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

N/ACompletedNCT00190372

Assistance Publique - Hôpitaux de Paris240 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Conditions

Alzheimer's Disease

Interventions

Controlled dietBEHAVIORAL

Controlled diet

Self-hypnotic relaxationBEHAVIORAL

Self-hypnotic relaxation

Eligibility

Sex: ALLMin age: 60 Years

Medical Language ↔ Plain English

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

Locations (1)

Assistance Publique-Hôpitaux de Paris

Paris, Île-de-France Region, France

Outcomes

Primary Outcomes

DAD scale (Disability Assessment for Dementia)

Time frame: at 6 months

Secondary Outcomes

cardiovascular mortality

Time frame: at 6 months

functional status

Time frame: at 4 weeks

for the patient: NPI and ADAS-Cog

Time frame: during the study

for the caregiver: ZARIT scale, questionnaire of feeling of competency, Montgomery and Asberg Depression Rating Scale (MADRS), Geriatric Depression Scale (GDS)

Time frame: during the study

all cause mortality

Time frame: at one year

score on a depression rating scale

Time frame: at 6 weeks

Data from ClinicalTrials.gov

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