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Effectiveness of Care Management in Alzheimer Patients (AIDALZ)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01081743
Recruitment Status : Completed
First Posted : March 5, 2010
Last Update Posted : August 28, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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.


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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 270 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Actual Study Start Date : November 24, 2009
Primary Completion Date : October 2, 2013
Study Completion Date : October 2, 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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)


Outcome Measures

Primary Outcome Measures :
  1. NeuroPsychiatric Inventory (NPI) [ Time Frame: 1 year ]
    Evaluation of frequency, severity and repercussion of several behavioural problems


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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01081743


Locations
France
ISPED (Institut de Santé Publique, d'Epidémiologie et de Développement)
Bordeaux, France, 33076
Sponsors and Collaborators
Institut de Sante Publique, d'Epidemiologie et de Developpement
More Information

Responsible Party: Institut de Sante Publique, d'Epidemiologie et de Developpement
ClinicalTrials.gov Identifier: NCT01081743     History of Changes
Other Study ID Numbers: RCB : 2009-A00326-51
First Posted: March 5, 2010    Key Record Dates
Last Update Posted: August 28, 2017
Last Verified: August 2017

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
Neurocognitive Disorders
Mental Disorders