NCT04752657

Second eFramngham Heart Study

eFramingham Heart Study Randomized Controlled Trial #2

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 492 (actual)
• Sponsor: Boston University · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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).

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.

Conditions

• Cardiovascular Diseases

Interventions

Type	Name	Description
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
OTHER	Regular administration of survey modules	The physical function, physical activity, and events survey modules are administered according to the regular pattern

Timeline

• Start date: 2021-06-21
• Primary completion: 2023-12-28
• Completion: 2023-12-28
• First posted: 2021-02-12
• Last updated: 2025-03-19
• Results posted: 2025-03-19

Locations

1 site across 1 country: United States