AIDMA: A Psycho-educational Program Designed to Support and Train Carers of Alzheimer's Disease (AD) Patients
Behavioral: Controlled diet
Behavioral: Self-hypnotic relaxation
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Health Services Research
|Official Title:||Contribution of a Psycho-Educational Program of Help to Help in the Pharmacological Assumption of Responsibility of the Disease of Alzheimer|
- DAD scale (Disability Assessment for Dementia) [ Time Frame: at 6 months ] [ Designated as safety issue: Yes ]
- cardiovascular mortality [ Time Frame: at 6 months ] [ Designated as safety issue: Yes ]
- functional status [ Time Frame: at 4 weeks ] [ Designated as safety issue: Yes ]
- for the patient: NPI and ADAS-Cog [ Time Frame: during the study ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
- all cause mortality [ Time Frame: at one year ] [ Designated as safety issue: Yes ]
- score on a depression rating scale [ Time Frame: at 6 weeks ] [ Designated as safety issue: Yes ]
|Study Start Date:||October 2004|
|Study Completion Date:||May 2008|
|Primary Completion Date:||May 2008 (Final data collection date for primary outcome measure)|
Behavioral: Controlled diet
Controlled dietBehavioral: Self-hypnotic relaxation
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00190372
|Assistance Publique-Hôpitaux de Paris|
|Paris, Ile de France, France, 75010|
|Principal Investigator:||Anne-Sophie Rigaud, Pr, MD, PhD||Assistance Publique - Hôpitaux de Paris|