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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Social worker | Experimental |
| |
| Control | No Intervention | Control group is followed-up as usually (usual care) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention of the social worker | Other | Systematic home visits and regular follow-ups by phone from a social worker |
|
| Measure | Description | Time Frame |
|---|---|---|
| NeuroPsychiatric Inventory (NPI) | Evaluation of frequency, severity and repercussion of several behavioural problems | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Cohen-Mansfield Agitation Inventory (CMAI) | 1 year | |
| Apathy Inventory | 1 year | |
| Disablement Assessment for Dementia (DAD) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ISPED (Institut de Santé Publique, d'Epidémiologie et de Développement) | Bordeaux | 33076 | France |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D003704 | Dementia |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
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| 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 |
| D019636 |
| Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |