mHealth Screening to Prevent Strokes (mSToPS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 6,135
- 试验地点
- 2
- 主要终点
- Incidence of Newly Diagnosed AF in the Immediate vs Delayed Monitoring Group
研究概览
简要总结
The purpose of this study is to investigate whether it is possible to identify a high-risk cohort suitable for screening for asymptomatic atrial fibrillation using claims data, and then engage those individuals in a mobile health technology-enabled home monitoring program in order to document previously undiagnosed atrial fibrillation, and provide clinical evidence of an outcomes benefit associated with this early detection.
详细描述
The purpose of this study is to propose to study two different methods of intermittent rhythm monitoring in a cohort of individuals without prior history of atrial fibrillation, but determined to be at increased risk based on clinical risk factors, and compare the rate of atrial fibrillation detection through monitoring relative to routine care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants:
- •The study population will be derived from the Aetna and Medicare populations.
- •Inclusion Criteria:
- •Male or females age > 75 or
- •Male age > 55, or females age > 65, and
- •Prior CVA, or
- •Heart failure, or
- •Diagnosis of both diabetes and hypertension, or
- •Mitral valve disease, or
- •Left ventricular hypertrophy, or
- •COPD requiring home O2, or
- •Sleep apnea, or
- •History of pulmonary embolism, or
- •History of myocardial infarction, or
- •Diagnosis of obesity
排除标准
- •Current or prior diagnosis of atrial fibrillation, atrial flutter or atrial tachycardia
- •Receiving chronic anticoagulation therapy
- •Hospice care
- •End stage renal disease
- •Diagnosis of moderate or greater dementia
- •Implantable pacemaker and/or defibrillator
- •History of skin allergies to adhesive patches
- •Known metastatic cancer
- •Aetna Compassionate Care Program (ACCP) participants - individuals with advanced illness and limited life expectancy
结局指标
主要结局
Incidence of Newly Diagnosed AF in the Immediate vs Delayed Monitoring Group
时间窗: End of 4 month monitoring period
Incidence of newly diagnosed AF as defined by at least 30 seconds of AF or atrial flutter at the end of the 4 month monitoring period compared to the delayed monitoring cohort (primary) and observational control (secondary)
次要结局
- Prevalence of Atrial Fibrillation in Both Monitoring Groups Versus the Matched Controls(1 year)
研究者
Steven Steinhubl
Director, Digital Medicine
Scripps Translational Science Institute