Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
650 participants
INTERVENTIONAL
2018-05-19
2019-03-23
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Second eFramngham Heart Study
NCT04752657
Mobile Application for Patient Engagement and Physician-Directed Remote Management of Heart Failure
NCT06750549
Heart Failure Self-care With the Aid of a Smartphone Application
NCT03194841
iCardia4HF: Multi-component mHealth Intervention for Patients With Heart Failure
NCT06205225
Proof-of-Concept Study of Heart Habits Application for Patients With Heart Failure
NCT03238729
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
FACTORIAL
PREVENTION
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Weekday am personalized notices
Participants in this arm receive personalized weekday am notices on Wednesday at 7am.
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.
am notices
notifications sent at 7 am.
weekday notices
notifications sent on Wednesday
Weekday pm personalized notices
Participants in this arm receive a personalized weekday pm notices on Wednesday at 7pm.
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.
pm notices
notifications sent at 7 pm.
weekday notices
notifications sent on Wednesday
Weekend am personalized notices
Participants in this arm receive a personalized weekend am notices on Saturday at 7am.
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.
am notices
notifications sent at 7 am.
weekend notices
notifications sent on Saturday
Weekend pm personalized notices
Participants in this arm receive personalized pm notices on Saturday at 7pm.
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.
pm notices
notifications sent at 7 pm.
weekend notices
notifications sent on Saturday
Weekday am standard notices
Participants in this arm receive standard weekday notices on Wednesday at 7am.
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.
weekday notices
notifications sent on Wednesday
Weekday pm standard notices
Participants in this arm receive standard weekday notices on Wednesday at 7pm
standard notices
The standard notices which are neutral and invite participants to wear the watch daily and to measure their blood pressure weekly.
pm notices
notifications sent at 7 pm.
weekday notices
notifications sent on Wednesday
Weekend am standard notices
Participants in this arm receive standard weekend notices on Saturday at 7am
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.
weekend notices
notifications sent on Saturday
Weekend pm standard notices
Participants in this arm receive standard weekend notices on Saturday at 7pm
standard notices
The standard notices which are neutral and invite participants to wear the watch daily and to measure their blood pressure weekly.
pm notices
notifications sent at 7 pm.
weekend notices
notifications sent on Saturday
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Robert Wood Johnson Foundation
OTHER
Boston University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Joanne Murabito, MD ScM
Role: PRINCIPAL_INVESTIGATOR
Framingham Heart Study
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Framingham Heart Study
Boston, Massachusetts, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
74624
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
H-36586
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.