Assessment of Portable Remote Health Monitor Using the Snap to Symptomatic Arrhythmia
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Evaluating the ability of handheld device with remote interpretation to screen for arrhythmia
研究概览
简要总结
Participants in the Snap arm were instructed to undertake once-day recording and transmission of a 30-second single-lead iECG trace to a secure server, plus additional submissions if symptomatic over a 3-month period. Snap traces were analyzed by an automated analysis software and cardiologists. Clinical review and appropriate care was arranged for those clinically significant arrhythmia. Patients in the RC group were followed up as normal methods including ECG, Holter.
详细描述
Individuals with symptomatic arrhythmia without known arrhythmia were recruited.
Participants were required to have access to the internet via WiFi and to be able to operate the Snap system after simple instruction. Written consent was obtained, and eligible participants were randomized (1:1) to an intervention (Snap) group or RC group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •symptomatic arrhythmia
排除标准
- •can not use the Snap instrument and Sign informed consent
结局指标
主要结局
Evaluating the ability of handheld device with remote interpretation to screen for arrhythmia
时间窗: 3-month
Participants in Snap group acquired ECG once od according to the rules and transmitted ECG immediately once symptom appeared between 3-month. Patients in the routine treatment (RT) group were administrated normal diagnostic techniques. At 3-month, compared the incidence atrial arrhythmia(atrial premature beats and atrial tachycardia) and ventricula arrhythmia(ventricular premature beats and ventricular tachycardia) between two groups.
次要结局
- Evaluating the patients' quality of life(3-month)
研究者
Chunjian Li
principal investigator
The First Affiliated Hospital with Nanjing Medical University