My Research Legacy Pilot Study
|ClinicalTrials.gov Identifier: NCT02958098|
Recruitment Status : Unknown
Verified November 2016 by American Heart Association.
Recruitment status was: Not yet recruiting
First Posted : November 8, 2016
Last Update Posted : November 9, 2016
|Condition or disease|
|Myocardial Infarction Stroke Cardiomyopathy, Dilated Systolic Heart Failure Atrial Fibrillation Aortic Dissection|
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.
Saliva kit sent
- If participants choose to participate in the genome sequencing portion of the study, participants will receive a saliva collection kit.
- DNA will be extracted from the saliva sample.
- Genomic sequence analysis will be performed.
- 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.
|Study Type :||Observational|
|Estimated Enrollment :||2000 participants|
|Official Title:||My Research Legacy Pilot Study|
|Study Start Date :||November 2016|
|Estimated Primary Completion Date :||April 2018|
|Estimated Study Completion Date :||April 2018|
Individuals with myocardial infarction before age 50 years.
Individuals with stroke before age 50 years
Individuals with aortic dissection before age 50 years
Systolic heart failure
Individuals with systolic heart failure/dilated cardiomyopathy before age 50 years.
Individuals with atrial fibrillation before age 50 years
- study retention [ Time Frame: 6 months ]
- Change in answers to AHA's Life's Simple 7™ My Life Check v4.0 [ Time Frame: 6 months ]
- Duration of time Fitbit Charge 2 used by participants [ Time Frame: 6 months ]
- Change in Fitbit Charge 2 step count [ Time Frame: 6 months ]
- Percent saliva kit return [ Time Frame: 6 months ]
- Percent of individuals that initiate but don't complete online process [ Time Frame: 6 months ]
- Activity duration [ Time Frame: 6 months ]Daily, weekly, monthly activity from Fitbit Charge 2
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02958098
|Contact: Jane A Leopold, MDemail@example.com|
|Principal Investigator:||Jane A Leopold, MD||American Heart Association|