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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:
Setting daily step goals and assessing potential obstacles
Scheduling regular calls (twice a week) for the duration of the study.
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
The end-of-study visit will take place at the hospital during a scheduled routine care appointment:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| "Passive" Smartwatch arm | No Intervention |
| |
| "Active" Smartwatch arm | Experimental |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Serge TIMSIT Pr, Neurologist | Contact | +33298147349 | serge.timsit@chu-brest.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Brest | Brest | 29200 | France |
|
All collected data that underlie results in a publication
Data will be available after the publication of result and ending fifteen years following the last visit of the last patient
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.
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D002546 | Ischemic Attack, Transient |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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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)
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| 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 |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D002545 | Brain Ischemia |