Adaptation of the Mini-Mental State Examination (MMSE) for the Reunion Island Population
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 400
- 试验地点
- 7
- 主要终点
- Internal consistency - Cronbach's alpha
研究概览
简要总结
The Mini-Mental State Examination (MMSE) is the most widely used cognitive screening and monitoring test for neurocognitive disorders in current clinical practice. Its French version was published in 1998 by the GRECO group (MMSE-GRECO). However, some items of this French version are not adapted to local Reunionese particularities.
The main objective is to propose and validate the psychometric properties of an adapted version of the MMSE, to the Reunionese culture (MMSE-RUN) in a healthy population and in a sick population (Alzheimer's Disease and Vascular Cognitive Disorder), and to compare its performance with the MMSE-GRECO.
详细描述
The MMSE score was described in 1975 by an American psychiatrist. Due to its good psychometric properties and its quick and simple administration, it has become the most widely known and used screening and monitoring test for neurocognitive disorders. The MMSE have been translated and adapted for use in many languages and cultures worldwide. Its brevity, ease of use, and established psychometric properties have contributed to its widespread adoption in clinical practice and research settings for detecting cognitive impairment and monitoring cognitive changes over time.
It has been adapted into French (MMSE-GRECO), as well as to other cultures in Europe, Asia, and Africa. In the French overseas territories, a Polynesian and Caribbean version have been published.
In Reunion Island, no adapted version has been published yet. Nevertheless, an early identification of cognitive disorders with adapted screening tools is essential because three risk factors for cognitive vulnerability converge: (1) an aging population (increasing the risk of developing Alzheimer's disease) with (2) a lower level of education (decreasing cognitive resilience), and (3) a higher frequency of cardiovascular risk factors (hypertension, diabetes, dyslipidemia), increasing the frequency of vascular cognitive disorders.
The objective of this study is to propose an adapted version of the test for the Reunion Island population (MMSE-RUN) and to validate its psychometric properties within a cohort of healthy subjects and patients (Alzheimer's disease and/or vascular cognitive disorder).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For the healthy population : aged 60 to 89 years, residing in Reunion for more than 5 years, able to understand the test instructions, available for a one-hour interview, affiliated with a social security scheme, with informed consent.
- •For the sick population : aged 60 to 89 years, residing in Reunion for more than 5 years, presenting probable or possible Alzheimer's disease and/or probable vascular cognitive disorder, able to understand the test instructions, available for a one-hour interview, affiliated with a social security scheme, with informed consent.
排除标准
- •For the healthy populationhistory of neurological pathology, neurodegenerative pathology with cognitive expression, refusing to participate in the study, under legal protection.
- •For the sick population: acute unresolved medical decompensation or acute psychic decompensation, refusing to participate in the study, under legal protection.
研究组 & 干预措施
Control Arm (Healthy indivuduals)
MMSE-RUN and MMSE GRECO questionnaires
干预措施: MMSE-RUN and MMSE GRECO (Diagnostic Test)
Case Arm (Patients with Alzheimer's disease or vascular cognitive impairment)
MMSE-RUN and MMSE GRECO questionnaires
干预措施: MMSE-RUN and MMSE GRECO (Diagnostic Test)
结局指标
主要结局
Internal consistency - Cronbach's alpha
时间窗: Day 1
Internal consistency measures the extent to which the items in the test measure the same dimension or concept, in this case overall cognitive efficiency. Internal consistency is commonly measured by Cronbach's alpha, which ranges from 0 (low) to 1 (high). A high coefficient indicates that the test items are similar in content, i.e. homogeneous. A Cronbach's alpha greater than 0.7 is acceptable.
Construct validity - Exploratory Factor Analysis
时间窗: Day 1
Construct validity allows us to visualise the construction of the test and the concept measured by the instrument in healthy population. The existence of seven independent factors must be demonstrated by Exploratory Factor Analysis: temporal orientation, spatial orientation, learning three words, mental arithmetic, recall, language and constructive praxis.
Criterion validity - t test
时间窗: Day 1
Criterion validity consists of verifying an instrument's ability to distinguish between individuals; ie, it is the test's ability to clearly identify a deficit in overall cognitive efficiency in a population affected by a pathology, compared to a cognitively healthy population. The validity of this criterion will be assessed using a Student's t-test comparing the MMSE-RUN scores obtained by the healthy subjects group and the pathological subjects group.
次要结局
未报告次要终点