objective Measurements of Physical Activity and Sedentary Behavior Using Wearable Devices in Patients With Axial Spondyloarthritis: Protocol for a Systematic Review", journal="JMIR Res Protoc", year="2021", month="Nov", day="25", volume="10", number="11", pages="e23359", keywords="axial spondyloarthritis", keywords="rheumatology", keywords="physical activity", keywords="sedentary behavior", keywords="objective measures", keywords="wearable", keywords="systematic review", abstract="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 ", doi="10.2196/23359", url="https://www.researchprotocols.org/2021/11/e23359", url="http://www.ncbi.nlm.nih.gov/pubmed/34842559" } @Article{info:doi/10.2196/31678, author="Beckers, B. Abraham and Snijkers, W. Johanna T. and Weerts, M. Zsa Zsa R. and Vork, Lisa and Klaassen, Tim and Smeets, M. Fabienne G. and Masclee, M. Ad A. and Keszthelyi, Daniel", title="Digital Instruments for Reporting of Gastrointestinal Symptoms in Clinical Trials: Comparison of End-of-Day Diaries Versus the Experience Sampling Method", journal="JMIR Form Res", year="2021", month="Nov", day="24", volume="5", number="11", pages="e31678", keywords="irritable bowel syndrome", keywords="functional dyspepsia", keywords="digital diary", keywords="experience sampling method", keywords="smartphone app", keywords="mobile phone application", keywords="mHealth", keywords="eHealth", keywords="compliance", keywords="patient-reported outcome measures", abstract="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. ", doi="10.2196/31678", url="https://formative.jmir.org/2021/11/e31678", url="http://www.ncbi.nlm.nih.gov/pubmed/34821561" } @Article{info:doi/10.2196/32521, author="Horvath, Mark and Grutman, Aurora and O'Malley, S. Stephanie and Gueorguieva, Ralitza and Khan, Nashmia and Brewer, A. Judson and Garrison, A. Kathleen", title="Smartband-Based Automatic Smoking Detection and Real-time Mindfulness Intervention: Protocol for a Feasibility Trial", journal="JMIR Res Protoc", year="2021", month="Nov", day="16", volume="10", number="11", pages="e32521", keywords="smartband", keywords="smartphone", keywords="smoking", keywords="mindfulness", keywords="craving", keywords="mHealth", abstract="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 ", doi="10.2196/32521", url="https://www.researchprotocols.org/2021/11/e32521", url="http://www.ncbi.nlm.nih.gov/pubmed/34783663" } @Article{info:doi/10.2196/30786, author="Baumgartner, L. Susan and Buffkin Jr, Eric D. and Rukavina, Elise and Jones, Jason and Weiler, Elizabeth and Carnes, C. Tony", title="A Novel Digital Pill System for Medication Adherence Measurement and Reporting: Usability Validation Study", journal="JMIR Hum Factors", year="2021", month="Nov", day="8", volume="8", number="4", pages="e30786", keywords="digital pills", keywords="digital medication", keywords="ingestible event marker", keywords="ingestible sensor", keywords="human factors", keywords="usability", keywords="validation study", keywords="medication adherence", keywords="medication nonadherence", keywords="remote patient monitoring", keywords="mobile phone", abstract="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. ", doi="10.2196/30786", url="https://humanfactors.jmir.org/2021/4/e30786", url="http://www.ncbi.nlm.nih.gov/pubmed/34747709" } @Article{info:doi/10.2196/25749, author="Paquette, E. Catherine and Rubalcava, T. Dillon and Chen, Yun and Anand, Deepika and Daughters, B. Stacey", title="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", journal="JMIR Form Res", year="2021", month="Nov", day="3", volume="5", number="11", pages="e25749", keywords="substance use disorder", keywords="smartphone app", keywords="mHealth", keywords="behavioral activation", keywords="mobile phone", abstract="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 ", doi="10.2196/25749", url="https://formative.jmir.org/2021/11/e25749", url="http://www.ncbi.nlm.nih.gov/pubmed/34730535" } @Article{info:doi/10.2196/30674, author="Diaz-Skeete, Maria Yohanca and McQuaid, David and Akinosun, Samuel Adewale and Ekerete, Idongesit and Carragher, Natacha and Carragher, Lucia", title="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", journal="JMIR Mhealth Uhealth", year="2021", month="Nov", day="2", volume="9", number="11", pages="e30674", keywords="mobile app", keywords="mHealth", keywords="medication app", keywords="heart failure", keywords="Mobile App Rating Scale", abstract="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. ", doi="10.2196/30674", url="https://mhealth.jmir.org/2021/11/e30674", url="http://www.ncbi.nlm.nih.gov/pubmed/34726613" } @Article{info:doi/10.2196/32548, author="Shi, Boqun and Liu, Xi and Dong, Qiuting and Yang, Yuxiu and Cai, Zhongxing and Wang, Haoyu and Yin, Dong and Wang, Hongjian and Dou, Kefei and Song, Weihua", title="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", journal="JMIR Mhealth Uhealth", year="2021", month="Oct", day="27", volume="9", number="10", pages="e32548", keywords="WeChat", keywords="telemedicine", keywords="coronary artery disease", keywords="medication adherence", keywords="mobile phone", abstract="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, $\beta$-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 ", doi="10.2196/32548", url="https://mhealth.jmir.org/2021/10/e32548", url="http://www.ncbi.nlm.nih.gov/pubmed/34569467" } @Article{info:doi/10.2196/27131, author="Sekandi, Nabbuye Juliet and Kasiita, Vicent and Onuoha, Amara Nicole and Zalwango, Sarah and Nakkonde, Damalie and Kaawa-Mafigiri, David and Turinawe, Julius and Kakaire, Robert and Davis-Olwell, Paula and Atuyambe, Lynn and Buregyeya, Esther", title="Stakeholders' Perceptions of Benefits of and Barriers to Using Video-Observed Treatment for Monitoring Patients With Tuberculosis in Uganda: Exploratory Qualitative Study", journal="JMIR Mhealth Uhealth", year="2021", month="Oct", day="27", volume="9", number="10", pages="e27131", keywords="tuberculosis", keywords="adherence", keywords="mHealth", keywords="video directly observed therapy", keywords="Uganda", keywords="mobile phone", abstract="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. ", doi="10.2196/27131", url="https://mhealth.jmir.org/2021/10/e27131", url="http://www.ncbi.nlm.nih.gov/pubmed/34704961" } @Article{info:doi/10.2196/32789, author="Psihogios, M. Alexandra and Rabbi, Mashfiqui and Ahmed, Annisa and McKelvey, R. Elise and Li, Yimei and Laurenceau, Jean-Philippe and Hunger, P. Stephen and Fleisher, Linda and Pai, LH Ahna and Schwartz, A. Lisa and Murphy, A. Susan and Barakat, P. Lamia", title="Understanding Adolescent and Young Adult 6-Mercaptopurine Adherence and mHealth Engagement During Cancer Treatment: Protocol for Ecological Momentary Assessment", journal="JMIR Res Protoc", year="2021", month="Oct", day="22", volume="10", number="10", pages="e32789", keywords="mHealth", keywords="ecological momentary assessment", keywords="adolescents", keywords="young adults", keywords="oncology", keywords="cancer", keywords="self-management", keywords="mobile phone", abstract="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 ", doi="10.2196/32789", url="https://www.researchprotocols.org/2021/10/e32789", url="http://www.ncbi.nlm.nih.gov/pubmed/34677129" } @Article{info:doi/10.2196/26361, author="Shade, Marcia and Rector, Kyle and Kupzyk, Kevin", title="Voice Assistant Reminders and the Latency of Scheduled Medication Use in Older Adults With Pain: Descriptive Feasibility Study", journal="JMIR Form Res", year="2021", month="Sep", day="28", volume="5", number="9", pages="e26361", keywords="adherence", keywords="pain medications", keywords="older adults", keywords="reminders", keywords="mHealth", keywords="voice assistants", abstract="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. ", doi="10.2196/26361", url="https://formative.jmir.org/2021/9/e26361", url="http://www.ncbi.nlm.nih.gov/pubmed/34581677" } @Article{info:doi/10.2196/25922, author="Moskowitz, Tedlie Judith and Addington, L. Elizabeth and Shiu, Eva and Bassett, M. Sarah and Schuette, Stephanie and Kwok, Ian and Freedman, E. Melanie and Leykin, Yan and Saslow, R. Laura and Cohn, A. Michael and Cheung, O. Elaine", title="Facilitator Contact, Discussion Boards, and Virtual Badges as Adherence Enhancements to a Web-Based, Self-guided, Positive Psychological Intervention for Depression: Randomized Controlled Trial", journal="J Med Internet Res", year="2021", month="Sep", day="22", volume="23", number="9", pages="e25922", keywords="mHealth", keywords="adherence", keywords="depression", keywords="discussion board", keywords="gamification", keywords="positive psychological intervention", keywords="mobile phone", abstract="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 ", doi="10.2196/25922", url="https://www.jmir.org/2021/9/e25922", url="http://www.ncbi.nlm.nih.gov/pubmed/34550076" } @Article{info:doi/10.2196/27999, author="Milne-Ives, Madison and Lam, Ching and Meinert, Edward", title="Digital Technologies for Monitoring and Improving Treatment Adherence in Children and Adolescents With Asthma: Scoping Review of Randomized Controlled Trials", journal="JMIR Pediatr Parent", year="2021", month="Sep", day="17", volume="4", number="3", pages="e27999", keywords="asthma", keywords="disease management", keywords="child", keywords="adolescent", keywords="telemedicine", abstract="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. ", doi="10.2196/27999", url="https://pediatrics.jmir.org/2021/3/e27999", url="http://www.ncbi.nlm.nih.gov/pubmed/34533463" } @Article{info:doi/10.2196/27576, author="Yu, Jing and Wu, Jiayi and Huang, Ou and Chen, Xiaosong and Shen, Kunwei", title="A Smartphone-Based App to Improve Adjuvant Treatment Adherence to Multidisciplinary Decisions in Patients With Early-Stage Breast Cancer: Observational Study", journal="J Med Internet Res", year="2021", month="Sep", day="16", volume="23", number="9", pages="e27576", keywords="breast cancer", keywords="adherence", keywords="multidisciplinary treatment", keywords="adjuvant treatment", keywords="smartphone-based app", keywords="mobile phone", abstract="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. ", doi="10.2196/27576", url="https://www.jmir.org/2021/9/e27576", url="http://www.ncbi.nlm.nih.gov/pubmed/34528890" } @Article{info:doi/10.2196/23916, author="Holtz, Bree and Mitchell, M. Katharine and Holmstrom, J. Amanda and Cotten, R. Shelia and Dunneback, K. Julie and Jimenez-Vega, Jose and Ellis, A. Deborah and Wood, A. Michael", title="An mHealth-Based Intervention for Adolescents With Type 1 Diabetes and Their Parents: Pilot Feasibility and Efficacy Single-Arm Study", journal="JMIR Mhealth Uhealth", year="2021", month="Sep", day="14", volume="9", number="9", pages="e23916", keywords="mobile health (mHealth)", keywords="adolescents", keywords="type 1 diabetes", keywords="mobile phone", keywords="parent-adolescent", keywords="chronic disease", keywords="feasibility", keywords="diabetes management", abstract="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 ", doi="10.2196/23916", url="https://mhealth.jmir.org/2021/9/e23916", url="http://www.ncbi.nlm.nih.gov/pubmed/34519670" } @Article{info:doi/10.2196/27162, author="Schwaninger, Philipp and Berli, Corina and Scholz, Urte and L{\"u}scher, Janina", title="Effectiveness of a Dyadic Buddy App for Smoking Cessation: Randomized Controlled Trial", journal="J Med Internet Res", year="2021", month="Sep", day="9", volume="23", number="9", pages="e27162", keywords="mHealth", keywords="smartphone app", keywords="smoking cessation", keywords="buddy", keywords="social support", keywords="mobile phone", abstract="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 ", doi="10.2196/27162", url="https://www.jmir.org/2021/9/e27162", url="http://www.ncbi.nlm.nih.gov/pubmed/34499045" } @Article{info:doi/10.2196/29018, author="Park, Sulki and Kum, Hye-Chung and Morrisey, A. Michael and Zheng, Qi and Lawley, A. Mark", title="Adherence to Telemonitoring Therapy for Medicaid Patients With Hypertension: Case Study", journal="J Med Internet Res", year="2021", month="Sep", day="6", volume="23", number="9", pages="e29018", keywords="telemedicine", keywords="hypertension", keywords="Medicaid", keywords="blood pressure", keywords="pulse", keywords="telemonitoring", keywords="mobile phone", abstract="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. ", doi="10.2196/29018", url="https://www.jmir.org/2021/9/e29018", url="http://www.ncbi.nlm.nih.gov/pubmed/34486977" } @Article{info:doi/10.2196/28784, author="Murphy, Jane and McSharry, Jenny and Hynes, Lisa and Molloy, J. Gerard", title="A Smartphone App to Support Adherence to Inhaled Corticosteroids in Young Adults With Asthma: Multi-Methods Feasibility Study", journal="JMIR Form Res", year="2021", month="Sep", day="1", volume="5", number="9", pages="e28784", keywords="asthma", keywords="young adult", keywords="medication adherence", keywords="self-management", keywords="mobile applications", keywords="mHealth", keywords="intervention", keywords="usability", keywords="acceptability", keywords="feasibility", keywords="multi-methods", keywords="mobile phone", abstract="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 ", doi="10.2196/28784", url="https://formative.jmir.org/2021/9/e28784", url="http://www.ncbi.nlm.nih.gov/pubmed/34468325" } @Article{info:doi/10.2196/26861, author="Saberi, Parya and Lisha, E. Nadra and Erguera, A. Xavier and Hudes, Sid Estie and Johnson, O. Mallory and Ruel, Theodore and Neilands, B. Torsten", title="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", journal="JMIR Form Res", year="2021", month="Aug", day="31", volume="5", number="8", pages="e26861", keywords="youth living with HIV", keywords="mobile health", keywords="mobile app", keywords="engagement in care", keywords="antiretroviral therapy adherence", keywords="pilot", abstract="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 ", doi="10.2196/26861", url="https://formative.jmir.org/2021/8/e26861", url="http://www.ncbi.nlm.nih.gov/pubmed/34463622" } @Article{info:doi/10.2196/29061, author="Arutyunov, P. Gregory and Arutyunov, G. Alexander and Ageev, T. Fail and Fofanova, V. Tatiana", title="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", journal="JMIR Res Protoc", year="2021", month="Aug", day="30", volume="10", number="8", pages="e29061", keywords="omega-3-acid ethyl esters", keywords="myocardial infarction", keywords="hypertriglyceridemia", keywords="adherence", keywords="compliance", keywords="persistence", keywords="mHealth", keywords="eHealth", keywords="patient-reported outcomes", abstract="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. ", doi="10.2196/29061", url="https://www.researchprotocols.org/2021/8/e29061", url="http://www.ncbi.nlm.nih.gov/pubmed/34459746" } @Article{info:doi/10.2196/28104, author="Timmers, Thomas and Keijsers, Manouk and Kremer, M. Jan A. and Janssen, Loes and Smeenk, Jesper", title="Supporting Women Undergoing IVF Treatment With Timely Patient Information Through an App: Randomized Controlled Trial", journal="JMIR Mhealth Uhealth", year="2021", month="Aug", day="27", volume="9", number="8", pages="e28104", keywords="patient education", keywords="fertilization in vitro", keywords="mobile health", keywords="health literacy", keywords="gynecology", abstract="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 ", doi="10.2196/28104", url="https://mhealth.jmir.org/2021/8/e28104", url="http://www.ncbi.nlm.nih.gov/pubmed/34448725" } @Article{info:doi/10.2196/28163, author="MacPherson, Megan and Cranston, Kaela and Johnston, Cara and Locke, Sean and Jung, E. Mary", title="Evaluation and Refinement of a Bank of SMS Text Messages to Promote Behavior Change Adherence Following a Diabetes Prevention Program: Survey Study", journal="JMIR Form Res", year="2021", month="Aug", day="27", volume="5", number="8", pages="e28163", keywords="text messaging", keywords="prediabetic state", keywords="telemedicine", keywords="telecommunications", keywords="exercise", keywords="diet", keywords="preventive medicine", keywords="mHealth", keywords="intervention development", keywords="behavior change", keywords="mobile phone", abstract="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. ", doi="10.2196/28163", url="https://formative.jmir.org/2021/8/e28163", url="http://www.ncbi.nlm.nih.gov/pubmed/34448713" } @Article{info:doi/10.2196/24555, author="Zhang, Lu and McLeod, L. Howard and Liu, Ke-Ke and Liu, Wen-Hui and Huang, Hang-Xing and Huang, Ya-Min and Sun, Shu-Sen and Chen, Xiao-Ping and Chen, Yao and Liu, Fang-Zhou and Xiao, Jian", title="Effect of Physician-Pharmacist Participation in the Management of Ambulatory Cancer Pain Through a Digital Health Platform: Randomized Controlled Trial", journal="JMIR Mhealth Uhealth", year="2021", month="Aug", day="16", volume="9", number="8", pages="e24555", keywords="cancer pain", keywords="self-management", keywords="ambulatory setting", keywords="digital health", keywords="physician-pharmacist", abstract="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 ", doi="10.2196/24555", url="https://mhealth.jmir.org/2021/8/e24555", url="http://www.ncbi.nlm.nih.gov/pubmed/34398796" } @Article{info:doi/10.2196/23464, author="de Castro, Paul Kim and Chiu, Henrison Harold and De Leon-Yao, Cheska Ronna and Almelor-Sembrana, Lorraine and Dans, Miguel Antonio", title="A Patient Decision Aid for Anticoagulation Therapy in Patients With Nonvalvular Atrial Fibrillation: Development and Pilot Study", journal="JMIR Cardio", year="2021", month="Aug", day="12", volume="5", number="2", pages="e23464", keywords="shared decision-making", keywords="patient decision aid", keywords="atrial fibrillation", keywords="anticoagulation", keywords="stroke prevention", keywords="mHealth", keywords="mobile health", abstract="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. ", doi="10.2196/23464", url="https://cardio.jmir.org/2021/2/e23464", url="http://www.ncbi.nlm.nih.gov/pubmed/34385138" } @Article{info:doi/10.2196/26000, author="Cha, KyeongMin and Woo, Hyun-Ki and Park, Dohyun and Chang, Kyung Dong and Kang, Mira", title="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", journal="JMIR Med Inform", year="2021", month="Jul", day="28", volume="9", number="7", pages="e26000", keywords="pill recognition", keywords="deep neural network", keywords="image processing", keywords="color space", keywords="color difference", keywords="pharmaceutical", keywords="imaging", keywords="photography", keywords="neural network", keywords="mobile phone", abstract="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. ", doi="10.2196/26000", url="https://medinform.jmir.org/2021/7/e26000", url="http://www.ncbi.nlm.nih.gov/pubmed/34319239" } @Article{info:doi/10.2196/25548, author="Bermon, Anderson and Uribe, Fernanda Ana and P{\'e}rez-Rivero, Fernanda Paula and Prieto-Merino, David and Saaibi, Federico Jose and Silva, Arturo Federico and Canon, Ivonne Diana and Castillo-Gonzalez, Melissa Karol and C{\'a}ceres-Rivera, Isabel Diana and Guio, Elizabeth and Meneses-Castillo, Janneth Karen and Castillo-Meza, Alberto and Atkins, Louise and Horne, Robert and Murray, Elizabeth and Serrano, Cecilia Norma and Free, Caroline and Casas, Pablo Juan and Perel, Pablo", title="Efficacy and Safety of Text Messages Targeting Adherence to Cardiovascular Medications in Secondary Prevention: TXT2HEART Colombia Randomized Controlled Trial", journal="JMIR Mhealth Uhealth", year="2021", month="Jul", day="28", volume="9", number="7", pages="e25548", keywords="randomized controlled trial", keywords="Colombia", keywords="text messaging", keywords="cardiovascular disease", keywords="secondary prevention", abstract="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 ", doi="10.2196/25548", url="https://mhealth.jmir.org/2021/7/e25548", url="http://www.ncbi.nlm.nih.gov/pubmed/34319247" } @Article{info:doi/10.2196/29475, author="Schulte, J. Mieke H. and Aardoom, J. Jiska and Loheide-Niesmann, Lisa and Verstraete, L. Leonie L. and Ossebaard, C. Hans and Riper, Heleen", title="Effectiveness of eHealth Interventions in Improving Medication Adherence for Patients With Chronic Obstructive Pulmonary Disease or Asthma: Systematic Review", journal="J Med Internet Res", year="2021", month="Jul", day="27", volume="23", number="7", pages="e29475", keywords="chronic obstructive pulmonary disease", keywords="asthma", keywords="medication adherence", keywords="exercise adherence", keywords="treatment adherence", keywords="eHealth", keywords="systematic review", keywords="COPD", keywords="adherence", keywords="exercise", keywords="treatment", keywords="review", abstract="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. ", doi="10.2196/29475", url="https://www.jmir.org/2021/7/e29475", url="http://www.ncbi.nlm.nih.gov/pubmed/34313593" } @Article{info:doi/10.2196/29463, author="Kumwichar, Ponlagrit and Chongsuvivatwong, Virasakdi and Prappre, Tagoon", title="Development of a Video-Observed Therapy System to Improve Monitoring of Tuberculosis Treatment in Thailand: Mixed-Methods Study", journal="JMIR Form Res", year="2021", month="Jul", day="27", volume="5", number="7", pages="e29463", keywords="app", keywords="mixed-methods analysis", keywords="remote monitoring", keywords="therapy", keywords="tuberculosis", keywords="user experience", keywords="video directly observed therapy", keywords="video-enhanced therapy", keywords="video-observed therapy", abstract="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. ", doi="10.2196/29463", url="https://formative.jmir.org/2021/7/e29463", url="http://www.ncbi.nlm.nih.gov/pubmed/34313602" } @Article{info:doi/10.2196/25796, author="Miguel, Andre and Smith, Crystal and Perea, Nicole and Johnson, Kim and McDonell, Michael and McPherson, Sterling", title="Development of Automated Reinforcement Management System (ARMS): Protocol for a Phase I Feasibility and Usability Study", journal="JMIR Form Res", year="2021", month="Jul", day="19", volume="5", number="7", pages="e25796", keywords="alcohol use disorder", keywords="contingency management", keywords="ecological momentary assessment", keywords="treatment", abstract="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. ", doi="10.2196/25796", url="https://formative.jmir.org/2021/7/e25796", url="http://www.ncbi.nlm.nih.gov/pubmed/34279238" } @Article{info:doi/10.2196/27327, author="Corbett, F. Cynthia and Combs, M. Elizabeth and Chandarana, S. Peyton and Stringfellow, Isabel and Worthy, Karen and Nguyen, Thien and Wright, J. Pamela and O'Kane, M. Jason", title="Medication Adherence Reminder System for Virtual Home Assistants: Mixed Methods Evaluation Study", journal="JMIR Form Res", year="2021", month="Jul", day="13", volume="5", number="7", pages="e27327", keywords="medication adherence", keywords="medication", keywords="virtual home assistants", keywords="virtual assistant", keywords="public health", keywords="health care costs", keywords="Echo device", keywords="device usability", keywords="digital health", keywords="mobile phone", abstract="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 ($\chi$21=0.9 and $\chi$21=0.4, respectively; McNemar test: P<.001 for both). However, there was no significant difference in participants' reported adherence to consistently taking medication within the same 2-hour time frame every day in the past 1 or 6 months at the end of the study compared with baseline ($\chi$21=3.5 and $\chi$21=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. ", doi="10.2196/27327", url="https://formative.jmir.org/2021/7/e27327", url="http://www.ncbi.nlm.nih.gov/pubmed/34255669" } @Article{info:doi/10.2196/25522, author="Song, Ting and Liu, Fang and Deng, Ning and Qian, Siyu and Cui, Tingru and Guan, Yingping and Arnolda, Leonard and Zhang, Zhenyu and Yu, Ping", title="A Comprehensive 6A Framework for Improving Patient Self-Management of Hypertension Using mHealth Services: Qualitative Thematic Analysis", journal="J Med Internet Res", year="2021", month="Jun", day="21", volume="23", number="6", pages="e25522", keywords="patient experience", keywords="mHealth", keywords="mobile phone", keywords="mobile app", keywords="intervention", keywords="self-management", keywords="high blood pressure", keywords="chronic disease management", keywords="qualitative research", abstract="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. ", doi="10.2196/25522", url="https://www.jmir.org/2021/6/e25522", url="http://www.ncbi.nlm.nih.gov/pubmed/34152272" } @Article{info:doi/10.2196/28094, author="Iribarren, Sarah and Milligan, Hannah and Goodwin, Kyle and Aguilar Vidrio, Alfonso Omar and Chirico, Cristina and Telles, Hugo and Morelli, Daniela and Lutz, Barry and Sprecher, Jennifer and Rubinstein, Fernando", title="Mobile Tuberculosis Treatment Support Tools to Increase Treatment Success in Patients with Tuberculosis in Argentina: Protocol for a Randomized Controlled Trial", journal="JMIR Res Protoc", year="2021", month="Jun", day="21", volume="10", number="6", pages="e28094", keywords="tuberculosis", keywords="disease management", keywords="infectious disease", keywords="mHealth", keywords="digital health", keywords="direct drug metabolite test", keywords="mobile phone", abstract="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 ", doi="10.2196/28094", url="https://www.researchprotocols.org/2021/6/e28094", url="http://www.ncbi.nlm.nih.gov/pubmed/34152281" } @Article{info:doi/10.2196/24510, author="Ragan, J. Elizabeth and Gill, J. Christopher and Banos, Matthew and Bouton, C. Tara and Rooney, Jennifer and Horsburgh, R. Charles and Warren, M. Robin and Myers, Bronwyn and Jacobson, R. Karen", title="Directly Observed Therapy to Measure Adherence to Tuberculosis Medication in Observational Research: Protocol for a Prospective Cohort Study", journal="JMIR Res Protoc", year="2021", month="Jun", day="16", volume="10", number="6", pages="e24510", keywords="tuberculosis", keywords="directly observed therapy", keywords="treatment adherence and compliance", keywords="medication adherence", keywords="mobile applications", abstract="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 ", doi="10.2196/24510", url="https://www.researchprotocols.org/2021/6/e24510", url="http://www.ncbi.nlm.nih.gov/pubmed/34132642" } @Article{info:doi/10.2196/17418, author="Twimukye, Adelline and Bwanika Naggirinya, Agnes and Parkes-Ratanshi, Rosalind and Kasirye, Ronnie and Kiragga, Agnes and Castelnuovo, Barbara and Wasswa, Jacob and Nabaggala, Sarah Maria and Katabira, Elly and Lamorde, Mohammed and King, Lisa Rachel", title="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", journal="JMIR Mhealth Uhealth", year="2021", month="Jun", day="14", volume="9", number="6", pages="e17418", keywords="HIV", keywords="mHealth", keywords="young adults", keywords="adherence", keywords="qualitative", keywords="Uganda", abstract="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 ", doi="10.2196/17418", url="https://mhealth.jmir.org/2021/6/e17418", url="http://www.ncbi.nlm.nih.gov/pubmed/34121665" } @Article{info:doi/10.2196/25958, author="Lauffenburger, C. Julie and Barlev, A. Renee and Sears, S. Ellen and Keller, A. Punam and McDonnell, E. Marie and Yom-Tov, Elad and Fontanet, P. Constance and Hanken, Kaitlin and Haff, Nancy and Choudhry, K. Niteesh", title="Preferences for mHealth Technology and Text Messaging Communication in Patients With Type 2 Diabetes: Qualitative Interview Study", journal="J Med Internet Res", year="2021", month="Jun", day="11", volume="23", number="6", pages="e25958", keywords="diabetes", keywords="technology", keywords="mobile health", keywords="medication adherence", keywords="mobile phone", abstract="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. ", doi="10.2196/25958", url="https://www.jmir.org/2021/6/e25958", url="http://www.ncbi.nlm.nih.gov/pubmed/34114964" } @Article{info:doi/10.2196/23294, author="Thomas, E. Beena and Kumar, Vignesh J. and Periyasamy, Murugesan and Khandewale, Subhash Amit and Hephzibah Mercy, J. and Raj, Michael E. and Kokila, S. and Walgude, Shashikant Apurva and Gaurkhede, Rahul Gunjan and Kumbhar, Dattatraya Jagannath and Ovung, Senthanro and Paul, Mariyamma and Rajkumar, Sathyan B. and Subbaraman, Ramnath", title="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", journal="J Med Internet Res", year="2021", month="Jun", day="10", volume="23", number="6", pages="e23294", keywords="tuberculosis", keywords="drug-resistant", keywords="medication adherence", keywords="mHealth", keywords="digital adherence technologies", keywords="India", abstract="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. ", doi="10.2196/23294", url="https://www.jmir.org/2021/6/e23294", url="http://www.ncbi.nlm.nih.gov/pubmed/34110300" } @Article{info:doi/10.2196/27496, author="Bilger, Marcel and Koong, Leng Agnes Ying and Phoon, Yun Ian Kwong and Tan, Chuan Ngiap and Bahadin, Juliana and Bairavi, Joann and Batcagan-Abueg, M. Ada Portia and Finkelstein, A. Eric", title="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", journal="JMIR Res Protoc", year="2021", month="Jun", day="9", volume="10", number="6", pages="e27496", keywords="telemedicine", keywords="home blood pressure monitoring", keywords="behavior change", keywords="hypertension", keywords="financial incentive", keywords="medication adherence", keywords="remote titration", abstract="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 ", doi="10.2196/27496", url="https://www.researchprotocols.org/2021/6/e27496", url="http://www.ncbi.nlm.nih.gov/pubmed/34106085" } @Article{info:doi/10.2196/20330, author="Odukoya, Ololade Oluwakemi and Ohazurike, Chidumga and Akanbi, Maxwell and O'Dwyer, C. Linda and Isikekpei, Brenda and Kuteyi, Ewemade and Ameh, O. Idaomeh and Osadiaye, Olanlesi and Adebayo, Khadijat and Usinoma, Adewunmi and Adewole, Ajoke and Odunukwe, Nkiruka and Okuyemi, Kola and Kengne, Pascal Andre", title="mHealth Interventions for Treatment Adherence and Outcomes of Care for Cardiometabolic Disease Among Adults Living With HIV: Systematic Review", journal="JMIR Mhealth Uhealth", year="2021", month="Jun", day="9", volume="9", number="6", pages="e20330", keywords="mHealth", keywords="HIV", keywords="cardiometabolic disease", keywords="text messaging", keywords="mobile", keywords="systematic review", keywords="telephone calls", keywords="wearable devices", keywords="smartphones", keywords="desktop", keywords="web-based", keywords="mobile apps", abstract="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 ", doi="10.2196/20330", url="https://mhealth.jmir.org/2021/6/e20330", url="http://www.ncbi.nlm.nih.gov/pubmed/34106075" } @Article{info:doi/10.2196/24952, author="Maddison, Ralph and Jiang, Yannan and Stewart, Ralph and Scott, Tony and Kerr, Andrew and Whittaker, Robyn and Benatar, Jocelyn and Rolleston, Anna and Estabrooks, Paul and Dale, Leila", title="An Intervention to Improve Medication Adherence in People With Heart Disease (Text4HeartII): Randomized Controlled Trial", journal="JMIR Mhealth Uhealth", year="2021", month="Jun", day="9", volume="9", number="6", pages="e24952", keywords="cardiovascular disease", keywords="self-management", keywords="text messaging", keywords="risk factors", abstract="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 recordswere 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 ", doi="10.2196/24952", url="https://mhealth.jmir.org/2021/6/e24952", url="http://www.ncbi.nlm.nih.gov/pubmed/34106081" } @Article{info:doi/10.2196/19941, author="Sun, Ruo-Ting and Han, Wencui and Chang, Hsin-Lu and Shaw, J. Michael", title="Motivating Adherence to Exercise Plans Through a Personalized Mobile Health App: Enhanced Action Design Research Approach", journal="JMIR Mhealth Uhealth", year="2021", month="Jun", day="2", volume="9", number="6", pages="e19941", keywords="adherence", keywords="mobile health", keywords="motivation", keywords="personality", keywords="MBTI", keywords="action design research", keywords="mobile phone", abstract="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{\texttimes}3{\texttimes}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. ", doi="10.2196/19941", url="https://mhealth.jmir.org/2021/6/e19941", url="http://www.ncbi.nlm.nih.gov/pubmed/34076580" } @Article{info:doi/10.2196/17858, author="Fakih El Khoury, Cosette and Crutzen, Rik and Schols, MGA Jos and Halfens, JG Ruud and Karavetian, Mirey", title="Adequate Management of Phosphorus in Patients Undergoing Hemodialysis Using a Dietary Smartphone App: Prospective Pilot Study", journal="JMIR Form Res", year="2021", month="Jun", day="1", volume="5", number="6", pages="e17858", keywords="renal diet", keywords="mhealth", keywords="dietary app", abstract="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. ", doi="10.2196/17858", url="https://formative.jmir.org/2021/6/e17858", url="http://www.ncbi.nlm.nih.gov/pubmed/34061034" } @Article{info:doi/10.2196/22513, author="Fonner, A. Virginia and Kennedy, Samuel and Desai, Rohan and Eichberg, Christie and Martin, Lisa and Meissner, G. Eric", title="Patient-Provider Text Messaging and Video Calling Among Case-Managed Patients Living With HIV: Formative Acceptability and Feasibility Study", journal="JMIR Form Res", year="2021", month="May", day="27", volume="5", number="5", pages="e22513", keywords="HIV", keywords="mHealth", keywords="text messaging", keywords="video calling", keywords="implementation science", keywords="mobile phone", abstract="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. ", doi="10.2196/22513", url="https://formative.jmir.org/2021/5/e22513", url="http://www.ncbi.nlm.nih.gov/pubmed/34042596" } @Article{info:doi/10.2196/26442, author="J{\'a}come, Cristina and Almeida, Rute and Pereira, Margarida Ana and Amaral, Rita and Mendes, Sandra and Alves-Correia, Magna and Vidal, Carmen and L{\'o}pez Freire, Sara and M{\'e}ndez Brea, Paula and Ara{\'u}jo, Lu{\'i}s and Couto, Mariana and Antol{\'i}n-Am{\'e}rigo, Dar{\'i}o and de la Hoz Caballer, Bel{\'e}n and Barra Castro, Alicia and Gonzalez-De-Olano, David and Todo Bom, Ana and Azevedo, Jo{\~a}o and Leiria Pinto, Paula and Pinto, Nicole and Castro Neves, Ana and Palhinha, Ana and Todo Bom, Filipa and Costa, Alberto and Chaves Loureiro, Cl{\'a}udia and Maia Santos, Lilia and Arrobas, Ana and Val{\'e}rio, Margarida and Cardoso, Jo{\~a}o and Emiliano, Madalena and Gerardo, Rita and Cidrais Rodrigues, Carlos Jos{\'e} and Oliveira, Georgeta and Carvalho, Joana and Mendes, Ana and Lozoya, Carlos and Santos, Natacha and Menezes, Fernando and Gomes, Ricardo and C{\^a}mara, Rita and Rodrigues Alves, Rodrigo and Moreira, Sofia Ana and Bordalo, Diana and Alves, Carlos and Ferreira, Alberto Jos{\'e} and Lopes, Cristina and Silva, Diana and Vasconcelos, Jo{\~a}o Maria and Teixeira, Fernanda Maria and Ferreira-Magalh{\~a}es, Manuel and Taborda-Barata, Lu{\'i}s and C{\'a}lix, Jos{\'e} Maria and Alves, Adelaide and Almeida Fonseca, Jo{\~a}o", title="Feasibility and Acceptability of an Asthma App to Monitor Medication Adherence: Mixed Methods Study", journal="JMIR Mhealth Uhealth", year="2021", month="May", day="25", volume="9", number="5", pages="e26442", keywords="mHealth", keywords="smartphone", keywords="technology assessment", keywords="medication adherence", keywords="self-management", keywords="gamification", keywords="patient participation", abstract="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. ", doi="10.2196/26442", url="https://mhealth.jmir.org/2021/5/e26442", url="http://www.ncbi.nlm.nih.gov/pubmed/34032576" } @Article{info:doi/10.2196/24190, author="Al-Arkee, Shahd and Mason, Julie and Lane, A. Deirdre and Fabritz, Larissa and Chua, Winnie and Haque, Sayeed M. and Jalal, Zahraa", title="Mobile Apps to Improve Medication Adherence in Cardiovascular Disease: Systematic Review and Meta-analysis", journal="J Med Internet Res", year="2021", month="May", day="25", volume="23", number="5", pages="e24190", keywords="mobile health care applications", keywords="medication adherence", keywords="cardiovascular disease", keywords="systematic review", keywords="mobile phone", abstract="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 ", doi="10.2196/24190", url="https://www.jmir.org/2021/5/e24190", url="http://www.ncbi.nlm.nih.gov/pubmed/34032583" } @Article{info:doi/10.2196/18984, author="Campos, L. Claudia and Jones, Deanna and Snively, M. Beverly and Rocco, Michael and Pedley, Carolyn and Atwater, Sara and Moore, B. Justin", title="Text Messaging and Home Blood Pressure Monitoring for Patients with Uncontrolled Hypertension: Proposal for a Feasibility Pilot Randomized Controlled Trial", journal="JMIR Res Protoc", year="2021", month="May", day="14", volume="10", number="5", pages="e18984", keywords="hypertension", keywords="home blood pressure monitoring", keywords="telehealth", keywords="medication adherence", keywords="SMS", keywords="health disparities", abstract="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 ", doi="10.2196/18984", url="https://www.researchprotocols.org/2021/5/e18984", url="http://www.ncbi.nlm.nih.gov/pubmed/33988513" } @Article{info:doi/10.2196/24494, author="Etminani, Kobra and G{\"o}ransson, Carina and Galozy, Alexander and Norell Pejner, Margaretha and Nowaczyk, S?awomir", title="Improving Medication Adherence Through Adaptive Digital Interventions (iMedA) in Patients With Hypertension: Protocol for an Interrupted Time Series Study", journal="JMIR Res Protoc", year="2021", month="May", day="12", volume="10", number="5", pages="e24494", keywords="medication adherence", keywords="hypertension", keywords="digital intervention", keywords="mHealth", keywords="artificial intelligence", abstract="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 ", doi="10.2196/24494", url="https://www.researchprotocols.org/2021/5/e24494", url="http://www.ncbi.nlm.nih.gov/pubmed/33978593" } @Article{info:doi/10.2196/25503, author="Sezgin, Emre and Noritz, Garey and Lin, Simon and Huang, Yungui", title="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", journal="JMIR Form Res", year="2021", month="May", day="11", volume="5", number="5", pages="e25503", keywords="children with special health care needs", keywords="care management", keywords="care coordination", keywords="voice-enabled mobile app", keywords="health information technology", keywords="voice assistant", keywords="voice interaction", keywords="mobile phone", abstract="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. ", doi="10.2196/25503", url="https://formative.jmir.org/2021/5/e25503", url="http://www.ncbi.nlm.nih.gov/pubmed/33865233" } @Article{info:doi/10.2196/26289, author="Nguyen, H. Minh Tam and Krause, G{\'e}rard and Keller-Stanislawski, Brigitte and Gl{\"o}ckner, Stephan and Mentzer, Dirk and Ott, J. J{\"o}rdis", title="Postmarketing Safety Monitoring After Influenza Vaccination Using a Mobile Health App: Prospective Longitudinal Feasibility Study", journal="JMIR Mhealth Uhealth", year="2021", month="May", day="7", volume="9", number="5", pages="e26289", keywords="mHealth", keywords="mobile health", keywords="digital health", keywords="adverse event", keywords="adverse event following immunization", keywords="active reporting", keywords="pharmacovigilance", keywords="therapeutic use", keywords="adverse effect", abstract="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. ", doi="10.2196/26289", url="https://mhealth.jmir.org/2021/5/e26289", url="http://www.ncbi.nlm.nih.gov/pubmed/33960950" } @Article{info:doi/10.2196/19163, author="Cohn, F. Wendy and Canan, E. Chelsea and Knight, Sarah and Waldman, Lena Ava and Dillingham, Rebecca and Ingersoll, Karen and Schexnayder, Julie and Flickinger, E. Tabor", title="An Implementation Strategy to Expand Mobile Health Use in HIV Care Settings: Rapid Evaluation Study Using the Consolidated Framework for Implementation Research", journal="JMIR Mhealth Uhealth", year="2021", month="Apr", day="28", volume="9", number="4", pages="e19163", keywords="mHealth", keywords="smartphone", keywords="mobile health", keywords="implementation strategy", keywords="implementation science", keywords="Consolidated Framework for Implementation Research", keywords="HIV care engagement", keywords="viral suppression", abstract="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. ", doi="10.2196/19163", url="https://mhealth.jmir.org/2021/4/e19163", url="http://www.ncbi.nlm.nih.gov/pubmed/33908893" } @Article{info:doi/10.2196/25811, author="Kan, Kristin and Shaunfield, Sara and Kanaley, Madeleine and Chadha, Avneet and Boon, Kathy and Foster, C. Carolyn and Morales, Luis and Labellarte, Patricia and Vojta, Deneen and Gupta, S. Ruchi", title="Parent Experiences With Electronic Medication Monitoring in Pediatric Asthma Management: Qualitative Study", journal="JMIR Pediatr Parent", year="2021", month="Apr", day="23", volume="4", number="2", pages="e25811", keywords="pediatric asthma", keywords="digital health", keywords="outpatient care", keywords="asthma management", keywords="pediatric", keywords="asthma", keywords="parents", keywords="caregivers", keywords="Bluetooth sensors", keywords="inhaler", abstract="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. ", doi="10.2196/25811", url="https://pediatrics.jmir.org/2021/2/e25811", url="http://www.ncbi.nlm.nih.gov/pubmed/33890861" } @Article{info:doi/10.2196/26213, author="Chai, R. Peter and Bustamante, J. Maria and Goodman, Georgia and Mohamed, Yassir and Najarro, Jesse and Sullivan, C. Matthew and Castillo-Mancilla, Jose and Coyle, P. Ryan and Mayer, H. Kenneth and Rosen, K. Rochelle and Baumgartner, L. Susan and Alpert, E. Pamela and Boyer, W. Edward and O'Cleirigh, Conall", title="A Brief Training Program to Support the Use of a Digital Pill System for Medication Adherence: Pilot Descriptive Study", journal="JMIR Form Res", year="2021", month="Apr", day="23", volume="5", number="4", pages="e26213", keywords="digital pill system", keywords="technology training", keywords="HIV prevention", keywords="PrEP", keywords="ingestible sensors", keywords="mobile phone", abstract="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. ", doi="10.2196/26213", url="https://formative.jmir.org/2021/4/e26213", url="http://www.ncbi.nlm.nih.gov/pubmed/33890863" } @Article{info:doi/10.2196/25496, author="Kumar, Ravindra and Das, Aparup", title="The Potential of mHealth as a Game Changer for the Management of Sickle Cell Disease in India", journal="JMIR Mhealth Uhealth", year="2021", month="Apr", day="13", volume="9", number="4", pages="e25496", keywords="sickle cell disease", keywords="drug adherence", keywords="mHealth", keywords="India", doi="10.2196/25496", url="https://mhealth.jmir.org/2021/4/e25496", url="http://www.ncbi.nlm.nih.gov/pubmed/33847598" } @Article{info:doi/10.2196/24565, author="Tanner, E. Amanda and Dowshen, Nadia and Philbin, M. Morgan and Rulison, L. Kelly and Camacho-Gonzalez, Andres and Lee, Susan and Moore, J. Shamia and Fortenberry, Dennis J. and Hussen, A. Sophia", title="An Intervention for the Transition From Pediatric or Adolescent to Adult-Oriented HIV Care: Protocol for the Development and Pilot Implementation of iTransition", journal="JMIR Res Protoc", year="2021", month="Apr", day="7", volume="10", number="4", pages="e24565", keywords="HIV", keywords="mHealth", keywords="transition to adult care", keywords="young adult", keywords="feasibility studies", keywords="retention in care", keywords="control groups", keywords="United States", keywords="telemedicine", keywords="HIV infections", keywords="mobile phone", abstract="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 ", doi="10.2196/24565", url="https://www.researchprotocols.org/2021/4/e24565", url="http://www.ncbi.nlm.nih.gov/pubmed/33825691" } @Article{info:doi/10.2196/23280, author="McCreesh-Toselli, Siobhan and Torline, John and Gouse, Hetta and Robbins, N. Reuben and Mellins, A. Claude and Remien, H. Robert and Rowe, Jessica and Peton, Neshaan and Rabie, Stephan and Joska, A. John", title="Staff Perceptions of Preimplementation Barriers and Facilitators to a Mobile Health Antiretroviral Therapy Adherence Counseling Intervention in South Africa: Qualitative Study", journal="JMIR Mhealth Uhealth", year="2021", month="Apr", day="6", volume="9", number="4", pages="e23280", keywords="HIV/AIDS", keywords="antiretroviral treatment", keywords="low-resource settings", keywords="mHealth", keywords="Masivukeni", keywords="Consolidated Framework for Implementation Research", keywords="implementation research", keywords="lay antiretroviral therapy adherence counselors", keywords="mobile phone", abstract="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. ", doi="10.2196/23280", url="https://mhealth.jmir.org/2021/4/e23280", url="http://www.ncbi.nlm.nih.gov/pubmed/33821806" } @Article{info:doi/10.2196/25810, author="Dopke, A. Cynthia and McBride, Alyssa and Babington, Pamela and Jonathan, K. Geneva and Michaels, Tania and Ryan, Chloe and Duffecy, Jennifer and Mohr, C. David and Goulding, H. Evan", title="Development of Coaching Support for LiveWell: A Smartphone-Based Self-Management Intervention for Bipolar Disorder", journal="JMIR Form Res", year="2021", month="Mar", day="24", volume="5", number="3", pages="e25810", keywords="human support", keywords="adherence", keywords="self-management", keywords="behavior change", keywords="mHealth", keywords="bipolar disorder", doi="10.2196/25810", url="https://formative.jmir.org/2021/3/e25810", url="http://www.ncbi.nlm.nih.gov/pubmed/33759798" } @Article{info:doi/10.2196/21128, author="Harshbarger, Camilla and Burrus, Olivia and Rangarajan, Sivakumar and Bollenbacher, John and Zulkiewicz, Brittany and Verma, Rohit and Galindo, A. Carla and Lewis, A. Megan", title="Challenges of and Solutions for Developing Tailored Video Interventions That Integrate Multiple Digital Assets to Promote Engagement and Improve Health Outcomes: Tutorial", journal="JMIR Mhealth Uhealth", year="2021", month="Mar", day="23", volume="9", number="3", pages="e21128", keywords="HIV video intervention", keywords="patient-provider communication", keywords="ART adherence", keywords="digital interventions", keywords="mobile interventions", keywords="computer based interventions", keywords="interactive technologies", abstract="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. ", doi="10.2196/21128", url="https://mhealth.jmir.org/2021/3/e21128", url="http://www.ncbi.nlm.nih.gov/pubmed/33755025" } @Article{info:doi/10.2196/25406, author="Rafiei, Ramin and Williams, Chelsea and Jiang, Jeannette and Aungst, Dy Timothy and Durrer, Matthias and Tran, Dao and Howald, Ralph", title="Digital Health Integration Assessment and Maturity of the United States Biopharmaceutical Industry: Forces Driving the Next Generation of Connected Autoinjectable Devices", journal="JMIR Mhealth Uhealth", year="2021", month="Mar", day="18", volume="9", number="3", pages="e25406", keywords="digital health", keywords="artificial intelligence", keywords="drug delivery", keywords="biopharma", keywords="autoinjector", keywords="injectable devices", keywords="disease management", keywords="autoimmune", keywords="oncology", keywords="rare diseases", doi="10.2196/25406", url="https://mhealth.jmir.org/2021/3/e25406", url="http://www.ncbi.nlm.nih.gov/pubmed/33621188" } @Article{info:doi/10.2196/22659, author="Van de Winckel, Ann and Nawshin, Tanjila and Byron, Casey", title="Combining a Hudl App With Telehealth to Increase Home Exercise Program Adherence in People With Chronic Diseases Experiencing Financial Distress: Randomized Controlled Trial", journal="JMIR Form Res", year="2021", month="Mar", day="18", volume="5", number="3", pages="e22659", keywords="chronic disease", keywords="spinal cord injury", keywords="stroke", keywords="telehealth", keywords="telemedicine", keywords="traumatic brain injury", abstract="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 ", doi="10.2196/22659", url="https://formative.jmir.org/2021/3/e22659", url="http://www.ncbi.nlm.nih.gov/pubmed/33640865" } @Article{info:doi/10.2196/21374, author="Burns, David and Boyer, Philip and Razmjou, Helen and Richards, Robin and Whyne, Cari", title="Adherence Patterns and Dose Response of Physiotherapy for Rotator Cuff Pathology: Longitudinal Cohort Study", journal="JMIR Rehabil Assist Technol", year="2021", month="Mar", day="11", volume="8", number="1", pages="e21374", keywords="rehabilitation", keywords="treatment adherence and compliance", keywords="wearable electronic devices", keywords="machine learning", keywords="rotator cuff", abstract="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 ", doi="10.2196/21374", url="https://rehab.jmir.org/2021/1/e21374", url="http://www.ncbi.nlm.nih.gov/pubmed/33704076" } @Article{info:doi/10.2196/24561, author="Waselewski, Elise Marika and Flickinger, Elisabeth Tabor and Canan, Chelsea and Harrington, William and Franklin, Taylor and Otero, Nicole Kori and Huynh, Jacqueline and Waldman, Davila Ava Lena and Hilgart, Michelle and Ingersoll, Karen and Ait-Daoud Tiouririne, Nassima and Dillingham, Anne Rebecca", title="A Mobile Health App to Support Patients Receiving Medication-Assisted Treatment for Opioid Use Disorder: Development and Feasibility Study", journal="JMIR Form Res", year="2021", month="Feb", day="23", volume="5", number="2", pages="e24561", keywords="opioid use disorder", keywords="mHealth", keywords="retention in care", keywords="self-management", keywords="opioids", keywords="public health", keywords="mobile phone", abstract="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. ", doi="10.2196/24561", url="https://formative.jmir.org/2021/2/e24561", url="http://www.ncbi.nlm.nih.gov/pubmed/33620324" } @Article{info:doi/10.2196/24893, author="Heneghan, B. Mallorie and Hussain, Tasmeen and Barrera, Leonardo and Cai, W. Stephanie and Haugen, Maureen and Morgan, Elaine and Rossoff, Jenna and Weinstein, Joanna and Hijiya, Nobuko and Cella, David and Badawy, M. Sherif", title="Access to Technology and Preferences for an mHealth Intervention to Promote Medication Adherence in Pediatric Acute Lymphoblastic Leukemia: Approach Leveraging Behavior Change Techniques", journal="J Med Internet Res", year="2021", month="Feb", day="18", volume="23", number="2", pages="e24893", keywords="acute lymphoblastic leukemia", keywords="medication adherence", keywords="behavior change technique", keywords="oral chemotherapy", keywords="mHealth", keywords="patient-centered", abstract="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. ", doi="10.2196/24893", url="http://www.jmir.org/2021/2/e24893/", url="http://www.ncbi.nlm.nih.gov/pubmed/33599621" } @Article{info:doi/10.2196/23912, author="Queiroz, Nunes Artur Acelino Francisco Luz and Mendes, Costa Isabel Am{\'e}lia and de Godoy, Simone and Velez Lap{\~a}o, Lu{\'i}s and Dias, S{\'o}nia", title="mHealth Strategies Related to HIV Postexposure Prophylaxis Knowledge and Access: Systematic Literature Review, Technology Prospecting of Patent Databases, and Systematic Search on App Stores", journal="JMIR Mhealth Uhealth", year="2021", month="Feb", day="16", volume="9", number="2", pages="e23912", keywords="HIV", keywords="eHealth", keywords="mHealth", keywords="postexposure prophylaxis", keywords="PEP", keywords="prevention", keywords="mobile phone", abstract="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. ", doi="10.2196/23912", url="http://mhealth.jmir.org/2021/2/e23912/", url="http://www.ncbi.nlm.nih.gov/pubmed/33591289" } @Article{info:doi/10.2196/24080, author="Kim, Mihui and Kim, Changhwan and Kim, Eunkyo and Choi, Mona", title="Effectiveness of Mobile Health--Based Exercise Interventions for Patients with Peripheral Artery Disease: Systematic Review and Meta-Analysis", journal="JMIR Mhealth Uhealth", year="2021", month="Feb", day="15", volume="9", number="2", pages="e24080", keywords="peripheral artery disease", keywords="mobile health", keywords="exercise", keywords="adherence", keywords="meta-analysis", abstract="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. ", doi="10.2196/24080", url="http://mhealth.jmir.org/2021/2/e24080/", url="http://www.ncbi.nlm.nih.gov/pubmed/33587042" } @Article{info:doi/10.2196/12218, author="Almonacid, Carlos and Melero, Carlos and L{\'o}pez Vi{\~n}a, Antol{\'i}n and Cisneros, Carolina and P{\'e}rez de Llano, Luis and Plaza, Vicente and Garc{\'i}a-Rivero, Luis Juan and Romero Falc{\'o}n, Auxiliadora and Ramos, Jacinto and Baz{\'u}s Gonz{\'a}lez, Teresa and Andr{\'e}s Prado, Mar{\'i}a and Muriel, Alfonso", title="Effectiveness of Text Message Reminders on Adherence to Inhaled Therapy in Patients With Asthma: Prospective Multicenter Randomized Clinical Trial", journal="JMIR Form Res", year="2021", month="Feb", day="9", volume="5", number="2", pages="e12218", keywords="asthma", keywords="adherence", keywords="SMS", keywords="control", keywords="cell phone", keywords="inhaler", keywords="Smartinhaler", abstract="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. ", doi="10.2196/12218", url="http://formative.jmir.org/2021/2/e12218/", url="http://www.ncbi.nlm.nih.gov/pubmed/33560235" } @Article{info:doi/10.2196/18328, author="Houston, Eric and Fadardi, Salehi Javad and Harawa, T. Nina and Argueta, Chris and Mukherjee, Sukrit", title="Individualized Web-Based Attention Training With Evidence-Based Counseling to Address HIV Treatment Adherence and Psychological Distress: Exploratory Cohort Study", journal="JMIR Ment Health", year="2021", month="Jan", day="28", volume="8", number="1", pages="e18328", keywords="depression", keywords="trauma", keywords="HIV", keywords="attention training", keywords="implicit cognition", abstract="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. ", doi="10.2196/18328", url="http://mental.jmir.org/2021/1/e18328/", url="http://www.ncbi.nlm.nih.gov/pubmed/33507152" } @Article{info:doi/10.2196/24736, author="Kidd, Sean and McKenzie, Kwame and Wang, Wei and Agrawal, Sacha and Voineskos, Aristotle", title="Examining a Digital Health Approach for Advancing Schizophrenia Illness Self-Management and Provider Engagement: Protocol for a Feasibility Trial", journal="JMIR Res Protoc", year="2021", month="Jan", day="25", volume="10", number="1", pages="e24736", keywords="schizophrenia", keywords="psychosis", keywords="digital health", keywords="mobile health", keywords="smartphone", abstract="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 ", doi="10.2196/24736", url="http://www.researchprotocols.org/2021/1/e24736/", url="http://www.ncbi.nlm.nih.gov/pubmed/33492235" } @Article{info:doi/10.2196/14774, author="Su, Pen-Hua and Yang, Chen and Chao, Mei-Chyn and Chiang, Chung-Lin", title="Monitoring Adherence Rate to Growth Hormone Therapy and Growth Outcomes in Taiwanese Children Using Easypod Connect: Observational Study", journal="JMIR Pediatr Parent", year="2021", month="Jan", day="15", volume="4", number="1", pages="e14774", keywords="growth hormone", keywords="adherence", keywords="easypod", keywords="eHealth", abstract="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--na{\"i}ve, 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. ", doi="10.2196/14774", url="https://pediatrics.jmir.org/2021/1/e14774", url="http://www.ncbi.nlm.nih.gov/pubmed/33448936" } @Article{info:doi/10.2196/18021, author="Sharif, Owaise Mohammad and Newton, Timothy Jonathon and Cunningham, J. Susan", title="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", journal="JMIR Res Protoc", year="2021", month="Jan", day="13", volume="10", number="1", pages="e18021", keywords="orthodontics", keywords="adherence", keywords="smartphone apps", keywords="mobile phone apps", keywords="personalized health care", keywords="information provision", abstract="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 {\textsterling}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 ", doi="10.2196/18021", url="http://www.researchprotocols.org/2021/1/e18021/", url="http://www.ncbi.nlm.nih.gov/pubmed/33439142" } @Article{info:doi/10.2196/13770, author="Chan, C. Eric and Sun, Yuting and Aitchison, J. Katherine and Sivapalan, Sudhakar", title="Mobile App--Based Self-Report Questionnaires for the Assessment and Monitoring of Bipolar Disorder: Systematic Review", journal="JMIR Form Res", year="2021", month="Jan", day="8", volume="5", number="1", pages="e13770", keywords="mobile apps", keywords="mental health", keywords="bipolar disorder", keywords="smartphone", keywords="cell phone", abstract="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-{\AA}sberg 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. ", doi="10.2196/13770", url="https://formative.jmir.org/2021/1/e13770", url="http://www.ncbi.nlm.nih.gov/pubmed/33416510" } @Article{info:doi/10.2196/20636, author="Kongshaug, Nina and Skolbekken, John-Arne and Faxvaag, Arild and Hofsli, Eva", title="Cancer Patients' Perceived Value of a Smartphone App to Enhance the Safety of Home-Based Chemotherapy: Feasibility Study", journal="JMIR Form Res", year="2021", month="Jan", day="6", volume="5", number="1", pages="e20636", keywords="mhealth", keywords="mobile app", keywords="smartphone app", keywords="oral chemotherapy", keywords="patient safety", keywords="home-based cancer treatment", abstract="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. ", doi="10.2196/20636", url="https://formative.jmir.org/2021/1/e20636", url="http://www.ncbi.nlm.nih.gov/pubmed/33404505" } @Article{info:doi/10.2196/19770, author="Miyashita Ochoa, Ayako and Paneda, Corpuz Christian and Wu, SC Elizabeth and Maxwell, Elizabeth Katherine and Garth, Gerald and Smith, Terry and Holloway, Walter Ian", title="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", journal="JMIR Res Protoc", year="2021", month="Jan", day="6", volume="10", number="1", pages="e19770", keywords="HIV", keywords="AIDS", keywords="mobile apps", keywords="African Americans", keywords="men's health", keywords="sexual minority", keywords="treatment adherence", keywords="mobile phones", abstract="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 ", doi="10.2196/19770", url="https://www.researchprotocols.org/2021/1/e19770", url="http://www.ncbi.nlm.nih.gov/pubmed/33404514" } @Article{info:doi/10.2196/18029, author="Sekandi, Nabbuye Juliet and Onuoha, Amara Nicole and Buregyeya, Esther and Zalwango, Sarah and Kaggwa, Evans Patrick and Nakkonde, Damalie and Kakaire, Robert and Atuyambe, Lynn and Whalen, C. Christopher and Dobbin, K. Kevin", title="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", journal="JMIR Res Protoc", year="2021", month="Jan", day="5", volume="10", number="1", pages="e18029", keywords="tuberculosis", keywords="mHealth", keywords="digital health", keywords="eHealth", keywords="directly observed therapy", keywords="video observed therapy", keywords="DOT Selfie", keywords="treatment adherence", keywords="Africa", abstract="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 ", doi="10.2196/18029", url="https://www.researchprotocols.org/2021/1/e18029", url="http://www.ncbi.nlm.nih.gov/pubmed/32990629" } @Article{info:doi/10.2196/23480, author="Agwu, Lorna Allison and Yusuf, Eihuri Hasiya and D'Angelo, Lawrence and Rathore, Mobeen and Marchesi, Jeanette and Rowell, Julia and Smith, Raina and Toppins, Jackie and Trexler, Constance and Carr, Rashida and Johnson, Betty and Selden, Keith Aaron and Mahmoudi, Saniyyah and Black, Susan and Guadamuz, Jisell and Huettner, Steven and Trent, Maria", title="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", journal="JMIR Res Protoc", year="2020", month="Dec", day="11", volume="9", number="12", pages="e23480", keywords="adolescent", keywords="youth", keywords="community health nursing", keywords="HIV", keywords="adherence", keywords="viral suppression", keywords="mobile health", abstract="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 ", doi="10.2196/23480", url="https://www.researchprotocols.org/2020/12/e23480", url="http://www.ncbi.nlm.nih.gov/pubmed/33306036" } @Article{info:doi/10.2196/21592, author="Kohli, Maulika and Pasipanodya, C. Elizabeth and Montoya, L. Jessica and Marquine, Maria and Hoenigl, Martin and Serrano, Vanessa and Cushman, Clint and Garcia, Rogelio and Kua, John and Gant, Verna and Rojas, Sarah and Moore, J. David", title="A Culturally Adapted SMS Text Messaging Intervention to Promote Antiretroviral Therapy Adherence Among African Americans: Protocol for a Single-Arm Trial", journal="JMIR Res Protoc", year="2020", month="Dec", day="10", volume="9", number="12", pages="e21592", keywords="medication adherence", keywords="behavior modification", keywords="short message service", keywords="mHealth", keywords="HIV/AIDS", abstract="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 ", doi="10.2196/21592", url="https://www.researchprotocols.org/2020/12/e21592", url="http://www.ncbi.nlm.nih.gov/pubmed/33300885" } @Article{info:doi/10.2196/20360, author="Strong, Carol and Wu, Huei-Jiuan and Tseng, Yuan-Chi and Yuan, Chien-Wen and Yu, Yi-Fang and Liao, Chiehen Jay and Chen, Yi-Wen and Hung, Yi-Chen and Li, Chia-Wen and Huang, Po-Hsien and Ko, Nai-Ying and Ku, Wen-Wei Stephane", title="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", journal="JMIR Res Protoc", year="2020", month="Dec", day="1", volume="9", number="12", pages="e20360", keywords="mobile apps", keywords="pre-exposure prophylaxis", keywords="event-driven", keywords="sexual behavior", keywords="men who have sex with men", keywords="user-centered design approach", abstract="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 ", doi="10.2196/20360", url="https://www.researchprotocols.org/2020/12/e20360", url="http://www.ncbi.nlm.nih.gov/pubmed/33258793" } @Article{info:doi/10.2196/18074, author="Faisal, Sadaf and Ivo, Jessica and McDougall, Aidan and Patel, Tejal", title="Stakeholder Feedback of Electronic Medication Adherence Products: Qualitative Analysis", journal="J Med Internet Res", year="2020", month="Dec", day="1", volume="22", number="12", pages="e18074", keywords="medication nonadherence", keywords="technology", keywords="aged", keywords="patient preferences", keywords="eHealth", keywords="qualitative research", keywords="adherence", abstract="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. ", doi="10.2196/18074", url="https://www.jmir.org/2020/12/e18074", url="http://www.ncbi.nlm.nih.gov/pubmed/33258778" } @Article{info:doi/10.2196/22631, author="Cai, Yiyuan and Gong, Wenjie and He, Hua and Hughes, P. James and Simoni, Jane and Xiao, Shuiyuan and Gloyd, Stephen and Lin, Meijuan and Deng, Xinlei and Liang, Zichao and He, Wenjun and Dai, Bofeng and Liao, Jing and Hao, Yuantao and Xu, (Roman) Dong", title="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", journal="J Med Internet Res", year="2020", month="Dec", day="1", volume="22", number="12", pages="e22631", keywords="medication adherence", keywords="mobile texting", keywords="lay health worker", keywords="resource-poor community", keywords="primary health care", keywords="quality of care", keywords="mHealth", keywords="schizophrenia", abstract="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 ", doi="10.2196/22631", url="https://www.jmir.org/2020/12/e22631", url="http://www.ncbi.nlm.nih.gov/pubmed/33258788" } @Article{info:doi/10.2196/19154, author="Morse, M. Rachel and Myburgh, Hanlie and Reubi, David and Archey, E. Ava and Busakwe, Leletu and Garcia-Prats, J. Anthony and Hesseling, C. Anneke and Jacobs, Stephanie and Mbaba, Sharon and Meyerson, Kyla and Seddon, A. James and van der Zalm, M. Marieke and Wademan, T. Dillon and Hoddinott, Graeme", title="Opportunities for Mobile App--Based Adherence Support for Children With Tuberculosis in South Africa", journal="JMIR Mhealth Uhealth", year="2020", month="Nov", day="11", volume="8", number="11", pages="e19154", keywords="eHealth", keywords="mHealth", keywords="tuberculosis", keywords="pediatric tuberculosis", keywords="adherence", doi="10.2196/19154", url="https://mhealth.jmir.org/2020/11/e19154", url="http://www.ncbi.nlm.nih.gov/pubmed/33174850" } @Article{info:doi/10.2196/21659, author="Roosan, Don and Chok, Jay and Karim, Mazharul and Law, V. Anandi and Baskys, Andrius and Hwang, Angela and Roosan, R. Moom", title="Artificial Intelligence--Powered Smartphone App to Facilitate Medication Adherence: Protocol for a Human Factors Design Study", journal="JMIR Res Protoc", year="2020", month="Nov", day="9", volume="9", number="11", pages="e21659", keywords="artificial intelligence", keywords="smartphone app", keywords="patient cognition", keywords="complex medication information", keywords="medication adherence", keywords="machine learning", keywords="mobile phone", abstract="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 ", doi="10.2196/21659", url="http://www.researchprotocols.org/2020/11/e21659/", url="http://www.ncbi.nlm.nih.gov/pubmed/33164898" } @Article{info:doi/10.2196/17470, author="McBride, M. Ciara and Morrissey, C. Eimear and Molloy, J. Gerard", title="Patients' Experiences of Using Smartphone Apps to Support Self-Management and Improve Medication Adherence in Hypertension: Qualitative Study", journal="JMIR Mhealth Uhealth", year="2020", month="Oct", day="28", volume="8", number="10", pages="e17470", keywords="hypertension", keywords="self-management", keywords="mobile applications", keywords="feasibility", keywords="usability", keywords="medication adherence", keywords="qualitative research", keywords="digital technology", keywords="mobile phone", abstract="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. ", doi="10.2196/17470", url="http://mhealth.jmir.org/2020/10/e17470/", url="http://www.ncbi.nlm.nih.gov/pubmed/33112251" } @Article{info:doi/10.2196/21759, author="Xu, Hongxuan and Long, Huanyu", title="The Effect of Smartphone App--Based Interventions for Patients With Hypertension: Systematic Review and Meta-Analysis", journal="JMIR Mhealth Uhealth", year="2020", month="Oct", day="19", volume="8", number="10", pages="e21759", keywords="hypertension", keywords="smartphone", keywords="blood pressure", keywords="mobile", keywords="lifestyle", keywords="adherence", keywords="smartphone app", keywords="medication adherence", abstract="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. ", doi="10.2196/21759", url="http://mhealth.jmir.org/2020/10/e21759/", url="http://www.ncbi.nlm.nih.gov/pubmed/33074161" } @Article{info:doi/10.2196/20480, author="Collado-Borrell, Roberto and Escudero-Vilaplana, Vicente and Ribed, Almudena and Gonzalez-Anleo, Cristina and Martin-Conde, Maite and Romero-Jimenez, Rosa and Iglesias-Peinado, Irene and Herranz-Alonso, Ana and Sanjurjo-Saez, Maria", title="Effect of a Mobile App for the Pharmacotherapeutic Follow-Up of Patients With Cancer on Their Health Outcomes: Quasi-Experimental Study", journal="JMIR Mhealth Uhealth", year="2020", month="Oct", day="16", volume="8", number="10", pages="e20480", keywords="e-OncoSalud", keywords="app", keywords="smartphone", keywords="oral antineoplastic agent", keywords="oncology", abstract="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. ", doi="10.2196/20480", url="http://mhealth.jmir.org/2020/10/e20480/", url="http://www.ncbi.nlm.nih.gov/pubmed/33064100" } @Article{info:doi/10.2196/22733, author="Turner, Marie Caitlin and Trujillo, Dillon and Le, Victory and Wilson, C. Erin and Arayasirikul, Sean", title="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", journal="JMIR Mhealth Uhealth", year="2020", month="Oct", day="15", volume="8", number="10", pages="e22733", keywords="ecological momentary assessment", keywords="event-level", keywords="alcohol", keywords="antiretroviral therapy", keywords="men who have sex with men", keywords="trans women", keywords="adherence", abstract="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 ", doi="10.2196/22733", url="http://mhealth.jmir.org/2020/10/e22733/", url="http://www.ncbi.nlm.nih.gov/pubmed/33055070" } @Article{info:doi/10.2196/19179, author="Kwan, Heng Yu and Weng, Dun Si and Loh, Fang Dionne Hui and Phang, Kie Jie and Oo, Yi Livia Jia and Blalock, V. Dan and Chew, Hui Eng and Yap, Zhen Kai and Tan, Koon Corrinne Yong and Yoon, Sungwon and Fong, Warren and {\O}stbye, Truls and Low, Leng Lian and Bosworth, Barry Hayden and Thumboo, Julian", title="Measurement Properties of Existing Patient-Reported Outcome Measures on Medication Adherence: Systematic Review", journal="J Med Internet Res", year="2020", month="Oct", day="9", volume="22", number="10", pages="e19179", keywords="systematic review", keywords="reliability and validity", keywords="medication adherence", keywords="patient reported outcome measures", abstract="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. ", doi="10.2196/19179", url="https://www.jmir.org/2020/10/e19179", url="http://www.ncbi.nlm.nih.gov/pubmed/33034566" } @Article{info:doi/10.2196/18985, author="Landers, R. Merrill and Ellis, D. Terry", title="A Mobile App Specifically Designed to Facilitate Exercise in Parkinson Disease: Single-Cohort Pilot Study on Feasibility, Safety, and Signal of Efficacy", journal="JMIR Mhealth Uhealth", year="2020", month="Oct", day="5", volume="8", number="10", pages="e18985", keywords="Parkinson disease", keywords="smartphone", keywords="mobile phone", keywords="telehealth", keywords="telerehabilitation", keywords="digital health", keywords="physical therapy", abstract="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 ", doi="10.2196/18985", url="https://mhealth.jmir.org/2020/10/e18985", url="http://www.ncbi.nlm.nih.gov/pubmed/33016887" } @Article{info:doi/10.2196/18351, author="Chen, Yilin and Ronen, Keshet and Matemo, Daniel and Unger, A. Jennifer and Kinuthia, John and John-Stewart, Grace and Levin, Carol", title="An Interactive Text Messaging Intervention to Improve Adherence to Option B+ Prevention of Mother-to-Child HIV Transmission in Kenya: Cost Analysis", journal="JMIR Mhealth Uhealth", year="2020", month="Oct", day="2", volume="8", number="10", pages="e18351", keywords="mHealth", keywords="cost analysis", keywords="prevention of mother-to-child transmission", keywords="antiretroviral therapy adherence", keywords="Kenya", keywords="mobile phone", abstract="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. ", doi="10.2196/18351", url="https://mhealth.jmir.org/2020/10/e18351", url="http://www.ncbi.nlm.nih.gov/pubmed/33006562" } @Article{info:doi/10.2196/21749, author="Bennell, Kim and Nelligan, K. Rachel and Schwartz, Sarah and Kasza, Jessica and Kimp, Alexander and Crofts, JC Samuel and Hinman, S. Rana", title="Behavior Change Text Messages for Home Exercise Adherence in Knee Osteoarthritis: Randomized Trial", journal="J Med Internet Res", year="2020", month="Sep", day="28", volume="22", number="9", pages="e21749", keywords="knee osteoarthritis", keywords="exercise", keywords="patient compliance", keywords="mobile phone", keywords="randomized controlled trial", abstract="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 ", doi="10.2196/21749", url="http://www.jmir.org/2020/9/e21749/", url="http://www.ncbi.nlm.nih.gov/pubmed/32985994" } @Article{info:doi/10.2196/17135, author="Schoenthaler, Antoinette and Leon, Michelle and Butler, Mark and Steinhaeuser, Karsten and Wardzinski, William", title="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", journal="JMIR Mhealth Uhealth", year="2020", month="Sep", day="23", volume="8", number="9", pages="e17135", keywords="mHealth", keywords="medication adherence", keywords="hypertension", keywords="type 2 diabetes", keywords="African Americans", abstract="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 ", doi="10.2196/17135", url="http://mhealth.jmir.org/2020/9/e17135/", url="http://www.ncbi.nlm.nih.gov/pubmed/32965230" } @Article{info:doi/10.2196/18640, author="Whiteley, Laura and Olsen, Elizabeth and Mena, Leandro and Haubrick, Kayla and Craker, Lacey and Hershkowitz, Dylan and Brown, K. Larry", title="A Mobile Gaming Intervention for Persons on Pre-Exposure Prophylaxis: Protocol for Intervention Development and Randomized Controlled Trial", journal="JMIR Res Protoc", year="2020", month="Sep", day="14", volume="9", number="9", pages="e18640", keywords="pre-exposure prophylaxis (PrEP)", keywords="adherence", keywords="mobile gaming intervention", keywords="HIV prevention", keywords="men who have sex with men (MSM)", abstract="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 ", doi="10.2196/18640", url="http://www.researchprotocols.org/2020/9/e18640/", url="http://www.ncbi.nlm.nih.gov/pubmed/32924954" } @Article{info:doi/10.2196/21378, author="Knights, Jonathan and Heidary, Zahra and Cochran, M. Jeffrey", title="Detection of Behavioral Anomalies in Medication Adherence Patterns Among Patients With Serious Mental Illness Engaged With a Digital Medicine System", journal="JMIR Ment Health", year="2020", month="Sep", day="10", volume="7", number="9", pages="e21378", keywords="digital medicine", keywords="mobile phone", keywords="entropy rate", keywords="Markov chains", keywords="medication adherence", keywords="contextual anomaly", keywords="psychiatric disorders", abstract="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. ", doi="10.2196/21378", url="https://mental.jmir.org/2020/9/e21378", url="http://www.ncbi.nlm.nih.gov/pubmed/32909950" } @Article{info:doi/10.2196/14739, author="Lee, B. Stephen and Valerius, Joanne", title="mHealth Interventions to Promote Anti-Retroviral Adherence in HIV: Narrative Review", journal="JMIR Mhealth Uhealth", year="2020", month="Aug", day="28", volume="8", number="8", pages="e14739", keywords="mHealth", keywords="HIV", keywords="antiretroviral", keywords="adherence", keywords="mobile phone", abstract="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. ", doi="10.2196/14739", url="https://mhealth.jmir.org/2020/8/e14739", url="http://www.ncbi.nlm.nih.gov/pubmed/32568720" } @Article{info:doi/10.2196/15680, author="Tanue, Asangbeng Elvis and Nsagha, Shey Dickson and Theophile, Njamen Nana and Assob, Nguedia Jules Clement", title="Improving Retention in Care and Promoting Adherence to HIV Treatment: Protocol for a Multisite Randomized Controlled Trial of Mobile Phone Text Messaging", journal="JMIR Res Protoc", year="2020", month="Aug", day="27", volume="9", number="8", pages="e15680", keywords="adherence", keywords="antiretroviral", keywords="HIV", keywords="randomized controlled trial", keywords="retention in care", keywords="text messaging", abstract="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 ", doi="10.2196/15680", url="http://www.researchprotocols.org/2020/8/e15680/", url="http://www.ncbi.nlm.nih.gov/pubmed/32852282" } @Article{info:doi/10.2196/17015, author="Wong, SY Zoie and Siy, Braylien and Da Silva Lopes, Katharina and Georgiou, Andrew", title="Improving Patients' Medication Adherence and Outcomes in Nonhospital Settings Through eHealth: Systematic Review of Randomized Controlled Trials", journal="J Med Internet Res", year="2020", month="Aug", day="20", volume="22", number="8", pages="e17015", keywords="eHealth", keywords="self-administered drug", keywords="self-management", keywords="medication adherence", keywords="nonhospital settings", keywords="randomized controlled trial", abstract="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 ", doi="10.2196/17015", url="http://www.jmir.org/2020/8/e17015/", url="http://www.ncbi.nlm.nih.gov/pubmed/32663145" } @Article{info:doi/10.2196/19861, author="Eaton, Cyd and Comer, Margaret and Pruette, Cozumel and Psoter, Kevin and Riekert, Kristin", title="Text Messaging Adherence Intervention for Adolescents and Young Adults with Chronic Kidney Disease: Pilot Randomized Controlled Trial and Stakeholder Interviews", journal="J Med Internet Res", year="2020", month="Aug", day="14", volume="22", number="8", pages="e19861", keywords="medication adherence", keywords="mobile health", keywords="pediatrics", keywords="kidney diseases", keywords="kidney", keywords="mHealth", keywords="adherence", keywords="adolescent", keywords="young adult", keywords="intervention", abstract="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 ", doi="10.2196/19861", url="http://www.jmir.org/2020/8/e19861/", url="http://www.ncbi.nlm.nih.gov/pubmed/32795983" } @Article{info:doi/10.2196/17834, author="Wiecek, Elyssa and Torres-Robles, Andrea and Cutler, Louise Rachelle and Benrimoj, Isaac Shalom and Garcia-Cardenas, Victoria", title="Impact of a Multicomponent Digital Therapeutic Mobile App on Medication Adherence in Patients with Chronic Conditions: Retrospective Analysis", journal="J Med Internet Res", year="2020", month="Aug", day="12", volume="22", number="8", pages="e17834", keywords="medication adherence", keywords="medication compliance", keywords="mobile phone", keywords="mobile apps", keywords="mHealth", keywords="gamification", abstract="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 ({\textpm}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. ", doi="10.2196/17834", url="http://www.jmir.org/2020/8/e17834/", url="http://www.ncbi.nlm.nih.gov/pubmed/32784183" } @Article{info:doi/10.2196/18465, author="Jim{\'e}nez-Reguera, Bego{\~n}a and Maroto L{\'o}pez, Eva and Fitch, Shane and Juarros, Lourdes and S{\'a}nchez Cort{\'e}s, Marta and Rodr{\'i}guez Hermosa, Luis Juan and Calle Rubio, Myriam and Hern{\'a}ndez Criado, Teresa Mar{\'i}a and L{\'o}pez, Marta and Angulo-D{\'i}az-Parre{\~n}o, Santiago and Mart{\'i}n-Pintado-Zugasti, Aitor and Vilar{\'o}, Jordi", title="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", journal="JMIR Mhealth Uhealth", year="2020", month="Jul", day="31", volume="8", number="7", pages="e18465", keywords="adherence", keywords="pulmonary rehabilitation", keywords="mHealth", keywords="COPD", keywords="chronic obstructive pulmonary disease", abstract="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 ", doi="10.2196/18465", url="http://mhealth.jmir.org/2020/7/e18465/", url="http://www.ncbi.nlm.nih.gov/pubmed/32513646" } @Article{info:doi/10.2196/17658, author="Guo, Xujun and Yang, Yarui and Takiff, E. Howard and Zhu, Minmin and Ma, Jianping and Zhong, Tao and Fan, Yuzheng and Wang, Jian and Liu, Shengyuan", title="A Comprehensive App That Improves Tuberculosis Treatment Management Through Video-Observed Therapy: Usability Study", journal="JMIR Mhealth Uhealth", year="2020", month="Jul", day="31", volume="8", number="7", pages="e17658", keywords="tuberculosis", keywords="management", keywords="video-observed therapy", keywords="directly observed therapy", keywords="mobile phone", abstract="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 ({\textyen}53 [US \$7.57] vs {\textyen}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. ", doi="10.2196/17658", url="https://mhealth.jmir.org/2020/7/e17658", url="http://www.ncbi.nlm.nih.gov/pubmed/32735222" } @Article{info:doi/10.2196/16634, author="Thomas, E. Beena and Kumar, Vignesh J. and Onongaya, Chidiebere and Bhatt, N. Spurthi and Galivanche, Amith and Periyasamy, Murugesan and Chiranjeevi, M. and Khandewale, Subhash Amit and Ramachandran, Geetha and Shah, Daksha and Haberer, E. Jessica and Mayer, H. Kenneth and Subbaraman, Ramnath", title="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", journal="JMIR Mhealth Uhealth", year="2020", month="Jul", day="31", volume="8", number="7", pages="e16634", keywords="tuberculosis", keywords="medication adherence", keywords="mobile phone", keywords="mHealth", keywords="implementation science", keywords="qualitative research", abstract="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. ", doi="10.2196/16634", url="http://mhealth.jmir.org/2020/7/e16634/", url="http://www.ncbi.nlm.nih.gov/pubmed/32735220" } @Article{info:doi/10.2196/16856, author="Rabinovich, Lila and Molton, Steven James and Ooi, Tsang Wei and Paton, Iain Nicholas and Batra, Shelly and Yoong, Joanne", title="Perceptions and Acceptability of Digital Interventions Among Tuberculosis Patients in Cambodia: Qualitative Study of Video-Based Directly Observed Therapy", journal="J Med Internet Res", year="2020", month="Jul", day="27", volume="22", number="7", pages="e16856", keywords="directly observed therapy", keywords="video recording", keywords="telemedicine", keywords="mobile health", keywords="mHealth", keywords="tuberculosis", keywords="low-income settings", keywords="developing countries", keywords="patient acceptance of health care", keywords="patient acceptability", keywords="Cambodia", abstract="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. ", doi="10.2196/16856", url="https://www.jmir.org/2020/7/e16856", url="http://www.ncbi.nlm.nih.gov/pubmed/32716309" } @Article{info:doi/10.2196/17534, author="Nelson, A. Lyndsay and Spieker, Andrew and Greevy, Robert and LeStourgeon, M. Lauren and Wallston, A. Kenneth and Mayberry, S. Lindsay", title="User Engagement Among Diverse Adults in a 12-Month Text Message--Delivered Diabetes Support Intervention: Results from a Randomized Controlled Trial", journal="JMIR Mhealth Uhealth", year="2020", month="Jul", day="21", volume="8", number="7", pages="e17534", keywords="engagement", keywords="text messaging", keywords="mobile health", keywords="mHealth", keywords="mobile phone", keywords="technology", keywords="diabetes mellitus, type 2", keywords="self-management", keywords="self-care", keywords="medication adherence", abstract="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