eFHS Messaging Trial

Sponsor

Boston University (Other)

Overall Status

Completed

CT.gov ID

NCT03516019

Collaborator

Robert Wood Johnson Foundation (Other)

650

Enrollment

Location

Arms

10.1

Actual Duration (Months)

64.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Diseases	Other: personalized notices Other: standard notices Other: am notices Other: pm notices Other: weekday notices Other: weekend notices	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

650 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Intervention Model Description:

The research design includes a cohort eFHS Study and an embedded randomized factorial trial on a subset of the cohort.The research design includes a cohort eFHS Study and an embedded randomized factorial trial on a subset of the cohort.

Masking:

Single (Investigator)

Masking Description:

eFHS researchers, statistician, research assistant, and clinic staff are masked to intervention assignment.

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

May 19, 2018

Actual Primary Completion Date :

Mar 23, 2019

Actual Study Completion Date :

Mar 23, 2019

Arms and Interventions

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: pm notices notifications sent at 7 pm. Other: weekday notices notifications sent on Wednesday
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: 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: weekday notices notifications sent on Wednesday
Experimental: Weekday pm standard notices Participants in this arm receive standard weekday notices on Wednesday at 7pm	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: pm notices notifications sent at 7 pm. Other: weekday notices notifications sent on Wednesday
Experimental: Weekend am standard notices Participants in this arm receive standard weekend notices on Saturday at 7am	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: weekend notices notifications sent on Saturday
Experimental: Weekend pm standard notices Participants in this arm receive standard weekend notices on Saturday at 7pm	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: pm notices notifications sent at 7 pm. Other: weekend notices notifications sent on Saturday

Outcome Measures

Primary Outcome Measures

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

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

Other Outcome Measures

Adherence to survey response [3 months]
proportion of participants who complete the eFHS survey at 3 months
Adherence at 6 months to the weekly BP recording [6 months]
Comparison between the groups receiving personalized notices to the groups receiving standard notices
Adherence at 6 months to the weekly HR recording [6 months]
Comparison between the groups receiving personalized notices to the groups receiving standard notices
Adherence at 6 months to survey response [6 months]
Comparison between the groups receiving personalized notices to the groups receiving standard notices

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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