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

Janssen (J&J Innovative Medicine)

Status: Completed

Conditions: Atrial Fibrillation

Treatments: Device: Anti-Coagulation Adherence Module with the Apple Watch Series 5 or later; Device: Heart healthy Engagement Program with the Apple Watch Series 5 or later

Study type: Observational

Funder types: Industry

Identifiers

NCT04276441

NOPRODAFL0002 (Other Identifier)

CR108633

Details and patient eligibility

About

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.

Enrollment: 34,244 patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

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

Exclusion criteria

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

Trial design

34,244 participants in 2 patient groups

Non- Atrial Fibrillation (AF) Cohort

Description:

Participants without a history of AF will be randomly assigned into the study to either an Apple Watch/iPhone group or an iPhone group only.

Treatment:

Device: Heart healthy Engagement Program with the Apple Watch Series 5 or later

Atrial Fibrillation (AF) Cohort

Description:

Participants with a diagnosis of AF taking a direct oral anti-coagulant (DOAC) for at least 30 days will be randomly assigned to Apple Watch/iPhone group or iPhone group only.

Treatment:

Device: Anti-Coagulation Adherence Module with the Apple Watch Series 5 or later