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Sponsor withdrew funding
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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 7â„¢ 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.
2,000 Participant My Research Legacy Pilot Study
Day 0 - Enroll online, complete AHA's Life's Simple 7â„¢ 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.
Day 90 Complete AHA's Life's Simple 7â„¢ 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 7â„¢ My Life Check v4.0 survey. Participants also have the option of determining whether or not they want to be contacted for future studies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| study retention | continues to engage with study after 6 months | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in answers to AHA's Life's Simple 7â„¢ My Life Check v4.0 | answers to second and other surveys | 6 months |
| Duration of time Fitbit Charge 2 used by participants | recorded time |
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Inclusion Criteria:
Age > or = to 18 years but < 50 years.
History of one (or more) of the following:
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:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Jane A Leopold, MD | American Heart Association | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34649522 | Derived | 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. |
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Individual participant data will not be made available to other researchers.
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| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D020521 | Stroke |
| D002311 | Cardiomyopathy, Dilated |
| D054143 | Heart Failure, Systolic |
| D001281 | Atrial Fibrillation |
| D000784 | Aortic Dissection |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| 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 |
| D007238 |
| Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006332 | Cardiomegaly |
| D009202 | Cardiomyopathies |
| D000083083 | Laminopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006333 | Heart Failure |
| D001145 | Arrhythmias, Cardiac |
| D000094665 | Dissection, Blood Vessel |
| D000783 | Aneurysm |
| D000094683 | Acute Aortic Syndrome |
| D001018 | Aortic Diseases |