Effectiveness of Care Management in Alzheimer Patients

NCT01081743 | Completed DMC

• 1 other identifier: RCB : 2009-A00326-51
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer Disease or Associated Disorder; Mild to Moderately Severe Dementia

Keywords

Alzheimer; Dementia; Mild to moderately severe; New diagnosis; Prevention of behavioural problems

Outcome Measures

Primary Outcomes (1)

• NeuroPsychiatric Inventory (NPI)

  Evaluation of frequency, severity and repercussion of several behavioural problems

  1 year

Secondary Outcomes (12)

• 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

Study Arms (2)

Social worker

EXPERIMENTAL

Other: Intervention of the social worker

Control

NO INTERVENTION

Control group is followed-up as usually (usual care)

Interventions

Intervention of the social worker OTHER

Systematic home visits and regular follow-ups by phone from a social worker

Social worker

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Institutionalized patient
• Patient on legal guardianship
• Behavioural problem with important clinical repercussion
• Psychotic syndrome
• Severe and unstable general pathology

Sponsors & Collaborators

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

Study Sites (1)

ISPED (Institut de Santé Publique, d'Epidémiologie et de Développement)

Bordeaux, 33076, France

Location

MeSH Terms

Conditions

Alzheimer Disease; Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2010
• First Posted: March 5, 2010
• Study Start: November 24, 2009
• Primary Completion: October 2, 2013
• Study Completion: October 2, 2013
• Last Updated: August 28, 2017

Record last verified: 2017-08

Locations

FR (1)