Effectiveness of Care Management in Alzheimer Patients (AIDALZ)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Institut de Sante Publique, d'Epidemiologie et de Developpement.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Institut de Sante Publique, d'Epidemiologie et de Developpement
ClinicalTrials.gov Identifier:
NCT01081743
First received: March 4, 2010
Last updated: July 5, 2011
Last verified: July 2011
  Purpose

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.


Condition Intervention
Alzheimer Disease or Associated Disorder
Mild to Moderately Severe Dementia
Other: Intervention of the social worker

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
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

Resource links provided by NLM:


Further study details as provided by Institut de Sante Publique, d'Epidemiologie et de Developpement:

Primary Outcome Measures:
  • NeuroPsychiatric Inventory (NPI) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Evaluation of frequency, severity and repercussion of several behavioural problems


Secondary Outcome Measures:
  • Cohen-Mansfield Agitation Inventory (CMAI) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Apathy Inventory [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Disablement Assessment for Dementia (DAD) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Mini Mental State Examination (MMSE) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Global Deterioration Scale (GDS) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Questionnaire Quality of Life - Alzheimer's Disease (QoL-AD) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Burden Interview of Zarit [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Resource utilization in dementia scale (RUD Lite) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Medical Outcome Study Short Form 36-item health survey (MOS SF-36) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Institutionalization [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Tiredness scale [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: November 2009
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01081743

Locations
France
ISPED (Institut de Santé Publique, d'Epidémiologie et de Développement) Recruiting
Bordeaux, France, 33076
Contact: Catherine HELMER, MD, PhD    33.5.57.57.15.96    catherine.helmer@isped.u-bordeaux2.fr   
Principal Investigator: Jean-François DARTIGUES, MD, PhD         
Sponsors and Collaborators
Institut de Sante Publique, d'Epidemiologie et de Developpement
  More Information

No publications provided

Responsible Party: DARTIGUES Jean-François/MD, PhD, ISPED
ClinicalTrials.gov Identifier: NCT01081743     History of Changes
Other Study ID Numbers: RCB : 2009-A00326-51
Study First Received: March 4, 2010
Last Updated: July 5, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Institut de Sante Publique, d'Epidemiologie et de Developpement:
Alzheimer
Dementia
Mild to moderately severe
New diagnosis
Prevention of behavioural problems

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 15, 2014