Smartwatch-Guided Secondary Prevention After Stroke (WATCH-STEP)
5. Juni 2026 aktualisiert von: 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.
Studienübersicht
Status
Noch keine Rekrutierung
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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
Studientyp
Interventionell
Einschreibung (Geschätzt)
50
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienkontakt
- Name: Serge TIMSIT Pr, Neurologist
- Telefonnummer: +33298147349
- E-Mail: serge.timsit@chu-brest.fr
Studienorte
-
-
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Brest, Frankreich, 29200
- CHU Brest
-
Kontakt:
- Principal Investigator
- Telefonnummer: +33298147349
- E-Mail: serge.timsit@chu-brest.fr
-
-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Nein
Beschreibung
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.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Kein Eingriff: "Passive" Smartwatch arm
|
|
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Experimental: "Active" Smartwatch arm
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Setting daily walking goals, assessing obstacles Regular phone calls (twice a week) to review progress, adjust goals, and provide support
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
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
Zeitfenster: Week 12
|
Difference in steps/day at 12 weeks between both arms (average of the final 14 valid days) (target Δ ≥ 1500)
|
Week 12
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
To evaluate feasibility to smartwatch wear
Zeitfenster: Week 6 and Week 12
|
Wear-time adherence at W6 and W12
|
Week 6 and Week 12
|
|
To evaluate adherence to smartwatch wear
Zeitfenster: Week 6 and Week 12
|
System Usability Scale (SUS) at W6 and W12
|
Week 6 and Week 12
|
|
To evaluate acceptability of digital feedback.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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
Zeitfenster: 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),
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: day 1 to week 12
|
Cognition : MoCA-short score at baseline, W6 and W12
|
day 1 to week 12
|
|
To examine effects on depression
Zeitfenster: 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
Zeitfenster: day 1 to week 12
|
Sleep : efficiency and fragmentation at baseline, W6 and W12 and continuous
|
day 1 to week 12
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Geschätzt)
1. September 2026
Primärer Abschluss (Geschätzt)
1. Dezember 2027
Studienabschluss (Geschätzt)
1. Dezember 2027
Studienanmeldedaten
Zuerst eingereicht
29. Mai 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
5. Juni 2026
Zuerst gepostet (Tatsächlich)
10. Juni 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
10. Juni 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
5. Juni 2026
Zuletzt verifiziert
1. Juni 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 29BRC23.0208
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
JA
Beschreibung des IPD-Plans
All collected data that underlie results in a publication
IPD-Sharing-Zeitrahmen
Data will be available after the publication of result and ending fifteen years following the last visit of the last patient
IPD-Sharing-Zugriffskriterien
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.
Art der unterstützenden IPD-Freigabeinformationen
- STUDIENPROTOKOLL
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
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