Second eFramngham Heart Study (eFHS-2)

eFramingham Heart Study Randomized Controlled Trial #2

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).

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases
• Intervention / Treatment: Other: Delayed administration of survey modules; Other: Regular administration of survey modules

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.

• Study Type: Interventional
• Enrollment (Actual): 492
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Joanne M Murabito, MD ScM; Phone Number: 508-935-3461; Email: murabito@bu.edu

Study Locations

• United States
  • Massachusetts
    • Framingham, Massachusetts, United States, 01702
      • Framingham Heart Study

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: 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
Active Comparator: 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.	Other: Regular administration of survey modules; The physical function, physical activity, and events survey modules are administered according to the regular pattern

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of questions/task completed per participant in period 1	Proportion of questions/task completed per participant from all survey modules administered from baseline to week 8, will be documented on the eFHS app.	baseline, up to week 8
Proportion of questions/task completed per participant in period 2	Proportion of questions/task completed per participant from week 8 to week 16, will be documented on the eFHS app.	week 8, up to week 16
Proportion of questions/task completed per participant in period 3	Proportion of questions/task completed per participant from week 16 to week 24, will be documented on the eFHS app.	week 16, up to week 24
Proportion of questions/task completed per participant in period 4	Proportion of questions/task completed per participant from week 24 to study completion, will be documented on the eFHS app.	week 24, to completion of study usually 26 weeks

Collaborators and Investigators

• Sponsor: Boston University
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Joanne Murabito, Framingham Heart Study

Study record dates

Study Major Dates

• Study Start (Actual): June 21, 2021
• Primary Completion (Actual): December 28, 2023
• Study Completion (Actual): December 28, 2023

Study Registration Dates

• First Submitted: February 9, 2021
• First Submitted That Met QC Criteria: February 9, 2021
• First Posted (Actual): February 12, 2021

Study Record Updates

• Last Update Posted (Actual): January 30, 2024
• Last Update Submitted That Met QC Criteria: January 29, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: mhealth; Framingham Heart Sudy; eFHS; patient provider communication; user engagement
• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: H-40737; 5R01HL141434-03 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No