AIDMA: A Psycho-educational Program Designed to Support and Train Carers of Alzheimer's Disease (AD) Patients
Contribution of a Psycho-Educational Program of Help to Help in the Pharmacological Assumption of Responsibility of the Disease of Alzheimer
1 other identifier
interventional
240
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2004
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 14, 2005
CompletedFirst Posted
Study publicly available on registry
September 19, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2008
CompletedFebruary 17, 2011
March 1, 2007
3.6 years
September 14, 2005
February 16, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
DAD scale (Disability Assessment for Dementia)
at 6 months
Secondary Outcomes (6)
cardiovascular mortality
at 6 months
functional status
at 4 weeks
for the patient: NPI and ADAS-Cog
during the study
for the caregiver: ZARIT scale, questionnaire of feeling of competency, Montgomery and Asberg Depression Rating Scale (MADRS), Geriatric Depression Scale (GDS)
during the study
all cause mortality
at one year
- +1 more secondary outcomes
Study Arms (1)
A
OTHERInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Assistance Publique-Hôpitaux de Paris
Paris, Île-de-France Region, 75010, France
Related 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. doi: 10.1016/s0035-3787(05)85035-0. French.
PMID: 15800450BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anne-Sophie Rigaud, Pr, MD, PhD
Assistance Publique - Hôpitaux de Paris
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- CARE PROVIDER
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 14, 2005
First Posted
September 19, 2005
Study Start
October 1, 2004
Primary Completion
May 1, 2008
Study Completion
May 1, 2008
Last Updated
February 17, 2011
Record last verified: 2007-03