eFHS Messaging Trial

Study Overview
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Brief Summary
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In this research the investigators will develop and test an innovative scalable mobile health and digital cardiovascular monitoring system within a longitudinal deeply characterized cohort with three components: 1) smartphone application (app) designed to promote adherence, integrate digital and mHealth information, and facilitate communication with participants and researchers; 2) smartwatch activity monitoring using the Apple iWatch; and 3) home blood pressure (BP) monitoring using the Withings blood pressure device. The objective of the messaging trial is to test the effect of messaging strategies on improving participants' long-term use of and engagement with our selected mobile health technologies and on increasing response rate of survey data collection.

Detailed Description
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The research design includes a cohort eFHS Study and an embedded randomized factorial trial on a subset of the cohort. For the primary e-cohort, the investigators will build a custom mobile app for use within the Framingham Heart Study (FHS) to digitally collect data, compare it against research clinic-collected data, quantify risk factor burden, and perform CVD risk prediction. The app development will focus on 1) CVD risk factor data that would benefit from more frequent ascertainment than the every four to eight year FHS examination cycles; 2) circumstances where in vivo assessment may be superior to clinic-based assessment; 3) key endpoints of the FHS that are considered FHS landmarks. In addition to the eFHS App, participants will be offered wireless devices (Withings BP) to measure blood pressure and an Apple Watch to measure heart rate and steps per day. For the messaging trial, the investigators will conduct a randomized factorial trial phase to test the effect of messaging strategies. Participants will be sent a weekly notification through the eFHS app. Participants will be randomly allocated to one of 8 groups defined according to the following: using personalized reminder messaging vs. standard neutral messaging; notification sent on a weekday vs. weekend; notification sent in the morning vs. the evening. The three main comparisons will be simultaneously evaluated according to a 2x2x2 factorial design.

Official Title
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Messaging Intervention Trial in the Electronic Framingham Heart Study (eFHS)

Conditions
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Cardiovascular Diseases

Intervention / Treatment
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* Other: personalized notices
* Other: standard notices
* Other: am notices
* Other: pm notices
* Other: weekday notices
* Other: weekend notices


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria for the eFHS study: Participants of the FHS Third Generation, Omni Group 2, and New Offspring Spouse Cohorts attending the in-person examination 3 with access to a smartphone or home internet access and English speaking/reading. Specifically for the RCT substudy (re: engagement with select mobile health technologies): English-speaking individual Owns an iPhone with compatible iOS (version 9 or higher); Residence in the United States Provision of permissions for notifications and data sharing with the Research Center Provision of signed and dated informed consent Exclusion Criteria: Participants who do not meet the inclusion criteria

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: The research design includes a cohort eFHS Study and an embedded randomized factorial trial on a subset of the cohort.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Weekday am personalized notices<br>Participants in this arm receive personalized weekday am notices on Wednesday at 7am. | Other: personalized notices<br>* The personalized notices take into account if data were received over the previous week, and accordingly encourages the participant to use the device and send her data, or encourages the participant to continue using the device and sending data. A library of personalized notices with alternative motivational content was developed. Each time a notification is sent, it will be drawn at random from the library.<br>Other: am notices<br>* notifications sent at 7 am.<br>Other: weekday notices<br>* notifications sent on Wednesday<br>|
| Experimental: Weekday pm personalized notices<br>Participants in this arm receive a personalized weekday pm notices on Wednesday at 7pm. | Other: personalized notices<br>* The personalized notices take into account if data were received over the previous week, and accordingly encourages the participant to use the device and send her data, or encourages the participant to continue using the device and sending data. A library of personalized notices with alternative motivational content was developed. Each time a notification is sent, it will be drawn at random from the library.<br>Other: pm notices<br>* notifications sent at 7 pm.<br>Other: weekday notices<br>* notifications sent on Wednesday<br>|
| Experimental: Weekend am personalized notices<br>Participants in this arm receive a personalized weekend am notices on Saturday at 7am. | Other: personalized notices<br>* The personalized notices take into account if data were received over the previous week, and accordingly encourages the participant to use the device and send her data, or encourages the participant to continue using the device and sending data. A library of personalized notices with alternative motivational content was developed. Each time a notification is sent, it will be drawn at random from the library.<br>Other: am notices<br>* notifications sent at 7 am.<br>Other: weekend notices<br>* notifications sent on Saturday<br>|
| Experimental: Weekend pm personalized notices<br>Participants in this arm receive personalized pm notices on Saturday at 7pm. | Other: personalized notices<br>* The personalized notices take into account if data were received over the previous week, and accordingly encourages the participant to use the device and send her data, or encourages the participant to continue using the device and sending data. A library of personalized notices with alternative motivational content was developed. Each time a notification is sent, it will be drawn at random from the library.<br>Other: pm notices<br>* notifications sent at 7 pm.<br>Other: weekend notices<br>* notifications sent on Saturday<br>|
| Experimental: Weekday am standard notices<br>Participants in this arm receive standard weekday notices on Wednesday at 7am. | Other: standard notices<br>* The standard notices which are neutral and invite participants to wear the watch daily and to measure their blood pressure weekly.<br>Other: am notices<br>* notifications sent at 7 am.<br>Other: weekday notices<br>* notifications sent on Wednesday<br>|
| Experimental: Weekday pm standard notices<br>Participants in this arm receive standard weekday notices on Wednesday at 7pm | Other: standard notices<br>* The standard notices which are neutral and invite participants to wear the watch daily and to measure their blood pressure weekly.<br>Other: pm notices<br>* notifications sent at 7 pm.<br>Other: weekday notices<br>* notifications sent on Wednesday<br>|
| Experimental: Weekend am standard notices<br>Participants in this arm receive standard weekend notices on Saturday at 7am | Other: standard notices<br>* The standard notices which are neutral and invite participants to wear the watch daily and to measure their blood pressure weekly.<br>Other: am notices<br>* notifications sent at 7 am.<br>Other: weekend notices<br>* notifications sent on Saturday<br>|
| Experimental: Weekend pm standard notices<br>Participants in this arm receive standard weekend notices on Saturday at 7pm | Other: standard notices<br>* The standard notices which are neutral and invite participants to wear the watch daily and to measure their blood pressure weekly.<br>Other: pm notices<br>* notifications sent at 7 pm.<br>Other: weekend notices<br>* notifications sent on Saturday<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence at 3 months to the weekly BP recording | proportion of participants who submit their weekly blood pressure measurement at 3 months | 3 months | 
| Adherence at 3 months to the weekly HR recording | proportion of participants who submit their weekly heart rate measurement at 3 months | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence at one month to the weekly BP recording | proportion of participants who submit their weekly blood pressure measurement at 1 month | 1 month | 
| Adherence at one month to the weekly HR recording | proportion of participants who submit their weekly heart rate measurement at 1 month | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mHealth, digital BP monitoring, patient provider communication, smart watch, user engagement, population health data