eFHS Messaging Trial
- Conditions
- Cardiovascular Diseases
- Interventions
- Other: standard noticesOther: personalized noticesOther: am noticesOther: pm noticesOther: weekend noticesOther: weekday notices
- Registration Number
- NCT03516019
- Lead Sponsor
- Boston University
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 650
Not provided
- Participants who do not meet the inclusion criteria
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Weekend am standard notices am notices Participants in this arm receive standard weekend notices on Saturday at 7am Weekend am personalized notices am notices Participants in this arm receive a personalized weekend am notices on Saturday at 7am. Weekend am standard notices weekend notices Participants in this arm receive standard weekend notices on Saturday at 7am Weekend pm personalized notices pm notices Participants in this arm receive personalized pm notices on Saturday at 7pm. Weekend pm personalized notices weekend notices Participants in this arm receive personalized pm notices on Saturday at 7pm. Weekday am standard notices weekday notices Participants in this arm receive standard weekday notices on Wednesday at 7am. Weekday pm standard notices standard notices Participants in this arm receive standard weekday notices on Wednesday at 7pm Weekday pm standard notices pm notices Participants in this arm receive standard weekday notices on Wednesday at 7pm Weekday pm personalized notices weekday notices Participants in this arm receive a personalized weekday pm notices on Wednesday at 7pm. Weekend am standard notices standard notices Participants in this arm receive standard weekend notices on Saturday at 7am Weekday am personalized notices personalized notices Participants in this arm receive personalized weekday am notices on Wednesday at 7am. Weekday am personalized notices am notices Participants in this arm receive personalized weekday am notices on Wednesday at 7am. Weekday pm personalized notices pm notices Participants in this arm receive a personalized weekday pm notices on Wednesday at 7pm. Weekend am personalized notices personalized notices Participants in this arm receive a personalized weekend am notices on Saturday at 7am. Weekend am personalized notices weekend notices Participants in this arm receive a personalized weekend am notices on Saturday at 7am. Weekday am personalized notices weekday notices Participants in this arm receive personalized weekday am notices on Wednesday at 7am. Weekday am standard notices standard notices Participants in this arm receive standard weekday notices on Wednesday at 7am. Weekday pm standard notices weekday notices Participants in this arm receive standard weekday notices on Wednesday at 7pm Weekday pm personalized notices personalized notices Participants in this arm receive a personalized weekday pm notices on Wednesday at 7pm. Weekend pm personalized notices personalized notices Participants in this arm receive personalized pm notices on Saturday at 7pm. Weekday am standard notices am notices Participants in this arm receive standard weekday notices on Wednesday at 7am. Weekend pm standard notices standard notices Participants in this arm receive standard weekend notices on Saturday at 7pm Weekend pm standard notices weekend notices Participants in this arm receive standard weekend notices on Saturday at 7pm Weekend pm standard notices pm notices Participants in this arm receive standard weekend notices on Saturday at 7pm
- Primary Outcome Measures
Name Time Method Adherence at 3 months to the weekly BP recording 3 months proportion of participants who submit their weekly blood pressure measurement at 3 months
Adherence at 3 months to the weekly HR recording 3 months proportion of participants who submit their weekly heart rate measurement at 3 months
- Secondary Outcome Measures
Name Time Method Adherence at one month to the weekly BP recording 1 month proportion of participants who submit their weekly blood pressure measurement at 1 month
Adherence at one month to the weekly HR recording 1 month proportion of participants who submit their weekly heart rate measurement at 1 month
Trial Locations
- Locations (1)
Framingham Heart Study
🇺🇸Boston, Massachusetts, United States