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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Stroke; Transient Ischemic Attack
• Intervention / Treatment: Other: Smartwatch-Guided Secondary Prevention after Stroke

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):

• 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

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Serge TIMSIT Pr, Neurologist; Phone Number: +33298147349; Email: serge.timsit@chu-brest.fr

Study Locations

• France
  • Brest, France, 29200
    • CHU Brest
    • Contact: Principal Investigator; Phone Number: +33298147349; Email: serge.timsit@chu-brest.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Other: 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate feasibility to smartwatch wear	Wear-time adherence at W6 and W12	Week 6 and Week 12
To evaluate adherence to smartwatch wear	System Usability Scale (SUS) at W6 and W12	Week 6 and Week 12
To evaluate acceptability of digital feedback.	TAM (technology Acceptance Model) at W6 and W12	Week 6 and Week 12
To assess the impact of active smartwatch feedback on sedentary time.	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.	gait performance metrics (data from the smartwatch)	day 1 to week 12
To assess the impact of active smartwatch feedback on blood pressure.	Continuous mean SBP and DBP and time-in-range at baseline, W6 and W12	day 1 to week 12
To monitor falls	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),	Number of cardiovascular events between baseline and W12.	day 1 to week 12
To examine effects on quality of life	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	LDL cholesterol, alcohol, tobacco, weight and waist circumference at baseline and W12	Day 1, week 6 and week 12
Recurrence and cardiovascular events	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	Fatigue : FAS and MFIS auto-questionnaires scores at baseline, W6 and W12	day 1 to week 12
To examine effects on cognition	Cognition : MoCA-short score at baseline, W6 and W12	day 1 to week 12
To examine effects on depression	Mood : PHQ-2 auto-questionnaire score at baseline, W6 and W12	day 1 to week 12
To examine effects on sleep	Sleep : efficiency and fragmentation at baseline, W6 and W12 and continuous	day 1 to week 12

Collaborators and Investigators

• Sponsor: University Hospital, Brest

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: May 29, 2026
• First Submitted That Met QC Criteria: June 5, 2026
• First Posted (Actual): June 10, 2026

Study Record Updates

• Last Update Posted (Actual): June 10, 2026
• Last Update Submitted That Met QC Criteria: June 5, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: SMARTWATCH
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Ischemia; Stroke; Ischemic Attack, Transient
• Other Study ID Numbers: 29BRC23.0208

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All collected data that underlie results in a publication
• IPD Sharing Time Frame: Data will be available after the publication of result and ending fifteen years following the last visit of the last patient
• IPD Sharing Access Criteria: 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 Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No