Prevention of Ischemic Stroke Recurrence Using Digital Technology Application: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,696
- 试验地点
- 1
- 主要终点
- Number of Participants With First Recurrent Stroke
研究概览
简要总结
The goal of this study is to find out whether a comprehensive management program that uses a smart bracelet and a mobile app can help people who have had an ischemic stroke (a type of stroke caused by a blocked blood vessel in the brain) to prevent another stroke. The investigators also want to see whether this program helps with controlling blood pressure, blood sugar, and blood lipids, as well as with taking medications correctly, improving daily habits, and supporting emotional well-being.
The investigators are focusing on two main questions:
- After using this digital management tool, will the chance of having another stroke within one year after leaving the hospital be lower?
- Compared with people who only receive regular care, will those who use the tool show better control of blood pressure, blood sugar, and blood lipids, better medication adherence, and healthier lifestyles?
People who join the study will be randomly assigned to one of two groups. One group will receive usual stroke prevention care (the control group). The other group will get the same usual care plus an additional 12-month program that includes a smart bracelet and a mobile app (the intervention group).
If participants are in the intervention group, participants will:
- Wear a smart bracelet continuously and use a mobile app for 12 months.
- Receive health tips, medication reminders, blood-pressure measurement reminders, activity goals, and vibration alerts when participants have been sitting too long through the app.
If participants are in either group, participants will:
- Come to the clinic for check-ups and assessments at the start of the study, and again at 3 months, 6 months, and 12 months.
- Have neurological function of participants, daily activity abilities, quality of life, medication adherence, and mood (depression and anxiety) assessed at those visits.
- Have blood tests to check metabolic risk factors of participants(e.g., blood lipids and glucose) at the same visits.
- Report to the research team if participants experience another stroke, any cardiovascular event, or death at each follow-up visit.
The investigators will compare the two groups to see if the digital program makes a real difference in reducing stroke recurrence and improving overall health after a stroke.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
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.
- •Diagnosed with ischemic stroke within the past 3 months, confirmed by cranial CT or MRI.
- •Have both hypertension and diabetes as concurrent metabolic risk factors for stroke recurrence.
- •Possess basic communication skills and ability to understand the study content and provide written informed consent.
- •The participant or their primary caregiver is able to use a smart wearable device, has access to a smartphone, and is willing to complete follow-up visits as required by the study protocol.
排除标准
- •Life expectancy less than 12 months, or presence of severe cardiac, hepatic, renal, or other systemic diseases that would make participation in follow-up inappropriate.
- •Severe cognitive impairment, aphasia, psychiatric disorders, or disturbance of consciousness that prevents cooperation with the study, without a stable caregiver to assist.
- •Severe physical disability or other reasons that preclude wearing or using the wearable device.
- •Currently participating in another interventional study that may affect stroke recurrence outcomes.
研究组 & 干预措施
Digital Prevention Management
This arm receives the wearable device + digital platform intervention, which is the focus of the study and is being tested for efficacy.
干预措施: Digital Prevention Management (Device)
Usual Stroke Secondary Prevention
This arm receives usual stroke secondary prevention management, which is the current standard of care and is considered effective in treating/ preventing the condition under study.
干预措施: Usual Stroke Secondary Prevention Management (Other)
结局指标
主要结局
Number of Participants With First Recurrent Stroke
时间窗: From randomization through 12 months
Recurrent stroke is defined as a new ischemic or hemorrhagic stroke occurring after randomization and confirmed by an independent blinded endpoint adjudication committee based on clinical findings and brain CT or MRI. If a participant experiences more than one recurrent stroke, only the first qualifying event will be counted.
次要结局
- Percentage of Participants Achieving the Prespecified Blood Pressure Target(At 3, 6, and 12 months after randomization)
- Percentage of Participants Achieving the Prespecified Glycemic Target(At 3, 6, and 12 months after randomization)
- Percentage of Participants Achieving the Prespecified Low-Density Lipoprotein Cholesterol Target(At 3, 6, and 12 months after randomization)
- Number of Participants Who Die From Any Cause(From randomization through 12 months)
- Number of Participants Who Die From a Cardiovascular Cause(From randomization through 12 months)
- Percentage of Participants With Functional Independence(At 3, 6, and 12 months after randomization)
- Number of Participants With Nonfatal Myocardial Infarction(From randomization through 12 months)
- Number of Participants Hospitalized for Heart Failure(From randomization through 12 months)
- Change From Baseline in the Adherence to Refills and Medications Scale Total Score(Baseline and 3, 6, and 12 months after randomization)
- Change From Baseline in the National Institutes of Health Stroke Scale Total Score(Baseline and 3, 6, and 12 months after randomization)
- Modified Rankin Scale Score(At 3, 6, and 12 months after randomization)
- Change From Baseline in the EQ-5D Index Score(Baseline and 3, 6, and 12 months after randomization)
- Change From Baseline in the EQ Visual Analogue Scale Score(Baseline and 3, 6, and 12 months after randomization)
- Change From Baseline in the Patient Health Questionnaire-9 Total Score(Baseline and 3, 6, and 12 months after randomization)
- Change From Baseline in the Generalized Anxiety Disorder-7 Total Score(Baseline and 3, 6, and 12 months after randomization)
- Percentage of Participants Who Currently Smoke(Baseline and 12 months after randomization)
- Mean Daily Step Count(During prespecified 7-day monitoring periods at baseline and 3, 6, and 12 months after randomization)
- Mean Daily Moderate-to-Vigorous Physical Activity Duration(During prespecified 7-day monitoring periods at baseline and 3, 6, and 12 months after randomization)
- Mean Daily Sedentary Time(During prespecified 7-day monitoring periods at baseline and 3, 6, and 12 months after randomization)
- Mean Nightly Sleep Duration(During prespecified 7-night monitoring periods at baseline and 3, 6, and 12 months after randomization)