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.
Study Type
OBSERVATIONAL
Enrollment
34,244
No drug will be given as part of this study. Participants without a diagnosis of AF will be enrolled and a heart healthy Engagement Program delivered via the Heartline app on the iPhone with the Apple Watch Series 5 or later.
No drug will be given as part of this study. Participants with a diagnosis of AF (taking a DOAC for at least 30 days) will be enrolled and an Anti-Coagulation Adherence Module delivered via the Heartline app on the iPhone with an Apple Watch Series 5 or later.
Evidation Health
San Mateo, California, United States
Time from Randomization to Clinical Diagnosis of Atrial Fibrillation (AF)
Time to a clinical diagnosis of AF obtained from healthcare claims database.
Time frame: Up to 3 years
Percent Days Covered (PDC) by Direct Oral Anti-Coagulant (DOAC) Prescription Fills
Percent days of covered prescription DOAC use minus any evidence of no prescription use/refills over the time interval chosen.
Time frame: Up to 3 years
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)
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 frame: Up to 3 years
Summary of Total Cost of Care Delivery, Total Health Resource Utilization (HRU), and Cost Effectiveness
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 frame: Up to 3 years
Time to Ischemic stroke/TIA
Ischemic stroke/TIA is defined as a hospitalization/diagnosis for Ischemic stroke/TIA.
Time frame: Up to 3 years
Time to MI
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MI is defined as a hospitalization/diagnosis for MI.
Time frame: Up to 3 years
Time to non-CNS Embolism or Thrombosis
Non-CNS embolism or thrombosis is defined as hospitalization for non-CNS thromboembolic events.
Time frame: Up to 3 years
Time to Hospitalization or ED for HF
Hospitalization or ED visit for HF is defined as an in-patient stay or an outpatient ED visit for HF.
Time frame: Up to 3 years
Time to CV Hospitalization
Hospitalization for CV is defined as an in-patient stay for CV disease.
Time frame: Up to 3 years
Time to all-Cause Mortality
All-cause mortality (ACM) is defined as deaths from all (reported) causes.
Time frame: Up to 3 years
Time to Composite Bleeding Events Resulting in Hospitalization
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 frame: Up to 3 years
Time to Hospitalization for Hemorrhagic Stroke
Hospitalization for hemorrhagic stroke is defined as an in-patient stay for a hemorrhagic stroke.
Time frame: Up to 3 years