Trial Outcomes & Findings for Second eFramngham Heart Study (NCT NCT04752657)
NCT ID: NCT04752657
Last Updated: 2025-03-19
Results Overview
Proportion of surveys/task returned per participant (partially or fully completed) from baseline, up to week 8, will be documented on the eFHS app.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
492 participants
Primary outcome timeframe
baseline, up to week 8
Results posted on
2025-03-19
Participant Flow
Participant milestones
| Measure |
Experimental- Two-week Group
Delayed administration of the physical function, physical activity, and events survey modules by 2 weeks.
|
Control- Four-week Group
The physical function, physical activity, and events survey modules are administered according to the regular 4-week pattern.
|
|---|---|---|
|
Period 1- Baseline up to Week 8
STARTED
|
248
|
244
|
|
Period 1- Baseline up to Week 8
COMPLETED
|
248
|
244
|
|
Period 1- Baseline up to Week 8
NOT COMPLETED
|
0
|
0
|
|
Period 2- Week 8 up to Week 16
STARTED
|
248
|
244
|
|
Period 2- Week 8 up to Week 16
COMPLETED
|
248
|
244
|
|
Period 2- Week 8 up to Week 16
NOT COMPLETED
|
0
|
0
|
|
Period 3- Week 16 up to Week 24
STARTED
|
248
|
244
|
|
Period 3- Week 16 up to Week 24
COMPLETED
|
248
|
244
|
|
Period 3- Week 16 up to Week 24
NOT COMPLETED
|
0
|
0
|
|
Period 4- Week 24 to Study Completion
STARTED
|
248
|
244
|
|
Period 4- Week 24 to Study Completion
COMPLETED
|
248
|
244
|
|
Period 4- Week 24 to Study Completion
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Second eFramngham Heart Study
Baseline characteristics by cohort
| Measure |
Experimental- Two-week Group
n=248 Participants
Delayed administration of the physical function, physical activity, and events survey modules by 2 weeks.
|
Control- Four-week Group
n=244 Participants
The physical function, physical activity, and events survey modules are administered according to the regular 4-week pattern.
|
Total
n=492 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
74.0 years
STANDARD_DEVIATION 6.2 • n=5 Participants
|
73.9 years
STANDARD_DEVIATION 6.3 • n=7 Participants
|
73.9 years
STANDARD_DEVIATION 6.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
148 Participants
n=5 Participants
|
136 Participants
n=7 Participants
|
284 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
100 Participants
n=5 Participants
|
108 Participants
n=7 Participants
|
208 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
209 Participants
n=5 Participants
|
205 Participants
n=7 Participants
|
414 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
39 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
248 participants
n=5 Participants
|
244 participants
n=7 Participants
|
492 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline, up to week 8Proportion of surveys/task returned per participant (partially or fully completed) from baseline, up to week 8, will be documented on the eFHS app.
Outcome measures
| Measure |
Experimental- Two-week Group
n=248 Participants
Delayed administration of the physical function, physical activity, and events survey modules by 2 weeks.
|
Control- Four-week Group
n=244 Participants
The physical function, physical activity, and events survey modules are administered according to the regular 4-week pattern.
|
|---|---|---|
|
Proportion of Surveys/Tasks Returned in Period 1
|
0.85 proportion of surveys returned
Standard Deviation 0.28
|
0.85 proportion of surveys returned
Standard Deviation 0.29
|
PRIMARY outcome
Timeframe: week 8, up to week 16Proportion of surveys/task returned per participant (partially or fully completed) from week 8, up to week 16, will be documented on the eFHS app.
Outcome measures
| Measure |
Experimental- Two-week Group
n=248 Participants
Delayed administration of the physical function, physical activity, and events survey modules by 2 weeks.
|
Control- Four-week Group
n=244 Participants
The physical function, physical activity, and events survey modules are administered according to the regular 4-week pattern.
|
|---|---|---|
|
Proportion of Surveys/Tasks Returned in Period 2
|
0.75 proportion of surveys returned
Standard Deviation 0.40
|
0.72 proportion of surveys returned
Standard Deviation 0.42
|
PRIMARY outcome
Timeframe: week 16, up to week 24Proportion of surveys/task returned per participant (partially or fully completed) week 16, up to week 24, will be documented on the eFHS app.
Outcome measures
| Measure |
Experimental- Two-week Group
n=248 Participants
Delayed administration of the physical function, physical activity, and events survey modules by 2 weeks.
|
Control- Four-week Group
n=244 Participants
The physical function, physical activity, and events survey modules are administered according to the regular 4-week pattern.
|
|---|---|---|
|
Proportion of Surveys/Tasks Returned in Period 3
|
0.71 proportion of surveys returned
Standard Deviation 0.43
|
0.67 proportion of surveys returned
Standard Deviation 0.45
|
PRIMARY outcome
Timeframe: week 24, to completion of study usually 26 weeksProportion 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.
Outcome measures
| Measure |
Experimental- Two-week Group
n=248 Participants
Delayed administration of the physical function, physical activity, and events survey modules by 2 weeks.
|
Control- Four-week Group
n=244 Participants
The physical function, physical activity, and events survey modules are administered according to the regular 4-week pattern.
|
|---|---|---|
|
Proportion of Surveys/Tasks Returned in Period 4
|
0.66 proportion of surveys returned
Standard Deviation 0.44
|
0.59 proportion of surveys returned
Standard Deviation 0.47
|
SECONDARY outcome
Timeframe: baseline, up to week 8Proportion of questions/task completed per participant from all survey modules administered from baseline to week 8, will be documented on the eFHS app.
Outcome measures
| Measure |
Experimental- Two-week Group
n=248 Participants
Delayed administration of the physical function, physical activity, and events survey modules by 2 weeks.
|
Control- Four-week Group
n=244 Participants
The physical function, physical activity, and events survey modules are administered according to the regular 4-week pattern.
|
|---|---|---|
|
Proportion of Questions/Task Completed Per Participant in Period 1
|
0.86 proportion of questions completed
Standard Deviation 0.28
|
0.88 proportion of questions completed
Standard Deviation 0.29
|
SECONDARY outcome
Timeframe: week 8, up to week 16Proportion of questions/task completed per participant from week 8 to week 16, will be documented on the eFHS app.
Outcome measures
| Measure |
Experimental- Two-week Group
n=248 Participants
Delayed administration of the physical function, physical activity, and events survey modules by 2 weeks.
|
Control- Four-week Group
n=244 Participants
The physical function, physical activity, and events survey modules are administered according to the regular 4-week pattern.
|
|---|---|---|
|
Proportion of Questions/Task Completed Per Participant in Period 2
|
0.77 proportion of questions completed
Standard Deviation 0.40
|
0.74 proportion of questions completed
Standard Deviation 0.42
|
SECONDARY outcome
Timeframe: week 16, up to week 24Proportion of questions/task completed per participant from week 16 to week 24, will be documented on the eFHS app.
Outcome measures
| Measure |
Experimental- Two-week Group
n=248 Participants
Delayed administration of the physical function, physical activity, and events survey modules by 2 weeks.
|
Control- Four-week Group
n=244 Participants
The physical function, physical activity, and events survey modules are administered according to the regular 4-week pattern.
|
|---|---|---|
|
Proportion of Questions/Task Completed Per Participant in Period 3
|
0.73 proportion of questions completed
Standard Deviation 0.43
|
0.70 proportion of questions completed
Standard Deviation 0.45
|
SECONDARY outcome
Timeframe: week 24, to completion of study usually 26 weeksProportion of questions/task completed per participant from week 24 to study completion, will be documented on the eFHS app.
Outcome measures
| Measure |
Experimental- Two-week Group
n=248 Participants
Delayed administration of the physical function, physical activity, and events survey modules by 2 weeks.
|
Control- Four-week Group
n=244 Participants
The physical function, physical activity, and events survey modules are administered according to the regular 4-week pattern.
|
|---|---|---|
|
Proportion of Questions/Task Completed Per Participant in Period 4
|
0.68 proportion of questions completed
Standard Deviation 0.44
|
0.61 proportion of questions completed
Standard Deviation 0.47
|
Adverse Events
Experimental- Two-week Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control- Four-week Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Joanne M Murabito, MD ScM
Framingham Heart Study, Boston University
Phone: 508-935-3461
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place