Second eFramngham Heart Study

NCT04752657 | Completed Results

• 2 other identifiers: H-407375R01HL141434-03
• Study Type: interventional
• Target: 492
• Locations: 1 country
• Sites: 1

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).

Conditions

Cardiovascular Diseases

Keywords

Framingham Heart Sudy; eFHS; mhealth; patient provider communication; user engagement

Outcome Measures

Primary Outcomes (4)

• Proportion of Surveys/Tasks Returned in Period 1

  Proportion of surveys/task returned per participant (partially or fully completed) from baseline, up to week 8, will be documented on the eFHS app.

  baseline, up to week 8

• Proportion of Surveys/Tasks Returned in Period 2

  Proportion of surveys/task returned per participant (partially or fully completed) from week 8, up to week 16, will be documented on the eFHS app.

  week 8, up to week 16

• Proportion of Surveys/Tasks Returned in Period 3

  Proportion of surveys/task returned per participant (partially or fully completed) week 16, up to week 24, will be documented on the eFHS app.

  week 16, up to week 24

• Proportion of Surveys/Tasks Returned in Period 4

  Proportion of surveys/task returned per participant (partially or fully completed) week 24, to completion of study usually 26 weeks, will be documented on the eFHS app.

  week 24, to completion of study usually 26 weeks

Secondary Outcomes (4)

• Proportion of Questions/Task Completed Per Participant in Period 1

  baseline, up to week 8

• Proportion of Questions/Task Completed Per Participant in Period 2

  week 8, up to week 16

• Proportion of Questions/Task Completed Per Participant in Period 3

  week 16, up to week 24

• Proportion of Questions/Task Completed Per Participant in Period 4

  week 24, to completion of study usually 26 weeks

Study Arms (2)

Experimental Group

EXPERIMENTAL

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.

Other: Delayed administration of survey modules

Control Group

ACTIVE COMPARATOR

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.

Other: Regular administration of survey modules

Interventions

Delayed administration of survey modules OTHER

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

Experimental Group

Regular administration of survey modules OTHER

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

Control Group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Limited and non-readers

Sponsors & Collaborators

• Boston University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Framingham Heart Study

Framingham, Massachusetts, 01702, United States

Location

Related Publications (1)

• 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.

  PMID: 41071587 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Results Point of Contact

• Title: Joanne M Murabito, MD ScM
• Organization: Framingham Heart Study, Boston University

murabito@bu.edu

508-935-3461

Study Officials

• Joanne Murabito

  Framingham Heart Study

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Each participant will be randomized to one of the 2 groups. A statistician will generate randomization lists with the use of randomly permuted blocks of varying sizes, with stratification according to participant's age (≤75 years vs. \>75 years) and type of phone (android vs. iphone). Randomization will be implemented centrally through the app.

Study Record Dates

• First Submitted: February 9, 2021
• First Posted: February 12, 2021
• Study Start: June 21, 2021
• Primary Completion: December 28, 2023
• Study Completion: December 28, 2023
• Last Updated: March 19, 2025
• Results First Posted: March 19, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Investigators can research out to the research team from time of publication.
• Access Criteria: The data will be accessible from the research team via FHS guidelines at https://www.framinghamheartstudy.org/fhs-for-researchers/data-available-overview/

Locations

US (1)