Smartwatch-Guided Secondary Prevention After Stroke (WATCH-STEP)
5 giugno 2026 aggiornato da: 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.
Panoramica dello studio
Stato
Non ancora reclutamento
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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
Tipo di studio
Interventistico
Iscrizione (Stimato)
50
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Serge TIMSIT Pr, Neurologist
- Numero di telefono: +33298147349
- Email: serge.timsit@chu-brest.fr
Luoghi di studio
-
-
-
Brest, Francia, 29200
- CHU Brest
-
Contatto:
- Principal Investigator
- Numero di telefono: +33298147349
- Email: serge.timsit@chu-brest.fr
-
-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
No
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Nessun intervento: "Passive" Smartwatch arm
|
|
|
Sperimentale: "Active" Smartwatch arm
|
Setting daily walking goals, assessing obstacles Regular phone calls (twice a week) to review progress, adjust goals, and provide support
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
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
Lasso di tempo: Week 12
|
Difference in steps/day at 12 weeks between both arms (average of the final 14 valid days) (target Δ ≥ 1500)
|
Week 12
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
To evaluate feasibility to smartwatch wear
Lasso di tempo: Week 6 and Week 12
|
Wear-time adherence at W6 and W12
|
Week 6 and Week 12
|
|
To evaluate adherence to smartwatch wear
Lasso di tempo: Week 6 and Week 12
|
System Usability Scale (SUS) at W6 and W12
|
Week 6 and Week 12
|
|
To evaluate acceptability of digital feedback.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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
Lasso di tempo: 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),
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: day 1 to week 12
|
Cognition : MoCA-short score at baseline, W6 and W12
|
day 1 to week 12
|
|
To examine effects on depression
Lasso di tempo: 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
Lasso di tempo: day 1 to week 12
|
Sleep : efficiency and fragmentation at baseline, W6 and W12 and continuous
|
day 1 to week 12
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Stimato)
1 settembre 2026
Completamento primario (Stimato)
1 dicembre 2027
Completamento dello studio (Stimato)
1 dicembre 2027
Date di iscrizione allo studio
Primo inviato
29 maggio 2026
Primo inviato che soddisfa i criteri di controllo qualità
5 giugno 2026
Primo Inserito (Effettivo)
10 giugno 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
10 giugno 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
5 giugno 2026
Ultimo verificato
1 giugno 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 29BRC23.0208
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
SÌ
Descrizione del piano IPD
All collected data that underlie results in a publication
Periodo di condivisione IPD
Data will be available after the publication of result and ending fifteen years following the last visit of the last patient
Criteri di accesso alla condivisione 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.
Tipo di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .