An interventional study of Delayed administration of survey modules and Regular administration of survey modules in Cardiovascular Diseases, sponsored by Boston University. Completed at 1 site in United States. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2025-03-19.
Sponsored by Boston University · Not applicable, Interventional, and Prevention
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).
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.
4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.
This study's enrollment of 492 is above the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.
Browse Cardiovascular Diseases studies →Boston University is the lead sponsor of 266 studies on the registry; 37 are open to participants now.
Of its 30 completed or terminated interventional studies of FDA-regulated products, 24 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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 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 intervention consists in delaying the administration of the physical function, physical activity, and events survey modules by 2 weeks
The physical function, physical activity, and events survey modules are administered according to the regular pattern
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: week 24, to completion of study usually 26 weeks
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: week 24, to completion of study usually 26 weeks
| Milestone | Experimental- Two-week Group | Control- Four-week Group |
|---|---|---|
| Started | 248 | 244 |
| Completed | 248 | 244 |
| Not completed | 0 | 0 |
| Milestone | Experimental- Two-week Group | Control- Four-week Group |
|---|---|---|
| Started | 248 | 244 |
| Completed | 248 | 244 |
| Not completed | 0 | 0 |
| Milestone | Experimental- Two-week Group | Control- Four-week Group |
|---|---|---|
| Started | 248 | 244 |
| Completed | 248 | 244 |
| Not completed | 0 | 0 |
| Milestone | Experimental- Two-week Group | Control- Four-week Group |
|---|---|---|
| Started | 248 | 244 |
| Completed | 248 | 244 |
| Not completed | 0 | 0 |
Proportion of surveys/task returned per participant (partially or fully completed) from baseline, up to week 8, will be documented on the eFHS app.
| proportion of surveys returned | Experimental- Two-week Group | Control- Four-week Group |
|---|---|---|
| Proportion of Surveys/Tasks Returned in Period 1 | 0.85 ± 0.28 | 0.85 ± 0.29 |
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.
| proportion of surveys returned | Experimental- Two-week Group | Control- Four-week Group |
|---|---|---|
| Proportion of Surveys/Tasks Returned in Period 2 | 0.75 ± 0.40 | 0.72 ± 0.42 |
Proportion of surveys/task returned per participant (partially or fully completed) week 16, up to week 24, will be documented on the eFHS app.
| proportion of surveys returned | Experimental- Two-week Group | Control- Four-week Group |
|---|---|---|
| Proportion of Surveys/Tasks Returned in Period 3 | 0.71 ± 0.43 | 0.67 ± 0.45 |
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.
| proportion of surveys returned | Experimental- Two-week Group | Control- Four-week Group |
|---|---|---|
| Proportion of Surveys/Tasks Returned in Period 4 | 0.66 ± 0.44 | 0.59 ± 0.47 |
Proportion of questions/task completed per participant from all survey modules administered from baseline to week 8, will be documented on the eFHS app.
| proportion of questions completed | Experimental- Two-week Group | Control- Four-week Group |
|---|---|---|
| Proportion of Questions/Task Completed Per Participant in Period 1 | 0.86 ± 0.28 | 0.88 ± 0.29 |
Proportion of questions/task completed per participant from week 8 to week 16, will be documented on the eFHS app.
| proportion of questions completed | Experimental- Two-week Group | Control- Four-week Group |
|---|---|---|
| Proportion of Questions/Task Completed Per Participant in Period 2 | 0.77 ± 0.40 | 0.74 ± 0.42 |
Proportion of questions/task completed per participant from week 16 to week 24, will be documented on the eFHS app.
| proportion of questions completed | Experimental- Two-week Group | Control- Four-week Group |
|---|---|---|
| Proportion of Questions/Task Completed Per Participant in Period 3 | 0.73 ± 0.43 | 0.70 ± 0.45 |
Proportion of questions/task completed per participant from week 24 to study completion, will be documented on the eFHS app.
| proportion of questions completed | Experimental- Two-week Group | Control- Four-week Group |
|---|---|---|
| Proportion of Questions/Task Completed Per Participant in Period 4 | 0.68 ± 0.44 | 0.61 ± 0.47 |
Collected over 26 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Experimental- Two-week Group | 0/248 (0%) | 0/248 (0%) | 0/248 (0%) |
| Control- Four-week Group | 0/244 (0%) | 0/244 (0%) | 0/244 (0%) |
| Age, Continuous(years) | Experimental- Two-week Group | Control- Four-week Group | Total |
|---|---|---|---|
| Mean | 74.0 ± 6.2 | 73.9 ± 6.3 | 73.9 ± 6.3 |
| Sex: Female, Male(Participants) | Experimental- Two-week Group | Control- Four-week Group | Total |
|---|---|---|---|
| Female | 148 | 136 | 284 |
| Male | 100 | 108 | 208 |
| Race/Ethnicity, Customized(Participants) | Experimental- Two-week Group | Control- Four-week Group | Total |
|---|---|---|---|
| White | 209 | 205 | 414 |
| Other | 39 | 39 | 78 |
| Region of Enrollment(participants) | Experimental- Two-week Group | Control- Four-week Group | Total |
|---|---|---|---|
| United States | 248 | 244 | 492 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — The datasets generated and analyzed during this study are available from the research team upon reasonable request.
Supporting information: Study protocol, Sap
This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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