StrokeWATCH-STEPNCT07640360
Smartwatch-Guided Secondary Prevention After Stroke
A study testing Smartwatch-Guided Secondary Prevention after Stroke in people with Stroke and Transient Ischemic Attack, run by University Hospital, Brest at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Stroke, Transient Ischemic Attack
- What is being tested?
- Smartwatch-Guided Secondary Prevention after Stroke
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
CHU Brest
Brest, 29200
Principal Investigator, +33298147349, serge.timsit@chu-brest.fr
About this study
Official 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.
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.
Read the 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:
- 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
- Conditions
- Stroke, Transient Ischemic Attack
- Being tested
- Smartwatch-Guided Secondary Prevention after Stroke
- Keywords
- SMARTWATCH
- Medical subject headings
- Stroke, Ischemic Attack, Transient
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smartwatch-Guided Secondary Prevention after StrokeOther
Setting daily walking goals, assessing obstacles Regular phone calls (twice a week) to review progress, adjust goals, and provide support
| Study group | Role | What they receive |
|---|---|---|
| "Passive" Smartwatch arm | No intervention | * 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. |
| "Active" Smartwatch arm | Experimental | * 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. Receives: Other: Smartwatch-Guided Secondary Prevention after Stroke |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Week 12
Secondary outcomes (15)
To evaluate feasibility to smartwatch wear
Wear-time adherence at W6 and W12
Measured: Week 6 and Week 12
To evaluate adherence to smartwatch wear
System Usability Scale (SUS) at W6 and W12
Measured: Week 6 and Week 12
To evaluate acceptability of digital feedback.
TAM (technology Acceptance Model) at W6 and W12
Measured: 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
Measured: 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)
Measured: 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
Measured: 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.
Measured: day 1 to week 12
To monitor cardiovascular events (atrial fibrillation, AF),
Number of cardiovascular events between baseline and W12.
Measured: 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
Measured: day 1 to week 12
To examine effects on risk factors
LDL cholesterol, alcohol, tobacco, weight and waist circumference at baseline and W12
Measured: 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
Measured: day 1 to week 12
To examine effects on fatigue
Fatigue : FAS and MFIS auto-questionnaires scores at baseline, W6 and W12
Measured: day 1 to week 12
To examine effects on cognition
Cognition : MoCA-short score at baseline, W6 and W12
Measured: day 1 to week 12
To examine effects on depression
Mood : PHQ-2 auto-questionnaire score at baseline, W6 and W12
Measured: day 1 to week 12
To examine effects on sleep
Sleep : efficiency and fragmentation at baseline, W6 and W12 and continuous
Measured: day 1 to week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2026
- Study startSep 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- * A prospective, randomized, parallel-group, superiority trial with 1:1 allocation.. * Randomization: Computer-generated, stratified by baseline steps (\<4,000 vs ≥4,000) * Blinding: Due to the behavioral nature of the intervention, participants and nurses cannot be blinded. * Outcome assessors will remain blinded to treatment allocation. * A CONSORT flowchart will document the passage from screening → randomization → follow-up. → end of study * Baseline (B), weeks (W) 12: o Face-to-face consultation: B and W12: Nurse + Clinical study technician for all patients * W6: phone call to provide feedback and get the information * Behavior multicomponent strategies (2X/week) for the active arm (Clinical study technician watch or phone incentive/prompt)
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07640360
- Sponsor's protocol ID
- 29BRC23.0208
- Acronym
- WATCH-STEP
- Status last verified
- Jun 2026
- First submitted
- 29 May 2026
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT07640360
- Acronym / sponsor ID
- WATCH-STEP / 29BRC23.0208
- Conditions
- Stroke, Transient Ischemic Attack
- Keywords
- SMARTWATCH
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 10 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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):
- 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:
- 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- * A prospective, randomized, parallel-group, superiority trial with 1:1 allocation.. * Randomization: Computer-generated, stratified by baseline steps (<4,000 vs ≥4,000) * Blinding: Due to the behavioral nature of the intervention, participants and nurses cannot be blinded. * Outcome assessors will remain blinded to treatment allocation. * A CONSORT flowchart will document the passage from screening → randomization → follow-up. → end of study * Baseline (B), weeks (W) 12: o Face-to-face consultation: B and W12: Nurse + Clinical study technician for all patients * W6: phone call to provide feedback and get the information * Behavior multicomponent strategies (2X/week) for the active arm (Clinical study technician watch or phone incentive/prompt)
| Arm | Type | Receives |
|---|---|---|
| "Passive" Smartwatch arm | No intervention | –* 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. |
| "Active" Smartwatch arm | Experimental | Other: Smartwatch-Guided Secondary Prevention after Stroke* 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. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (10 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smartwatch-Guided Secondary Prevention after StrokeSetting daily walking goals, assessing obstacles Regular phone calls (twice a week) to review progress, adjust goals, and provide support | Other | "Active" Smartwatch arm |
Primary outcome
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)
15 secondary outcomes
To evaluate feasibility to smartwatch wear
Time frame: Week 6 and Week 12
To evaluate adherence to smartwatch wear
Time frame: Week 6 and Week 12
To evaluate acceptability of digital feedback.
Time frame: Week 6 and Week 12
To assess the impact of active smartwatch feedback on sedentary time.
Time frame: day 1 to week 12
To assess the impact of active smartwatch feedback on gait-related activity patterns.
Time frame: day 1 to week 12
To assess the impact of active smartwatch feedback on blood pressure.
Time frame: day 1 to week 12
To monitor falls
Time frame: day 1 to week 12
To monitor cardiovascular events (atrial fibrillation, AF),
Time frame: day 1 to week 12
To examine effects on quality of life
Time frame: day 1 to week 12
To examine effects on risk factors
Time frame: Day 1, week 6 and week 12
Recurrence and cardiovascular events
Time frame: day 1 to week 12
To examine effects on fatigue
Time frame: day 1 to week 12
To examine effects on cognition
Time frame: day 1 to week 12
To examine effects on depression
Time frame: day 1 to week 12
To examine effects on sleep
Time frame: day 1 to week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smartwatch-Guided Secondary Prevention after Stroke in people with Stroke and Transient Ischemic Attack, run by University Hospital, Brest at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Serge TIMSIT Pr, Neurologist (+33298147349, serge.timsit@chu-brest.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026; AzTrials last refreshed its copy on 31 Oct 2026.