Effectiveness of Care Management in Alzheimer Patients (AIDALZ)
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Purpose
Context: The French Alzheimer plan 2008-2012 includes the implementation of "disease managers" or social workers, from the onset of the disease, for every patient with a diagnosis of Alzheimer disease or associated disorder. However, previous trials evaluating the efficacy of a systematic intervention for each case from the onset of the disease, including non complex cases, have shown little evidence.
Objective: To evaluate the efficacy of a social worker to prevent behavioural problem for patient with a new diagnosis of Alzheimer disease or associated disorder.
Design and setting: Multicentric cluster randomized control trial. Patients from several memory consultations and specialists (neurologist, psychiatrist or geriatrician) in France are included.
Intervention: In addition to usual care, patients in the intervention group have systematic home visits from a social worker and regular follow-ups by phone over a one-year period. This social worker informs the patient and caregiver, evaluates the needs, gives advices to prevent complications and is a link between the patient and the memory consultation or the specialist. Patient in the control group have absolutely no intervention and are followed-up as usually. In order to not modify the usual care, they have no information on their participation in this trial before the one-year evaluation.
Main outcome measure: NeuroPsychiatric Inventory (NPI) administrated at one year, which evaluates frequency, severity and repercussion of several behavioural problems. Secondary outcomes included disability, cognition, depression, health, quality of life, institutionalization, and resource use.
| Condition | Intervention |
|---|---|
|
Alzheimer Disease or Associated Disorder Mild to Moderately Severe Dementia |
Other: Intervention of the social worker |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | Evaluation de la Mise en Place d'un Auxiliaire d'évaluation Dans la Prise en Charge de la Maladie d'Alzheimer et Des Maladies apparentées en France |
- NeuroPsychiatric Inventory (NPI) [ Time Frame: 1 year ] [ Designated as safety issue: No ]Evaluation of frequency, severity and repercussion of several behavioural problems
- Cohen-Mansfield Agitation Inventory (CMAI) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Apathy Inventory [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Disablement Assessment for Dementia (DAD) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Mini Mental State Examination (MMSE) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Global Deterioration Scale (GDS) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Questionnaire Quality of Life - Alzheimer's Disease (QoL-AD) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Burden Interview of Zarit [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Resource utilization in dementia scale (RUD Lite) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Medical Outcome Study Short Form 36-item health survey (MOS SF-36) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Institutionalization [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Tiredness scale [ Time Frame: 1 year ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 400 |
| Study Start Date: | November 2009 |
| Estimated Study Completion Date: | December 2011 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Social worker |
Other: Intervention of the social worker
Systematic home visits and regular follow-ups by phone from a social worker
|
|
No Intervention: Control
Control group is followed-up as usually (usual care)
|
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Clinical diagnosis of Alzheimer's Disease or other dementia (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition [DSM IV] criteria of dementia)
- Presence of an informal caregiver
- Mild to moderately severe dementia (MMSE [10-28])
- Diagnosis of dementia made by a specialist ≤ 6 months
- Patient affiliated to the national health insurance system
Exclusion Criteria:
- Institutionalized patient
- Patient on legal guardianship
- Behavioural problem with important clinical repercussion
- Psychotic syndrome
- Severe and unstable general pathology
Contacts and Locations| France | |
| ISPED (Institut de Santé Publique, d'Epidémiologie et de Développement) | Recruiting |
| Bordeaux, France, 33076 | |
| Contact: Catherine HELMER, MD, PhD 33.5.57.57.15.96 catherine.helmer@isped.u-bordeaux2.fr | |
| Principal Investigator: Jean-François DARTIGUES, MD, PhD | |
More Information
No publications provided
| Responsible Party: | DARTIGUES Jean-François/MD, PhD, ISPED |
| ClinicalTrials.gov Identifier: | NCT01081743 History of Changes |
| Other Study ID Numbers: | RCB : 2009-A00326-51 |
| Study First Received: | March 4, 2010 |
| Last Updated: | July 5, 2011 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by Institut de Sante Publique, d'Epidemiologie et de Developpement:
|
Alzheimer Dementia Mild to moderately severe New diagnosis Prevention of behavioural problems |
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 |
ClinicalTrials.gov processed this record on May 16, 2013