RedStroke - Reducing Europe's Stroke Incidence: Highly Cost-effective Population Screening Programs for Atrial Fibrillation Coupled With High Diagnostic Yield Confirmation Services
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,019
- 试验地点
- 14
- 主要终点
- Prevalence of Atrial Fibrillation
研究概览
简要总结
In the RedStroke study, the effect of a smartphone application in detecting Atrial Fibrillation (AF) will be assessed in a double-blind randomised controlled multicenter trial. Outpatients with an elevated risk for atrial fibrillation will be randomized to an intervention arm (app group) and to a standard-of-care arm (control group). Both groups will have the app installed on their private smartphones and will be asked to perform a predefined measurement protocol. All patients will continue their prior therapy with their general practitioner and obtain every medical treatment indicated. This study will not cause any restrictions on the usual treatment of the study patients.
The only difference between the two groups will be, that patients in the app group will be informed by their local PI, if the recordings of the app indicate AF (and obtain a 14 day Holter ECG for AF verification), whereas the patients in the "usual care" group will obtain the read out of the app at the end of the study.
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
Patients and study team will remain blind to the assigned groups until the end of the trial. Only in case of a positive app finding, patients and site team will be unblinded for the remaining time of the trial.
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •written informed consent
- •CHA2DS2-VASc score of 3 and above, if patients are aged under 65 years
- •CHA2DS2-VASc score of 2 and above, if patients are aged 65 years or older
排除标准
- •history of Atrial Fibrillation
- •current anticoagulation treatment,
- •cardiac implanted electronic device (ICD or/and PM)
- •app cannot be installed due to technical problems (smartphone type, reduced smartphone storage capacity, other)
- •inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
- •enrollment of the investigator, his/her family members, employees and other dependent persons
结局指标
主要结局
Prevalence of Atrial Fibrillation
时间窗: 6 months
Prevalence of Atrial Fibrillation confirmed by ECG in the app group compared with the standard care group
次要结局
- Compliance of patients using the app(6 months)
- Costs related to the AF screening(6 months)