The Effect of a Case-finding App on the Detection Rate of Atrial Fibrillation Compared With Opportunistic Screening in Primary Care Patients: Protocol for a Cluster Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- KU Leuven
- 入组人数
- 8,765
- 主要终点
- Detection rate of AF in patients 65 years and older
研究概览
简要总结
Atrial fibrillation is a cardiac arrhythmia commonly encountered in a primary care setting. Current screening is limited to pulse palpation and ECG confirmation when an irregular pulse is found. Paroxysmal atrial fibrillation will, however, still be difficult to pick up. With the advent of smartphones, screening could be more cost-efficient by making use of simple applications, lowering the need for intensive screening to discover (paroxysmal) atrial fibrillation.
This cluster randomized trial will examine the effect of using a smartphone-based application such as FibriCheck® on the detection rate of atrial fibrillation in a Flemish general practice population. This study will be conducted in 22 primary care practices across the Flanders region of Belgium and will last 12 months. Patients above 65 years of age will be divided in control and intervention groups on the practice level. The control group will be subjected to standard opportunistic screening only, while the intervention group will be prescribed the FibriCheck® app on top of this opportunistic screening. The difference in detection rate between control and intervention groups will be calculated at the end of the study.
The investigators will use the online platform INTEGO for pseudonymized data collection and analysis, and risk calculation.
Smartphone applications might offer a way to cost-effectively screen for (paroxysmal) atrial fibrillation in a primary care setting. This could open the door for the update of future screening guidelines.
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
- None
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
- •The patient is 65 years or older.
- •The patient has an electronic medical record (EMR) in the practice. This EMR contains all the patient information, for instance regarding medical history and medication and is managed by the general practitioner.
- •If the patient will be prescribed the FibriCheck® app, he/she signs the relevant patient consent form
排除标准
- •The patient has already been diagnosed with AF.
- •The patient is already under anticoagulant therapy.
- •The patient has a pacemaker. Active pacing during measurements influences the results obtained with the FibriCheck® app (26).
- •The patient is unable to use the FibriCheck® application independently due to cognitive disorders, functional limitations, visual impairments...
结局指标
主要结局
Detection rate of AF in patients 65 years and older
时间窗: 4 weeks for each participant
The detection rate of AF in both the control and intervention group will be calculated after 4 weeks. A significant difference in both groups will be noted. Compared with previous studies of similar design (32-34), we will realistically assume a 2-fold increase in the detection rate of AF in the intervention group to be significant.
次要结局
- Thromboembolic complications(12 months)
- Compliance(12 months)
- Death(12 months)