Clinical trial NCT06837311: Post-Stroke Secondary Prevention With Digital Monitoring
Official title: Medical Benefit of Digital Monitoring Using apTeleCare for Secondary Prevention in Patients With a Recent Transient Ischemic Attack or Stroke
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stroke
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2025-02-20
Enrollment: 388
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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 problems though they are major population attributable risk factors of stroke and constitute major barriers of behavior changes achievement. Yet, post-stroke emotional impairments are frequent, post-stroke depression and anxiety being the most frequent (prevalence is 30% and 25%, respectively). Importantly, independently from stroke, emotional impairments or disorders and Substance Related and Addiction Disorders (SRADs) are frequent comorbid conditions (dual disorders) with debilitating consequences and the interplay between the two conditions makes rehabilitation more complex. This suggests that taking into account stroke patients' mental health status might improve not only the management of post-stroke emotional impairments but also the control of stroke vascular risk factors.

Regarding secondary prevention programs focusing on behavioral changes among Cardiovascular and Cerebrovascular Disease (CVD) patients, the literature is sparse and studies on smoking cessation are the most widely documented. Despite the risk of smoking after a myocardial infarct or a stroke/Transient Ischemic Attack (TIA), less than half of patients quit smoking after the event or achieve long-term abstinence.

To increase treatment adherence and efficacy, besides systematically screening lifestyle habits and evaluating the patients' mental health and motivation to change in clinical routine, experts in the domain emphasize the need to:

* start delivering treatment as early as possible, ideally during hospitalization;
* tailor the intensity of the treatment (combination of pharmacological medications +/- behavioral intervention; frequency of the follow-up/contacts) according to the risk profile of each patient, particularly depending on the level of dependence and the presence of comorbid emotional difficulties/psychiatric disorders.

After hospital discharge, in standard care, the follow-up visit is scheduled 4 to 6 months post-stroke. Knowing that the vast majority of smoking relapses occur in the weeks following stroke, it appears that this period is of high risk for missing the goal of stroke secondary prevention. Therefore, new approaches are urgently needed that would allow for the day-to-day examination of clinical change in the immediate days and weeks following discharge from the stroke acute-care unit to optimize the patient's recovery and quality of life.

The potential pivotal role of eHealth development has been advocated by the World Health Organization, which considers e-Health as a cost-effective and secure use of information and communication technologies (ICT). Used in the context of stroke secondary prevention, eHealth technologies should give each patient the opportunity to describe his/her own experiences and symptoms and the contexts of daily life in which they occur that may constitute negative factors for post-stroke recovery. Post-stroke management would thus be optimized through a person-centered, intense and multidisciplinary care program.

Investigators believe apTeleCare would allow for such a day-to-day examination of clinical change in the immediate days and weeks following discharge from the stroke acute-care unit. It offers the possibility not only to closely monitor patients' experiences and symptoms and the contexts of daily life in which they occur, but also to inform the clinical team in real-time via specific alerts that depend on the type and level of difficulties the patients encounter for adopting the expected changes in their lifestyle


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

Primary outcomes:
measure: Expired carbon monoxide (CO) rate
timeFrame: 6 months
Secondary outcomes:
measure: Level of risk and prevalence of Substance-related and addictive disorders (SRADs)
timeFrame: Day 0
measure: Level of risk and prevalence of Substance-related and addictive disorders (SRADs)
timeFrame: 3 Months
measure: Level of risk and prevalence of Substance-related and addictive disorders (SRADs)
timeFrame: 6 Months
measure: Level of risk and prevalence of Substance-related and addictive disorders (SRADs)
timeFrame: 12 Months
measure: Fagerström Test for Nicotine Dependence (FTND) score
timeFrame: Day 0
measure: Fagerström Test for Nicotine Dependence (FTND) score
timeFrame: 3 months
measure: Fagerström Test for Nicotine Dependence (FTND) score
timeFrame: 6 months
measure: Fagerström Test for Nicotine Dependence (FTND) score
timeFrame: 12 months
measure: modified Yale Food Addiction Scale 2.0 (mYFAS 2.0) score
timeFrame: Day 0
measure: modified Yale Food Addiction Scale 2.0 (mYFAS 2.0) score
timeFrame: 3 Months
measure: modified Yale Food Addiction Scale 2.0 (mYFAS 2.0) score
timeFrame: 6 Months
measure: modified Yale Food Addiction Scale 2.0 (mYFAS 2.0) score
timeFrame: 12 Months
measure: Alcohol Use Disorder Identification Test (AUDIT) Score
timeFrame: Day 0
measure: Alcohol Use Disorder Identification Test (AUDIT) Score
timeFrame: 3 months
measure: Alcohol Use Disorder Identification Test (AUDIT) Score
timeFrame: 6 months
measure: Alcohol Use Disorder Identification Test (AUDIT) Score
timeFrame: 12 months
measure: Cannabis Abuse Screening Test (CAST) score
timeFrame: Day 0
measure: Cannabis Abuse Screening Test (CAST) score
timeFrame: 3 Months
measure: Cannabis Abuse Screening Test (CAST) score
timeFrame: 6 Months
measure: Cannabis Abuse Screening Test (CAST) score
timeFrame: 12 Months
measure: Readiness Ruler or Substance Use Motivation Ruler score
timeFrame: Day 0
measure: Readiness Ruler or Substance Use Motivation Ruler score
timeFrame: 3 months
measure: Readiness Ruler or Substance Use Motivation Ruler score
timeFrame: 6 months
measure: Readiness Ruler or Substance Use Motivation Ruler score
timeFrame: 12 months
measure: Hospital Anxiety and Depression scale (HAD) score
timeFrame: Day 0
measure: Hospital Anxiety and Depression scale (HAD) score
timeFrame: 3 Months
measure: Hospital Anxiety and Depression scale (HAD) score
timeFrame: 6 Months
measure: Hospital Anxiety and Depression scale (HAD) score
timeFrame: 12 Months
measure: Multidimensional Assessment of Thymic States scale (MAThYS) Score
timeFrame: Day 0
measure: Multidimensional Assessment of Thymic States scale (MAThYS) Score
timeFrame: 3 Months
measure: Multidimensional Assessment of Thymic States scale (MAThYS) Score
timeFrame: 6 Months
measure: Multidimensional Assessment of Thymic States scale (MAThYS) Score
timeFrame: 12 Months
measure: Checklist for Cognitive and Emotional Consequences following stroke (CLCE-24) score
timeFrame: Day 0
measure: Checklist for Cognitive and Emotional Consequences following stroke (CLCE-24) score
timeFrame: 3 Months
measure: Checklist for Cognitive and Emotional Consequences following stroke (CLCE-24) score
timeFrame: 6 Months
measure: Checklist for Cognitive and Emotional Consequences following stroke (CLCE-24) score
timeFrame: 12 Months
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU de Bordeaux
Study officials:
affiliation: University Hospital, Bordeaux
name: Igor SIBON
role: PRINCIPAL_INVESTIGATOR
References: