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Post-Stroke Secondary Prevention With Digital Monitoring

RecruitingNAAges 18 Years - 80 YearsAllUniversity Hospital, Bordeaux
NCT06837311 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Stroke is the second leading cause of death and a major cause of disability worldwide. In 2019, Disability-Adjusted Life-Years (DALYs) related to stroke was estimated to have reached 143 million. Modifiable stroke risk-factors, which include poor lifestyle habits (tobacco, alcohol and illicit drug abuse, dietary patterns at risk, low physical activity), account for 90 % of the risk of stroke. Stroke complications and the risk of stroke recurrence is highly dependent on the control of these risk factors. Thus, the secondary prevention of stroke requires profound lifestyle modifications including substance use cessation and diet changes. National guidelines for stroke clinical practice advocate an immediate cessation of consumption of all substances but without recommendations on specific therapeutic regimens. Moreover, none address the management of poor coping with stress or mood problem

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📋 Eligibility rules (as published)
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
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What it tests

  • Ecological Momentary Assessment (EMA)
  • Biological assessment
  • Psychological examination and Substance Use symptomatology
  • Treatment as usual (TAU)
  • Expired carbon monoxide (CO)
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Where

1 site
CHU de Bordeaux
Bordeaux, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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