NCT04752657: eFHS-2

Second eFramngham Heart Study

Completed NA Results posted Last updated 19 March 2025

What this trial tests

NA trial testing Delayed administration of survey modules in Cardiovascular Diseases in 492 participants. Completed in 28 December 2023.

Timeline

21 June 2021

Primary endpoint
28 December 2023

28 December 2023

Quick facts

Lead sponsor	Boston University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	prevention
Enrollment	492
Start date	21 June 2021
Primary completion	28 December 2023
Estimated completion	28 December 2023
Sites	1 location across United States

Drugs / interventions tested

• Delayed administration of survey modules
• Regular administration of survey modules

Conditions studied

• Cardiovascular Diseases — all drugs for Cardiovascular Diseases →

Sponsor

Boston University

Who can join

50 and older, any sex, with Cardiovascular Diseases. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Proportion of Surveys/Tasks Returned in Period 1 Primary · baseline, up to week 8

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

Group	Value	95% CI
Experimental- Two-week Group	0.85	± 0.28
Control- Four-week Group	0.85	± 0.29

Proportion of Surveys/Tasks Returned in Period 2 Primary · week 8, up to week 16

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.

Group	Value	95% CI
Experimental- Two-week Group	0.75	± 0.40
Control- Four-week Group	0.72	± 0.42

Proportion of Surveys/Tasks Returned in Period 3 Primary · week 16, up to week 24

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

Group	Value	95% CI
Experimental- Two-week Group	0.71	± 0.43
Control- Four-week Group	0.67	± 0.45

Proportion of Surveys/Tasks Returned in Period 4 Primary · week 24, to completion of study usually 26 weeks

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.

Group	Value	95% CI
Experimental- Two-week Group	0.66	± 0.44
Control- Four-week Group	0.59	± 0.47

Proportion of Questions/Task Completed Per Participant in Period 1 Secondary · baseline, up to week 8

Proportion of questions/task completed per participant from all survey modules administered from baseline to week 8, will be documented on the eFHS app.

Group	Value	95% CI
Experimental- Two-week Group	0.86	± 0.28
Control- Four-week Group	0.88	± 0.29

Proportion of Questions/Task Completed Per Participant in Period 2 Secondary · week 8, up to week 16

Proportion of questions/task completed per participant from week 8 to week 16, will be documented on the eFHS app.

Group	Value	95% CI
Experimental- Two-week Group	0.77	± 0.40
Control- Four-week Group	0.74	± 0.42

Proportion of Questions/Task Completed Per Participant in Period 3 Secondary · week 16, up to week 24

Proportion of questions/task completed per participant from week 16 to week 24, will be documented on the eFHS app.

Group	Value	95% CI
Experimental- Two-week Group	0.73	± 0.43
Control- Four-week Group	0.70	± 0.45

Proportion of Questions/Task Completed Per Participant in Period 4 Secondary · week 24, to completion of study usually 26 weeks

Proportion of questions/task completed per participant from week 24 to study completion, will be documented on the eFHS app.

Group	Value	95% CI
Experimental- Two-week Group	0.68	± 0.44
Control- Four-week Group	0.61	± 0.47

Sponsor's own description

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).

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. Baseline Smartphone App Survey Return in the Electronic Framingham Heart Study Offspring and Omni 1 Study: eCohort Study.
   Rong J, Pathiravasan CH, Zhang Y, Faro JM, et al · · 2024 · cited 2× · PMID 39740111 · DOI 10.2196/64636
2. Smartphone App-Based Survey Deployment Patterns and Longitudinal Response Rate: Randomized Controlled Trial.
   Zhang Y, Rong J, Wang X, Schramm E, et al · · 2025 · PMID 41071587 · DOI 10.2196/73972
3. MOBILE APP-BASED SURVEY DEPLOYMENT PATTERNS AND LONGITUDINAL ENGAGEMENT: A RANDOMIZED CONTROLLED TRIAL
   · 2024
4. GOING OUTDOORS AND COMPUTER USE PREDICT CHANGES IN SELF-RATED CHEERFULNESS OF OLDER ADULTS OVER 10 YEARS
   · 2024
5. OLDER DRIVER REPORTS OF EXPERIENCE WITH SENSORS IN VEHICLES TO RECORD DRIVING BEHAVIOR
   · 2024
6. PRELIMINARY FEASIBILITY OF AN MHEALTH INTERVENTION FOR OLDER ADULTS WITH SERIOUS MEDICAL ILLNESS AND CAREGIVERS
   · 2024
7. Full GSA 2024 Abstract Book PDF
   · 2024