My Research Legacy Pilot Study

Sponsor

American Heart Association (Other)

Overall Status

Terminated

CT.gov ID

NCT02958098

Collaborator

(none)

2,267

Enrollment

23.6

Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Myocardial Infarction Stroke Cardiomyopathy, Dilated Systolic Heart Failure Atrial Fibrillation Aortic Dissection

Detailed Description

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.

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 Design

Study Type:

Observational

Actual Enrollment :

2267 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

My Research Legacy Pilot Study

Actual Study Start Date :

Nov 11, 2016

Actual Primary Completion Date :

Oct 30, 2018

Actual Study Completion Date :

Oct 30, 2018

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

study retention [6 months]
continues to engage with study after 6 months

Secondary Outcome Measures

Change in answers to AHA's Life's Simple 7™ My Life Check v4.0 [6 months]
answers to second and other surveys
Duration of time Fitbit Charge 2 used by participants [6 months]
recorded time
Change in Fitbit Charge 2 step count [6 months]
recorded steps
Percent of individuals that initiate but don't complete online process [6 months]
number that start but don't finish first surveys
Activity duration [6 months]
Daily, weekly, monthly activity from Fitbit Charge 2

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 89 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age > or = to 18 years but < 50 years.
History of one (or more) of the following:
Myocardial infarction
Stroke
Aortic dissection
Systolic heart failure/cardiomyopathy
Atrial fibrillation
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.