Clinical trial NCT06187025: Addiction & Stroke
Official title: Addiction in the Secondary Prevention of Stroke
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Keywords: Stroke
Transient Ischemic Attack
Substance Related and Addiction Disorders
Mood disorders
Anxiety Disorders
Secondary prevention
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2024-01-02
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Modifiable stroke risk-factors, which include poor lifestyle habits, account for 90 % of the risk of stroke. Disability Adjusted Life Years (DALYs) related to cerebrovascular disorders rely on three main factors, including the severity of stroke-related symptoms, the occurrence of stroke complications, and stroke recurrences.

Stroke complications and the risk of stroke recurrence are highly dependent on the control of vascular risk factors. Thus, the secondary prevention of stroke involves profound lifestyle modifications including substance use cessation and diet changes.

Detailed description: National guidelines for stroke clinical practice advocate an immediate cessation of consumption of all substances but without recommendations on specific therapeutic regimens. Yet, the ability to engage and maintain such lifestyle changes depend on the patient's mental health status. Moreover, independently of 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.

Post-stroke emotional impairments are frequent, post-stroke depression and anxiety being the most frequent with a prevalence of 30% and 25% respectively. The consequences of these "invisible handicaps" are observable across a wide range of stroke clinical outcomes. They have been shown to be associated with increased mortality, reduced functional status, decreased quality of life, medication adherence, efficient use of rehabilitation services and cognitive impairment.

Conversely, despite the obvious connection between drugs and stroke, the prevalence and types of SRADs among stroke patients together with their impact and potential interplay with emotional impairments on post-stroke outcomes are still overlooked. The literature is too sparse to guide clinical practice.

Paradoxically, clinicians are facing the devastating effects of addiction in this population and must be informed by solid empirical data. Moreover, the COVID19 pandemic has critically favored or exacerbated poor lifestyle habits (legal and illicit drug use, compulsive overeating) and negative affectivity - including mood and anxiety disorders -, not only in the adult but also the adolescent population. In this context, we believe it is legitimate to expect a noticeable impact on stroke incidence and prognosis in the coming years.

It thus appears that there is an urgent need to allow stroke healthcare professionals to be better equipped to screen and treat problematic substance use in stroke patients. The WHO promotes tools that could effectively support these two priorities.

First, the WHO sponsored the development of the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) to address the need for a reliable and valid screening test. The core criteria chosen for the development of such an instrument were the following: adaptable to different cultures, languages and settings; flexible enough to identify different substances and different patterns of substance use; capable of screening for risk as well as for confirmed cases; ability to link easily into a brief intervention; available at a reasonable/or no cost. Planning and development of the instrument followed a three-phase program; the instrument that is currently available is the ASSIST version 3, for which the French language validation has been already conducted among clients attending primary health care, psychiatric, addiction, and geriatric treatment facilities. These study findings strongly suggest that the ASSIST tool would be suitable for stroke populations.

Additionally, the potential pivotal role of eHealth development has been advocated by the WHO, who considers e-health as a cost-effective and secure use of information and communication technologies (ICT) in support of health and health-related fields. There is a pressing need to develop such a device for the early detection of post-stroke neuropsychiatric complications for each individual patient. The rapid expansion of ambulatory monitoring techniques, such as Ecological Momentary Assessment (EMA), allows daily evaluations of symptoms in real time and in the natural contexts of daily life. We have previously validated the feasibility and validity of EMA to assess daily life emotional symptoms after stroke, demonstrating its utility to investigate their evolution during the 3 months following stroke and to identify early predictors of post-stroke depression such as stress reactivity and social support, suggesting that EMA could be used in the early personalized care management of these neuropsychiatric complications. Moreover, we have developed an Ecological Momentary Intervention via smartphone to improve the outcome of post-stroke emotional status. This eHealth device uses algorithms for detecting at-risk patients depending on the level of mood symptomatology (DSM5 criteria for depression, generalized anxiety, post-traumatic stress disorder, suicidal risk) measured by a daily 3-5 min EMA at the end of the day. Data are sent on-line via secured servers and coded alerts are sent to the hospital clinical team in case risk levels are reached and/or if high levels of symptom persist. This approach permits clinicians to rapidly contact patients and to initiate psychiatric care without requiring the usual 4-month wait (on average) before the standard care follow-up visit. Specifically, based on the alerts, the care pathway is adapted according to each individual condition. The eHealth device is flexible and can be optimized by implementing algorithms and alerts indexing difficulties in controlling substance and unhealthy food intake.

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 ABCD2 score ≥ 4;
* Returning to the Bordeaux Hospital neurovascular unit for the standard care 3-months post-stroke follow-up visit;
* National Institute Health Stroke Scale (NIHSS) \< 15;
* modified Rankin scale ≤ 4;
* No severe cognitive impairment as defined by the neurologist;
* Written informed consent by the patient;
* Coverage by the French National Health Insurance.

For the feasibility study assessing the acceptability of the eHealth device to optimize stroke secondary prevention, additional inclusion criteria will be the ability to use a smartphone and living in an area with internet coverage.

Exclusion Criteria:

* Subarachnoid hemorrhage; Dementia syndrome or other neurologic disorder;
* Severe aphasia (NIHSS item 9 ≥ 2) and/or 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;
* Pregnancy or breastfeeding;
* Inability to read French;
* Individuals under legal protection or unable to personally express their consent
* Participation in another protocol modifying the patient's follow-up status

Primary outcomes:
measure: Organization Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)
timeFrame: Day 0
measure: Organization Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)
timeFrame: 12 Month
measure: Addiction Severity Index - Lite version (ASI)
timeFrame: Day 0
measure: modified Yale Food Addiction Scale 2.0 (mYFAS 2.0)
timeFrame: Day 0
measure: modified Yale Food Addiction Scale 2.0 (mYFAS 2.0)
timeFrame: 12 Month
measure: Fagerström Test for Nicotine Dependence (FTND) Score
timeFrame: Day 0
measure: Fagerström Test for Nicotine Dependence (FTND) Score
timeFrame: 3 Month
measure: Fagerström Test for Nicotine Dependence (FTND) Score
timeFrame: 6 Month
measure: Fagerström Test for Nicotine Dependence (FTND) Score
timeFrame: 12 Month
measure: Alcohol Use Disorder Identification Test (AUDIT) Score
timeFrame: Day 0
measure: Alcohol Use Disorder Identification Test (AUDIT) Score
timeFrame: 3 Month
measure: Alcohol Use Disorder Identification Test (AUDIT) Score
timeFrame: 6 Month
measure: Alcohol Use Disorder Identification Test (AUDIT) Score
timeFrame: 12 Month
measure: Cannabis Abuse Screening Test (CAST) Score
timeFrame: Day 0
measure: Cannabis Abuse Screening Test (CAST) Score
timeFrame: 3 Month
measure: Cannabis Abuse Screening Test (CAST) Score
timeFrame: 6 Month
measure: Cannabis Abuse Screening Test (CAST) Score
timeFrame: 12 Month
measure: Readiness Ruler or Substance Use Motivation Ruler Score
timeFrame: Day 0
measure: Readiness Ruler or Substance Use Motivation Ruler Score
timeFrame: 3 Month
measure: Readiness Ruler or Substance Use Motivation Ruler Score
timeFrame: 6 Month
measure: Readiness Ruler or Substance Use Motivation Ruler Score
timeFrame: 12 Month
measure: Multidimensional Assessment of Thymic States scale (MAThYS)
timeFrame: Day 0
measure: Multidimensional Assessment of Thymic States scale (MAThYS)
timeFrame: 3 Month
measure: Multidimensional Assessment of Thymic States scale (MAThYS)
timeFrame: 6 Month
measure: Multidimensional Assessment of Thymic States scale (MAThYS)
timeFrame: 12 Month
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 Month
measure: Checklist for Cognitive and Emotional Consequences following stroke (CLCE-24) Score
timeFrame: 6 Month
measure: Checklist for Cognitive and Emotional Consequences following stroke (CLCE-24) Score
timeFrame: 12 Month
measure: EuroQoL 5-Dimensions Questionnaire (EQ-5D)
timeFrame: 3 Month
measure: EuroQoL 5-Dimensions Questionnaire (EQ-5D)
timeFrame: 6 Month
measure: Stroke Risk
timeFrame: Day 0
measure: Stroke Risk
timeFrame: 3 Month
measure: Stroke Risk
timeFrame: 6 Month
measure: Stroke Risk
timeFrame: 12 Month
Secondary outcomes:
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU de Bordeaux
Study officials:
affiliation: University Hospital, Bordeaux
name: Igor Sibon
role: PRINCIPAL_INVESTIGATOR
affiliation: CNRS UMR 5287 - INCIA
name: Sylvie Berthoz
role: STUDY_DIRECTOR
References: