My Research Legacy Pilot Study

Terminated

• Conditions: Systolic Heart Failure; Atrial Fibrillation; Stroke; Aortic Dissection; Myocardial Infarction; Cardiomyopathy, Dilated

• Registration Number: NCT02958098
• Lead Sponsor: American Heart Association

Brief Summary

The My Research Legacy Pilot Study will establish a participant registry that collects self-reported health data and answers to online survey questions about individual daily choices, diets, and exercise; data from wearable devices; and, (optional) data from genome sequencing analysis. Individuals under the age of 50 who meet eligibility criteria will answer questions using the American Heart Association's (AHA) Life's Simple 7™ My Life Check v4.0 three times over the course of 6 months and transmit data from a Fitbit Charge 2 device. All other individuals who are interested in the study and meet entry criteria may also enroll.

Detailed Description

2,000 Participant My Research Legacy Pilot Study

1. Day 0 - Enroll online, complete AHA's Life's Simple 7™ Survey Prospective participants will enroll in the research initiative via the My Research Legacy website (MyResearchLegacy.org). They will go through an online process in which they will answer brief, pre-qualifying questions before consenting to participate in the study.

* Participants will attest to their age and US residence, and will provide a self-reported diagnosis of cardiovascular disease (myocardial infarction, atrial fibrillation, aortic dissection, systolic congestive heart failure/cardiomyopathy) and/or stroke.

* Eligible participants will read and sign an online consent form.

* Within the participant console, the participants will answer AHA's Life's Simple 7™ My Life Check v4.0 assessment.

* Participants will be asked during the consent process if they will consent to provide medical records relevant to their diagnosis.

2. Day 90 Complete AHA's Life's Simple 7™ My Life Check v4.0 assessment; Start transmission from the Fitbit Charge 2.

3. Online Survey and contact Day 180 after enrollment, participants will receive an email requesting that they visit the participant console to repeat AHA's Life's Simple 7™ My Life Check v4.0 survey. Participants also have the option of determining whether or not they want to be contacted for future studies.

Study Timeline

• Study First Submitted: 2016-11-04
• Study First Submitted QC: 2016-11-04
• Study First Posted: 2016-11-08
• Study Start: 2016-11-11
• Primary Completion: 2018-10-30
• Study Completion: 2018-10-30
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-04
• Last Update Posted: 2021-03-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2267

Inclusion Criteria

1. Age > or = to 18 years but < 50 years.

2. History of one (or more) of the following:

   1. Myocardial infarction
   2. Stroke
   3. Aortic dissection
   4. Systolic heart failure/cardiomyopathy
   5. Atrial fibrillation

3. Individuals of any age > or = 18 years who don't have above medical conditions but want to participate in the study.

4. Access to a computer and/or cell phone with internet access.

Exclusion Criteria

1. Unwillingness to sign informed consent
2. No access to a computer and/or cell phone with internet access.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
study retention	6 months	continues to engage with study after 6 months

Secondary Outcome Measures

Name	Time	Method
Change in answers to AHA's Life's Simple 7™ My Life Check v4.0	6 months	answers to second and other surveys
Duration of time Fitbit Charge 2 used by participants	6 months	recorded time
Change in Fitbit Charge 2 step count	6 months	recorded steps
Percent of individuals that initiate but don't complete online process	6 months	number that start but don't finish first surveys
Activity duration	6 months	Daily, weekly, monthly activity from Fitbit Charge 2