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

This study has been completed.
Sponsor:
Information provided by:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00190372
First received: September 14, 2005
Last updated: February 16, 2011
Last verified: March 2007
History of Changes
  Purpose

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.


Condition Intervention
Alzheimer's Disease
 Behavioral: Controlled diet
Behavioral: Self-hypnotic relaxation

Study Type: Interventional
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • DAD scale (Disability Assessment for Dementia) [ Time Frame: at 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 240
Study Start Date: October 2004
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A Behavioral: Controlled diet
Controlled diet
Other Name: Controlled diet
Behavioral: Self-hypnotic relaxation
Self-hypnotic relaxation
Other Name: Self-hypnotic relaxation

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

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00190372

Locations
France
Assistance Publique-Hôpitaux de Paris
Paris, Ile de France, France, 75010
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Anne-Sophie Rigaud, Pr, MD, PhD Assistance Publique - Hôpitaux de Paris
  More Information

Publications:

Responsible Party: Amel OUSLIMANI, Department of Clinical Research of developpement
ClinicalTrials.gov Identifier: NCT00190372     History of Changes
Other Study ID Numbers: P030437
Study First Received: September 14, 2005
Last Updated: February 16, 2011
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Alzheimer's disease training programme
educational programme caregivers carers dementia treatment
Dementia Cognitive disorder

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
 Mental Disorders
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013