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Smartwatch-Guided Secondary Prevention After Stroke (WATCH-STEP)

5. juni 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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

Studietype

Intervensjonell

Registrering (Antatt)

50

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Ingen inngripen: "Passive" Smartwatch arm
  • 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.
Eksperimentell: "Active" Smartwatch arm
  • 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.
Annen: 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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
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
Tidsramme: Week 12
Difference in steps/day at 12 weeks between both arms (average of the final 14 valid days) (target Δ ≥ 1500)
Week 12

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
To evaluate feasibility to smartwatch wear
Tidsramme: Week 6 and Week 12
Wear-time adherence at W6 and W12
Week 6 and Week 12
To evaluate adherence to smartwatch wear
Tidsramme: Week 6 and Week 12
System Usability Scale (SUS) at W6 and W12
Week 6 and Week 12
To evaluate acceptability of digital feedback.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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
Tidsramme: 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),
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: day 1 to week 12
Cognition : MoCA-short score at baseline, W6 and W12
day 1 to week 12
To examine effects on depression
Tidsramme: 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
Tidsramme: day 1 to week 12
Sleep : efficiency and fragmentation at baseline, W6 and W12 and continuous
day 1 to week 12

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University Hospital, Brest

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. september 2026

Primær fullføring (Antatt)

1. desember 2027

Studiet fullført (Antatt)

1. desember 2027

Datoer for studieregistrering

Først innsendt

29. mai 2026

Først innsendt som oppfylte QC-kriteriene

5. juni 2026

Først lagt ut (Faktiske)

10. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

10. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

5. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 29BRC23.0208

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

All collected data that underlie results in a publication

IPD-delingstidsramme

Data will be available after the publication of result and ending fifteen years following the last visit of the last patient

Tilgangskriterier for IPD-deling

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.

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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