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Effectiveness of Care Management in Alzheimer Patients (AIDALZ)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2011 by Institut de Sante Publique, d'Epidemiologie et de Developpement.
Recruitment status was:  Recruiting
Information provided by:
Institut de Sante Publique, d'Epidemiologie et de Developpement Identifier:
First received: March 4, 2010
Last updated: July 5, 2011
Last verified: July 2011

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
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 ]
    Evaluation of frequency, severity and repercussion of several behavioural problems

Secondary Outcome Measures:
  • Cohen-Mansfield Agitation Inventory (CMAI) [ Time Frame: 1 year ]
  • Apathy Inventory [ Time Frame: 1 year ]
  • Disablement Assessment for Dementia (DAD) [ Time Frame: 1 year ]
  • Mini Mental State Examination (MMSE) [ Time Frame: 1 year ]
  • Global Deterioration Scale (GDS) [ Time Frame: 1 year ]
  • Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: 1 year ]
  • Questionnaire Quality of Life - Alzheimer's Disease (QoL-AD) [ Time Frame: 1 year ]
  • Burden Interview of Zarit [ Time Frame: 1 year ]
  • Resource utilization in dementia scale (RUD Lite) [ Time Frame: 1 year ]
  • Medical Outcome Study Short Form 36-item health survey (MOS SF-36) [ Time Frame: 1 year ]
  • Institutionalization [ Time Frame: 1 year ]
  • Tiredness scale [ Time Frame: 1 year ]

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)


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01081743

ISPED (Institut de Santé Publique, d'Epidémiologie et de Développement) Recruiting
Bordeaux, France, 33076
Contact: Catherine HELMER, MD, PhD   
Principal Investigator: Jean-François DARTIGUES, MD, PhD         
Sponsors and Collaborators
Institut de Sante Publique, d'Epidemiologie et de Developpement
  More Information

Responsible Party: DARTIGUES Jean-François/MD, PhD, ISPED Identifier: NCT01081743     History of Changes
Other Study ID Numbers: RCB : 2009-A00326-51
Study First Received: March 4, 2010
Last Updated: July 5, 2011

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

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders processed this record on May 25, 2017