N/A
Completed N=492
Second eFramngham Heart Study
Source: ClinicalTrials.gov NCT04752657 ↗Enrolled (actual)
492
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcomePrimary: Proportion of Surveys/Tasks Returned in Period 1 — 0.85; 0.85 proportion of surveys returned
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Surveys/Tasks Returned in Period 1 |
0.85; 0.85 | — |
| PRIMARY Proportion of Surveys/Tasks Returned in Period 2 |
0.75; 0.72 | — |
| PRIMARY Proportion of Surveys/Tasks Returned in Period 3 |
0.71; 0.67 | — |
| PRIMARY Proportion of Surveys/Tasks Returned in Period 4 |
0.66; 0.59 | — |
| SECONDARY Proportion of Questions/Task Completed Per Participant in Period 1 |
0.86; 0.88 | — |
| SECONDARY Proportion of Questions/Task Completed Per Participant in Period 2 |
0.77; 0.74 | — |
| SECONDARY Proportion of Questions/Task Completed Per Participant in Period 3 |
0.73; 0.70 | — |
| SECONDARY Proportion of Questions/Task Completed Per Participant in Period 4 |
0.68; 0.61 | — |
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
Data sourced from ClinicalTrials.gov (NCT04752657). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.