Clinical trial NCT01081743: Effectiveness of Care Management in Alzheimer Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer Disease or Associated Disorder
Mild to Moderately Severe Dementia
Keywords: Alzheimer
Dementia
Mild to moderately severe
New diagnosis
Prevention of behavioural problems
Lead sponsor: Institut de Sante Publique, d'Epidemiologie et de Developpement
Sponsor class: OTHER
First posted: 2010-03-05
Enrollment: 270
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: NeuroPsychiatric Inventory (NPI)
timeFrame: 1 year
Secondary outcomes:
measure: Cohen-Mansfield Agitation Inventory (CMAI)
timeFrame: 1 year
measure: Apathy Inventory
timeFrame: 1 year
measure: Disablement Assessment for Dementia (DAD)
timeFrame: 1 year
measure: Mini Mental State Examination (MMSE)
timeFrame: 1 year
measure: Global Deterioration Scale (GDS)
timeFrame: 1 year
measure: Montgomery-Asberg Depression Rating Scale (MADRS)
timeFrame: 1 year
measure: Questionnaire Quality of Life - Alzheimer's Disease (QoL-AD)
timeFrame: 1 year
measure: Burden Interview of Zarit
timeFrame: 1 year
measure: Resource utilization in dementia scale (RUD Lite)
timeFrame: 1 year
measure: Medical Outcome Study Short Form 36-item health survey (MOS SF-36)
timeFrame: 1 year
measure: Institutionalization
timeFrame: 1 year
measure: Tiredness scale
timeFrame: 1 year
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: ISPED (Institut de Santé Publique, d'Epidémiologie et de Développement)
Study officials:
References: