My Research Legacy Pilot Study

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.

Study Overview

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

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 Type: Observational
• Enrollment (Actual): 2267

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All individuals equal to or older than 18 years but younger than 50 years of age who have a history of, or have, an aortic dissection; or systolic heart failure/cardiomyopathy; or atrial fibrillation; or myocardial infarction; or stroke. All other individuals equal to or older than 18 years who don't meet the above health criteria but are interested in the study.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort
Myocardial infarction; Individuals with myocardial infarction before age 50 years.
Stroke; Individuals with stroke before age 50 years
Aortic dissection; Individuals with aortic dissection before age 50 years
Systolic heart failure; Individuals with systolic heart failure/dilated cardiomyopathy before age 50 years.
Atrial fibrillation; Individuals with atrial fibrillation before age 50 years

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
study retention	continues to engage with study after 6 months	6 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: American Heart Association
• Investigators: Principal Investigator: Jane A Leopold, MD, American Heart Association

Publications and helpful links

General Publications

• Leopold JA, Antman EM. Digital health device measured sleep duration and ideal cardiovascular health: an observational study. BMC Cardiovasc Disord. 2021 Oct 14;21(1):497. doi: 10.1186/s12872-021-02284-z.

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2016
• Primary Completion (Actual): October 30, 2018
• Study Completion (Actual): October 30, 2018

Study Registration Dates

• First Submitted: November 4, 2016
• First Submitted That Met QC Criteria: November 4, 2016
• First Posted (Estimate): November 8, 2016

Study Record Updates

• Last Update Posted (Actual): March 8, 2021
• Last Update Submitted That Met QC Criteria: March 4, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: stroke; atrial fibrillation; myocardial infarction; dilated cardiomyopathy; aortic dissection; wearable devices; systolic heart failure; genomic sequencing
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Genetic Diseases, Inborn; Arrhythmias, Cardiac; Cardiomegaly; Laminopathies; Aneurysm; Myocardial Infarction; Infarction; Heart Failure; Atrial Fibrillation; Cardiomyopathies; Cardiomyopathy, Dilated; Aneurysm, Dissecting; Heart Failure, Systolic
• Other Study ID Numbers: My Research Legacy Pilot Study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be made available to other researchers.