试验速览
- 阶段
- 不适用
- 发起方
- Region Skane
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Usability
研究概览
简要总结
This open, multicenter, prospective, singel-arm study will evaluate usability and feasibility of a wearable stroke indication system (Stroke Alarm) in patients with recent TIA, recent minor stroke without persistent arm motor deficit, or atrial fibrillation up to 1 month.
详细描述
The aim of this study is to test the safety and feasibility of the CE-marked wearable system for early stroke indication to indicate the onset of stroke in real life.
Our hypothesis is that the device is well tolerated with an acceptable number of adverse events such as direct complications of the bracelets or unbearable amounts of false alarms or false alarms during sleep.
The device can be used to monitor arm motor function for long time. The ability to detect arm paresis (indicating the onset of a stroke) will be studied as well, but the trial is single-armed and not designed to assess neither the efficacy of stroke indication nor shortened patient-delay.
Anticipated adverse device effects that are to be assessed.
- Participants being unable to operate the device.
- Frequency of alarms specified for the different alarm escalation steps.
- User compliance.
- User experience.
- Alarm recipient experience
- Barriers for use will be identified (for example advanced age or other patients' characteristics)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
The patients are in this clinical trial instructed to use the device continuously for 1 month. There will be no masking.
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
- •Age 18 years or older
- •Patients with 2A. Diagnosed (ICD-10) TIA (G45.9: Transitory ischemic attack or G45.3: Amaurosis fugax, or 2B. ICD-10 ischemic stroke, I63.0-
- •2C. Newly diagnosed atrial fibrillation. 2D. Atrial fibrillation with an increased risk of stroke (contraindication to oral anticoagulants, reduced dose of oral anticoagulants or other risk factors presenting an estimated annual stroke risk of 5% or more despite anticoagulants treatment.
- •Subject has after study specific information consent to participation by signing the Ethics committee-approved inform consent form.
排除标准
- •Already included in the study in connection with previous TIA/stroke.
- •Has an affected arm function due to previous stroke or other illness/trauma.
- •Cannot provide informed consent to participation in the study.
- •Does not speak Swedish or English in speech and writing.
- •Assessed due to other diseases or circumstances in general cannot contribute to planned follow-up within the framework of the study.
- •Do not want to participate.
- •During the study period, do not have access to a compatible smartPhone.
- •Not deemed capable of managing the Stroke Alarm smartphone app.
研究组 & 干预措施
StrokeAlarm use
This is a single arm study. All participants will be instructed to use the StrokeAlarm medical device for 1 month.
干预措施: Stroke Alarm (Device)
结局指标
主要结局
Usability
时间窗: 1 month
Usability of the CE marked medical device Stroke Alarm.
次要结局
- Stroke indication(1 month)