eFHS Messaging Trial
Messaging Intervention Trial in the Electronic Framingham Heart Study (eFHS)
2 other identifiers
interventional
650
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable cardiovascular-diseases
Started May 2018
Shorter than P25 for not_applicable cardiovascular-diseases
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 24, 2018
CompletedFirst Posted
Study publicly available on registry
May 4, 2018
CompletedStudy Start
First participant enrolled
May 19, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 23, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 23, 2019
CompletedFebruary 11, 2021
February 1, 2021
10 months
April 24, 2018
February 9, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (2)
Adherence at one month to the weekly BP recording
1 month
Adherence at one month to the weekly HR recording
1 month
Other Outcomes (4)
Adherence to survey response
3 months
Adherence at 6 months to the weekly BP recording
6 months
Adherence at 6 months to the weekly HR recording
6 months
- +1 more other outcomes
Study Arms (8)
Weekday am personalized notices
EXPERIMENTALParticipants in this arm receive personalized weekday am notices on Wednesday at 7am.
Weekday pm personalized notices
EXPERIMENTALParticipants in this arm receive a personalized weekday pm notices on Wednesday at 7pm.
Weekend am personalized notices
EXPERIMENTALParticipants in this arm receive a personalized weekend am notices on Saturday at 7am.
Weekend pm personalized notices
EXPERIMENTALParticipants in this arm receive personalized pm notices on Saturday at 7pm.
Weekday am standard notices
EXPERIMENTALParticipants in this arm receive standard weekday notices on Wednesday at 7am.
Weekday pm standard notices
EXPERIMENTALParticipants in this arm receive standard weekday notices on Wednesday at 7pm
Weekend am standard notices
EXPERIMENTALParticipants in this arm receive standard weekend notices on Saturday at 7am
Weekend pm standard notices
EXPERIMENTALParticipants in this arm receive standard weekend notices on Saturday at 7pm
Interventions
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.
The standard notices which are neutral and invite participants to wear the watch daily and to measure their blood pressure weekly.
notifications sent at 7 am.
notifications sent at 7 pm.
notifications sent on Wednesday
notifications sent on Saturday
Eligibility Criteria
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Boston Universitylead
- Robert Wood Johnson Foundationcollaborator
Study Sites (1)
Framingham Heart Study
Boston, Massachusetts, 02118, United States
Related Publications (1)
Trinquart L, Liu C, McManus DD, Nowak C, Lin H, Spartano NL, Borrelli B, Benjamin EJ, Murabito JM. Increasing Engagement in the Electronic Framingham Heart Study: Factorial Randomized Controlled Trial. J Med Internet Res. 2023 Jan 20;25:e40784. doi: 10.2196/40784.
PMID: 36662544DERIVED
MeSH Terms
Conditions
Study Officials
- PRINCIPAL INVESTIGATOR
Joanne Murabito, MD ScM
Framingham Heart Study
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Masking Details
- eFHS researchers, statistician, research assistant, and clinic staff are masked to intervention assignment.
- Purpose
- PREVENTION
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 24, 2018
First Posted
May 4, 2018
Study Start
May 19, 2018
Primary Completion
March 23, 2019
Study Completion
March 23, 2019
Last Updated
February 11, 2021
Record last verified: 2021-02
Data Sharing
- IPD Sharing
- Will not share