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

Alzheimer's Disease Clinical Trial

Official title:

Contribution of a Psycho-Educational Program of Help to Help in the Pharmacological Assumption of Responsibility of the Disease of Alzheimer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00190372
• Other study ID #: P030437
• Status: Completed
• Phase: N/A
• First received: September 14, 2005
• Last updated: February 16, 2011
• Start date: October 2004
• Est. completion date: May 2008

Study information

• Verified date: March 2007
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Behavioral:
• Controlled diet
Controlled diet
• Self-hypnotic relaxation
Self-hypnotic relaxation

Locations

Country	Name	City	State
France	Assistance Publique-Hôpitaux de Paris	Paris	Ile de France

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (1)

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. French. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DAD scale (Disability Assessment for Dementia)		at 6 months	Yes
Secondary	cardiovascular mortality		at 6 months	Yes
Secondary	functional status		at 4 weeks	Yes
Secondary	for the patient: NPI and ADAS-Cog		during the study	Yes
Secondary	for the caregiver: ZARIT scale, questionnaire of feeling of competency, Montgomery and Asberg Depression Rating Scale (MADRS), Geriatric Depression Scale (GDS)		during the study	Yes
Secondary	all cause mortality		at one year	Yes
Secondary	score on a depression rating scale		at 6 weeks	Yes