Evaluation of the Montreal Cognitive Assessment Test as a Screening Tool for Cognitive Dysfunction in in Adults With Sickle Cell Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- sensitivity of a Montreal Cognitive Assessment score < 26 to detect cognitive impairment confirmed by a neuropsychological standardized evaluation
研究概览
简要总结
This study will assess the performances of the Montreal Cognitive Assessment (MoCA) to screen for cognitive impairment in adults with sickle cell anemia. The results of the MoCA and its subscores will be compared to a standardized neuropsychological evaluation using validated tests.
详细描述
Sickle cell anemia is a monogenic disease affecting the beta-chain of hemoglobin. Cognitive impairment is more prevalent in patients with sickle cell disease than in matched unaffected individuals. Validated tests to screen for cognitive impairment are lacking in this population. Our goal is therefore to assess the performance of the Montreal Cognitive Assessment (MoCA) as a screening tool for cognitive impairment in adults with sickle cell anemia. The results of the MoCA and its subscales will be compared to a standardized neuropsychological evaluation using validated tests.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 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
- •Sickle cell disease, SS or SBêta0 subtypes only
- •Attending a consultation or a daycare hospitalization in the Tenon hospital sickle cell center
- •Aged 18 years old or more
- •Providing written informed consent
- •With Health Insurance
排除标准
- •Obvious cognitive impairment of neurologic (e.g. previous stroke) or psychiatric origin (e.g. psychotic disorder with negative symptoms)
- •Insufficient French language fluency to understand the tests, inability to read and write or with no schooling beyond primary school
- •Anticipated unavailability in the next 6 months
- •Patients under supervision & guardianship
研究组 & 干预措施
Intervention
All patients will undergo both the MoCA test and the standardized neuropsychological evaluation Montreal cognitive assessment and standardized neuropsychological evaluation (Test of Attentional Performance of Zimmermann and Fimm ; Wechsler Adult Intelligence Scale 4th version digit span ; Wechsler memory scale III, spatial span ; Wisconsin Card Scoring Test, GREFEX version ; Wechsler Adult Intelligence Scale 4th version block design ; Six elements test GREFEX version; free and cued selective reminding test, 16 items, B version ; Behavioral Rating Inventory of Executive Function ; Modified Fatigue Impact Scale)
干预措施: Montreal cognitive assessment (Other)
结局指标
主要结局
sensitivity of a Montreal Cognitive Assessment score < 26 to detect cognitive impairment confirmed by a neuropsychological standardized evaluation
时间窗: Month 3
sensitivity of a Montreal Cognitive Assessment score \< 26 to detect cognitive impairment defined as an abnormal result in at least one of the following tests : Test of Attentional Performance of Zimmermann and and Fimm (\< 5th percentile in at least one of the subscales) ; Wechsler Adult Intelligence Scale 4th version digit span (standard score ≤ 5) ; Wechsler memory scale III, spatial span (standard score ≤ 5) ; Wisconsin Card Scoring Test, GREFEX version (number of categories ≤ 5th percentile or if the number of perseverations is ≥ 95th percentile) Wechsler Adult Intelligence Scale 4th version block design (standard score ≤ 5) ; Six elements test GREFEX version (rank score ≤ 5th percentile ); free and cued selective reminding test, 16 items, B version (Z-score ≤ -1,65 in at least one of the subscales)
次要结局
- specificity of a Montreal Cognitive Assessment score < 26 to detect cognitive impairment confirmed by a neuropsychological standardized evaluation(Month 3)
- sensitivity of a Montreal Cognitive Assessment score < 23 to detect cognitive impairment confirmed by a neuropsychological standardized evaluation(Month 3)
- sensitivity and specificity of a score ≤ 4/5 in the visuospatial/executive subscale of the Montreal Cognitive Assessment to detect executive impairment confirmed by a neuropsychological standardized evaluation(Month 3)
- sensitivity and specificity of a score ≤ 4/5 in the delayed recall subscale of the Montreal Cognitive Assessment to detect a long term memory impairment confirmed by a neuropsychological standardized evaluation(Month 3)
- sensitivity and specificity of a score ≤ 5/6 in the attention subscale of the Montreal Cognitive Assessment to detect attentional impairment confirmed by a neuropsychological standardized evaluation(Month 3)