Prevention of Ischemic Stroke Recurrence Using Digital Technology Application (DESIRE)
13 сентября 2026 г. обновлено: 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.
Обзор исследования
Статус
Еще не набирают
Условия
Тип исследования
Интервенционный
Регистрация (Оцененный)
1696
Фаза
- Непригодный
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Контакты исследования
- Имя: Qiuhong Ji
- Номер телефона: +8613962916293
- Электронная почта: jiqiuhong@ntu.edu.cn
Учебное резервное копирование контактов
- Имя: Lei Li
- Номер телефона: +8613815434184
- Электронная почта: lilei.nj@live.cn
Места учебы
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Jiangsu
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Nantong, Jiangsu, Китай, 226000
- Affiliated Hospital of Nantong University
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Контакт:
- Tian Xu, MD, PhD
- Номер телефона: +8618251313276
- Электронная почта: xutian84@163.com
-
Контакт:
- Qiuhong Ji, MD, PhD
- Номер телефона: +8613962916293
- Электронная почта: jigiuhong@ntu.edu.cn
-
-
Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Нет
Описание
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.
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Профилактика
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: 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.
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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)
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Активный компаратор: 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.
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Participants in this arm receive standard care according to current clinical guidelines for stroke secondary prevention.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Number of Participants With First Recurrent Stroke
Временное ограничение: From randomization through 12 months
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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.
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From randomization through 12 months
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Percentage of Participants Achieving the Prespecified Blood Pressure Target
Временное ограничение: 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.
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At 3, 6, and 12 months after randomization
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Percentage of Participants Achieving the Prespecified Glycemic Target
Временное ограничение: At 3, 6, and 12 months after randomization
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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.
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At 3, 6, and 12 months after randomization
|
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Percentage of Participants Achieving the Prespecified Low-Density Lipoprotein Cholesterol Target
Временное ограничение: At 3, 6, and 12 months after randomization
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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.
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At 3, 6, and 12 months after randomization
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Number of Participants Who Die From Any Cause
Временное ограничение: 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.
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From randomization through 12 months
|
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Number of Participants Who Die From a Cardiovascular Cause
Временное ограничение: From randomization through 12 months
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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.
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From randomization through 12 months
|
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Number of Participants With Nonfatal Myocardial Infarction
Временное ограничение: From randomization through 12 months
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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.
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From randomization through 12 months
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Number of Participants Hospitalized for Heart Failure
Временное ограничение: From randomization through 12 months
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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.
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From randomization through 12 months
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Change From Baseline in the Adherence to Refills and Medications Scale Total Score
Временное ограничение: Baseline and 3, 6, and 12 months after randomization
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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.
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Baseline and 3, 6, and 12 months after randomization
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Change From Baseline in the National Institutes of Health Stroke Scale Total Score
Временное ограничение: Baseline and 3, 6, and 12 months after randomization
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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.
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Baseline and 3, 6, and 12 months after randomization
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Modified Rankin Scale Score
Временное ограничение: At 3, 6, and 12 months after randomization
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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.
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At 3, 6, and 12 months after randomization
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Percentage of Participants With Functional Independence
Временное ограничение: At 3, 6, and 12 months after randomization
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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.
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At 3, 6, and 12 months after randomization
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Change From Baseline in the EQ-5D Index Score
Временное ограничение: Baseline and 3, 6, and 12 months after randomization
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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.
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Baseline and 3, 6, and 12 months after randomization
|
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Change From Baseline in the EQ Visual Analogue Scale Score
Временное ограничение: 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.
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Baseline and 3, 6, and 12 months after randomization
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Change From Baseline in the Patient Health Questionnaire-9 Total Score
Временное ограничение: Baseline and 3, 6, and 12 months after randomization
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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.
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Baseline and 3, 6, and 12 months after randomization
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Change From Baseline in the Generalized Anxiety Disorder-7 Total Score
Временное ограничение: Baseline and 3, 6, and 12 months after randomization
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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.
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Baseline and 3, 6, and 12 months after randomization
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Percentage of Participants Who Currently Smoke
Временное ограничение: Baseline and 12 months after randomization
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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.
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Baseline and 12 months after randomization
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Mean Daily Step Count
Временное ограничение: During prespecified 7-day monitoring periods at baseline and 3, 6, and 12 months after randomization
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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.
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During prespecified 7-day monitoring periods at baseline and 3, 6, and 12 months after randomization
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Mean Daily Moderate-to-Vigorous Physical Activity Duration
Временное ограничение: During prespecified 7-day monitoring periods at baseline and 3, 6, and 12 months after randomization
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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.
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During prespecified 7-day monitoring periods at baseline and 3, 6, and 12 months after randomization
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Mean Daily Sedentary Time
Временное ограничение: During prespecified 7-day monitoring periods at baseline and 3, 6, and 12 months after randomization
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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.
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During prespecified 7-day monitoring periods at baseline and 3, 6, and 12 months after randomization
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Mean Nightly Sleep Duration
Временное ограничение: During prespecified 7-night monitoring periods at baseline and 3, 6, and 12 months after randomization
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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.
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During prespecified 7-night monitoring periods at baseline and 3, 6, and 12 months after randomization
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Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Следователи
- Учебный стул: Qiuhong Ji, Affiliated Hospital of Nantong University
Публикации и полезные ссылки
Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Оцененный)
1 сентября 2026 г.
Первичное завершение (Оцененный)
1 сентября 2028 г.
Завершение исследования (Оцененный)
30 июня 2029 г.
Даты регистрации исследования
Первый отправленный
6 сентября 2026 г.
Впервые представлено, что соответствует критериям контроля качества
13 сентября 2026 г.
Первый опубликованный (Действительный)
17 сентября 2026 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
17 сентября 2026 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
13 сентября 2026 г.
Последняя проверка
1 августа 2026 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 2026-K241-01
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
НЕТ
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Нет
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .