Addiction in the Secondary Prevention of Stroke
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Organization Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Organization Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)
时间窗: 12 Month
8 questions covering tobacco, alcohol, cannabis, amphetamine type stimulants, inhalants, sedatives, hallucinogens, opiates and 'other drugs' (e.g. sugar, caffeine; fatty food items will be included). It begins by a screening item that asks about lifetime use. In case of a " No " answer, the evaluation terminates. When a " Yes " answer is provided, the remaining questions ask for the substances endorsed during the prior 3 months: 1) the frequency of use, 2) problems and usage patterns, 3) the compulsion to use (psychological dependence), 4) the domains of the problems (personal, health, financial, legal), 5) failure in meeting role obligations, 6) a screening of lifetime in addition to recent problems, 7) attempts at controlling substance use, and 8) current and lifetime injection of drugs (if appropriate). Twenty-eight domains/scores are derived from these questions
Cannabis Abuse Screening Test (CAST) Score
时间窗: 12 Month
includes 6 items. Scores can range from 0 to 6. The recommended cut-off scores to index the categories of cannabis dependence severity are as follows: below 2 = low risk of dependence, a score of 2 = moderate risk of dependence, 3 or more = high risk of dependence
Readiness Ruler or Substance Use Motivation Ruler Score
时间窗: 12 Month
asks the respondent to rank his/her motivation to end his/her substance use on a VAS scale from 1 (Absolutely no motivation to quit) to 10 (No doubt about the decision to be sober) and to list some motivations
Multidimensional Assessment of Thymic States scale (MAThYS)
时间窗: 12 Month
evaluation of a broad spectrum of mixed mood states. It is based on the concept that mood can be defined using emotional reactivity and not only tonality of affects. It consists in a visual analog scale of 20 items relating to individual states as perceived by the patient for the preceding week. Items can be grouped in five quantitative dimensions ranging each from inhibition to excitation: 1. emotional reactivity, 2. thought processes, 3. psychomotor function, 4. motivation and 5. sensory perception.
EuroQoL 5-Dimensions Questionnaire (EQ-5D)
时间窗: 6 Month
standardized instrument for use as a measure of health outcome in stroke and was designed for self-completion by respondents. The 5 items of the questionnaire provide a simple descriptive profile and a single index value for health status. The EQ-Index has shown reasonable validity and acceptable responsiveness for detecting the health-related quality of life in stroke patients (Chen et al., 2016). This questionnaire has been used in several stroke studies and is currently the primary outcome measure of the Stroke and Carer Optimal Health Program trial
Fagerström Test for Nicotine Dependence (FTND) Score
时间窗: 12 Month
includes 10 items. Scores can range from 0 to 10. The recommended cut-off scores to index the categories of nicotine dependence severity are as follows: below 2 = no dependence, 3 to 4 = mild severity, 5 to 6 = moderate severity, 7 to 10 = extreme severity
Stroke Risk
时间窗: 12 Month
The Stroke Riskometer app assesses the possibility of suffering a stroke using a number of health and lifestyle factors including age, sex, ethnic origin, blood pressure, atrial fibrillation, left ventricular hypertrophy, anti-hypertension, tobacco, cardiovascular history, weight / height ratio, cholesterol level, diabetes, alcohol, stress, cognitive decline, family and personal history of stroke and TIA, history of head trauma and myocardial infarction
Addiction Severity Index - Lite version (ASI)
时间窗: Day 0
shortened version of the Addiction Severity Index (French version Denis et al., 2016). It covers areas that may be affected by addiction: medical status, employment/support status, drug and alcohol use, family and social relationships, legal and psychological status. It provides lifetime information as well as over the previous 30 days
modified Yale Food Addiction Scale 2.0 (mYFAS 2.0)
时间窗: 12 Month
abbreviated, 13-item version of the Yale Food Addiction Scale 2.0 (mYFAS 2.0; French version Brunault et al., 2020), which was designed specifically to assess signs of addictive-like eating behavior. It includes one question to assess each of the 11 DSM 5 diagnostic criteria for SRADs with two questions to assess clinically significant distress and impairment. There are two scoring options: 1) a "symptom count" that reflects the number of addiction-like criteria endorsed and 2) a "diagnosis" when the participant endorses 2 or more symptom criteria plus clinically significant impairment or distress). FA is mild if there are 2 or 3 symptoms and clinically significant impairment/distress, moderate if there are 4 or 5 symptoms and significant impairment/distress, and severe if there are 6 or more symptoms and significant impairment/distress. It will be proposed either as a self-report or an interviewer-based questionnaire as decided by the psychologist
Alcohol Use Disorder Identification Test (AUDIT) Score
时间窗: 12 Month
includes 10 items. Scores can range from 0 to 40. The recommended cut-off scores to index the categories of alcohol dependence severity are as follows: from 6 to 12 for women and 7 to 12 for men = moderate severity, above 12 = extreme severity for both sexes
Checklist for Cognitive and Emotional Consequences following stroke (CLCE-24) Score
时间窗: 12 Month
standardized instrument that has been developed to quickly evaluate post-stroke cognitive, emotional and behavioral complaints. It includes 13 cognitive items, 9 emotional items and 2 additional open-ended, non-specified items concerning potential additional difficulties not evaluated by the other items. Scoring of each item ranges from 0 (not present) to 3 (present and affecting daily life).
次要结局
未报告次要终点