이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

Smartwatch-Guided Secondary Prevention After Stroke (WATCH-STEP)

2026년 6월 5일 업데이트: University Hospital, Brest

WATCH-STEP : Pilot Trial: Smartwatch-Guided Secondary Prevention After Stroke Randomized Trial of Nurse-led Program With Active vs Passive Smartwatch in Minor Stroke. A Randomized Controlled Trial Evaluating a Nurse-led Secondary Prevention and Physical Activity Program Supported by Either an Active Smartwatch (Structured Feedback) or Passive Smartwatch in Patients With Minor Stroke.

After a first stroke or transient ischemic attack (TIA), the risk of recurrence is high in the weeks and months following the initial event. There are several modifiable risk factors that can reduce this risk, such as blood pressure, diet, physical activity, and smoking. Many stroke patients (NIHSS < 5) have a low daily step count during the early recovery period, despite a good functional prognosis.

Active smartwatches provide real-time feedback, track progress, and set personalized walking goals, thereby boosting motivation and adherence to physical activity recommendations.

The combination of advice provided by nurses and active behavioral coaching supported by a smartwatch, compared to passive monitoring, could significantly increase daily step counts over a 12-week period. The results of this research will help guide future large-scale secondary prevention strategies integrating digital health and structured nursing support.

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

상세 설명

To meet the study's objectives, 50 patients who have recently suffered a stroke or a transient ischemic attack (TIA) (< 30 days) will be recruited at Brest University Hospital.

Participation in this study will last 12 weeks. It consists of 3 visits, described below:

=> Visit #1: Enrollment (hospital)

Enrollment will take place during a routine hospital visit. The investigator will obtain the patient's written consent. Randomization will then be performed to assign the patient to a group ("active" or "passive" watch).

For all patients ("active" and "passive" watch groups):

  • Program led by nurses, conducted as part of routine care following a recent ischemic stroke or TIA (secondary prevention).
  • Issuance of a smartwatch and a smartphone
  • Data collection (sociodemographic information, medical history, current treatments, risk factors)
  • Questionnaires
  • Clinical examination, neurological examination, and blood draw.

For patients in the "passive" smartwatch group:

o The smartwatch will collect data passively, without notifications.

For patients in the "active" smartwatch group:

  • Setting daily step goals and assessing potential obstacles

  • Scheduling regular calls (twice a week) for the duration of the study.

    • Visit #2: Phone call

For all patients (both "active" and "passive" watch):

  • Phone contact to collect data on changes in risk factors and the occurrence of events of interest (stroke, TIA, and cardiovascular events).

  • Questionnaires

    • Visit #3: End of study (hospital)

The end-of-study visit will take place at the hospital during a scheduled routine care appointment:

  • Assessment with a nurse as part of the secondary prevention program (routine care)
  • Data collection (risk factors)
  • Questionnaires
  • Clinical examination, neurological examination, and blood draw
  • Return of the smartwatch and smartphone

연구 유형

중재적

등록 (추정된)

50

단계

  • 해당 없음

연락처 및 위치

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

연구 연락처

연구 장소

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 ≤ 40-75
  • Patients with recent minor ischemic stroke or TIA, initial NIHSS ≤5 (< 30 days)
  • mRS ≤2 before stroke and on discharge
  • Patient with Wifi access (for data transmission)
  • Able to understand smartwatch instructions
  • Written informed consent
  • Ambulatory ≥10 meters without assistance and without walking aid
  • Expected to live at home during the study period.

Exclusion Criteria:

  • Patients with transient neurological deficits resolving within one hour and normal brain imaging will be excluded
  • Not affiliated to social security
  • Patient under legal protection or deprived of liberty by a judicial or administrative decision
  • Patient whose follow-up will be impossible
  • Cognitive impairment interfering with participation (e.g., MoCA <20).
  • Unstable cardiac conditions preventing walking goals.
  • Major visual or upper limb impairment preventing use of the smartwatch.
  • Life expectancy <1 year.
  • Already highly active (>10,000 steps/day, or about 1.5 hours of walking).
  • Participation in competing interventional trials.

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: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
간섭 없음: "Passive" Smartwatch arm
  • Smartwatch collects step and wear-time data passively.
  • Participants do not receive daily goals, structured prompts, or real-time feedback regarding progress.
  • Nurses provide general advice but do not review detailed step graphs.
  • Data used only for endpoint assessment at M3.
실험적: "Active" Smartwatch arm
  • Smartwatch provides real-time structured feedback, including daily step counts, a visual progress bar, and automated prompts.
  • Research technician review step graphs during tele-visits, highlighting high/low activity days, barriers, and facilitators personalized daily step goals (twice a week) defined as +15-20% above baseline will be adjusted by Research technician based on progress and symptoms.
  • Goals increased by +10% if ≥4/7 days meet targets; maintained or decreased if symptomatic or not meeting goals.
다른: Smartwatch-Guided Secondary Prevention after Stroke
Setting daily walking goals, assessing obstacles Regular phone calls (twice a week) to review progress, adjust goals, and provide support

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
To determine whether the addition of an active smartwatch providing structured feedback to a nurse-led activity program produces a significantly greater increase in daily step count over 12 weeks compared with the same program paired with a passive smart
기간: Week 12
Difference in steps/day at 12 weeks between both arms (average of the final 14 valid days) (target Δ ≥ 1500)
Week 12

2차 결과 측정

결과 측정
측정값 설명
기간
To evaluate feasibility to smartwatch wear
기간: Week 6 and Week 12
Wear-time adherence at W6 and W12
Week 6 and Week 12
To evaluate adherence to smartwatch wear
기간: Week 6 and Week 12
System Usability Scale (SUS) at W6 and W12
Week 6 and Week 12
To evaluate acceptability of digital feedback.
기간: Week 6 and Week 12
TAM (technology Acceptance Model) at W6 and W12
Week 6 and Week 12
To assess the impact of active smartwatch feedback on sedentary time.
기간: day 1 to week 12
Resting time (excluding sleep) at baseline, W6 and W12
day 1 to week 12
To assess the impact of active smartwatch feedback on gait-related activity patterns.
기간: day 1 to week 12
gait performance metrics (data from the smartwatch)
day 1 to week 12
To assess the impact of active smartwatch feedback on blood pressure.
기간: day 1 to week 12
Continuous mean SBP and DBP and time-in-range at baseline, W6 and W12
day 1 to week 12
To monitor falls
기간: day 1 to week 12
Number of falls (collected continuously via the smartwatch) between baseline and W6 and between baseline and W12.
day 1 to week 12
To monitor cardiovascular events (atrial fibrillation, AF),
기간: day 1 to week 12
Number of cardiovascular events between baseline and W12.
day 1 to week 12
To examine effects on quality of life
기간: day 1 to week 12
Quality of life : physical and mental SF-36 auto-questionnaire scores at baseline, W6 and W12
day 1 to week 12
To examine effects on risk factors
기간: Day 1, week 6 and week 12
LDL cholesterol, alcohol, tobacco, weight and waist circumference at baseline and W12
Day 1, week 6 and week 12
Recurrence and cardiovascular events
기간: day 1 to week 12
Recurrent stroke or TIA or cardiovascular events at W6 and W12 and in case of alert or hospitalization
day 1 to week 12
To examine effects on fatigue
기간: day 1 to week 12
Fatigue : FAS and MFIS auto-questionnaires scores at baseline, W6 and W12
day 1 to week 12
To examine effects on cognition
기간: day 1 to week 12
Cognition : MoCA-short score at baseline, W6 and W12
day 1 to week 12
To examine effects on depression
기간: day 1 to week 12
Mood : PHQ-2 auto-questionnaire score at baseline, W6 and W12
day 1 to week 12
To examine effects on sleep
기간: day 1 to week 12
Sleep : efficiency and fragmentation at baseline, W6 and W12 and continuous
day 1 to week 12

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

University Hospital, Brest

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)

2027년 12월 1일

연구 완료 (추정된)

2027년 12월 1일

연구 등록 날짜

최초 제출

2026년 5월 29일

QC 기준을 충족하는 최초 제출

2026년 6월 5일

처음 게시됨 (실제)

2026년 6월 10일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 10일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 6월 5일

마지막으로 확인됨

2026년 6월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 29BRC23.0208

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

All collected data that underlie results in a publication

IPD 공유 기간

Data will be available after the publication of result and ending fifteen years following the last visit of the last patient

IPD 공유 액세스 기준

Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.

IPD 공유 지원 정보 유형

  • 연구_프로토콜

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. .

뇌졸중에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Slovakia

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

구독하다