Evaluation de la Mise en Place d'un Auxiliaire d'évaluation Dans la Prise en Charge de la Maladie d'Alzheimer et Des Maladies apparentées en France
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 270
- 试验地点
- 2
- 主要终点
- NeuroPsychiatric Inventory (NPI)
研究概览
简要总结
Context: The French Alzheimer plan 2008-2012 includes the implementation of "disease managers" or social workers, from the onset of the disease, for every patient with a diagnosis of Alzheimer disease or associated disorder. However, previous trials evaluating the efficacy of a systematic intervention for each case from the onset of the disease, including non complex cases, have shown little evidence.
Objective: To evaluate the efficacy of a social worker to prevent behavioural problem for patient with a new diagnosis of Alzheimer disease or associated disorder.
Design and setting: Multicentric cluster randomized control trial. Patients from several memory consultations and specialists (neurologist, psychiatrist or geriatrician) in France are included.
Intervention: In addition to usual care, patients in the intervention group have systematic home visits from a social worker and regular follow-ups by phone over a one-year period. This social worker informs the patient and caregiver, evaluates the needs, gives advices to prevent complications and is a link between the patient and the memory consultation or the specialist. Patient in the control group have absolutely no intervention and are followed-up as usually. In order to not modify the usual care, they have no information on their participation in this trial before the one-year evaluation.
Main outcome measure: NeuroPsychiatric Inventory (NPI) administrated at one year, which evaluates frequency, severity and repercussion of several behavioural problems. Secondary outcomes included disability, cognition, depression, health, quality of life, institutionalization, and resource use.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of Alzheimer's Disease or other dementia (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition [DSM IV] criteria of dementia)
- •Presence of an informal caregiver
- •Mild to moderately severe dementia (MMSE [10-28])
- •Diagnosis of dementia made by a specialist ≤ 6 months
- •Patient affiliated to the national health insurance system
排除标准
- •Institutionalized patient
- •Patient on legal guardianship
- •Behavioural problem with important clinical repercussion
- •Psychotic syndrome
- •Severe and unstable general pathology
研究组 & 干预措施
Social worker
干预措施: Intervention of the social worker (Other)
Control
Control group is followed-up as usually (usual care)
结局指标
主要结局
NeuroPsychiatric Inventory (NPI)
时间窗: 1 year
Evaluation of frequency, severity and repercussion of several behavioural problems
次要结局
- Questionnaire Quality of Life - Alzheimer's Disease (QoL-AD)(1 year)
- Cohen-Mansfield Agitation Inventory (CMAI)(1 year)
- Medical Outcome Study Short Form 36-item health survey (MOS SF-36)(1 year)
- Disablement Assessment for Dementia (DAD)(1 year)
- Montgomery-Asberg Depression Rating Scale (MADRS)(1 year)
- Burden Interview of Zarit(1 year)
- Resource utilization in dementia scale (RUD Lite)(1 year)
- Tiredness scale(1 year)
- Apathy Inventory(1 year)
- Mini Mental State Examination (MMSE)(1 year)
- Global Deterioration Scale (GDS)(1 year)
- Institutionalization(1 year)
