Effectiveness of Care Management in Alzheimer Patients

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Alzheimer Disease or Associated Disorder, Mild to Moderately Severe Dementia

Intervention / Treatment
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* Other: Intervention of the social worker


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Social worker<br> | Other: Intervention of the social worker<br>* Systematic home visits and regular follow-ups by phone from a social worker<br>|
| No Intervention: Control<br>Control group is followed-up as usually (usual care) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NeuroPsychiatric Inventory (NPI) | Evaluation of frequency, severity and repercussion of several behavioural problems | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cohen-Mansfield Agitation Inventory (CMAI) |  | 1 year | 
| Apathy Inventory |  | 1 year | 
| Disablement Assessment for Dementia (DAD) |  | 1 year | 
| Mini Mental State Examination (MMSE) |  | 1 year | 
| Global Deterioration Scale (GDS) |  | 1 year | 
| Montgomery-Asberg Depression Rating Scale (MADRS) |  | 1 year | 
| Questionnaire Quality of Life - Alzheimer's Disease (QoL-AD) |  | 1 year | 
| Burden Interview of Zarit |  | 1 year | 
| Resource utilization in dementia scale (RUD Lite) |  | 1 year | 
| Medical Outcome Study Short Form 36-item health survey (MOS SF-36) |  | 1 year | 
| Institutionalization |  | 1 year | 
| Tiredness scale |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alzheimer, Dementia, Mild to moderately severe, New diagnosis, Prevention of behavioural problems