My Research Legacy Pilot Study

Study Overview
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Brief Summary
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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
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2,000 Participant My Research Legacy Pilot Study 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. Day 90 Complete AHA's Life's Simple 7™ My Life Check v4.0 assessment; Start transmission from the Fitbit Charge 2. 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.

Official Title
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My Research Legacy Pilot Study

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

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > or = to 18 years but < 50 years. History of one (or more) of the following: Myocardial infarction Stroke Aortic dissection Systolic heart failure/cardiomyopathy Atrial fibrillation Individuals of any age > or = 18 years who don't have above medical conditions but want to participate in the study. Access to a computer and/or cell phone with internet access. Exclusion Criteria: Unwillingness to sign informed consent No access to a computer and/or cell phone with internet access.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Myocardial infarction<br>Individuals with myocardial infarction before age 50 years. | |
| Stroke<br>Individuals with stroke before age 50 years | |
| Aortic dissection<br>Individuals with aortic dissection before age 50 years | |
| Systolic heart failure<br>Individuals with systolic heart failure/dilated cardiomyopathy before age 50 years. | |
| Atrial fibrillation<br>Individuals with atrial fibrillation before age 50 years | |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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myocardial infarction, stroke, dilated cardiomyopathy, systolic heart failure, atrial fibrillation, aortic dissection, wearable devices, genomic sequencing