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My Research Legacy Pilot Study

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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
Sponsor:
Information provided by (Responsible Party):
American Heart Association

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, transmit data from a Fitbit Charge 2 device, and (optional) provide a saliva sample for whole genome sequencing.

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

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. 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.
  3. Day 90 Complete AHA's Life's Simple 7™ My Life Check v4.0 assessment; Start transmission from the Fitbit Charge 2.
  4. 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.

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Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: My Research Legacy Pilot Study
Study Start Date : November 2016
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : April 2018


Group/Cohort
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



Primary Outcome Measures :
  1. study retention [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Change in answers to AHA's Life's Simple 7™ My Life Check v4.0 [ Time Frame: 6 months ]
  2. Duration of time Fitbit Charge 2 used by participants [ Time Frame: 6 months ]
  3. Change in Fitbit Charge 2 step count [ Time Frame: 6 months ]
  4. Percent saliva kit return [ Time Frame: 6 months ]
  5. Percent of individuals that initiate but don't complete online process [ Time Frame: 6 months ]
  6. Activity duration [ Time Frame: 6 months ]
    Daily, weekly, monthly activity from Fitbit Charge 2



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years to 49 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All individuals older than 21 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.
Criteria

Inclusion Criteria:

  1. Age > 21 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. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02958098


Contacts
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Contact: Jane A Leopold, MD 617-525-4846 t-jane.leopold@heart.org

Sponsors and Collaborators
American Heart Association
Investigators
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Principal Investigator: Jane A Leopold, MD American Heart Association

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Responsible Party: American Heart Association
ClinicalTrials.gov Identifier: NCT02958098     History of Changes
Other Study ID Numbers: My Research Legacy Pilot Study
First Posted: November 8, 2016    Key Record Dates
Last Update Posted: November 9, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual participant data will not be made available to other researchers.
Keywords provided by American Heart Association:
myocardial infarction
stroke
dilated cardiomyopathy
systolic heart failure
atrial fibrillation
aortic dissection
wearable devices
genomic sequencing
Additional relevant MeSH terms:
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Heart Failure
Atrial Fibrillation
Myocardial Infarction
Cardiomyopathies
Aneurysm, Dissecting
Heart Failure, Systolic
Cardiomyopathy, Dilated
Infarction
Vascular Diseases
Cardiovascular Diseases
Heart Diseases
Arrhythmias, Cardiac
Pathologic Processes
Ischemia
Necrosis
Myocardial Ischemia
Aneurysm
Cardiomegaly