Digital monitoring to prevent repeat strokes after a recent stroke

Medical Benefit of Digital Monitoring Using apTeleCare for Secondary Prevention in Patients With a Recent Transient Ischemic Attack or Stroke

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

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 388 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: University Hospital, Bordeaux (Academic / other)
• Locations: 1 site (Bordeaux)
• Trial ID: NCT06837311 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility 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 this trial is running

Bordeaux

• CHU de Bordeaux — Bordeaux, France (Recruiting)

Study contacts

• Principal investigator: Igor SIBON — University Hospital, Bordeaux
• Study coordinator: Igor SIBON

Conditions Stroke