A Study to Investigate if Early Atrial Fibrillation (AF) Diagnosis Reduces Risk of Events Like Stroke in the Real-World

  • STATUS
    Recruiting
  • participants needed
    150000
  • sponsor
    Janssen Scientific Affairs, LLC
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Updated on 19 February 2024
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stroke
fibrillation

Summary

The primary objectives of this study are to identify and diagnose Atrial Fibrillation (AF), evaluate improvement in cardiovascular (CV) outcomes, improve direct oral anti-coagulant (DOAC) adherence and persistence, and better characterize participants and identify predictors of disease.

Details
Condition Arrhythmia, Arrhythmia, Atrial Fibrillation, Atrial Fibrillation
Age 65years - 100years
Treatment Heart healthy Engagement Program with the Apple Watch Series 4 or later, Anti-Coagulation Adherence Module with the Apple Watch Series 5 or later
Clinical Study IdentifierNCT04276441
SponsorJanssen Scientific Affairs, LLC
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

b'Medicare beneficiary with Traditional or Original Medicare coverage'
b'Medicare beneficiary with Medicare Advantage (waitlisted)'
b'Authorize electronic access to their healthcare claims data'
b'Authorize sharing of device sensor, health, and Heartline app data from their iPhone'
b'and Apple Watch (if applicable). This includes Apple Watch and iPhone sensor data that'
b'is not publicly available'
b'Willing and able to provide informed consent by electronically signing the remote'
b'e-consent directly in the Heartline app prior to any study-related activities.'
b'Electronically signing the remote e-consent indicates that he/she understands the'
b'purpose of, and activities required for the study and is willing to participate for'
b'the 2-year Active Engagement Phase, with continued passive collection of their device'
b'and healthcare claims data for an additional 1 year in the Post-Engagement Follow-Up'
b'Phase'
b'Current resident of the US at the time of eligibility screening, defined by'
b'elf-reported state of residence within the 50 states or the US or District of'
b'Columbia'
b'Own an iPhone 6s or later with iOS Version 12.2 or later'

Exclusion Criteria

b'Limited life expectancy and/or current diagnosis of terminal cancer'
b'Unable to confirm meeting inclusion criteria, including ability to consent and'
b"participate in human participant's research"
b'Own an Apple Watch Series 0 paired with an iPhone at the time of screening eligibility'
b'(these participants are not eligible for any study cohorts [randomized or'
b'observational])'
b'Have a confirmed diagnosis of Atrial Fibrillation (AF) at study entry and currently'
b'taking a direct oral anti-coagulant (DOAC) for less then (<) 30 days, currently taking'
b'other anti-coagulant medication(s) for AF other than a DOAC, or currently not taking'
b'medication for AF'
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