The Use of Wireless, Smartphone App–Assisted Home Blood Pressure Monitoring Among Hypertensive Patients in Singapore: Pilot Randomized Controlled Trial

Background Reliable home blood pressure monitoring (HBPM) is essential to effective hypertension management; however, manual recording is subject to underreporting and inaccuracies. Mobile health technologies hold great potential as HBPM tools, but the fidelity of a smartphone app in HBPM has not been adequately assessed. Objective The primary aim of the trial was to compare the fidelity of a smartphone app to that of a handwritten logbook in making HBPM data available to clinicians at follow-up visits. Fidelity was defined as the percentage of scheduled blood pressure (BP) recordings over a 3-week period that were properly recorded and reported to the clinic. The secondary aims were to investigate patient factors associated with HBPM fidelity and to explore the effect of time on the fidelity. Methods A 2-arm, parallel, unblinded, randomized controlled pilot trial was conducted in a government polyclinic in Singapore. Hypertensive adults, aged 40 to 70 years, who were on antihypertensive medication and owned a smartphone were recruited and randomized by a computer-generated randomization schedule to 3 weeks of either semiautomated HBPM utilizing a Bluetooth-enabled BP monitor and a smartphone app or a fully manual process utilizing a conventional handwritten logbook. The primary outcome was home BP recording fidelity. Results Of the 80 patients randomized, 79 (smartphone app: 38 and logbook: 41) were included in the final analysis. Although fidelity was higher among the app users, it did not differ significantly between study arms (smartphone app: 66.7% and logbook: 52.4%; P=.21). Chinese and Indian ethnicities were associated with higher fidelity (absolute percent and 95% CI) by 35.6% (4.27 to 66.9) and 45.0% (8.69 to 81.3), respectively, in comparison with other ethnicities (P=.03); longer smartphone ownership increased fidelity on an average of 10.5% (0.83 to 20.2) per year (P=.03); the number of apps on the smartphone decreased fidelity at a rate of −0.32% (−0.58 to −0.05) per app (P=.02); years of hypertension morbidity increased fidelity at a rate of 1.56% (0.03 to 3.09) per year (P=.046); and the number of people working in the household decreased fidelity at a rate of −8.18% (−16.3 to −0.08) per additional working person (P=.048). The fidelity of the app was significantly higher in the first week (64.4%) than the second (55.1%, P=.001) and third (58.2%, P=.03) weeks of monitoring. Conclusions Amid the increasing integration of health technologies into clinical practice, our study demonstrates the feasibility of smartphone app–assisted HBPM in hypertensive adults of Singapore. Our pilot study found no statistically significant difference in mean BP recording fidelity between a smartphone app and conventional handwritten logbook. However, the small sample size precludes definitive conclusions and highlights the need for a larger, adequately powered trial. Trial Registration ClinicalTrials.gov NCT03209024; https://clinicaltrials.gov/ct2/show/NCT03209024 (Archived by WebCite at http://www.webcitation.org/78EVWBg0T)

Is this a full powered effectiveness trial or a pilot/feasibility trial? * Manuscript tracking number * If this is a JMIR submission, please provide the manuscript tracking number under "other" (The ms tracking number can be found in the submission acknowledgement email, or when you login as author in JMIR. If the paper is already published in JMIR, then the ms tracking number is the fourdigit number at the end of the DOI, to be found at the bottom of each published article in JMIR) TITLE AND ABSTRACT 1a-i) Identify the mode of delivery in the title Identify the mode of delivery. Preferably use "web-based" and/or "mobile" and/or "electronic game" in the title. Avoid ambiguous terms like "online", "virtual", "interactive". Use "Internet-based" only if Intervention includes non-web-based Internet components (e.g. email), use "computer-based" or "electronic" only if orine products are used. Use "virtual" only in the context of "virtual reality" (3-D worlds). Use "online" only in the context of "online support groups". Complement or substitute product names with broader terms for the class of products (such as "mobile" or "smart phone" instead of "iphone"), especially if the application runs on different platforms.
Does your paper address subitem 1a-i? * Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study "Wireless, Smartphone Application-Assisted Home Blood Pressure Monitoring" https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oimq…l=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 1a-ii) Non-web-based components or important co-interventions in title Mention non-web-based components or important co-interventions in title, if any (e.g., "with telephone support").
Does your paper address subitem 1a-ii?
Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study There were no non-web-based co-interventions in this study 1a-iii) Primary condition or target group in the title Mention primary condition or target group in the title, if any (e.g., "for children with Type I Diabetes") Example: A Web-based and Mobile Intervention with Telephone Support for Children with Type I Diabetes: Randomized Controlled Trial Does your paper address subitem 1a-iii? * Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study "Among Hypertensive Patients in Singapore" 1b) ABSTRACT: Structured summary of trial design, methods, results, and conclusions NPT extension: Description of experimental treatment, comparator, care providers, centers, and blinding status.
subitem not at all important 1 2 3 4 5 essential 1b-i) Key features/functionalities/components of the intervention and comparator in the METHODS section of the ABSTRACT Mention key features/functionalities/components of the intervention and comparator in the abstract. If possible, also mention theories and principles used for designing the site. Keep in mind the needs of systematic reviewers and indexers by including important synonyms. (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) Does your paper address subitem 1b-i? * Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study "Hypertensive adults, ages 40-70 years who were on antihypertensive medication and owned a smartphone were recruited from clinic and randomized by a computer-generated randomization schedule to 3 weeks of home blood pressure monitoring using either a semi-automated process utilizing Bluetooth®-enabled BP monitor and a smartphone app or a fully-manual process utilizing a conventional handwritten logbook." https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oimq…=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 1b-ii) Level of human involvement in the METHODS section of the ABSTRACT Clarify the level of human involvement in the abstract, e.g., use phrases like "fully automated" vs. "therapist/nurse/care provider/physician-assisted" (mention number and expertise of providers involved, if any). (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) Does your paper address subitem 1b-ii?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study "home blood pressure monitoring using either a semi-automated process utilizing Bluetooth®-enabled BP monitor and a smartphone app or a fully-manual process utilizing a conventional handwritten logbook." 1b-iii) Open vs. closed, web-based (self-assessment) vs. face-toface assessments in the METHODS section of the ABSTRACT Mention how participants were recruited (online vs. orine), e.g., from an open access website or from a clinic or a closed online user group (closed usergroup trial), and clarify if this was a purely web-based trial, or there were face-to-face components (as part of the intervention or for assessment). Clearly say if outcomes were self-assessed through questionnaires (as common in web-based trials). Note: In traditional orine trials, an open trial (open-label trial) is a type of clinical trial in which both the researchers and participants know which treatment is being administered. To avoid confusion, use "blinded" or "unblinded" to indicated the level of blinding instead of "open", as "open" in web-based trials usually refers to "open access" (i.e. participants can self-enrol). (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 1b-iii?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study "A two-arm, parallel, unblinded, randomized controlled pilot trial was conducted in a government polyclinic in Singapore. Hypertensive adults, ages 40-70 years who were on antihypertensive medication and owned a smartphone were recruited from clinic and randomized by a computer-generated randomization schedule" 1b-iv) RESULTS section in abstract must contain use data Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study "Amidst the increasing integration of health technologies into clinical practice, our study demonstrates the feasibility of smartphone app-assisted home blood pressure monitoring in hypertensive adults in the multi-ethnic population of Singapore. Our pilot study found no signiUcant difference in mean BP recording Udelity between a smartphone app and a conventional hand-written logbook.
However, the small sample size precludes deUnitive conclusions and highlights the need for a larger, adequately powered trial." 2a-i) Problem and the type of system/solution Describe the problem and the type of system/solution that is object of the study: intended as standalone intervention vs. incorporated in broader health care program? Intended for a particular patient population? Goals of the intervention, e.g., being more cost-effective to other interventions, replace or complement other solutions? (Note: Details about the intervention are provided in "Methods" under 5) Does your paper address subitem 2a-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study "Lack of reliability in the conventional home BP monitoring method could be an important contributing factor in the failure to achieve effective BP control and cardiovascular risk reduction in these patients. Shortcomings of conventional home blood pressure monitoring using handwritten logbooks is well known and include inaccuracies, underreporting of data and failure to bring logbooks to clinic visits. The purpose of home blood pressure monitoring is undermined and the value of reported measurements diminished without an effective means of making accurate home BP readings available to clinicians. It is these considerations that motivate and necessitate the exploration of more reliable methods of communicating home BP values to healthcare providers." "(Smartphone apps with tracking function for BP values), when coupled with the wireless data transfer capabilities of Bluetooth® enabled BP monitors, would allow a mobile app to function as an electronic logbook that is more convenient to use and more readily accessible to clinicians than a handwritten log." "Our pilot study aimed to begin addressing the abovementioned knowledge gaps by assessing whether there is any beneUt in using mHealth technology (smartphone app) to store home BP values compared to using handwritten logbooks in terms of making these records available at clinic visits. The primary aim of our RCT was to compare the home BP recording Udelity over a 3-week period using a smartphone app versus a handwritten logbook in the Singaporean hypertensive patient population. Fidelity was deUned as the percentage of scheduled home BP readings that are compliant with the home blood pressure monitoring regimen and are successfully reported at the follow-up visit. function as an electronic logbook that is more convenient to use and more readily accessible to clinicians than a handwritten log. Singapore, with a 91% smartphone penetration rate, holds favourable conditions to utilize a wireless platform in clinical setting. However, there are relatively few studies in the literature that present a quantitative comparison between smartphone app and manual logbook in terms of their respective reliability as a recording tool for home blood pressure monitoring by the patients. Also, because operating technological devices is highly user dependent, speciUc patient factors associated with the effectiveness of smartphone app-assisted home blood pressure monitoring need to be explored." "The prognostic value of home blood pressure monitoring improves with the number of home BP measurements that patients are able to provide their healthcare providers, thus emphasizing the importance of having a reliable means of collecting and reporting home BP data at each ojce visit." As the "shortcomings of conventional home blood pressure monitoring using handwritten logbooks are well known and include inaccuracies, underreporting of data and failure to bring logbooks to clinic visits," having a more reliable method of home blood pressure recording via use of smartphone app could potentially improve management of hypertension and its consequent cardiovascular disease and death. https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oimq…=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full METHODS 3a) Description of trial design (such as parallel, factorial) including allocation ratio 3b) Important changes to methods after trial commencement (such as eligibility criteria), with reasons Does your paper address CONSORT subitem 2b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study "The primary aim of our RCT was to compare the home BP recording Udelity over a 3-week period using a smartphone app versus a handwritten logbook in the Singaporean hypertensive patient population. Fidelity was deUned as the percentage of scheduled home BP readings that are compliant with the home blood pressure monitoring regimen and are successfully reported at the followup visit. The null hypothesis postulated no difference in BP recording Udelity between smartphone app and handwritten logbook. As there was no a priori basis for postulating greater Udelity with the app, the null was tested against a two-sided alternative, although the desired outcome was higher recording Udelity with the smartphone app. Secondary Aims were (i) to explore associations among participant characteristics and the recording Udelity within each study arm, and (ii) to determine the effect of monitoring time duration on weekly recording Udelity in each study arm." Does your paper address CONSORT subitem 3a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study "This study was an open-label, parallel group randomized controlled trial of two study arms with 1:1 allocation ratio. Does your paper address subitem 4a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study Participants did not require computer or internet literacy 4a-ii) Open vs. closed, web-based vs. face-to-face assessments: Open vs. closed, web-based vs. face-to-face assessments: Mention how participants were recruited (online vs. orine), e.g., from an open access website or from a clinic, and clarify if this was a purely web-based trial, or there were face-to-face components (as part of the intervention or for assessment), i.e., to what degree got the study team to know the participant. In online-only trials, clarify if participants were quasi-anonymous and whether having multiple identities was possible or whether technical or logistical measures (e.g., cookies, email conUrmation, phone calls) were used to detect/prevent these. https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oimq…=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 4a-ii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study "Participants were recruited from Pasir Ris Polyclinic, a public primary care clinic serving the multi-ethnic population of a district in Singapore composed of approximately 143,000 residents." Face-to-face components: "At the baseline visit, all the participants were instructed on how to properly record BP values using the home blood pressure monitoring method to which they were assigned, and they were given the opportunity to practice this process under supervision." "All participants received the same instructions on the home BP recording regimen and the correct BP measurement technique" 4a-iii) Information giving during recruitment Information given during recruitment. Specify how participants were briefed for recruitment and in the informed consent procedures (e.g., publish the informed consent documentation as appendix, see also item X26), as this information may have an effect on user self-selection, user expectation and may also bias results.
Does your paper address subitem 4a-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study "Patients were enrolled into the study via convenience sampling. Patients in the polyclinic waiting area were approached, a brief explanation of the study was provided, and pre-screening questions were administered. Interested patients were subsequently screened for eligibility based on study inclusion/exclusion criteria, and written informed consent was obtained from eligible patients. Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study "Participants were recruited from Pasir Ris Polyclinic, a public primary care clinic serving the multi-ethnic population of a district in Singapore composed of approximately 143,000 residents." 4b-i) Report if outcomes were (self-)assessed through online questionnaires Clearly report if outcomes were (self-)assessed through online questionnaires (as common in webbased trials) or otherwise.
Does your paper address subitem 4b-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study 5) The interventions for each group with sujcient details to allow replication, including how and when they were actually administered subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 4b-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study Not applicable to this study, as Omron smartphone app was used 5-i) Mention names, credential, ajliations of the developers, sponsors, and owners Mention names, credential, ajliations of the developers, sponsors, and owners [6] (if authors/evaluators are owners or developer of the software, this needs to be declared in a "Consict of interest" section or mentioned elsewhere in the manuscript).
Does your paper address subitem 5-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study Omron BP monitor and smartphone app were used in this study: "Smartphone app-assisted home blood pressure monitoring was performed using the Bluetooth®-enabled Omron HEM7280T BP monitor to wirelessly record BP values onto the Omron Connect app" https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oim…=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 5-ii) Describe the history/development process Describe the history/development process of the application and previous formative evaluations (e.g., focus groups, usability testing), as these will have an impact on adoption/use rates and help with interpreting results.
Does your paper address subitem 5-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study Not applicable to this study, as Omron smartphone app was used and authors did not develop the app.

5-iii) Revisions and updating
Revisions and updating. Clearly mention the date and/or version number of the application/intervention (and comparator, if applicable) evaluated, or describe whether the intervention underwent major changes during the evaluation process, or whether the development and/or content was "frozen" during the trial. Describe dynamic components such as news feeds or changing content which may have an impact on the replicability of the intervention (for unexpected events see item 3b).
Does your paper address subitem 5-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study "Smartphone app-assisted home blood pressure monitoring was performed using the Bluetooth®-enabled Omron HEM7280T BP monitor to wirelessly record BP values onto the Omron Connect app, which was available free of charge on both Google Play store and Apple App Store and did not undergo major updates during the evaluation process. Does your paper address subitem 5-iv?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study Not applicable to this study, as Omron smartphone app was used and authors did not develop the app.
5-v) Ensure replicability by publishing the source code, and/or providing screenshots/screen-capture video, and/or providing sowcharts of the algorithms used Ensure replicability by publishing the source code, and/or providing screenshots/screen-capture video, and/or providing sowcharts of the algorithms used. Replicability (i.e., other researchers should in principle be able to replicate the study) is a hallmark of scientiUc reporting.
Does your paper address subitem 5-v?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study

5-vi) Digital preservation
Digital preservation: Provide the URL of the application, but as the intervention is likely to change or disappear over the course of the years; also make sure the intervention is archived (Internet Archive, webcitation.org, and/or publishing the source code or screenshots/videos alongside the article). As pages behind login screens cannot be archived, consider creating demo pages which are accessible without login.
Does your paper address subitem 5-vi?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study Not applicable to this study, as we did not use any web page ajliated to the Omron smartphone app.

5-vii) Access
Access: Describe how participants accessed the application, in what setting/context, if they had to pay (or were paid) or not, whether they had to be a member of speciUc group. If known, describe how participants obtained "access to the platform and Internet" [1]. To ensure access for editors/reviewers/readers, consider to provide a "backdoor" login account or demo mode for reviewers/readers to explore the application (also important for archiving purposes, see vi Does your paper address subitem 5-viii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study Description of theoretical framework for app design is largely not applicable to this study, as Omron smartphone app was used and authors did not develop the app.
As for the features/functionalities of the intervention and comparator: "Smartphone app-assisted home blood pressure monitoring was performed using the Bluetooth®-enabled Omron HEM7280T BP monitor to wirelessly record BP values onto the Omron Connect app, which was available free of charge on both Google Play store and Apple App Store and did not undergo major updates during the evaluation process. In brief, this was a semi-automated process that required patients to refresh the app's home screen upon completion of a BP measurement in order to initiate transfer of the monitor reading into the app's electronic log. Logbook home blood pressure monitoring was performed by reading the BP values displayed on the Omron HEM7280T BP monitor and recording them into a physical logbook. At the baseline visit, all the participants were instructed on how to properly record BP values using the home blood pressure monitoring method to which they were assigned, and they were given the opportunity to practice this process under supervision." Other features of Omron

5-ix) Describe use parameters
Describe use parameters (e.g., intended "doses" and optimal timing for use). Clarify what instructions or recommendations were given to the user, e.g., regarding timing, frequency, heaviness of use, if any, or was the intervention used ad libitum.
Does your paper address subitem 5-ix?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study "The home BP recording regimen was based on guidelines and recommendations of the European Society of Hypertension (ESH) [13,14] and consisted of consecutive duplicate readings in the morning (0600-0900hrs) and evening (1800-2100hrs). The patients were asked to follow the recording regimen over a 3-week (21 days) study period for a total of 84 measurements."

5-x) Clarify the level of human involvement
Clarify the level of human involvement (care providers or health professionals, also technical assistance) in the e-intervention or as co-intervention (detail number and expertise of professionals involved, if any, as well as "type of assistance offered, the timing and frequency of the support, how it is initiated, and the medium by which the assistance is delivered". It may be necessary to distinguish between the level of human involvement required for the trial, and the level of human involvement required for a routine application outside of a RCT setting (discuss under item 21generalizability Does your paper address subitem 5-x? Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study "All participants were provided a phone number to reach the designated study team member should they require any help troubleshooting errors with the app or the BP monitor." 5-xi) Report any prompts/reminders used Report any prompts/reminders used: Clarify if there were prompts (letters, emails, phone calls, SMS) to use the application, what triggered them, frequency etc. It may be necessary to distinguish between the level of prompts/reminders required for the trial, and the level of prompts/reminders for a routine application outside of a RCT setting (discuss under item 21 -generalizability).
Does your paper address subitem 5-xi? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study No prompts/reminders to use the application were used.

5-xii) Describe any co-interventions (incl. training/support)
Describe any co-interventions (incl. training/support): Clearly state any interventions that are provided in addition to the targeted eHealth intervention, as ehealth intervention may not be designed as stand-alone intervention. This includes training sessions and support [1]. It may be necessary to distinguish between the level of training required for the trial, and the level of training for a routine application outside of a RCT setting (discuss under item 21 -generalizability. https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oimq…=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full 6a) Completely deUned pre-speciUed primary and secondary outcome measures, including how and when they were assessed Does your paper address subitem 5-xii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study "At the baseline visit, all the participants were instructed on how to properly record BP values using the home blood pressure monitoring method to which they were assigned, and they were given the opportunity to practice this process under supervision. All participants were provided a phone number to reach the designated study team member should they require any help troubleshooting errors with the app or the BP monitor." "All participants received the same instructions on the home BP recording regimen and the correct BP measurement technique." https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oim…=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 6a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study "The primary outcome measure was home BP recording Udelity, deUned a priori as the percentage of scheduled home BP readings over the 3-week home blood pressure monitoring regimen which was recorded, regimen compliant and successfully reported at the Unal clinic visit.
Secondary outcomes were (i) "Generalized Udelity" deUned as home BP recording Udelity in which the BP recording times of the regimen was less stringently deUned: the timeframe for a measurement to be considered regimen compliant was expanded to 0101-1300hrs for morning readings and 1301-0100hrs for evening readings; and (ii) weekly Udelity calculated as the percentage of scheduled weekly readings (28) which was home blood pressure monitoring regimen compliant and reported at Unal clinic visit." "At the end of the 3-week home blood pressure monitoring period participants returned to the clinic for a single (Unal) follow-up visit. During the visit, the electronic log on the app used by the Smartphone app group was exported for further analysis; similarly, a copy of the logbook was made for patients in the Logbook group." 6a-i) Online questionnaires: describe if they were validated for online use and apply CHERRIES items to describe how the questionnaires were designed/deployed The primary outcome incorporates the measure of app "use" "The primary outcome measure was home BP recording Udelity, deUned a priori as the percentage of scheduled home BP readings over the 3-week home blood pressure monitoring regimen which was recorded, regimen compliant and successfully reported at the Unal clinic visit." App "use" over time is resected by trending the secondary outcome of weekly Udelity calculated as the percentage of scheduled weekly readings (28)  Does your paper address CONSORT subitem 6b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study There were no changes to trial outcomes after the trial commenced 7a-i) Describe whether and how expected attrition was taken into account when calculating the sample size Describe whether and how expected attrition was taken into account when calculating the sample size. https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oim…=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full 7b) When applicable, explanation of any interim analyses and stopping guidelines 8a) Method used to generate the random allocation sequence NPT: When applicable, how care providers were allocated to each trial group Does your paper address subitem 7a-i?
Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study "Based on a 2-sided 2-sample t-test at α=.05, a sample size of n=35 patients per study arm was calculated to provide 80% power to detect an effect size (Cohen's d) of 0.6, where 0.5 is generally considered a 'medium' effect size. 80 participants were recruited anticipating a 10% withdrawal rate." Does your paper address CONSORT subitem 7b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study There were to formal interim analysis and stopping guidelines as this was a pilot study of relatively short duration.
Does your paper address CONSORT subitem 8a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study "A treatment allocation sequence accommodating 80 patients was generated by computer using permuted block randomization with block of size 6 and 1 block of size 8." https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oim…=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full 8b) Type of randomisation; details of any restriction (such as blocking and block size) 9) Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assigned 10) Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions Does your paper address CONSORT subitem 8b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study "A computer-generated treatment allocation sequence accommodating 80 patients was generated by study statistician (Allen JC) using permuted block randomization with block of size 6 and 1 block of size 8." Does your paper address CONSORT subitem 9? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study "Sequentially numbered, opaque, sealed envelopes (SNOSE) were prepared, with each envelope containing a treatment group assignment. The primary investigator enrolled all patients, while allocation concealment and sequential dispensing of envelopes was enforced by an on-site research coordinator. Patients were randomly assigned to either the Smartphone app or the handwritten Logbook study groups." https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oimq…=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full 11a) If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how NPT: Whether or not administering co-interventions were blinded to group assignment subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 10? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study "A computer-generated treatment allocation sequence accommodating 80 patients was generated by study statistician (Allen JC) using permuted block randomization with block of size 6 and 1 block of size 8. Sequentially numbered, opaque, sealed envelopes (SNOSE) were prepared, with each envelope containing a treatment group assignment. The primary investigator enrolled all patients, while allocation concealment and sequential dispensing of envelopes was enforced by an on-site research coordinator. Patients were randomly assigned to either the Smartphone app or the handwritten Logbook study groups." 11a-i) Specify who was blinded, and who wasn't Specify who was blinded, and who wasn't. Usually, in web-based trials it is not possible to blind the participants [1, 3] (this should be clearly acknowledged), but it may be possible to blind outcome assessors, those doing data analysis or those administering co-interventions (if any Does your paper address subitem 11a-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study "This was an unblinded study because participants were required to learn the procedures for their respective home blood pressure monitoring methods; investigators were not masked, but we attempted to reduce bias by deUning our primary outcome measure and the primary statistical method a priori." 11a-ii) Discuss e.g., whether participants knew which intervention was the "intervention of interest" and which one was the "comparator" Informed consent procedures (4a-ii) can create biases and certain expectations -discuss e.g., whether participants knew which intervention was the "intervention of interest" and which one was the "comparator".
Does your paper address subitem 11a-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study App assisted home blood pressure monitoring was not explicitly labeled as the intervention of interest. https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oim…=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full 12a) Statistical methods used to compare groups for primary and secondary outcomes NPT: When applicable, details of whether and how the clustering by care providers or centers was addressed Does your paper address CONSORT subitem 11b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study Not applicable to this study, as the two interventions have no need to appear similar in this study.
Does your paper address CONSORT subitem 12a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study "the primary comparison on Udelity between the study groups was tested using the Wilcoxon rank-sum test appropriate for two independent samples. The median difference was estimated by the Hodges-Lehmann shift parameter estimate. In a sensitivity analyses, mean Udelity was also compared using (i) the 2-sample t-test and (ii) a general linear mixed-model, repeated-measures analysis to adjust the treatment group comparison for possible confounders of age, gender, baseline systolic and diastolic BP, as well as to assess the effects of follow-up time (week) and time × treatment group interaction. In this model, participants were included as random effects and time as a repeated-measures Uxed effect within participants. In addition, same analyses were also performed on the outcomes deUned under the "generalized Udelity" between the two study arms. The same general linear mixed-model was also used to assess effect of time on weekly home BP recording Udelity in each study arm. 12a-i) Imputation techniques to deal with attrition / missing values Imputation techniques to deal with attrition / missing values: Not all participants will use the intervention/comparator as intended and attrition is typically high in ehealth trials. Specify how participants who did not use the application or dropped out from the trial were treated in the statistical analysis (a complete case analysis is strongly discouraged, and simple imputation techniques such as LOCF may also be problematic [4]).
Does your paper address subitem 12a-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study "The data from the sole patent who withdrew the follow up period was omitted from the analyses." Does your paper address CONSORT subitem 12b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study Does your paper address subitem X26-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study "The (orine) informed consent procedure included explanation of the purpose of the study, the study procedures and visit schedule, participants' responsibilities and rights, and conUdentiality of medical records." https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oim…=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full subitem not at all important 1 2 3 4 5 essential RESULTS 13a) For each group, the numbers of participants who were randomly assigned, received intended treatment, and were analysed for the primary outcome NPT: The number of care providers or centers performing the intervention in each group and the number of patients treated by each care provider in each center X26-iii) Safety and security procedures Safety and security procedures, incl. privacy considerations, and any steps taken to reduce the likelihood or detection of harm (e.g., education and training, availability of a hotline) Does your paper address subitem X26-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study "For security precautions, all participant data were anonymized and stored in password protected computers or in locked cabinets." 13b) For each group, losses and exclusions after randomisation, together with reasons Does your paper address CONSORT subitem 13a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study "928 patients were approached during the recruitment and follow-up period (15/03/17-15/07/17). As shown in the CONSORT sow diagram, of the 102 patients undergoing screening, 83 were eligible for enrolment. Of those eligible, 80 were randomized. One patient randomized to the Smartphone app arm was re-allocated to the Logbook arm at the baseline visit prior to commencing home blood pressure monitoring due to unexplained smartphone incompatibility with the study app during the initial set-up process. One participant in the Smartphone app arm withdrew from the study." Does your paper address CONSORT subitem 13b? (NOTE: Preferably, this is shown in a CONSORT sow diagram) * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study "One patient randomized to the Smartphone app arm was re-allocated to the Logbook arm at the baseline visit prior to commencing home blood pressure monitoring due to unexplained smartphone incompatibility with the study app during the initial set-up process. One participant in the Smartphone app arm withdrew from the study." (reason for withdrawal shown in the CONSORT sow Strongly recommended: An attrition diagram (e.g., proportion of participants still logging in or using the intervention/comparator in each group plotted over time, similar to a survival curve) or other Ugures or tables demonstrating usage/dose/engagement. Does your paper address subitem 13b-i?
Copy and paste relevant sections from the manuscript or cite the Ugure number if applicable (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study Separate attrition diagram is not presented in this paper as attrition was low and 78 of 80 participants used the intervention/comparator to which they were assigned.
Does your paper address CONSORT subitem 14a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study "928 patients were approached during the recruitment and follow-up period (15/03/17-15/07/17)." 14a-i) Indicate if critical "secular events" fell into the study period Indicate if critical "secular events" fell into the study period, e.g., signiUcant changes in Internet resources available or "changes in computer hardware or Internet delivery resources" https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oim…=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full 14b) Why the trial ended or was stopped (early)

15) A table showing baseline demographic and clinical characteristics for each group
NPT: When applicable, a description of care providers (case volume, qualiUcation, expertise, etc.) and centers (volume) in each group Does your paper address subitem 14a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study Not applicable to this study, as there were no signiUcant changes in computer hardware or Internet delivery resources during study period.
Does your paper address CONSORT subitem 14b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study Not applicable to this study, as the trial was not stopped early.
Does your paper address CONSORT subitem 15? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study "The Smartphone app and Logbook arms were comparable in all baseline characteristics with the exception of systolic blood pressure (SBP) ( Does your paper address subitem 15-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study Demographics associated with digital divide issues are resected in Table 1. 16-i) Report multiple "denominators" and provide deUnitions Report multiple "denominators" and provide deUnitions: Report N's (and effect sizes) "across a range of study participation [and use] thresholds" [1], e.g., N exposed, N consented, N used more than x times, N used more than y weeks, N participants "used" the intervention/comparator at speciUc pre-deUned time points of interest (in absolute and relative numbers per group). Always clearly deUne "use" of the intervention. https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oim…=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 16-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study The number of participants included in each analysis is shown in CONSORT sow diagram.
"One patient randomized to the Smartphone app arm was re-allocated to the Logbook arm at the baseline visit prior to commencing home blood pressure monitoring due to unexplained smartphone incompatibility with the study app during the initial set-up process." "In the Smartphone app arm, 28 were included in the Unal analysis, and 11 had home blood pressure recording Udelity >80% at the end of 3 week follow up period. For the Logbook arm, 41 were included in analysis, and 7 had home blood pressure recording Udelity >80% at end of 3 weeks."

16-ii) Primary analysis should be intent-to-treat
Primary analysis should be intent-to-treat, secondary analyses could include comparing only "users", with the appropriate caveats that this is no longer a randomized sample (see 18-i).
Does your paper address subitem 16-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study "Of those eligible, 80 were randomized. One patient randomized to the Smartphone app arm was re-allocated to the Logbook arm at the baseline visit prior to commencing home blood pressure monitoring due to unexplained smartphone incompatibility with the study app during the initial set-up process. One participant in the Smartphone app arm withdrew from the study." (The patient who withdrew was not included in primary analysis; the re-allocated participant was included in the Logbook arm for the primary analysis). https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oim…=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full 17a) For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% conUdence interval) subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 17a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study Shown in Tables 2, 3, 4, 5 17a-i) Presentation of process outcomes such as metrics of use and intensity of use In addition to primary/secondary (clinical) outcomes, the presentation of process outcomes such as metrics of use and intensity of use (dose, exposure) and their operational deUnitions is critical. This does not only refer to metrics of attrition (13-b) (often a binary variable), but also to more continuous exposure metrics such as "average session length". These must be accompanied by a technical description how a metric like a "session" is deUned (e.g., timeout after idle time) [1] (report under item 6a).
Does your paper address subitem 17a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study Weekly home blood pressure recording Udelity trend over 3 weeks is presented in Figure 2. "In assessing weekly Udelity trend over the 3-week period within each study arm, Udelity was highest in the Urst week and lower in subsequent weeks (Figure 2).
This difference was most pronounced among the app users, whose Udelity in the Urst week (64.4%) was signiUcantly higher than that of the second (55.1%, P=.001) and third (58.2%, P=.03) weeks of monitoring. Though a similar trend was seen in the Logbook arm, no change in Udelity among weeks was signiUcant." 17b) For binary outcomes, presentation of both absolute and relative effect sizes is recommended 18) Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing pre-speciUed from exploratory subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 17b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study Not applicable to this study, as home blood pressure recording Udelity is a continuous outcome measure.
Does your paper address CONSORT subitem 18? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study Analysis of participant characteristics associated with Udelity, Udelity trend by study week, and subgroup analysis of the elderly are presented.

18-i) Subgroup analysis of comparing only users
A subgroup analysis of comparing only users is not uncommon in ehealth trials, but if done, it must be stressed that this is a self-selected sample and no longer an unbiased sample from a randomized trial (see 16-iii Does your paper address subitem 19-i? Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study "One patient randomized to the Smartphone app arm was re-allocated to the Logbook arm at the baseline visit prior to commencing home blood pressure monitoring due to unexplained smartphone incompatibility with the study app during the initial set-up process. Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study "The Undings from a recent systematic review and meta-analysis showed that home blood pressure monitoring alone did not have higher association with BP lowering and BP control compared to no-home monitoring (usual care), while home BP monitoring with additional patient support via feedback, education, and counselling demonstrated signiUcantly higher association. This emphasizes the importance of future studies to further explore smartphone app use, not only as a high-Udelity recording tool for home blood pressure monitoring but also as a platform for delivering effective patient adherence support such as health information and reminders." "For the future full-scale trial to be sujciently powered, the sample standard deviation of approximately 28% and mean difference in Udelity of about 8% observed in this study can be used to ensure that a 2-arm study with n=175 participants per group would provide 80% power to detect an effect size of 8/28 (approximately 0.30) at α=.05. Moreover, other important clinical outcomes in hypertension management, such as magnitude of BP lowering and proportion of BP control, must be assessed."

20-i) Typical limitations in ehealth trials
Typical limitations in ehealth trials: Participants in ehealth trials are rarely blinded. Ehealth trials often look at a multiplicity of outcomes, increasing risk for a Type I error. Discuss biases due to non-use of the intervention/usability issues, biases through informed consent procedures, unexpected events. Does your paper address subitem 20-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study "This study has a number of limitations. First, as a pilot trial, sample size was limited by time and available resources. Because we had no knowledge of either the expected difference in mean Udelity or the population standard deviation, the sample size calculation was based on a targeted Cohen effect size (ES) of 0.6, which was the smallest feasible and realistically achievable ES given the available resources and timeframe of the study. The observed ES for Udelity was 0.33, hence the study was obviously underpowered. Second, recruitment was limited to one polyclinic, which could preclude the generalizability of the results to the greater hypertensive population in Singapore or around the world. Third, this was an unblinded study because participants were required to learn the procedures for their respective home blood pressure monitoring methods; investigators were not masked, but we attempted to reduce bias by deUning our primary outcome measure and the primary statistical method a priori. Finally, the Hawthorne effect could not be precluded, and the magnitude of the effect on the two study arms may have differed." Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study "Second, recruitment was limited to one polyclinic, which could preclude the generalizability of the results to the greater hypertensive population in Singapore or around the world." 21-ii) Discuss if there were elements in the RCT that would be different in a routine application setting Discuss if there were elements in the RCT that would be different in a routine application setting (e.g., prompts/reminders, more human involvement, training sessions or other co-interventions) and what impact the omission of these elements could have on use, adoption, or outcomes if the intervention is applied outside of a RCT setting.

21-i) Generalizability to other populations
Does your paper address subitem 21-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study "The signiUcant attenuation of Udelity from weeks 1 to 2 in the Smartphone app arm may be explained in part by the duration of BP monitoring. The ESH guidelines specify a 7-day period of monitoring for its home blood pressure monitoring regimen, and prolonging this rigorous regimen beyond the recommended period of 1 week may have led to study fatigue among participants in the Smartphone app arm." https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oim…=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full 24) Where the full trial protocol can be accessed, if available 25) Sources of funding and other support (such as supply of drugs), role of funders X27) Consicts of Interest (not a CONSORT item) Does your paper address CONSORT subitem 23? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study ClinicalTrials.gov -NCT03209024 Does your paper address CONSORT subitem 24? * Cite a Multimedia Appendix, other reference, or copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study Full trial protocol: available from corresponding author upon request.
Does your paper address CONSORT subitem 25? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study In addition to the usual declaration of interests (Unancial or otherwise), also state the relation of the study team towards the system being evaluated, i.e., state if the authors/evaluators are distinct from or identical with the developers/sponsors of the intervention.
Does your paper address subitem X27-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study "Consicts of Interest None declared" As a result of using this checklist, did you make changes in your manuscript? * What were the most important changes you made as a result of using this checklist? STOP -Save this form as PDF before you click submit To generate a record that you Ulled in this form, we recommend to generate a PDF of this page (on a Mac, simply select "print" and then select "print as PDF") before you submit it.
When you submit your (revised) paper to JMIR, please upload the PDF as supplementary Ule.
Don't worry if some text in the textboxes is cut off, as we still have the complete information in our database. Thank you!