An interventional study of Smartwatch-Guided Secondary Prevention after Stroke in Stroke and Transient Ischemic Attack, sponsored by University Hospital, Brest. Not yet recruiting at 1 site in France. Open to participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-06-10.
Sponsored by University Hospital, Brest · Not applicable, Interventional, and Prevention
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.
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):
For patients in the "passive" smartwatch group:
o The smartwatch will collect data passively, without notifications.
For patients in the "active" smartwatch group:
Scheduling regular calls (twice a week) for the duration of the study.
For all patients (both "active" and "passive" watch):
Questionnaires
The end-of-study visit will take place at the hospital during a scheduled routine care appointment:
8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.
This study's planned enrollment of 50 is close to the median of 49 across 6,024 interventional studies indexed under Stroke.
Browse Stroke studies →University Hospital, Brest is the lead sponsor of 601 studies on the registry; 136 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
* 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.
* 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
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)
Time frame: Week 12
To evaluate feasibility to smartwatch wear
Wear-time adherence at W6 and W12
Time frame: Week 6 and Week 12
To evaluate adherence to smartwatch wear
System Usability Scale (SUS) at W6 and W12
Time frame: Week 6 and Week 12
To evaluate acceptability of digital feedback.
TAM (technology Acceptance Model) at W6 and W12
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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.
Time frame: day 1 to week 12
To monitor cardiovascular events (atrial fibrillation, AF),
Number of cardiovascular events between baseline and W12.
Time frame: 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
Time frame: day 1 to week 12
To examine effects on risk factors
LDL cholesterol, alcohol, tobacco, weight and waist circumference at baseline and W12
Time frame: 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
Time frame: day 1 to week 12
To examine effects on fatigue
Fatigue : FAS and MFIS auto-questionnaires scores at baseline, W6 and W12
Time frame: day 1 to week 12
To examine effects on cognition
Cognition : MoCA-short score at baseline, W6 and W12
Time frame: day 1 to week 12
To examine effects on depression
Mood : PHQ-2 auto-questionnaire score at baseline, W6 and W12
Time frame: day 1 to week 12
To examine effects on sleep
Sleep : efficiency and fragmentation at baseline, W6 and W12 and continuous
Time frame: day 1 to week 12
Plan to share: Yes — All collected data that underlie results in a publication
Supporting information: Study protocol
Time frame: Data will be available after the publication of result and ending fifteen years following the last visit of the last patient
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.
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Dec 2027, 15 months later.
Of 3,108 non-industry interventional studies with no phase under Stroke, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 46. This study's planned 15 months is below that.
Counting every sponsor, half of 3,252 studies reached it within 23 months; a quarter within 10 and three quarters within 46.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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