A Study to Investigate if Early Atrial Fibrillation (AF) Diagnosis Reduces Risk of Events Like Stroke in the Real-World
- Conditions
- Atrial Fibrillation
- Interventions
- Device: Heart healthy Engagement Program with the Apple Watch Series 5 or laterDevice: Anti-Coagulation Adherence Module with the Apple Watch Series 5 or later
- Registration Number
- NCT04276441
- Lead Sponsor
- Janssen Scientific Affairs, LLC
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 34244
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Non- Atrial Fibrillation (AF) Cohort Heart healthy Engagement Program with the Apple Watch Series 5 or later 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. Atrial Fibrillation (AF) Cohort Anti-Coagulation Adherence Module with the Apple Watch Series 5 or later 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.
- Primary Outcome Measures
Name Time Method Time from Randomization to Clinical Diagnosis of Atrial Fibrillation (AF) Up to 3 years Time to a clinical diagnosis of AF obtained from healthcare claims database.
Percent Days Covered (PDC) by Direct Oral Anti-Coagulant (DOAC) Prescription Fills Up to 3 years Percent days of covered prescription DOAC use minus any evidence of no prescription use/refills over the time interval chosen.
- Secondary Outcome Measures
Name Time Method Time to Composite of 6-component Events (Ischemic Stroke/TIA, MI, Non-CNS Embolism or Thrombosis, Hospitalization or ED Visit for HF, CV Hospitalization and ACM) Up to 3 years Time to composite of 6-component events (ischemic stroke/transient ischemic attack \[TIA\], myocardial infarction \[MI\], non-central nervous system \[CNS\] embolism or thrombosis, hospitalization or emergency department \[ED\] visit due to heart failure \[HF\], cardiovascular \[CV\] hospitalization, and all-cause mortality \[ACM\]), obtained from randomization in the healthcare claims database, will be reported.
Time to non-CNS Embolism or Thrombosis Up to 3 years Non-CNS embolism or thrombosis is defined as hospitalization for non-CNS thromboembolic events.
Time to all-Cause Mortality Up to 3 years All-cause mortality (ACM) is defined as deaths from all (reported) causes.
Time to Composite Bleeding Events Resulting in Hospitalization Up to 3 years Hospitalization for composite bleeding events (such as intracranial hemorrhage, gastrointestinal \[GI\], respiratory, intraocular) is defined as in-patient stay for bleeding events, as reported in the healthcare claims database.
Time to Hospitalization for Hemorrhagic Stroke Up to 3 years Hospitalization for hemorrhagic stroke is defined as an in-patient stay for a hemorrhagic stroke.
Time to Hospitalization or ED for HF Up to 3 years Hospitalization or ED visit for HF is defined as an in-patient stay or an outpatient ED visit for HF.
Time to Ischemic stroke/TIA Up to 3 years Ischemic stroke/TIA is defined as a hospitalization/diagnosis for Ischemic stroke/TIA.
Time to MI Up to 3 years MI is defined as a hospitalization/diagnosis for MI.
Summary of Total Cost of Care Delivery, Total Health Resource Utilization (HRU), and Cost Effectiveness Up to 3 years Summary of total cost of care delivery, total HRU, and cost effectiveness will be reported. Total costs of care reported as number of HRU events times the unit cost for each event. HRU reported as counts of HRU events. Cost effectiveness to be assessed by including the cost to diagnosis, treatment and reported clinical outcome.
Time to CV Hospitalization Up to 3 years Hospitalization for CV is defined as an in-patient stay for CV disease.
Trial Locations
- Locations (1)
Evidation Health
🇺🇸San Mateo, California, United States