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临床试验/NCT04043052
NCT04043052已完成不适用

MObile Technologies In the preVention of POSt-stroke DEPression

University Hospital, Bordeaux10 个研究点 分布在 1 个国家目标入组 401 人开始时间: 2020年9月9日最近更新:
适应症
干预措施
相关药物

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

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)

Active Comparator

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)

Active Comparator

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)

Active Comparator

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)

Experimental

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)

Experimental

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)

Experimental

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)

Experimental

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)

研究者

发起方
University Hospital, Bordeaux
申办方类型
Other
责任方
Sponsor

研究点 (10)

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