Randomised Controlled Trial of the Use of a Smart Phone Based Event Recorder Versus Standard Care for Patients Presenting to the Emergency Department With Palpitations and Pre-syncope
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- NHS Lothian
- 入组人数
- 243
- 试验地点
- 13
- 主要终点
- Number of Participants With Symptomatic Rhythm Detection up to 90 Days
研究概览
简要总结
Palpitations (noticeable pounding, fluttering or irregular heart beat) and pre-syncope (near blackout) are common ED problems sometimes due to an abnormal cardiac rhythm. This is difficult to diagnose as examination and electrocardiogram (ECG) are commonly normal and symptoms have usually resolved by the time the patient arrives in the ED. Diagnosing an abnormal heart rhythm as the cause of symptoms rests on capturing it on an ECG and patients are usually discharged with advice to return to the ED again for a 12-lead ECG should symptoms recur. The investigators will recruit 242 adult participants to either study or control arms. All study arm participants will be given an AliveCor Heart Monitor and trained in the use of the device. Control arm participants will receive standard care only. Both groups will be followed-up at 90 days. The investigators believe a smart phone based event recorder will allow better and earlier diagnosis in patients with a compatible smart phone or tablet, and revolutionise ED care in this area.
详细描述
Palpitations (noticeable pounding, fluttering or irregular heart beat) and pre syncope (near blackout) are common ED problems sometimes due to an abnormal heart rhythm. Diagnosis is difficult as examination and electrocardiogram (ECG) are commonly normal and symptoms have usually resolved by the time the patient arrives in the ED. Diagnosing an abnormal heart rhythm as the cause of symptoms rests on capturing it on an ECG and patients are usually advised to return to the ED for a 12-lead ECG should symptoms recur. The investigators will recruit 242 participants aged 16 years or over presenting to the ED or Medical Assessment Unit of the Royal Infirmary of Edinburgh with an episode of palpitations or pre-syncope and who remain undiagnosed after ED assessment. The investigators will randomise and allocate participants to either study or control arms. All study arm participants will be given an AliveCor Heart Monitor and trained in the use of the device. Control arm participants will receive standard care only. If a participant allocated to the study arm has palpitations or pre-syncope during the 90-day study period, the participant can record an ECG using the AliveCor Monitor which can be viewed by the study team. Participants will be asked to log symptoms and whether the participant was able to record an ECG during the symptoms in a participant symptom diary, which the participant will return to the research team along with the Participant satisfaction and compliance questionnaire, and smart phone based event recorder at the end of the 90 days in a pre-paid stamped, addressed envelope. Participants will be phoned at 90 days to remind the participant to complete the Participant satisfaction and compliance questionnaire and to return this with the symptom diary and smart phone based event recorder. The investigators believe a smart phone based event recorder will allow better and earlier diagnosis in patients.
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
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant aged 16 years or over
- •Participant presenting with an episode of palpitations or pre-syncope
- •Participant's underlying ECG rhythm during these episodes remains undiagnosed after clinical assessment.
排除标准
- •Prior diagnostic ECG
- •Palpitations or pre-syncope present during an admission ECG
- •Frequent episodes (i.e. at least once a day)
- •Participants under 16 years of age
- •Previous participation in the study
- •Inability or unwilling to give informed consent.
- •Participants with recent (i.e. within 3 months) myocardial infarction, severe heart failure (NYHA class 4) or unstable angina
- •Participants unwilling or unable to use the AliveCor Heart Monitor and AliveECG app
- •Participants without a compatible smart phone or tablet
- •Participants with cardiac pacemakers or other implanted electronic devices
- •No telephone number for follow-up
- •Participant in custody
结局指标
主要结局
Number of Participants With Symptomatic Rhythm Detection up to 90 Days
时间窗: 90 days
Symptomatic rhythm detection rate of a smart phone based event recorder for symptomatic rhythm detection versus standard care.
次要结局
- Number of Participants With Symptomatic Cardiac Rhythm Detection up to 90 Days(90 days)
- Number of Participants Treated or (Planned for Treatment) for Cardiac Arrhythmia(90 days)
- Number of Participants Finding the AliveCor Heart Monitor Easy to Use(90 days)
- Number of Participants Completing Questionnaire(90 days)
- Time to Detection of Symptomatic Rhythm(90 days)
- Number of Participants With Serious Outcome up to 90 Days(90 days)
- Financial Cost Per Diagnosis of Symptomatic Rhythm(90 days)
- Time to Detection of Cardiac Arrhythmia Rhythm(90 days)