MObile Technologies In the preVention of POSt-stroke DEPression
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 401
- 试验地点
- 10
- 主要终点
- Hamilton Depression Rating Scale score (HDRS)
研究概览
简要总结
The recent development of acute phase treatments has dramatically improved stroke functional outcome but post-stroke neuropsychiatric disorders, notably post-stroke depression, continue to contribute to the heavy burden of stroke. While these conditions affect about 25% of stroke patients at 3 months, they are under-reported spontaneously by patients and are under-evaluated and treated by clinicians. Other than stroke severity and psychiatric history, risk factors for post-stroke depression remain a matter of debate, thus preventing identification of high-risk patients. Moreover, to date, neither pharmacological nor nonpharmacological treatments have demonstrated a significant benefit in the prevention of this disorder, thereby also impeding the development of early treatment strategies. Yet,the early management of post-stroke depression is critical given its negative influence on long-term functional outcomes, medication adherence, efficient use of rehabilitation services and the risk of stroke recurrence or vascular events. There is a pressing need to develop new tools allowing 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 mood symptoms in real time and in the natural contexts of daily life. The investigators 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. Recently, preliminary data have also emphasized the potential of EMA interventions to improve the outcome of psychiatric disorders.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years.
- •Male or Female.
- •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 ≥
- •Patient discharged to home after hospitalization in the stroke unit.
- •No severe neurological handicap: modified Rankin scale ≤ 3 at inclusion.
- •No severe cognitive impairment or dementia: MoCA ≥ 16 at inclusion.
- •Written informed consent by the patient.
- •Covered by French Social Insurance
排除标准
- •Transient Non Cerebrovascular Event.
- •Subarachnoid hemorrhage.
- •Dementia syndrome or other neurologic disorder and/or severe aphasia (NIHSS item 9 ≥ 2) interfering with the completion of evaluations and the utilization of EMA.
- •Severe visual impairment interfering with the utilization of EMA.
- •Severely impaired physical and/or mental health that, according to the investigator, may affect the participant's compliance with the study
- •Patients with a severe substance use disorder (DSM-5 criteria)
- •Patients under antidepressant and/or anxiolytic and/or neuroleptic and/or mood stabilizer treatment during the month preceding inclusion
- •Participation in another protocol modifying the patient's follow-up status.
- •Pregnancy or breastfeeding
- •Inability to read French or to use a smartphone
- •Individuals under legal protection or unable to express personnally their consent
- •Individuals living in an area without 3G/4G internet coverage
研究组 & 干预措施
Treatment As Usual (TAU)
Evaluation of depression and anxiety disorders at 3 and 6 months post-stroke using psychological and functional examination
干预措施: Biological assessment (Biological)
Treatment As Usual (TAU)
Evaluation of depression and anxiety disorders at 3 and 6 months post-stroke using psychological and functional examination
干预措施: Psychological evaluation (Other)
Treatment As Usual (TAU)
Evaluation of depression and anxiety disorders at 3 and 6 months post-stroke using psychological and functional examination
干预措施: Functional evaluation (Other)
EMA intervention assocuated to Treatment As Usual (EMA-TAU)
Evaluation of depression and anxiety disorders at 3 and 6 months post-stroke using psychological and functional examination in addition with Ecological Momentary Assessment (EMA) evaluation.
干预措施: Psychological evaluation (Other)
EMA intervention assocuated to Treatment As Usual (EMA-TAU)
Evaluation of depression and anxiety disorders at 3 and 6 months post-stroke using psychological and functional examination in addition with Ecological Momentary Assessment (EMA) evaluation.
干预措施: Functional evaluation (Other)
EMA intervention assocuated to Treatment As Usual (EMA-TAU)
Evaluation of depression and anxiety disorders at 3 and 6 months post-stroke using psychological and functional examination in addition with Ecological Momentary Assessment (EMA) evaluation.
干预措施: Biological assessment (Biological)
EMA intervention assocuated to Treatment As Usual (EMA-TAU)
Evaluation of depression and anxiety disorders at 3 and 6 months post-stroke using psychological and functional examination in addition with Ecological Momentary Assessment (EMA) evaluation.
干预措施: Ecological Momentary Assessment (Other)
结局指标
主要结局
Hamilton Depression Rating Scale score (HDRS)
时间窗: 6 months
Semi-structured interview questionnaire designed to be used by a health care professional to investigate depressive symptomatology. 17 items are used to provide a score.
次要结局
- Multidimensional Fatigue Inventory (MFI)(6 months)
- International Physical Activity Questionnaire (7 items IPAQ)(6 months)
- Recurrent stroke(6 months)
- CRPus plasmatic measure(3 months ; 6 months)
- Beck Anxiety Inventory (BAI)(6 months)
- EuroQoL 5-Dimensions Questionnaire (EQ-5D)(6 months)
- Long-term Unmet Needs after Stroke (LUNS)(6 months)
- Short version of Sarason's Social Support Questionnaire (6 items SSQ)(6 months)
- Ruminative Response Scale-short form (RRS-short form)(6 months)
- Percentage of stroke risk(6 months)
- LDLc plasmatic measure(3 months ; 6 months)
- Cardiovascular events post-stroke(6 months)
- Pittsburgh Sleep Quality Index(Visit 1 ; 3 months ; 6 months)
- Mood Disorder Questionnaire (MDQ)(6 months)
- Primary Care PTSD Screen for DSM-5 (PC-PTSD-5)(6 months)
- Intensity of post-stroke pain(6 months)
- Blood pressure(Visit 1 ; 3 months ; 6 months)
- HbA1c measure(3 months ; 6 months)
- Mini International Neuropsychiatric Interview (MINI)(6 months)
- Generalized Anxiety Disorder-7 scale (GAD-7)(6 months)
- Center of Epidemiological Studies-Depression Scale (CES-D)(6 months)
- Smoking Index (HSI)(3 months ; 6 months)
