AIDMA: A Psycho-educational Program Designed to Support and Train Carers of Alzheimer's Disease (AD) Patients
NCT ID: NCT00190372
Last Updated: 2011-02-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
240 participants
INTERVENTIONAL
2004-10-31
2008-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
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A
Controlled diet
Controlled diet
Self-hypnotic relaxation
Self-hypnotic relaxation
Interventions
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Controlled diet
Controlled diet
Self-hypnotic relaxation
Self-hypnotic relaxation
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
60 Years
ALL
No
Sponsors
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Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Department of Clinical Research of developpement
Principal Investigators
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Anne-Sophie Rigaud, Pr, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Locations
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Assistance Publique-Hôpitaux de Paris
Paris, Île-de-France Region, France
Countries
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References
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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.
Other Identifiers
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P030437
Identifier Type: -
Identifier Source: org_study_id
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