Digital Screening for Atrial Fibrillation to Prevent Stroke: The Randomized Austrian Digital Heart Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100,060
- 试验地点
- 1
- 主要终点
- Hospitalization for stroke of any type (ischemic or hemorrhagic)
研究概览
简要总结
The Austrian Digital Heart Study is a population-based, siteless, randomized, controlled digital trial testing whether a smartphone-based atrial fibrillation screening and management pathway reduces stroke hospitalizations compared with usual care. Adults aged 65 years or older in Austria are randomized to either a digital intervention using the 'Pulskontrolle' app or to usual care. The intervention includes smartphone-camera photoplethysmography for atrial fibrillation screening, confirmatory 7-day ECG patch monitoring in case of suspected atrial fibrillation, and digital education and management support. The primary outcome is hospitalization for stroke of any type within 48 months.
详细描述
Atrial fibrillation is common in older adults, often remains undetected, and is a major risk factor for stroke, heart failure, hospitalization, and death. Digital screening using smartphone-based photoplethysmography provides substantial benefits in detecting atrial fibrillation compared to usual care, but it remains unclear whether such screening improves clinical outcomes.
The Austrian Digital Heart Study tests a brand-independent digital atrial fibrillation screening and management pathway embedded in the Austrian public health-care system. Participants randomized to the intervention arm use the 'Pulskontrolle' smartphone application for repeated photoplethysmographic pulse-wave (PPG) recordings. If atrial fibrillation is suspected, confirmatory 7-day ECG patch monitoring is initiated. Participants with positive PPG receive structured digital information, telehealth support, and guideline-oriented management recommendations.
The control arm receives usual care without active app-based atrial fibrillation screening. The primary endpoint is hospitalization for stroke of any type within 48 months after randomization. Secondary outcomes include mortality, cardiovascular morbidity, bleeding, atrial fibrillation-related outcomes, health-care utilization, and health-economic endpoints.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 65 years
- •Policyholder in Austria (active unique social insurance number)
- •Written electronic informed consent
排除标准
- •a) Currently treated with oral anticoagulation b) Cardiac implanted electronic device (CIED)
结局指标
主要结局
Hospitalization for stroke of any type (ischemic or hemorrhagic)
时间窗: Up to 48 months
次要结局
- Hospitalization for Ischemic stroke(Up to 48 months)
- Hospitalization for Hemorrhagic stroke(Up to 48 months)
- All-cause mortality(Up to 48 months)
- Cardiovascular mortality(Up to 48 months)
- Hospitalization for heart failure(Up to 48 months)
- The combination of hospitalization for stroke, hospitalization for heart failure and cardiovascular death.(Up to 48 months)
- Hospitalization for bleeding(up to 48 months)
- Fatal bleeding(up to 48 months)
- Cost and incremental cost effectiveness ratio(Up to 48 months)