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.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- University Hospital, Brest
- Enrollment
- 50
- Locations
- 1
Study Overview
Brief Summary
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.
Detailed Description
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):
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 40 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.