Contribution of a Psycho-Educational Program of Help to Help in the Pharmacological Assumption of Responsibility of the Disease of Alzheimer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 2
- 主要终点
- DAD scale (Disability Assessment for Dementia)
研究概览
简要总结
The aim of the project is to demonstrate that a psycho-educational programme designed to support and train carers of Alzheimer's disease (AD) patients induces a significantly higher benefit than anticholinesterase drug treatment alone or associated to memantine treatment. This training programme focuses on the explanation/description of behavioral, cognitive and functional disorders induced by the disease, as well as principles of cognitive and psycho-social stimulation of the patients in daily life.
详细描述
Context: Research showing the benefit of a combined approach including specific antidementia drugs and psycho-educational programmes for caregivers in the caring of Alzheimer's disease patients is still lacking. We venture the hypothesis that combined treatment including a specific antidementia drug for the AD patient and a psycho-educational programme for the caregivers has a larger benefit for both the patient and the caregiver on psychological, behavioural, and cognitive parameters.
Main objective: to demonstrate that a psycho-educational programme designed to support and train carers of Alzheimer's disease (AD) patients induces a significantly higher benefit than anticholinesterase drug treatment alone or associated to memantine treatment.
Secondary objective: identify patterns of responders and non-responders (taking into account cognitive, psychological parameters).
Methodology: national multicentric, randomized trial, single blinded, with 2 parallel groups of 120 patients and 120 caregivers trained for a 3 month period with 3 assessments: before, just after and 3 months after the training period. Patients and caregivers are recruited (according to exclusion and inclusion criteria) and followed up in memory centers participating in the trial.
Evaluation criteria:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Care Provider)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •AD outpatients
- •Stable pharmacological treatment
- •Mini-Mental State Examination (MMSE) [10 -28]
- •Age [60-90]
- •Informed consent
- •Caregivers:
- •Reliability
- •Motivation
- •Psychological disorder related to patient's disease
- •Need for information or help
- •Informed consent
排除标准
- •Other dementia
- •Severe general disease
- •No reliable caregiver
- •Caregivers:
- •Physical or mental disease incompatible with patient's management
- •Impossibility to participate in the educational program
- •Absence of anxiety-depression
- •Psychotherapy
结局指标
主要结局
DAD scale (Disability Assessment for Dementia)
时间窗: at 6 months
次要结局
- cardiovascular mortality(at 6 months)
- functional status(at 4 weeks)
- for the patient: NPI and ADAS-Cog(during the study)
- for the caregiver: ZARIT scale, questionnaire of feeling of competency, Montgomery and Asberg Depression Rating Scale (MADRS), Geriatric Depression Scale (GDS)(during the study)
- all cause mortality(at one year)
- score on a depression rating scale(at 6 weeks)