Second eFramngham Heart Study

NCT ID: NCT04752657

Last Updated: 2025-03-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 492 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-21
• Study Completion Date: 2023-12-28

Brief Summary

In the electronic Framingham Heart Study (eFHS), the investigators developed and deployed a mobile app to collect cardiovascular risk factors and event data and test them against cardiovascular data collected in the Framingham research clinic for the FHS.

Participants enrolled in eFHS receive a series of digital surveys modules to complete on a regularly occurring schedule. The objective of the planned randomized trial is to test the effect of administering half of survey modules every 2 weeks versus all survey modules every 4 weeks on improving participants' response rates.

There will be 4 survey periods. Period 1 encompasses all survey modules administered from baseline up to week 8 (19 surveys/tasks per participant); period 2 from week 8 up to week 16 (18 surveys/tasks per participant); period 3 from week 16 up to week 24; period 4 from week 24 (16 surveys/tasks per participant).

Detailed Description

Participants in eFHS are invited to enroll from the FHS Offspring and Omni Group 1 Cohorts during the in-person examination 10/5 at the FHS Research Center in Framingham, Massachusetts (MA), USA or remotely from home after the in-person examination. All eFHS participants have the eFHS myDataHelps mobile app (developed by FHS investigators with CareEvolution our industry partner) installed on their smartphone. The eFHS app allows communication with participants through notifications and data collection. Participants are asked to answer health surveys administered through the app.

Survey assessments will include 6 modules: cognition, pain, mood, physical function and performance, physical activity, and events. The interventions are defined by the patterns of administration of survey modules to the experimental and control groups. The administration of the cognition, pain, mood, and psychosocial modules follow the same pattern for both groups. However, the administration of the physical function, physical activity, and events modules is delayed by 2 weeks in the experimental group as compared to the control group.

Conditions

Cardiovascular Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Experimental Group

The experimental group will receive the physical function survey at weeks 2, 10, 18, and 26; the physical activity survey at weeks 2, 14, and 26; the events survey at weeks 2, 6, 10, 14, 18, 22, and 26. The administration of the cognition, pain, mood, and psychosocial surveys follow the same pattern for both groups.

Group Type: EXPERIMENTAL

Delayed administration of survey modules

Intervention Type: OTHER

The intervention consists in delaying the administration of the physical function, physical activity, and events survey modules by 2 weeks

Control Group

The control group will receive the physical function survey at weeks 0, 8, 16, and 24; the physical activity survey at weeks 0, 12, and 24; the events survey at weeks 0, 4, 8, 12, 16, 20, and 24. The administration of the cognition, pain, mood, and psychosocial surveys follow the same pattern for both groups.

Group Type: ACTIVE_COMPARATOR

Regular administration of survey modules

Intervention Type: OTHER

The physical function, physical activity, and events survey modules are administered according to the regular pattern

Interventions

Delayed administration of survey modules

The intervention consists in delaying the administration of the physical function, physical activity, and events survey modules by 2 weeks

Intervention Type: OTHER

Regular administration of survey modules

The physical function, physical activity, and events survey modules are administered according to the regular pattern

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Invited to enroll from the FHS Offspring and Omni Group 1 Cohorts during the in-person examination 10/5 at the FHS Research Center
• English speaking
• English language reading proficiency
• Owns an iPhone with compatible iOS (version 10.0 or higher) or Android (version 5.0 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 (within the eFHS mobile app)

Exclusion Criteria

• Limited and non-readers

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Boston University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joanne Murabito

Role: PRINCIPAL_INVESTIGATOR

Framingham Heart Study

Locations

Framingham Heart Study

Framingham, Massachusetts, United States

Countries

United States

References

Zhang Y, Rong J, Wang X, Schramm E, Pathiravasan CH, Borrelli B, Faro JM, Benjamin EJ, Trinquart L, Liu C, Murabito JM. Smartphone App-Based Survey Deployment Patterns and Longitudinal Response Rate: Randomized Controlled Trial. J Med Internet Res. 2025 Oct 10;27:e73972. doi: 10.2196/73972.

Reference Type: DERIVED

PMID: 41071587 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

5R01HL141434-03

Identifier Type: NIH

Identifier Source: secondary_id

View Link

H-40737

Identifier Type: -

Identifier Source: org_study_id