Second eFramngham Heart Study

Cardiovascular Diseases Clinical Trial

— eFHS-2  

Official title:

eFramingham Heart Study Randomized Controlled Trial #2

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04752657
• Other study ID #: H-40737
• Secondary ID: 5R01HL141434-03
• Status: Completed
• Phase: N/A
• Start date: June 21, 2021
• Est. completion date: December 28, 2023

Study information

• Verified date: January 2024
• Source: Boston University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 492
• Est. completion date: December 28, 2023
• Est. primary completion date: December 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

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
• Regular administration of survey modules
The physical function, physical activity, and events survey modules are administered according to the regular pattern

Locations

Country	Name	City	State
United States	Framingham Heart Study	Framingham	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Boston University	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	baseline, up to week 8
Primary	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.	week 8, up to week 16
Primary	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.	week 16, up to week 24
Primary	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.	week 24, to completion of study usually 26 weeks
Secondary	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.	baseline, up to week 8
Secondary	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.	week 8, up to week 16
Secondary	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.	week 16, up to week 24
Secondary	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.	week 24, to completion of study usually 26 weeks