A Study to Investigate if Early Atrial Fibrillation (AF) Diagnosis Reduces Risk of Events Like Stroke in the Real-World
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|ClinicalTrials.gov Identifier: NCT04276441|
Recruitment Status : Recruiting
First Posted : February 19, 2020
Last Update Posted : December 7, 2022
|Condition or disease||Intervention/treatment|
|Atrial Fibrillation||Device: Heart healthy Engagement Program with the Apple Watch Series 5 or later Device: Anti-Coagulation Adherence Module with the Apple Watch Series 5 or later|
|Study Type :||Observational|
|Estimated Enrollment :||28000 participants|
|Official Title:||HEARTLINE - A Heart Health Study Using Digital Technology to Investigate if Early AF Diagnosis Reduces the Risk of Thromboembolic Events Like Stroke IN the Real-world Environment|
|Actual Study Start Date :||February 25, 2020|
|Estimated Primary Completion Date :||November 30, 2024|
|Estimated Study Completion Date :||November 28, 2025|
Non- Atrial Fibrillation (AF) Cohort
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.
Device: Heart healthy Engagement Program with the Apple Watch Series 5 or later
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.
Atrial Fibrillation (AF) Cohort
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.
Device: Anti-Coagulation Adherence Module 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.
- Time from Randomization to Clinical Diagnosis of Atrial Fibrillation (AF) [ Time Frame: 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 [ Time Frame: Up to 3 years ]Percent days of covered prescription DOAC use minus any evidence of no prescription use/refills over the time interval chosen.
- 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 Frame: 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.
- Summary of Total Cost of Care Delivery, Total Health Resource Utilization (HRU), and Cost Effectiveness [ Time Frame: 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 Ischemic stroke/TIA [ Time Frame: Up to 3 years ]Ischemic stroke/TIA is defined as a hospitalization/diagnosis for Ischemic stroke/TIA.
- Time to MI [ Time Frame: Up to 3 years ]MI is defined as a hospitalization/diagnosis for MI.
- Time to non-CNS Embolism or Thrombosis [ Time Frame: Up to 3 years ]Non-CNS embolism or thrombosis is defined as hospitalization for non-CNS thromboembolic events.
- Time to Hospitalization or ED for HF [ Time Frame: 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 CV Hospitalization [ Time Frame: Up to 3 years ]Hospitalization for CV is defined as an in-patient stay for CV disease.
- Time to all-Cause Mortality [ Time Frame: Up to 3 years ]All-cause mortality (ACM) is defined as deaths from all (reported) causes.
- Time to Composite Bleeding Events Resulting in Hospitalization [ Time Frame: 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 [ Time Frame: Up to 3 years ]Hospitalization for hemorrhagic stroke is defined as an in-patient stay for a hemorrhagic stroke.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04276441
|Contact: Study Contact||844-434-4210||Participate-In-This-Study@its.jnj.com|
|United States, California|
|San Mateo, California, United States, 94401|
|Study Director:||Janssen Scientific Affairs, LLC Clinical Trial||Janssen Scientific Affairs, LLC|