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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02958098
Other study ID # My Research Legacy Pilot Study
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date November 11, 2016
Est. completion date October 30, 2018

Study information

Verified date March 2021
Source American Heart Association
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 2267
Est. completion date October 30, 2018
Est. primary completion date October 30, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 89 Years
Eligibility 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.

Study Design


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
American Heart Association

Outcome

Type Measure Description Time frame Safety issue
Primary study retention continues to engage with study after 6 months 6 months
Secondary Change in answers to AHA's Life's Simple 7™ My Life Check v4.0 answers to second and other surveys 6 months
Secondary Duration of time Fitbit Charge 2 used by participants recorded time 6 months
Secondary Change in Fitbit Charge 2 step count recorded steps 6 months
Secondary Percent of individuals that initiate but don't complete online process number that start but don't finish first surveys 6 months
Secondary Activity duration Daily, weekly, monthly activity from Fitbit Charge 2 6 months
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