NCT03516019

eFHS Messaging Trial

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 650 (actual)
• Sponsor: Boston University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cardiovascular Diseases

Interventions

Type	Name	Description
OTHER	personalized notices	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.
OTHER	standard notices	The standard notices which are neutral and invite participants to wear the watch daily and to measure their blood pressure weekly.
OTHER	am notices	notifications sent at 7 am.
OTHER	pm notices	notifications sent at 7 pm.
OTHER	weekday notices	notifications sent on Wednesday
OTHER	weekend notices	notifications sent on Saturday

Timeline

• Start date: 2018-05-19
• Primary completion: 2019-03-23
• Completion: 2019-03-23
• First posted: 2018-05-04
• Last updated: 2021-02-11

Locations

1 site across 1 country: United States