Smartwatch-Guided Secondary Prevention After Stroke

Sponsor
University Hospital, Brest
Study ID
NCT07640360
Status
Not Yet Recruiting

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Conditions

  • Stroke
  • Transient Ischemic Attack

Eligibility Criteria

Sex
ALL
Age
40 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Smartwatch-Guided Secondary Prevention after Stroke — OTHER
    Setting daily walking goals, assessing obstacles Regular phone calls (twice a week) to review progress, adjust goals, and provide support

Study Details

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.

Key Dates

First listed
Jun 10, 2026
Start date
Sep 30, 2026
Status verified
Jun 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • No Intervention: "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.
  • Experimental: "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.

Primary Outcome Measure

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 [ Time Frame: Week 12 ]

Central Contacts

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