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

2026년 9월 13일 업데이트: 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.

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

연구 유형

중재적

등록 (추정된)

1696

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

연구 장소

  • 중국
    • Jiangsu
      • Nantong, Jiangsu, 중국, 226000
        • Affiliated Hospital of Nantong University
        • 연락하다:
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 방지
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
장치: 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)
활성 비교기: 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.
다른: Usual Stroke Secondary Prevention Management
Participants in this arm receive standard care according to current clinical guidelines for stroke secondary prevention.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Number of Participants With First Recurrent Stroke
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Percentage of Participants Achieving the Prespecified Blood Pressure Target
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Affiliated Hospital of Nantong University

수사관

  • 연구 의자: Qiuhong Ji, Affiliated Hospital of Nantong University

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 9월 1일

기본 완료 (추정된)

2028년 9월 1일

연구 완료 (추정된)

2029년 6월 30일

연구 등록 날짜

최초 제출

2026년 9월 6일

QC 기준을 충족하는 최초 제출

2026년 9월 13일

처음 게시됨 (실제)

2026년 9월 17일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 9월 17일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 9월 13일

마지막으로 확인됨

2026년 8월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 2026-K241-01

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다