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

Primary Purpose

Alzheimer's Disease

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Controlled diet
Self-hypnotic relaxation
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Alzheimer's Disease focused on measuring Alzheimer's disease training programme, educational programme caregivers carers dementia treatment, Dementia Cognitive disorder

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Assistance Publique-Hôpitaux de Paris

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

A

Arm Description

Outcomes

Primary Outcome Measures

DAD scale (Disability Assessment for Dementia)

Secondary Outcome Measures

cardiovascular mortality
functional status
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)
all cause mortality
score on a depression rating scale

Full Information

First Posted
September 14, 2005
Last Updated
February 16, 2011
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT00190372
Brief Title
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

2. Study Status

Record Verification Date
March 2007
Overall Recruitment Status
Completed
Study Start Date
October 2004 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
May 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
Keywords
Alzheimer's disease training programme, educational programme caregivers carers dementia treatment, Dementia Cognitive disorder

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
240 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Other
Intervention Type
Behavioral
Intervention Name(s)
Controlled diet
Intervention Description
Controlled diet
Intervention Type
Behavioral
Intervention Name(s)
Self-hypnotic relaxation
Intervention Description
Self-hypnotic relaxation
Primary Outcome Measure Information:
Title
DAD scale (Disability Assessment for Dementia)
Time Frame
at 6 months
Secondary Outcome Measure Information:
Title
cardiovascular mortality
Time Frame
at 6 months
Title
functional status
Time Frame
at 4 weeks
Title
for the patient: NPI and ADAS-Cog
Time Frame
during the study
Title
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
Title
all cause mortality
Time Frame
at one year
Title
score on a depression rating scale
Time Frame
at 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne-Sophie Rigaud, Pr, MD, PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assistance Publique-Hôpitaux de Paris
City
Paris
State/Province
Ile de France
ZIP/Postal Code
75010
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
15800450
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.
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AIDMA: A Psycho-educational Program Designed to Support and Train Carers of Alzheimer's Disease (AD) Patients

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