CHU Brest
Brest, 29200, France
NCT Number: NCT07640360
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.
Trial opening soon.
Get Notified40 year–75 year
All sexes
Interventional
Not applicable
Brest, 29200, France
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:
For all patients (both "active" and "passive" watch):
The end-of-study visit will take place at the hospital during a scheduled routine care appointment:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Setting daily walking goals, assessing obstacles Regular phone calls (twice a week) to review progress, adjust goals, and provide support
Time frame: Week 12
Difference in steps/day at 12 weeks between both arms (average of the final 14 valid days) (target Δ ≥ 1500)
Time frame: Week 6 and Week 12
Wear-time adherence at W6 and W12
Time frame: Week 6 and Week 12
System Usability Scale (SUS) at W6 and W12
Time frame: Week 6 and Week 12
TAM (technology Acceptance Model) at W6 and W12
Time frame: day 1 to week 12
Resting time (excluding sleep) at baseline, W6 and W12
Time frame: day 1 to week 12
gait performance metrics (data from the smartwatch)
Time frame: day 1 to week 12
Continuous mean SBP and DBP and time-in-range at baseline, W6 and W12
Time frame: day 1 to week 12
Number of falls (collected continuously via the smartwatch) between baseline and W6 and between baseline and W12.
Time frame: day 1 to week 12
Number of cardiovascular events between baseline and W12.
Time frame: day 1 to week 12
Quality of life : physical and mental SF-36 auto-questionnaire scores at baseline, W6 and W12
Time frame: Day 1, week 6 and week 12
LDL cholesterol, alcohol, tobacco, weight and waist circumference at baseline and W12
Time frame: day 1 to week 12
Recurrent stroke or TIA or cardiovascular events at W6 and W12 and in case of alert or hospitalization
Time frame: day 1 to week 12
Fatigue : FAS and MFIS auto-questionnaires scores at baseline, W6 and W12
Time frame: day 1 to week 12
Cognition : MoCA-short score at baseline, W6 and W12
Time frame: day 1 to week 12
Mood : PHQ-2 auto-questionnaire score at baseline, W6 and W12
Time frame: day 1 to week 12
Sleep : efficiency and fragmentation at baseline, W6 and W12 and continuous
Contact information is provided by the study sponsor or research team.
University Hospital, Brest
Other
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.
Acronym: WATCH-STEP
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07628283
Brain Diseases, Brain Ischemia
Suqian, Jiangsu, China
View Trial DetailsNCT05820295
Arrhythmias, Cardiac, Atrial Fibrillation
New York, United States
View Trial DetailsNCT06253000
Acute Cerebrovascular Accident, Arrhythmias, Cardiac
Moscow, Russia
View Trial DetailsNCT06091319
Acute Coronary Syndrome, Atherosclerosis of Artery
Ottawa, Ontario, Canada
View Trial Details