Validation of the MBI-C Scale in French
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 170
- 试验地点
- 5
- 主要终点
- Consistency for Internal validity of the Mild Behavioral Impairment-Checklist score
研究概览
简要总结
This study aims to validate the French version of the Mild Behavioral Impairment-Checklist (MBI-C) scale, hypothetically effective for measuring behavioral symptoms in patients presenting with a subjective cognitive complaint or mild cognitive impairment (MCI).
详细描述
Neuropsychiatric symptoms are common in the prodromal stage of dementia and may precede cognitive impairment. Their presence in patients without cognitive impairment, but with a subjective cognitive complaint or mild cognitive impairment (MCI), is associated with an increased risk of progression to dementia. The concept of Mild Behavioral Impairment (MBI) was developed to identify populations at risk from the early stages of the disease. MBI is characterized by long-lasting psychiatric symptoms appearing late, in patients without cognitive deficits or with MCI, and can precede dementia.
The general hypothesis is that the French version of the Mild Behavioral Impairment-Checklist (MBI-C) scale has good psychometric capabilities to correctly measure behavioral symptoms in patients with subjective cognitive complaint or MCI. The main objective is to verify the reliability and internal and external validity of the MBI-C score. Secondary objectives include studying the prevalence of MBI and determining the best cutoff for the diagnosis of MBI in patients with MBI or subjective cognitive complaint.
This is an observational, national, multicenter and cross-sectional study. It will include 170 patients (5 per scale item, or 34 items), with an inclusion period of 24 months and a total research duration of 25 months. Patients must be over 50 years old, have had subjective cognitive complaint or mild cognitive impairment for at least 6 months, and have a person who visits them at least once a week.
Validation of the MBI-C scale in French could play a crucial role in the identification and early management of neurodegenerative disorders.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient presenting a subjective cognitive complaint (SCP) or mild cognitive impairment (MCI) for at least 6 months.
- •Patient with a relative visiting them at least once a week.
- •No opposition from the patient and his loved one
排除标准
- •Patient presenting criteria for major neurocognitive disorder according to DSM-V criteria.
- •Neuropsychiatric symptoms secondary to concomitant treatments, or to a medical or psychiatric pathology.
- •Concomitant major depressive episode (DSM-V).
- •Presence of concomitant pathologies preventing participation in the study (taking tests).
结局指标
主要结局
Consistency for Internal validity of the Mild Behavioral Impairment-Checklist score
时间窗: Baseline
consistency will be assessed using Cronbach's alpha and McDonald's Omega coefficients.
External validation of the Mild Behavioral Impairment-Checklist score
时间窗: Baseline
Comparison of differences between the scores of the five domains of the NeuroPsychiatric Inventory-Total Questionnaire (NPI-Q) and the MBI-C.
次要结局
- Prevalence of Mild Behavioral Impairment (MBI) in memory center patients presenting mild cognitive impairment (MCI) or a subjective cognitive complaint (SCC).(Baseline)
- Determination of the best threshold for the diagnosis of Mild Behavioral Impairment (MBI) in patients with mild cognitive impairment (MCI) or subjective cognitive complaint (SCC).(Baseline)