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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

March 4, 2010
July 5, 2011
November 2009
December 2011   (final data collection date for primary outcome measure)
NeuroPsychiatric Inventory (NPI) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Evaluation of frequency, severity and repercussion of several behavioural problems
Same as current
Complete list of historical versions of study NCT01081743 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Effectiveness of Care Management in Alzheimer Patients
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
  • Alzheimer Disease or Associated Disorder
  • Mild to Moderately Severe Dementia
Other: Intervention of the social worker
Systematic home visits and regular follow-ups by phone from a social worker
  • Experimental: Social worker
    Intervention: Other: Intervention of the social worker
  • No Intervention: Control
    Control group is followed-up as usually (usual care)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
400
December 2011
December 2011   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
France
 
NCT01081743
RCB : 2009-A00326-51
Yes
DARTIGUES Jean-François/MD, PhD, ISPED
Institut de Sante Publique, d'Epidemiologie et de Developpement
Not Provided
Not Provided
Institut de Sante Publique, d'Epidemiologie et de Developpement
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP