AIDMA: A Psycho-educational Program Designed to Support and Train Carers of Alzheimer's Disease (AD) Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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: Primary criteria for the patient: DAD scale (Disability Assessment for Dementia). Secondary evaluation criteria - for the patient: NPI and ADAS-Cog; for the caregiver: ZARIT scale, Questionnaire of feeling of competency, Montgomery and Asberg Depression Rating Scale (MADRS), Geriatric Depression Scale (GDS). Statistical analysis by the department of biostatistics and medical computing of the Hospital Cochin will be performed.

Official Title
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Contribution of a Psycho-Educational Program of Help to Help in the Pharmacological Assumption of Responsibility of the Disease of Alzheimer

Conditions
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Alzheimer's Disease

Intervention / Treatment
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* Behavioral: Controlled diet
* Behavioral: Self-hypnotic relaxation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients: 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 Exclusion Criteria: Patients: 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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: A<br> | Behavioral: Controlled diet<br>* Controlled diet<br>Behavioral: Self-hypnotic relaxation<br>* Self-hypnotic relaxation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DAD scale (Disability Assessment for Dementia) |  | at 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alzheimer's disease training programme, educational programme caregivers carers dementia treatment, Dementia Cognitive disorder