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NCT Number: NCT07640360

Smartwatch-Guided Secondary Prevention After 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.

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Key information

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. 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

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

Secondary outcomes

  1. To evaluate feasibility to smartwatch wear

    Time frame: Week 6 and Week 12

    Wear-time adherence at W6 and W12

  2. To evaluate adherence to smartwatch wear

    Time frame: Week 6 and Week 12

    System Usability Scale (SUS) at W6 and W12

  3. To evaluate acceptability of digital feedback.

    Time frame: Week 6 and Week 12

    TAM (technology Acceptance Model) at W6 and W12

  4. To assess the impact of active smartwatch feedback on sedentary time.

    Time frame: day 1 to week 12

    Resting time (excluding sleep) at baseline, W6 and W12

  5. To assess the impact of active smartwatch feedback on gait-related activity patterns.

    Time frame: day 1 to week 12

    gait performance metrics (data from the smartwatch)

  6. To assess the impact of active smartwatch feedback on blood pressure.

    Time frame: day 1 to week 12

    Continuous mean SBP and DBP and time-in-range at baseline, W6 and W12

  7. To monitor falls

    Time frame: day 1 to week 12

    Number of falls (collected continuously via the smartwatch) between baseline and W6 and between baseline and W12.

  8. To monitor cardiovascular events (atrial fibrillation, AF),

    Time frame: day 1 to week 12

    Number of cardiovascular events between baseline and W12.

  9. To examine effects on quality of life

    Time frame: day 1 to week 12

    Quality of life : physical and mental SF-36 auto-questionnaire scores at baseline, W6 and W12

  10. To examine effects on risk factors

    Time frame: Day 1, week 6 and week 12

    LDL cholesterol, alcohol, tobacco, weight and waist circumference at baseline and W12

  11. Recurrence and cardiovascular events

    Time frame: day 1 to week 12

    Recurrent stroke or TIA or cardiovascular events at W6 and W12 and in case of alert or hospitalization

  12. To examine effects on fatigue

    Time frame: day 1 to week 12

    Fatigue : FAS and MFIS auto-questionnaires scores at baseline, W6 and W12

  13. To examine effects on cognition

    Time frame: day 1 to week 12

    Cognition : MoCA-short score at baseline, W6 and W12

  14. To examine effects on depression

    Time frame: day 1 to week 12

    Mood : PHQ-2 auto-questionnaire score at baseline, W6 and W12

  15. To examine effects on sleep

    Time frame: day 1 to week 12

    Sleep : efficiency and fragmentation at baseline, W6 and W12 and continuous

Study contacts

Contact information is provided by the study sponsor or research team.

Serge TIMSIT Pr, Neurologist

CONTACT

[email protected]

+33298147349

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Official study title

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.

Acronym: WATCH-STEP

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 10, 2026
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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