Digital monitoring to prevent repeat strokes after a recent stroke
Official title: Medical Benefit of Digital Monitoring Using apTeleCare for Secondary Prevention in Patients With a Recent Transient Ischemic Attack or Stroke
Run by University Hospital, Bordeaux · NCT06837311 · Data updated 2026-11-12
This trial will test whether smartphone-based digital monitoring with biological and psychological checks helps people who recently had a stroke and currently smoke to stop smoking and lower their risk of another stroke.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 388 (estimated) |
| Sponsor | University Hospital, Bordeaux Academic / other |
| Locations | 1 site (Bordeaux) |
| Status | Recruiting |
| Started | March 25, 2025 |
| Main results expected | March 25, 2027 |
| Study ends | March 25, 2028 |
| Registry record updated | July 21, 2025 |
| Trial ID | NCT06837311 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–79 with a recent (≤15 days) symptomatic ischemic or hemorrhagic stroke or a high-risk TIA (ABCD2 ≥ 4) who smoke, can use a smartphone, live in an area with internet coverage, attend post-stroke follow-up at the neurovascular unit, and have French national health insurance.
✕Probably not a fit
Patients with severe cognitive impairment, severe aphasia or visual deficits that prevent participation, subarachnoid hemorrhage, non-smokers, those without smartphone/internet access, or people not eligible for French national health insurance are unlikely to benefit from this program.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Adults who recently experienced an ischemic or hemorrhagic stroke (or a high-risk TIA) and who smoke are enrolled during routine post-stroke follow-up at the neurovascular unit. Participants use smartphone ecological momentary assessment (EMA) to report behaviors and symptoms, undergo biological measures including expired carbon monoxide, and receive psychological and substance-use evaluations alongside standard care. The digital monitoring is intended to support behavior change and smoking cessation in the early post-stroke period. The program is delivered at CHU de Bordeaux and requires smartphone and internet access and French national health insurance.
Why it matters
Potential benefit: If successful, this approach could help recent stroke survivors who smoke quit sooner and reduce their risk of stroke recurrence and related disability.
How similar studies have gone: Digital and EMA-based interventions for smoking cessation and risk-factor monitoring have shown promising results in other populations, but applying them specifically to immediate post-stroke secondary prevention is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male or female * At least 18 years of age and younger than 80 years; * Recent (≤ 15 days) clinically symptomatic ischemic or hemorrhagic stroke documented through brain imaging (CT or MRI) or a Transient Ischemic Attack with an Predictive Risk Score (ABCD2) ≥ 4; * Returning to the neurovascular unit for the standard care post-stroke follow-up visits; * National Institute Health Stroke Scale (NIHSS) \< 15; * modified Rankin scale ≤ 4; * No severe cognitive impairment as defined by the neurologist; * Current smokers (smoking at least 1 cigarette per day during the month before admission) * Able to use a smartphone * Living in an area with internet coverage * Written informed consent by the patient; * Coverage by the French National Health Insurance Exclusion Criteria: * Subarachnoid hemorrhage; Dementia syndrome or other central neurologic disorder; * Severe aphasia (NIHSS item 9 ≥ 2) * Severe visual impairment interfering with the completion of evaluations; * Severely impaired physical and/or mental health that, according to the neurologist, may affect the participant's capacity to participate in the study; * Individuals already undergoing treatment for tobacco cessation and/or SRADs at admission in the stroke unit; * Pregnancy or breastfeeding; * Inability to read French; * Individuals under legal protection or unable to express personally their consent * Participation in another protocol modifying the patient's follow-up status. * Person deprived of liberty * Person in emergency situation
Where it's running
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CHU de Bordeaux
Bordeaux, France Recruiting
Study contacts
- Principal investigator: Igor SIBON — University Hospital, Bordeaux
- Study coordinator: Igor SIBON
- Email: igor.sibon@chu-bordeaux.fr
- Phone: 0556795520
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.