Smartwatch-Guided Secondary Prevention After Stroke (WATCH-STEP)
5 juin 2026 mis à jour par: University Hospital, Brest
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.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Intervention / Traitement
Description détaillée
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
Type d'étude
Interventionnel
Inscription (Estimé)
50
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Serge TIMSIT Pr, Neurologist
- Numéro de téléphone: +33298147349
- E-mail: serge.timsit@chu-brest.fr
Lieux d'étude
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Brest, France, 29200
- CHU Brest
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Contact:
- Principal Investigator
- Numéro de téléphone: +33298147349
- E-mail: serge.timsit@chu-brest.fr
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-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La 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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Aucune intervention: "Passive" Smartwatch arm
|
|
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Expérimental: "Active" Smartwatch arm
|
Setting daily walking goals, assessing obstacles Regular phone calls (twice a week) to review progress, adjust goals, and provide support
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
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
Délai: Week 12
|
Difference in steps/day at 12 weeks between both arms (average of the final 14 valid days) (target Δ ≥ 1500)
|
Week 12
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
To evaluate feasibility to smartwatch wear
Délai: Week 6 and Week 12
|
Wear-time adherence at W6 and W12
|
Week 6 and Week 12
|
|
To evaluate adherence to smartwatch wear
Délai: Week 6 and Week 12
|
System Usability Scale (SUS) at W6 and W12
|
Week 6 and Week 12
|
|
To evaluate acceptability of digital feedback.
Délai: Week 6 and Week 12
|
TAM (technology Acceptance Model) at W6 and W12
|
Week 6 and Week 12
|
|
To assess the impact of active smartwatch feedback on sedentary time.
Délai: day 1 to week 12
|
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.
Délai: day 1 to week 12
|
gait performance metrics (data from the smartwatch)
|
day 1 to week 12
|
|
To assess the impact of active smartwatch feedback on blood pressure.
Délai: day 1 to week 12
|
Continuous mean SBP and DBP and time-in-range at baseline, W6 and W12
|
day 1 to week 12
|
|
To monitor falls
Délai: day 1 to week 12
|
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),
Délai: day 1 to week 12
|
Number of cardiovascular events between baseline and W12.
|
day 1 to week 12
|
|
To examine effects on quality of life
Délai: day 1 to week 12
|
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
Délai: Day 1, week 6 and week 12
|
LDL cholesterol, alcohol, tobacco, weight and waist circumference at baseline and W12
|
Day 1, week 6 and week 12
|
|
Recurrence and cardiovascular events
Délai: day 1 to week 12
|
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
Délai: day 1 to week 12
|
Fatigue : FAS and MFIS auto-questionnaires scores at baseline, W6 and W12
|
day 1 to week 12
|
|
To examine effects on cognition
Délai: day 1 to week 12
|
Cognition : MoCA-short score at baseline, W6 and W12
|
day 1 to week 12
|
|
To examine effects on depression
Délai: day 1 to week 12
|
Mood : PHQ-2 auto-questionnaire score at baseline, W6 and W12
|
day 1 to week 12
|
|
To examine effects on sleep
Délai: day 1 to week 12
|
Sleep : efficiency and fragmentation at baseline, W6 and W12 and continuous
|
day 1 to week 12
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
1 septembre 2026
Achèvement primaire (Estimé)
1 décembre 2027
Achèvement de l'étude (Estimé)
1 décembre 2027
Dates d'inscription aux études
Première soumission
29 mai 2026
Première soumission répondant aux critères de contrôle qualité
5 juin 2026
Première publication (Réel)
10 juin 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
10 juin 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
5 juin 2026
Dernière vérification
1 juin 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 29BRC23.0208
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
OUI
Description du régime IPD
All collected data that underlie results in a publication
Délai de partage IPD
Data will be available after the publication of result and ending fifteen years following the last visit of the last patient
Critères d'accès au partage IPD
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.
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .