My Research Legacy Pilot Study

NCT ID: NCT02958098

Last Updated: 2021-03-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

2267 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-11-11

Study Completion Date

2018-10-30

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

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.

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Myocardial infarction

Individuals with myocardial infarction before age 50 years.

No interventions assigned to this group

Stroke

Individuals with stroke before age 50 years

No interventions assigned to this group

Aortic dissection

Individuals with aortic dissection before age 50 years

No interventions assigned to this group

Systolic heart failure

Individuals with systolic heart failure/dilated cardiomyopathy before age 50 years.

No interventions assigned to this group

Atrial fibrillation

Individuals with atrial fibrillation before age 50 years

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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American Heart Association

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jane A Leopold, MD

Role: PRINCIPAL_INVESTIGATOR

American Heart Association

References

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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.

Reference Type DERIVED
PMID: 34649522 (View on PubMed)

Other Identifiers

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My Research Legacy Pilot Study

Identifier Type: -

Identifier Source: org_study_id

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