NCT04276441已完成不适用
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
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34,244
- 试验地点
- 1
- 主要终点
- Time from Randomization to Clinical Diagnosis of Atrial Fibrillation (AF)
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Time from Randomization to Clinical Diagnosis of Atrial Fibrillation (AF)
时间窗: 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
时间窗: Up to 3 years
Percent days of covered prescription DOAC use minus any evidence of no prescription use/refills over the time interval chosen.
次要结局
- 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 non-CNS Embolism or Thrombosis(Up to 3 years)
- Time to all-Cause Mortality(Up to 3 years)
- Time to Composite Bleeding Events Resulting in Hospitalization(Up to 3 years)
- Time to Hospitalization for Hemorrhagic Stroke(Up to 3 years)
- Time to Hospitalization or ED for HF(Up to 3 years)
- Time to Ischemic stroke/TIA(Up to 3 years)
- Time to MI(Up to 3 years)
- Summary of Total Cost of Care Delivery, Total Health Resource Utilization (HRU), and Cost Effectiveness(Up to 3 years)
- Time to CV Hospitalization(Up to 3 years)
研究者
研究点 (1)
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