eFHS Messaging Trial

Cardiovascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03516019
• Other study ID #: H-36586
• Secondary ID: 74624
• Status: Completed
• Phase: N/A
• Start date: May 19, 2018
• Est. completion date: March 23, 2019

Study information

• Verified date: February 2021
• Source: Boston University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 650
• Est. completion date: March 23, 2019
• Est. primary completion date: March 23, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

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

Locations

Country	Name	City	State
United States	Framingham Heart Study	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Boston University	Robert Wood Johnson Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adherence to survey response	proportion of participants who complete the eFHS survey at 3 months	3 months
Other	Adherence at 6 months to the weekly BP recording	Comparison between the groups receiving personalized notices to the groups receiving standard notices	6 months
Other	Adherence at 6 months to the weekly HR recording	Comparison between the groups receiving personalized notices to the groups receiving standard notices	6 months
Other	Adherence at 6 months to survey response	Comparison between the groups receiving personalized notices to the groups receiving standard notices	6 months
Primary	Adherence at 3 months to the weekly BP recording	proportion of participants who submit their weekly blood pressure measurement at 3 months	3 months
Primary	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	Adherence at one month to the weekly BP recording	proportion of participants who submit their weekly blood pressure measurement at 1 month	1 month
Secondary	Adherence at one month to the weekly HR recording	proportion of participants who submit their weekly heart rate measurement at 1 month	1 month