Clinical trial NCT04276441: A Study to Investigate if Early Atrial Fibrillation (AF) Diagnosis Reduces Risk of Events Like Stroke in the Real-World
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Lead sponsor: Janssen Scientific Affairs, LLC
Sponsor class: INDUSTRY
Collaborators: name: Apple Inc.
First posted: 2020-02-19
Enrollment: 34244
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population includes an older age group in whom the risk of developing Atrial Fibrillation (AF) is increased and who may benefit from a broad, health-focused Engagement Program paired with the irregular rhythm notification (IRN) alert (photoplethysmogram \[PPG\] sensor based) and electrocardiogram (ECG) sensor of the Apple Watch Series 5 or later.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Time from Randomization to Clinical Diagnosis of Atrial Fibrillation (AF)
timeFrame: Up to 3 years
measure: Percent Days Covered (PDC) by Direct Oral Anti-Coagulant (DOAC) Prescription Fills
timeFrame: Up to 3 years
Secondary outcomes:
measure: 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)
timeFrame: Up to 3 years
measure: Summary of Total Cost of Care Delivery, Total Health Resource Utilization (HRU), and Cost Effectiveness
timeFrame: Up to 3 years
measure: Time to Ischemic stroke/TIA
timeFrame: Up to 3 years
measure: Time to MI
timeFrame: Up to 3 years
measure: Time to non-CNS Embolism or Thrombosis
timeFrame: Up to 3 years
measure: Time to Hospitalization or ED for HF
timeFrame: Up to 3 years
measure: Time to CV Hospitalization
timeFrame: Up to 3 years
measure: Time to all-Cause Mortality
timeFrame: Up to 3 years
measure: Time to Composite Bleeding Events Resulting in Hospitalization
timeFrame: Up to 3 years
measure: Time to Hospitalization for Hemorrhagic Stroke
timeFrame: Up to 3 years
Other outcomes:
Locations:
city: San Mateo
country: United States
facility: Evidation Health
state: California
Study officials:
affiliation: Janssen Scientific Affairs, LLC
name: Janssen Scientific Affairs, LLC Clinical Trial
role: STUDY_DIRECTOR
References:
citation: Nikolovski J, Koldijk M, Weverling GJ, Spertus J, Turakhia M, Saxon L, Gibson M, Whang J, Sarich T, Zambon R, Ezeanochie N, Turgiss J, Jones R, Stoddard J, Burton P, Navar AM. Factors indicating intention to vaccinate with a COVID-19 vaccine among older U.S. adults. PLoS One. 2021 May 24;16(5):e0251963. doi: 10.1371/journal.pone.0251963. eCollection 2021.