Phase
Condition
Chest Pain
Atrial Fibrillation
Arrhythmia
Treatment
Heart healthy Engagement Program with the Apple Watch Series 5 or later
Anti-Coagulation Adherence Module with the Apple Watch Series 5 or later
Clinical Study ID
Ages > 65 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Medicare beneficiary either with Original or Medicare advantage
Authorize electronic access to their healthcare claims data
Authorize sharing of device sensor, health, and Heartline app data from their iPhoneand Apple Watch (if applicable). This includes Apple Watch and iPhone sensor datathat is not publicly available
Willing and able to provide informed consent by electronically signing the remotee-consent directly in the Heartline app prior to any study-related activities.Electronically signing the remote e-consent indicates that he/she understands thepurpose of, and activities required for the study and is willing to participate forthe 2-year Active Engagement Phase, with continued passive collection of theirdevice and healthcare claims data for an additional 1 year in the Post-EngagementFollow-Up Phase
Current resident of the US at the time of eligibility screening, defined byself-reported state of residence within the 50 states or the US or District ofColumbia
Own an iPhone 6s or later with iOS Version 12.2 or later
Exclusion
Exclusion Criteria:
Limited life expectancy and/or current diagnosis of terminal cancer
Unable to confirm meeting inclusion criteria, including ability to consent andparticipate in human participant's research
Own an Apple Watch Series 0 paired with an iPhone at the time of screeningeligibility (these participants are not eligible for any study cohorts [randomizedor observational])
Have a confirmed diagnosis of Atrial Fibrillation (AF) at study entry and currentlytaking a direct oral anti-coagulant (DOAC) for less than (<) 30 days, currentlytaking other anti-coagulant medication(s) for AF other than a DOAC, or currently nottaking medication for AF
Study Design
Connect with a study center
Evidation Health
San Mateo, California 94401
United StatesSite Not Available

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