Effectiveness of Care Management in Alzheimer Patients (AIDALZ)

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

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.

Study Overview

• Status: Completed
• Conditions: Alzheimer Disease or Associated Disorder; Mild to Moderately Severe Dementia
• Intervention / Treatment: Other: Intervention of the social worker

• Study Type: Interventional
• Enrollment (Actual): 270
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bordeaux, France, 33076
    • ISPED (Institut de Santé Publique, d'Epidémiologie et de Développement)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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)

What is the study measuring?

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	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

Collaborators and Investigators

• Sponsor: Institut de Sante Publique, d'Epidemiologie et de Developpement

Study record dates

Study Major Dates

• Study Start (Actual): November 24, 2009
• Primary Completion (Actual): October 2, 2013
• Study Completion (Actual): October 2, 2013

Study Registration Dates

• First Submitted: March 4, 2010
• First Submitted That Met QC Criteria: March 4, 2010
• First Posted (Estimate): March 5, 2010

Study Record Updates

• Last Update Posted (Actual): August 28, 2017
• Last Update Submitted That Met QC Criteria: August 25, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: Dementia; Alzheimer; New diagnosis; Mild to moderately severe; Prevention of behavioural problems
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Tauopathies; Dementia; Alzheimer Disease
• Other Study ID Numbers: RCB : 2009-A00326-51