eFHS Messaging Trial

Not Applicable

Completed

• Conditions: Cardiovascular Diseases

• 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.

Study Timeline

• Study First Submitted: 2018-04-24
• Study First Submitted QC: 2018-05-03
• Study First Posted: 2018-05-04
• Study Start: 2018-05-19
• Primary Completion: 2019-03-23
• Study Completion: 2019-03-23
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-09
• Last Update Posted: 2021-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 650

Inclusion Criteria

Not provided

Exclusion Criteria

• Participants who do not meet the inclusion criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

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