Second eFramngham Heart Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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eFramingham Heart Study Randomized Controlled Trial #2

Conditions
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Cardiovascular Diseases

Intervention / Treatment
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* Other: Delayed administration of survey modules
* Other: Regular administration of survey modules


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Each participant will be randomized to one of the 2 groups. A statistician will generate randomization lists with the use of randomly permuted blocks of varying sizes, with stratification according to participant's age (≤75 years vs. >75 years) and type of phone (android vs. iphone). Randomization will be implemented centrally through the app.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Group<br>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<br>* The intervention consists in delaying the administration of the physical function, physical activity, and events survey modules by 2 weeks<br>|
| Active Comparator: Control Group<br>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<br>* The physical function, physical activity, and events survey modules are administered according to the regular pattern<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Framingham Heart Sudy, eFHS, mhealth, patient provider communication, user engagement