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Prevention of Ischemic Stroke Recurrence Using Digital Technology Application (DESIRE)

2026年9月13日 更新者：Affiliated Hospital of Nantong University

Prevention of Ischemic Stroke Recurrence Using Digital Technology Application: a Randomized Controlled Trial

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.

研究概览

地位

尚未招聘

条件

干预/治疗

研究类型

介入性

注册 (估计的)

1696

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

  • 中国
    • Jiangsu
      • Nantong、Jiangsu、中国、226000
        • Affiliated Hospital of Nantong University
        • 接触：
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：预防
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
实验性的：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.
设备：Digital Prevention Management
Participants in this arm receive usual stroke secondary prevention management plus a 12-month comprehensive digital intervention consisting of: Wearable Device (Smart Bracelet) + Digital Platform (Mobile Application)
有源比较器：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.
其他：Usual Stroke Secondary Prevention Management
Participants in this arm receive standard care according to current clinical guidelines for stroke secondary prevention.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Number of Participants With First Recurrent Stroke
大体时间：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.
From randomization through 12 months

次要结果测量

结果测量
措施说明
大体时间
Percentage of Participants Achieving the Prespecified Blood Pressure Target
大体时间：At 3, 6, and 12 months after randomization
Blood pressure control is defined as a mean seated systolic blood pressure below 130 mm Hg and a mean seated diastolic blood pressure below 80 mm Hg. Blood pressure will be measured using a validated device after at least 5 minutes of rest. The mean of three measurements obtained at each visit will be used. The outcome will be reported as the percentage of participants meeting both targets.
At 3, 6, and 12 months after randomization
Percentage of Participants Achieving the Prespecified Glycemic Target
大体时间：At 3, 6, and 12 months after randomization
Glycemic control is defined as a glycated hemoglobin A1c level below 7.0 percent. The outcome will be calculated as the number of participants meeting the prespecified target divided by the number of participants with an available glycated hemoglobin A1c measurement at the corresponding visit.
At 3, 6, and 12 months after randomization
Percentage of Participants Achieving the Prespecified Low-Density Lipoprotein Cholesterol Target
大体时间：At 3, 6, and 12 months after randomization
Lipid control is defined as a low-density lipoprotein cholesterol level below 1.8 mmol/L or achievement of the individualized target specified in the protocol. If individualized targets are used, the target-assignment algorithm will be prespecified before enrollment. The outcome will be reported as the percentage of participants achieving their assigned target.
At 3, 6, and 12 months after randomization
Number of Participants Who Die From Any Cause
大体时间：From randomization through 12 months
All-cause mortality is defined as death from any cause occurring after randomization. Deaths will be verified using hospital records, death certificates, or other available source documents and reviewed by an independent endpoint adjudication committee blinded to treatment allocation.
From randomization through 12 months
Number of Participants Who Die From a Cardiovascular Cause
大体时间：From randomization through 12 months
Cardiovascular death is defined as death attributable to stroke, myocardial infarction, heart failure, sudden cardiac death, or another vascular cause, according to prespecified endpoint definitions. All suspected cardiovascular deaths will be adjudicated by an independent blinded endpoint committee.
From randomization through 12 months
Number of Participants With Nonfatal Myocardial Infarction
大体时间：From randomization through 12 months
Nonfatal myocardial infarction is defined according to the prespecified clinical, electrocardiographic, imaging, and cardiac biomarker criteria in the study protocol. Participants with at least one confirmed nonfatal myocardial infarction will be counted once.
From randomization through 12 months
Number of Participants Hospitalized for Heart Failure
大体时间：From randomization through 12 months
Heart failure hospitalization is defined as an unplanned hospital admission primarily due to signs or symptoms of heart failure that requires initiation or intensification of heart failure treatment. Participants with at least one confirmed hospitalization will be counted once.
From randomization through 12 months
Change From Baseline in the Adherence to Refills and Medications Scale Total Score
大体时间：Baseline and 3, 6, and 12 months after randomization
Medication adherence will be assessed using the 12-item Adherence to Refills and Medications Scale. Each item is scored from 1 to 4, producing a total score ranging from 12 to 48. Lower scores indicate better medication adherence. Change from baseline will be calculated as the follow-up score minus the baseline score.
Baseline and 3, 6, and 12 months after randomization
Change From Baseline in the National Institutes of Health Stroke Scale Total Score
大体时间：Baseline and 3, 6, and 12 months after randomization
Neurological impairment will be assessed using the National Institutes of Health Stroke Scale. Total scores range from 0 to 42, with higher scores indicating greater neurological impairment. Change from baseline will be calculated as the follow-up score minus the baseline score.
Baseline and 3, 6, and 12 months after randomization
Modified Rankin Scale Score
大体时间：At 3, 6, and 12 months after randomization
Global functional status will be assessed using the modified Rankin Scale. Scores range from 0 to 6, where 0 indicates no symptoms, 5 indicates severe disability, and 6 indicates death. Higher scores indicate worse functional outcomes. The distribution of scores will be compared between the study groups.
At 3, 6, and 12 months after randomization
Percentage of Participants With Functional Independence
大体时间：At 3, 6, and 12 months after randomization
Functional independence is defined as a modified Rankin Scale score of 0 to 2. The outcome will be reported as the percentage of participants meeting this definition at each follow-up visit.
At 3, 6, and 12 months after randomization
Change From Baseline in the EQ-5D Index Score
大体时间：Baseline and 3, 6, and 12 months after randomization
Health-related quality of life will be assessed using the prespecified version of the EQ-5D instrument. Health states will be converted to an index score using the prespecified Chinese population value set. Higher index scores indicate better health-related quality of life. Change from baseline will be calculated as the follow-up score minus the baseline score.
Baseline and 3, 6, and 12 months after randomization
Change From Baseline in the EQ Visual Analogue Scale Score
大体时间：Baseline and 3, 6, and 12 months after randomization
Participants will rate their overall health using the EQ Visual Analogue Scale, which ranges from 0 to 100. A score of 0 represents the worst imaginable health and a score of 100 represents the best imaginable health. Change from baseline will be calculated as the follow-up score minus the baseline score.
Baseline and 3, 6, and 12 months after randomization
Change From Baseline in the Patient Health Questionnaire-9 Total Score
大体时间：Baseline and 3, 6, and 12 months after randomization
Depressive symptoms will be assessed using the 9-item Patient Health Questionnaire. Total scores range from 0 to 27, with higher scores indicating greater severity of depressive symptoms. Change from baseline will be calculated as the follow-up score minus the baseline score.
Baseline and 3, 6, and 12 months after randomization
Change From Baseline in the Generalized Anxiety Disorder-7 Total Score
大体时间：Baseline and 3, 6, and 12 months after randomization
Anxiety symptoms will be assessed using the 7-item Generalized Anxiety Disorder scale. Total scores range from 0 to 21, with higher scores indicating greater severity of anxiety symptoms. Change from baseline will be calculated as the follow-up score minus the baseline score.
Baseline and 3, 6, and 12 months after randomization
Percentage of Participants Who Currently Smoke
大体时间：Baseline and 12 months after randomization
Current smoking will be determined using the prespecified lifestyle questionnaire. The definition of current smoking, including the type and frequency of tobacco use and the applicable reference period, will be specified before enrollment.
Baseline and 12 months after randomization
Mean Daily Step Count
大体时间：During prespecified 7-day monitoring periods at baseline and 3, 6, and 12 months after randomization
Daily step count will be measured using the study wearable device. The mean daily step count will be calculated using data collected during a prespecified valid monitoring window. A valid day will require at least 10 hours of device wear, and participants must have at least 4 valid days during each assessment window.
During prespecified 7-day monitoring periods at baseline and 3, 6, and 12 months after randomization
Mean Daily Moderate-to-Vigorous Physical Activity Duration
大体时间：During prespecified 7-day monitoring periods at baseline and 3, 6, and 12 months after randomization
Moderate-to-vigorous physical activity will be estimated using the study wearable device and the prespecified device algorithm. The mean number of minutes per valid monitoring day will be calculated during each assessment window.
During prespecified 7-day monitoring periods at baseline and 3, 6, and 12 months after randomization
Mean Daily Sedentary Time
大体时间：During prespecified 7-day monitoring periods at baseline and 3, 6, and 12 months after randomization
Sedentary time will be estimated using the study wearable device and the prespecified device algorithm. The mean number of sedentary minutes per valid monitoring day will be calculated during each assessment window.
During prespecified 7-day monitoring periods at baseline and 3, 6, and 12 months after randomization
Mean Nightly Sleep Duration
大体时间：During prespecified 7-night monitoring periods at baseline and 3, 6, and 12 months after randomization
Sleep duration will be estimated using the study wearable device and the prespecified sleep-detection algorithm. Mean nightly sleep duration will be calculated using nights with valid device recordings during each assessment window.
During prespecified 7-night monitoring periods at baseline and 3, 6, and 12 months after randomization

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Affiliated Hospital of Nantong University

调查人员

  • 学习椅：Qiuhong Ji、Affiliated Hospital of Nantong University

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年9月1日

初级完成 (估计的)

2028年9月1日

研究完成 (估计的)

2029年6月30日

研究注册日期

首次提交

2026年9月6日

首先提交符合 QC 标准的

2026年9月13日

首次发布 (实际的)

2026年9月17日

研究记录更新

最后更新发布 (实际的)

2026年9月17日

上次提交的符合 QC 标准的更新

2026年9月13日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 2026-K241-01

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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