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

Assistance Publique - Hôpitaux de Paris

Status: Completed

Conditions: Alzheimer's Disease

Treatments: Behavioral: Controlled diet; Behavioral: Self-hypnotic relaxation

Study type: Interventional

Funder types: Other

Identifiers

NCT00190372

P030437

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 240 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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240 participants in 1 patient group

A

Other group

Treatment:

Behavioral: Self-hypnotic relaxation

Behavioral: Controlled diet