eFHS Messaging Trial

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

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases
• Intervention / Treatment: Other: personalized notices; Other: am notices; Other: weekday notices; Other: pm notices; Other: weekend notices; Other: standard notices

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 Type: Interventional
• Enrollment (Actual): 650
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Framingham Heart Study

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Weekday am personalized notices; Participants in this arm receive personalized weekday am notices on Wednesday at 7am.	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: am notices; notifications sent at 7 am.; Other: weekday notices; notifications sent on Wednesday
Experimental: Weekday pm personalized notices; Participants in this arm receive a personalized weekday pm notices on Wednesday at 7pm.	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: weekday notices; notifications sent on Wednesday; Other: pm notices; notifications sent at 7 pm.
Experimental: Weekend am personalized notices; Participants in this arm receive a personalized weekend am notices on Saturday at 7am.	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: am notices; notifications sent at 7 am.; Other: weekend notices; notifications sent on Saturday
Experimental: Weekend pm personalized notices; Participants in this arm receive personalized pm notices on Saturday at 7pm.	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: pm notices; notifications sent at 7 pm.; Other: weekend notices; notifications sent on Saturday
Experimental: Weekday am standard notices; Participants in this arm receive standard weekday notices on Wednesday at 7am.	Other: am notices; notifications sent at 7 am.; Other: weekday notices; notifications sent on Wednesday; Other: standard notices; The standard notices which are neutral and invite participants to wear the watch daily and to measure their blood pressure weekly.
Experimental: Weekday pm standard notices; Participants in this arm receive standard weekday notices on Wednesday at 7pm	Other: weekday notices; notifications sent on Wednesday; Other: pm notices; notifications sent at 7 pm.; Other: standard notices; The standard notices which are neutral and invite participants to wear the watch daily and to measure their blood pressure weekly.
Experimental: Weekend am standard notices; Participants in this arm receive standard weekend notices on Saturday at 7am	Other: am notices; notifications sent at 7 am.; Other: weekend notices; notifications sent on Saturday; Other: standard notices; The standard notices which are neutral and invite participants to wear the watch daily and to measure their blood pressure weekly.
Experimental: Weekend pm standard notices; Participants in this arm receive standard weekend notices on Saturday at 7pm	Other: pm notices; notifications sent at 7 pm.; Other: weekend notices; notifications sent on Saturday; Other: standard notices; The standard notices which are neutral and invite participants to wear the watch daily and to measure their blood pressure weekly.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence to survey response	proportion of participants who complete the eFHS survey at 3 months	3 months
Adherence at 6 months to the weekly BP recording	Comparison between the groups receiving personalized notices to the groups receiving standard notices	6 months
Adherence at 6 months to the weekly HR recording	Comparison between the groups receiving personalized notices to the groups receiving standard notices	6 months
Adherence at 6 months to survey response	Comparison between the groups receiving personalized notices to the groups receiving standard notices	6 months

Collaborators and Investigators

• Sponsor: Boston University
• Collaborators: Robert Wood Johnson Foundation
• Investigators: Principal Investigator: Joanne Murabito, MD ScM, Framingham Heart Study

Study record dates

Study Major Dates

• Study Start (Actual): May 19, 2018
• Primary Completion (Actual): March 23, 2019
• Study Completion (Actual): March 23, 2019

Study Registration Dates

• First Submitted: April 24, 2018
• First Submitted That Met QC Criteria: May 3, 2018
• First Posted (Actual): May 4, 2018

Study Record Updates

• Last Update Posted (Actual): February 11, 2021
• Last Update Submitted That Met QC Criteria: February 9, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: mHealth; smart watch; patient provider communication; user engagement; digital BP monitoring; population health data
• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: H-36586; 74624 (Other Grant/Funding Number: Robert Wood Johnson Foundation)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No