Clinical trial NCT02958098: My Research Legacy Pilot Study
Official title: My Research Legacy Pilot Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Myocardial Infarction
Stroke
Cardiomyopathy, Dilated
Systolic Heart Failure
Atrial Fibrillation
Aortic Dissection
Keywords: myocardial infarction
stroke
dilated cardiomyopathy
systolic heart failure
atrial fibrillation
aortic dissection
wearable devices
genomic sequencing
Lead sponsor: American Heart Association
Sponsor class: OTHER
First posted: 2016-11-08
Enrollment: 2267
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: study retention
timeFrame: 6 months
Secondary outcomes:
measure: Change in answers to AHA's Life's Simple 7™ My Life Check v4.0
timeFrame: 6 months
measure: Duration of time Fitbit Charge 2 used by participants
timeFrame: 6 months
measure: Change in Fitbit Charge 2 step count
timeFrame: 6 months
measure: Percent of individuals that initiate but don't complete online process
timeFrame: 6 months
measure: Activity duration
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: American Heart Association
name: Jane A Leopold, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.