Effectiveness of Care Management in Alzheimer Patients
- Conditions
- Alzheimer Disease or Associated DisorderMild to Moderately Severe Dementia
- Interventions
- Other: Intervention of the social worker
- Registration Number
- NCT01081743
- Lead Sponsor
- Institut de Sante Publique, d'Epidemiologie et de Developpement
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 270
- 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
- Institutionalized patient
- Patient on legal guardianship
- Behavioural problem with important clinical repercussion
- Psychotic syndrome
- Severe and unstable general pathology
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Social worker Intervention of the social worker -
- Primary Outcome Measures
Name Time Method NeuroPsychiatric Inventory (NPI) 1 year Evaluation of frequency, severity and repercussion of several behavioural problems
- Secondary Outcome Measures
Name Time Method Questionnaire Quality of Life - Alzheimer's Disease (QoL-AD) 1 year Cohen-Mansfield Agitation Inventory (CMAI) 1 year Medical Outcome Study Short Form 36-item health survey (MOS SF-36) 1 year Disablement Assessment for Dementia (DAD) 1 year Montgomery-Asberg Depression Rating Scale (MADRS) 1 year Burden Interview of Zarit 1 year Resource utilization in dementia scale (RUD Lite) 1 year Tiredness scale 1 year Apathy Inventory 1 year Mini Mental State Examination (MMSE) 1 year Global Deterioration Scale (GDS) 1 year Institutionalization 1 year
Trial Locations
- Locations (1)
ISPED (Institut de Santé Publique, d'Epidémiologie et de Développement)
🇫🇷Bordeaux, France