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

2026年6月5日 更新者：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.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

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

研究类型

介入性

注册 (估计的)

50

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

学习地点

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 ≤ 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.

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：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
无干预："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.
实验性的："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.
其他：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

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
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
大体时间：Week 12
Difference in steps/day at 12 weeks between both arms (average of the final 14 valid days) (target Δ ≥ 1500)
Week 12

次要结果测量

结果测量
措施说明
大体时间
To evaluate feasibility to smartwatch wear
大体时间：Week 6 and Week 12
Wear-time adherence at W6 and W12
Week 6 and Week 12
To evaluate adherence to smartwatch wear
大体时间：Week 6 and Week 12
System Usability Scale (SUS) at W6 and W12
Week 6 and Week 12
To evaluate acceptability of digital feedback.
大体时间：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.
大体时间：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.
大体时间：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.
大体时间：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
大体时间：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),
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：day 1 to week 12
Cognition : MoCA-short score at baseline, W6 and W12
day 1 to week 12
To examine effects on depression
大体时间：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
大体时间：day 1 to week 12
Sleep : efficiency and fragmentation at baseline, W6 and W12 and continuous
day 1 to week 12

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

University Hospital, Brest

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)

2027年12月1日

研究完成 (估计的)

2027年12月1日

研究注册日期

首次提交

2026年5月29日

首先提交符合 QC 标准的

2026年6月5日

首次发布 (实际的)

2026年6月10日

研究记录更新

最后更新发布 (实际的)

2026年6月10日

上次提交的符合 QC 标准的更新

2026年6月5日

最后验证

2026年6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

  • 29BRC23.0208

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

All collected data that underlie results in a publication

IPD 共享时间框架

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

IPD 共享访问标准

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 共享支持信息类型

  • 研究方案

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

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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