Clinical trial NCT00190372: AIDMA: A Psycho-educational Program Designed to Support and Train Carers of Alzheimer's Disease (AD) Patients
Official title: Contribution of a Psycho-Educational Program of Help to Help in the Pharmacological Assumption of Responsibility of the Disease of Alzheimer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer's Disease
Keywords: Alzheimer's disease training programme
educational programme caregivers carers dementia treatment
Dementia Cognitive disorder
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2005-09-19
Enrollment: 240
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: DAD scale (Disability Assessment for Dementia)
timeFrame: at 6 months
Secondary outcomes:
measure: cardiovascular mortality
timeFrame: at 6 months
measure: functional status
timeFrame: at 4 weeks
measure: for the patient: NPI and ADAS-Cog
timeFrame: during the study
measure: for the caregiver: ZARIT scale, questionnaire of feeling of competency, Montgomery and Asberg Depression Rating Scale (MADRS), Geriatric Depression Scale (GDS)
timeFrame: during the study
measure: all cause mortality
timeFrame: at one year
measure: score on a depression rating scale
timeFrame: at 6 weeks
Other outcomes:
Locations:
city: Paris
country: France
facility: Assistance Publique-Hôpitaux de Paris
state: Ile de France
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Anne-Sophie Rigaud, Pr, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wenisch E, Stoker A, Bourrellis C, Pasquet C, Gauthier E, Corcos E, Banchi MT, De Rotrou J, Rigaud AS. [A global intervention program for institutionalized demented patients]. Rev Neurol (Paris). 2005 Mar;161(3):290-8. doi: 10.1016/s0035-3787(05)85035-0. French.