Increasing Engagement in the Electronic Framingham Heart Study: Factorial Randomized Controlled Trial

Background Smartphone apps and mobile health devices offer innovative ways to collect longitudinal cardiovascular data. Randomized evidence regarding effective strategies to maintain longitudinal engagement is limited. Objective This study aimed to evaluate smartphone messaging interventions on remote transmission of blood pressure (BP) and heart rate (HR) data. Methods We conducted a 2 × 2 × 2 factorial blinded randomized trial with randomization implemented centrally to ensure allocation concealment. We invited participants from the Electronic Framingham Heart Study (eFHS), an e-cohort embedded in the FHS, and asked participants to measure their BP (Withings digital cuff) weekly and wear their smartwatch daily. We assessed 3 weekly notification strategies to promote adherence: personalized versus standard; weekend versus weekday; and morning versus evening. Personalized notifications included the participant’s name and were tailored to whether or not data from the prior week were transmitted to the research team. Intervention notification messages were delivered weekly automatically via the eFHS app. We assessed if participants transmitted at least one BP or HR measurement within 7 days of each notification after randomization. Outcomes were adherence to BP and HR transmission at 3 months (primary) and 6 months (secondary). Results Of the 791 FHS participants, 655 (82.8%) were eligible and randomized (mean age 53, SD 9 years; 392/655, 59.8% women; 596/655, 91% White). For the personalized versus standard notifications, 38.9% (126/324) versus 28.8% (94/327) participants sent BP data at 3 months (difference=10.1%, 95% CI 2.9%-17.4%; P=.006), but no significant differences were observed for HR data transmission (212/324, 65.4% vs 209/327, 63.9%; P=.69). Personalized notifications were associated with increased BP and HR data transmission versus standard at 6 months (BP: 107/291, 36.8% vs 66/295, 22.4%; difference=14.4%, 95% CI 7.1- 21.7%; P<.001; HR: 186/281, 66.2% vs 158/281, 56.2%; difference=10%, 95% CI 2%-18%; P=.02). For BP and HR primary or secondary outcomes, there was no evidence of differences in data transmission for notifications sent on weekend versus weekday or morning versus evening. Conclusions Personalized notifications increased longitudinal adherence to BP and HR transmission from mobile and digital devices among eFHS participants. Our results suggest that personalized messaging is a powerful tool to promote adherence to mobile health systems in cardiovascular research. Trial Registration ClinicalTrials.gov NCT03516019; https://clinicaltrials.gov/ct2/show/NCT03516019

yes: all primary outcomes were signi cantly better in intervention group vs control partly: SOME primary outcomes were signi cantly better in intervention group vs control no statistically signi cant difference between control and intervention potentially harmful: control was signi cantly better than intervention in one or more outcomes inconclusive: more research is needed Other: Approx. Percentage of Users (starters) still using the app as recommended after 3 months * at 3 months 43% of participants greater than 55 years transmitted blo 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 o ine 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 brie y explain why the item is not applicable/relevant for your study "Increasing engagement in the Electronic Framingham Heart Study (eFHS): a factorial randomized controlled trial"

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").
subitem not at all important 1 2 3 4 5 essential 1b) ABSTRACT: Structured summary of trial design, methods, results, and conclusions NPT extension: Description of experimental treatment, comparator, care providers, centers, and blinding status.
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 brie y explain why the item is not applicable/relevant for your study We used a smartphone notification intervention to increase engagement with mobile devices 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 brie y explain why the item is not applicable/relevant for your study No specific group targeted-community-based sample, "Electronic Framingham Heart Study (eFHS)" subitem not at all important 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 brie y explain why the item is not applicable/relevant for your study "To evaluate smartphone messaging interventions on remote transmission of blood pressure (BP) and heart rate (HR) data"

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) subitem not at all important 1 2 3 4 5 essential 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 brie y explain why the item is not applicable/relevant for your study "Intervention notification messages were delivered weekly automatically via the eFHS app." 1b-iii) Open vs. closed, web-based (self-assessment) vs. face-to-face assessments in the METHODS section of the ABSTRACT Mention how participants were recruited (online vs. o ine), 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 o ine 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) 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 brie y explain why the item is not applicable/relevant for your study "We conducted a 2x2x2 factorial blinded randomized trial with randomization implemented centrally to ensure allocation concealment. We invited participants from the eFHS, an ecohort embedded in the Framingham Heart Study and asked participants to measure their BP (Withings digital cuff) weekly and wear their smartwatch daily. " and mitigate any concern of attrition bias to harness the potential health impacts technology can provide." 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 brie y explain why the item is not applicable/relevant for your study "We conducted a randomized controlled trial to test the effect of smartphone app notification messaging strategies on improving participants' long-term (3 month) use of, and return of HR and blood pressure (BP) data (Trial registration: ClinicalTrials.gov NCT03516019). We hypothesized that personalized messaging compared to standard messaging would improve device use. We also tested the effect of time of day of message delivery (morning vs. evening) and day of the week (weekday vs. weekend) on device use. " 3b) Important changes to methods after trial commencement (such as eligibility criteria), with reasons 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 brie y explain why the item is not applicable/relevant for your study "We conducted a 2x2x2 factorial randomized trial embedded into the eFHS. The trial was registered on clinicaltrials.gov under NCT03516019. The current study was approved by the Boston University Medical Campus Institutional Review Board under protocol number H-36586." Does your paper address CONSORT subitem 3b? * 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 brie y explain why the item is not applicable/relevant for your study "We enrolled participants in the messaging trial between April 13, 2018 and February 8th, 2019 and completed follow-up of all enrolled participants by March 23, 2019 for the primary outcome. We invited all new eFHS enrollees to participate in the messaging trial during their in-person exam 3 at the FHS research center. In addition, we contacted eligible participants who had been enrolled in eFHS prior to the onset of the messaging trial (n=586) by email and phone to invite them to participate" There was no change in eligibility criteria after commencement of the trial. Bug xes, Downtimes, Content Changes: ehealth systems are often dynamic systems. A description of changes to methods therefore also includes important changes made on the intervention or comparator during the trial (e.g., major bug xes or changes in the functionality or content) (5-iii) and other "unexpected events" that may have in uenced study design such as staff changes, system failures/downtimes, etc. [2].
Does your paper address subitem 3b-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 brie y explain why the item is not applicable/relevant for your study There were no changes during the trial.
Does your paper address CONSORT subitem 4a? * 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 brie y explain why the item is not applicable/relevant for your study "We enrolled participants in the messaging trial between April 13, 2018 and February 8th, 2019 and completed follow-up of all enrolled participants by March 23, 2019 for the primary outcome. We invited all new eFHS enrollees to participate in the messaging trial during their in-person exam 3 at the FHS research center. In addition, we contacted eligible participants who had been enrolled in eFHS prior to the onset of the messaging trial (n=586) by email and phone to invite them to participate" "eFHS participants using an Android phone or who did not choose to use both devices were not eligible for the messaging trial."

4a-i) Computer / Internet literacy
Computer / Internet literacy is often an implicit "de facto" eligibility criterion -this should be explicitly clari ed.
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 brie y explain why the item is not applicable/relevant for your study "eFHS eligibility criteria were as follows: English-speaking individuals who owned an iPhone with compatible iOS (version 9 or higher) or Android phone; residence in the United States; provision of permissions for notifications and data sharing with the Research Center; provision of signed and dated informed consent (two-step consent as part of the research examination and within the eFHS mobile app). eFHS participants using an Android phone or who did not choose to use both devices were not eligible for the messaging trial." 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. o ine), 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 con rmation, phone calls) were used to detect/prevent these. 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 brie y explain why the item is not applicable/relevant for your study "Participants in the eFHS were enrolled from the Gen 3, Omni Group 2, and New Offspring Spouse Cohorts during the in-person examination 3 (2016-2019) at the FHS Research Center in Framingham, MA, USA." "We invited all new eFHS enrollees to participate in the messaging trial during their in-person exam 3 at the FHS research center. In addition, we contacted eligible participants who had been enrolled in eFHS prior to the onset of the messaging trial (n=586) by email and phone to invite them to participate"

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 brie y explain why the item is not applicable/relevant for your study For newly enrolled eFHS participants to participate in the trial, "provision of signed and dated informed consent (two-step consent as part of the research examination and within the eFHS mobile app)." For eFHS participants enrolled prior to trial start, "A consent form for participation in the trial was sent via smartphone app one month before the trial initiation. Participants who did not return the consent survey received up to three reminder notifications. " 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 brie y explain why the item is not applicable/relevant for your study "participants with iPhones were provided with choices to pair the eFHS app with a Withings-Nokia BP cuff and an Apple Watch (series 0). Participants were trained in use of the devices and asked to wear the watch daily and send a BP measurement once per week." "The app automatically transmits data to the FHS research center, such as HR or BP measurements, if participants have paired their devices with their iPhone."

4b-i) Report if outcomes were (self-)assessed through online questionnaires
Clearly report if outcomes were (self-)assessed through online questionnaires (as common in web-based 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 brie y explain why the item is not applicable/relevant for your study "The app automatically transmits data to the FHS research center, such as HR or BP measurements, if participants have paired their devices with their iPhone." The study outcomes were HR and BP transmission. 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 brie y explain why the item is not applicable/relevant for your study Participants are long standing members of the Framingham Heart Study.

5-i) Mention names, credential, affiliations of the developers, sponsors, and owners
Mention names, credential, a liations of the developers, sponsors, and owners [6] (if authors/evaluators are owners or developer of the software, this needs to be declared in a "Con ict of interest" section or mentioned elsewhere in the manuscript). subitem not at all important 1 2 3 4 5 essential 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 brie y explain why the item is not applicable/relevant for your study The investigators have a partnership with CareEvolution. CareEvolution is noted in the manuscript. "All weekly notifications were delivered automatically via the eFHS app by CareEvolution."

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 brie y explain why the item is not applicable/relevant for your study We are investigating engagement with use of two devices to collect objective physiologic data. The devices are noted in the manuscript. "Withings-Nokia BP cuff and an Apple Watch (series 0)"

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 brie y explain why the item is not applicable/relevant for your study There were no changes to the notification intervention messages during the trial. Notification messages are provided in the appendix.

5-iv) Quality assurance methods
Provide information on quality assurance methods to ensure accuracy and quality of information provided [1], if applicable. 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 brie y explain why the item is not applicable/relevant for your study Your answer 5-v) Ensure replicability by publishing the source code, and/or providing screenshots/screen-capture video, and/or providing flowcharts of the algorithms used Ensure replicability by publishing the source code, and/or providing screenshots/screencapture video, and/or providing owcharts of the algorithms used. Replicability (i.e., other researchers should in principle be able to replicate the study) is a hallmark of scienti c reporting. subitem not at all important 1 2 3 4 5 essential 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 brie y explain why the item is not applicable/relevant for your study "We sent weekly notifications through the app focusing on the following 3 comparisons: 1) personalized motivational reminder messaging vs. standard messaging; 2) messaging sent on a weekend vs. weekday; and 3) messaging sent in the morning vs. the evening. " "The standard notification invited participants to wear the watch daily and to measure their BP weekly and was sent as a single message as follows: "We appreciate your involvement in the eFHS. Please wear your watch daily and measure your blood pressure weekly." With regard to personalized notification messages, all messages included the participant's name and were customized to whether or not data were received over the prior week. One set of personalized messages targeted the use of the watch, and the other targeted the use of the BP cuff. The two messages (one for watch, one for BP) were sent each week alternating the message order each week." Message content is included in the appendix materials.

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 brie y explain why the item is not applicable/relevant for your study There is no URL associated with the trial. The intervention notifications are described and the notification message content provided. The trial is registered at clinicaltrial.gov.

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 speci c 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-vii? * 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 brie y explain why the item is not applicable/relevant for your study Participants in the trial were part of the electronic Framingham Heart Study (eFHS). eFHS participants were invited to enroll at the time of an in-person FHS exam. The application and devices were provided to participants who enrolled in eFHS. Participants did not receive financial compensation. 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 brie y explain why the item is not applicable/relevant for your study "We sent weekly notifications through the app" " Based upon our prior experience and literature review, we designed the notification messaging interventions to improve both the use of the mobile devices and response rate to surveys." "While digital interventions delivered via smartphone may be more likely to produce better engagement, [11] there is limited evidence available on the characteristics influencing the effectiveness of the intervention including timing, duration, frequency, and type of behavior change techniques.
[12-15] We designed our notification messages and comparisons to address intervention characteristics that could be easily implemented and thus widely used."

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 brie y explain why the item is not applicable/relevant for your study Participants were asked to wear smartwatch daily and measure blood pressure weekly. "We sent weekly notifications through the app focusing on the following 3 comparisons: 1) personalized motivational reminder messaging vs. standard messaging; 2) messaging sent on a weekend vs. weekday; and 3) messaging sent in the morning vs. the evening."

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 21 -generalizability). subitem not at all important 1 2 3 4 5 essential 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 brie y explain why the item is not applicable/relevant for your study "We sent weekly notifications through the app focusing on the following 3 comparisons: 1) personalized motivational reminder messaging vs. standard messaging; 2) messaging sent on a weekend vs. weekday; and 3) messaging sent in the morning vs. the evening. We evaluated the three comparisons simultaneously according to a 2x2x2 factorial design." "The standard notification invited participants to wear the watch daily and to measure their BP weekly and was sent as a single message as follows: "We appreciate your involvement in the eFHS. Please wear your watch daily and measure your blood pressure weekly." With regard to personalized notification messages, all messages included the participant's name and were customized to whether or not data were received over the prior week. One set of personalized messages targeted the use of the watch, and the other targeted the use of the BP cuff. The two messages (one for watch, one for BP) were sent each week alternating the message order each week."

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. 6a) Completely defined pre-specified 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 brie y explain why the item is not applicable/relevant for your study ", the study technician invited participants to download the eFHS app. The eFHS app allows communication with participants through notifications permitting us to send messaging intervention notifications defined below.. Participants were asked to answer health surveys administered through the app at baseline and every 3 months. In addition, participants with iPhones were provided with choices to pair the eFHS app with a Withings-Nokia BP cuff and an Apple Watch (series 0). Participants were trained in use of the devices and asked to wear the watch daily and send a BP measurement once per week. Participants were provided with written instructions if they preferred remote enrollment. " 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 brie y explain why the item is not applicable/relevant for your study "For the primary outcomes, we assessed if participants transmitted at least one BP or HR measurement within 7 days of each notification 3 months after randomization (after 12 notifications). In secondary analyses, we examined the transmission of BP and HR measurements at 1 month and 6 months after random allocation (after 4 and 24 notifications, respectively). We also performed a longitudinal analysis of the repeated weekly transmissions. " Does your paper address subitem 6a-i?

Copy and paste relevant sections from manuscript text
The focus of the investigation was engagement with devices (blood pressure cuff and smartwatch). Participants in the eFHS study did complete smartphone app surveys designed using questionnaires from the FHS examinations. An exploratory analysis included app survey completion at 3 months.
6a-ii) Describe whether and how "use" (including intensity of use/dosage) was defined/measured/monitored Describe whether and how "use" (including intensity of use/dosage) was de ned/measured/monitored (logins, log le analysis, etc.). Use/adoption metrics are important process outcomes that should be reported in any ehealth trial.
subitem not at all important 1 2 3 4 5 essential 6b) Any changes to trial outcomes after the trial commenced, with reasons Does your paper address subitem 6a-ii? 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 brie y explain why the item is not applicable/relevant for your study No changes in 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.
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 brie y explain why the item is not applicable/relevant for your study "Based on preliminary data from June 2016 to July 2017, the proportion of participants transmitting data at 3 months from the watch and the cuff was about 50%.
[10] With a twosided test with alpha 0.05, and with anticipated proportions of participants transmitting data of 50% and 70% in the groups without and with any intervention, 650 participants would give >99% power for the main effect of each intervention (Multimedia Appendix 3, Power calculations). This sample size assumed no interaction effect between intervention groups. We powered the trial for the three main comparisons: (1) using personalized motivational reminder messaging vs. standard messaging; (2) messaging sent on a weekend vs. weekday; (3) messaging sent in the morning vs. the evening, when no interaction is present." 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 brie y explain why the item is not applicable/relevant for your study No interim analyses or stopping guidelines 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 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 brie y explain why the item is not applicable/relevant for your study "We randomly allocated each participant to one of 8 groups. Randomization was stratified according to sex, age (≤55 years vs. >55 years), and enrollment in eFHS prior to the beginning of the current messaging trial. A statistician (LT) generated blocked randomization lists for each stratum. Randomization was implemented centrally by CareEvolution through the eFHS app, ensuring allocation concealment. Research staff enrolled participants in the FHS research center before random allocation to one of the intervention groups, which occurred afterwards. eFHS researchers, statistician, research assistant, and research center staff were masked to group assignment. " 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 brie y explain why the item is not applicable/relevant for your study "We conducted a 2x2x2 factorial randomized trial embedded into the eFHS." "Randomization was stratified according to sex, age (≤55 years vs. >55 years), and enrollment in eFHS prior to the beginning of the current messaging trial. A statistician (LT) generated blocked randomization lists for each stratum." 10) Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions 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 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 brie y explain why the item is not applicable/relevant for your study "We randomly allocated each participant to one of 8 groups. Randomization was stratified according to sex, age (≤55 years vs. >55 years), and enrollment in eFHS prior to the beginning of the current messaging trial. A statistician (LT) generated blocked randomization lists for each stratum. Randomization was implemented centrally by CareEvolution through the eFHS app, ensuring allocation concealment. " 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 brie y explain why the item is not applicable/relevant for your study "A statistician (LT) generated blocked randomization lists for each stratum. Randomization was implemented centrally by CareEvolution through the eFHS app, ensuring allocation concealment. Research staff enrolled participants in the FHS research center before random allocation to one of the intervention groups, which occurred afterwards." 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 cointerventions (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 brie y explain why the item is not applicable/relevant for your study "eFHS researchers, statistician, research assistant, and research center staff were masked to group assignment" 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".

11b) If relevant, description of the similarity of interventions
(this item is usually not relevant for ehealth trials as it refers to similarity of a placebo or sham intervention to a active medication/intervention) This is a required question 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 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 brie y explain why the item is not applicable/relevant for your study Participants were not aware of assignment group of interest vs comparison 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 brie y explain why the item is not applicable/relevant for your study Your answer subitem not at all important 1 2 3 4 5 essential 12b) Methods for additional analyses, such as subgroup analyses and adjusted analyses 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 brie y explain why the item is not applicable/relevant for your study "We performed analyses "at the margins" to assess the main effect of each intervention meaning that, for example, we determined the effect of personalized vs. standard notifications by comparing outcomes among all participants randomly allocated to personalized notifications (regardless of days and times of messaging) with those of all participants randomly allocated to standard notifications.

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 brie y explain why the item is not applicable/relevant for your study The aim of the trial was to test notifications for engagement with device use. 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 brie y explain why the item is not applicable/relevant for your study "We also evaluated three-way and two-way interactions between the 3 interventions (messaging content, day, and time) on transmission of BP and HR data. For the analyses at any specific time point (1 month, 3 months, and 6 months), we used logistic regression models. We estimated the absolute difference in the proportion of participants adequately transmitting data as well as the odds ratio. For the longitudinal analysis of the repeated weekly transmissions, we used a logistic regression model with random intercept."

X26-i) Comment on ethics committee approval
Does your paper address subitem X26-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 brie y 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 brie y explain why the item is not applicable/relevant for your study "provision of signed and dated informed consent (two-step consent as part of the research examination and within the eFHS mobile app)" For participants enrolled in eFHS at time trial was started, "A consent form for participation in the trial was sent via smartphone app one month before the trial initiation. Participants who did not return the consent survey received up to three reminder notifications. "

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)

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 13b) For each group, losses and exclusions after randomisation, together with reasons 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 brie y explain why the item is not applicable/relevant for your study CareEvolution platform is HIPPA compliant and meaningful use certified to ensure security, auditability, and data loss protection.
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 brie y explain why the item is not applicable/relevant for your study "Of 791 eligible FHS participants, we consented and randomly allocated 655 (82.8%) participants " subitem not at all important 1 2 3 4 5 essential 14a) Dates defining the periods of recruitment and follow-up Does your paper address CONSORT subitem 13b? (NOTE: Preferably, this is shown in a CONSORT flow 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 brie y explain why the item is not applicable/relevant for your study All 655 participants randomized contributed to primary and secondary trial outcomes. No participant was excluded after randomization.

13b-i) Attrition diagram
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 gures or tables demonstrating usage/dose/engagement.

Does your paper address subitem 13b-i?
Copy and paste relevant sections from the manuscript or cite the gure 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 brie y explain why the item is not applicable/relevant for your study Figure 1 shows the participant flow in the trial 14b) Why the trial ended or was stopped (early) 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 brie y explain why the item is not applicable/relevant for your study "We enrolled participants in the messaging trial between April 13, 2018 and February 8th, 2019 and completed follow-up of all enrolled participants by March 23, 2019 for the primary outcome." 14a-i) Indicate if critical "secular events" fell into the study period Indicate if critical "secular events" fell into the study period, e.g., signi cant changes in Internet resources available or "changes in computer hardware or Internet delivery resources" 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 brie y explain why the item is not applicable/relevant for your study No critical secular events fell in the study period that the investigators are aware of 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 brie y explain why the item is not applicable/relevant for your study Trial was ended at completion and 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 brie y explain why the item is not applicable/relevant for your study Table 1 provides baseline demographic and clinical characteristics for the full trial group.

15-i) Report demographics associated with digital divide issues
In ehealth trials it is particularly important to report demographics associated with digital divide issues, such as age, education, gender, social-economic status, computer/Internet/ehealth literacy of the participants, if known.

16) For each group, number of participants (denominator) included in each
analysis and whether the analysis was by original assigned groups subitem not at all important 1 2 3 4 5 essential 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 brie y explain why the item is not applicable/relevant for your study The manuscript provides information on number of older participants defined as > 55 years.

16-i) Report multiple "denominators" and provide definitions
Report multiple "denominators" and provide de nitions: 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 speci c pre-de ned time points of interest (in absolute and relative numbers per group). Always clearly de ne "use" of the intervention. subitem not at all important 1 2 3 4 5 essential 17a) For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% confidence interval) 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 brie y explain why the item is not applicable/relevant for your study "We performed analyses "at the margins" to assess the main effect of each intervention meaning that, for example, we determined the effect of personalized vs. standard notifications by comparing outcomes among all participants randomly allocated to personalized notifications (regardless of days and times of messaging) with those of all participants randomly allocated to standard notifications.
[21] We also evaluated three-way and two-way interactions between the 3 interventions (messaging content, day, and time) on transmission of BP and HR data."

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 brie y explain why the item is not applicable/relevant for your study The primary and secondary outcomes are presented in Tables 2 and 3 for intervention and non-intervention groups. 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 brie y explain why the item is not applicable/relevant for your study The primary and secondary outcomes for Blood pressure measurements and heart rates are presented in Tables 2 and 3 for intervention and non-intervention groups. Proportion transmitting data, odds ratio with 95% confidence intervals, and difference in proportions with 95% confidence intervals are reported.

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 de nitions 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 de ned (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 brie y explain why the item is not applicable/relevant for your study We are reporting device use defined as transmitting heart rate data (for smartwatch us) and blood pressure measurement (for digital blood pressure cuff use) for the intervention and non-intervention groups; and for intervention messaging sent in morning vs evening and weekday vs weekend.
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-specified from exploratory 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 brie y explain why the item is not applicable/relevant for your study As in 17a we are reporting proportion transmitting data in the intervention and nonintervention groups, odds ratio with 95% confidence intervals, and difference in proportions with 95% confidence intervals .
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 brie y explain why the item is not applicable/relevant for your study Exploratory analysis of smartphone survey completion: "For the analysis of 3-month survey completion, we defined complete, partial, and missing response as all, some, no survey questions answered. We performed this analysis in the subgroup of individuals who had not been enrolled in eFHS prior to the beginning of the messaging trial. We used chi-square tests to compare the proportion of complete, partial, and missing response between intervention groups "at the margins". "

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 18-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 brie y explain why the item is not applicable/relevant for your study We did not analyze intervention only group.
Does your paper address CONSORT subitem 19? * 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 brie y explain why the item is not applicable/relevant for your study No unintended effects or harms were observed. 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 brie y explain why the item is not applicable/relevant for your study We are unaware of any privacy breaches. "As part of eFHS, support staff helped participants complete their remote monitoring and data transmission. The support staff used standardized scripts to interact with participants over the phone. To limit the possibility of encouraging participants to use the device, we trained the support staff not to ask participants about the notification messaging content. "

19-ii) Include qualitative feedback from participants or observations from staff/researchers
Include qualitative feedback from participants or observations from staff/researchers, if available, on strengths and shortcomings of the application, especially if they point to unintended/unexpected effects or uses. This includes (if available) reasons for why people did or did not use the application as intended by the developers.

22) Interpretation consistent with results, balancing benefits and harms, and considering other relevant evidence
NPT: In addition, take into account the choice of the comparator, lack of or partial blinding, and unequal expertise of care providers or centers in each group subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 19-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 brie y explain why the item is not applicable/relevant for your study In the discussion we note the strengths of embedding this trial in the FHS. "We embedded this trial in eFHS providing several strengths. FHS participants have been enrolled in the parent study for over a decade (first exam 2002-2005), demonstrate loyalty to the parent study; developed trust in parent study investigators and staff that may have facilitated higher levels of retention and engagement than seen in other eCohorts" 22-i) Restate study questions and summarize the answers suggested by the data, starting with primary outcomes and process outcomes (use) Restate study questions and summarize the answers suggested by the data, starting with primary outcomes and process outcomes (use). 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 brie y explain why the item is not applicable/relevant for your study "We evaluated 3 smartphone app notification intervention strategies sent to eFHS participants, in a randomized trial aimed at improving the use of a smartwatch and a digital blood pressure cuff for remote monitoring of HR and BP. We observed evidence that personalized motivational notifications increased adherence over 3 months for BP data transmission and over 6 months for BP and HR transmission. Personalization included the participant's name and the message content was contextualized to the individual's device use each week of the trial. "

22-ii) Highlight unanswered new questions, suggest future research
Highlight unanswered new questions, suggest future research.

Does your paper address subitem 22-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 brie y explain why the item is not applicable/relevant for your study Our results need to be extended to participants of diverse backgrounds. "persons of diverse racial or ethnic backgrounds or regions or with different measures of social determinants of health or levels of digital literacy."

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 brie y explain why the item is not applicable/relevant for your study We have a section in the discussion on trial limitations. "We did not adjust for multiplicity related to co-primary BP and HR outcomes. We could have considered a multiplicity testing procedure such the Holm procedure to preserve the familywise error rate and calculated the required sample size for the simple disjunctive power.
[31] In retrospect, our conclusions would be similar. Participants were generally healthier than the full FHS cohorts and not recruited for any specific health condition. Personalized notifications may have resulted in greater observed differences in HR and BP transmission in persons with underlying hypertension and cardiovascular disease. Our sample participants were primarily White, well educated, and residing in New England. Thus our results may not be generalizable to persons of diverse racial or ethnic backgrounds or regions or with different measures of social determinants of health or levels of digital literacy. Our trial was conducted prior to the COVID-19 pandemic. Many clinical trials replaced in-person visits with remote data collection and personalized notifications may help reducing drop out in decentralized trials.
[32] Finally we could not confirm the notification messages were actually read by participants. "

21-i) Generalizability to other populations
Generalizability to other populations: In particular, discuss generalizability to a general Internet population, outside of a RCT setting, and general patient population, including applicability of the study results for other organizations Does your paper address subitem 21-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 brie y explain why the item is not applicable/relevant for your study "Our sample participants were primarily White, well educated, and residing in New England. Thus our results may not be generalizable to persons of diverse racial or ethnic backgrounds or regions or with different measures of social determinants of health or levels of digital literacy." 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 cointerventions) 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.

OTHER INFORMATION
23) Registration number and name of trial registry 24) Where the full trial protocol can be accessed, if available 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 brie y explain why the item is not applicable/relevant for your study "Our trial was conducted prior to the COVID-19 pandemic. Many clinical trials replaced inperson visits with remote data collection and personalized notifications may help reducing drop out in decentralized trials." 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 brie y explain why the item is not applicable/relevant for your study Clinical trial registration: NCT03516019 subitem not at all important 1 2 3 4 5 essential 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 brie y explain why the item is not applicable/relevant for your study Trial is registered at clinical trial.gov. Data is available upon request from study investigators.
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 brie y explain why the item is not applicable/relevant for your study "This study was supported by an award from the Robert Wood Johnson Foundation (number 74624) and a grant from the National Heart Lung and Blood Institute (R01HL141434); Framingham Heart Study is supported by contract from NHLBI (PI VSR 75N92019D00031)"

X27-i) State the relation of the study team towards the system being evaluated
In addition to the usual declaration of interests ( nancial 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. How much time did you spend on going through the checklist INCLUDING making changes in your manuscript * This form was very long and took hours to complete even copying and pasting from the manuscript document As a result of using this checklist, do you think your manuscript has improved? *

Would you like to become involved in the CONSORT EHEALTH group?
This would involve for example becoming involved in participating in a workshop and writing an "Explanation and Elaboration" document C l e a r s e l e c t i o n

Any other comments or questions on CONSORT EHEALTH
Your answer