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Effectiveness of Care Management in Alzheimer Patients (AIDALZ)

Primary Purpose

Alzheimer Disease or Associated Disorder, Mild to Moderately Severe Dementia

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Intervention of the social worker
Sponsored by
Institut de Sante Publique, d'Epidemiologie et de Developpement
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Alzheimer Disease or Associated Disorder focused on measuring Alzheimer, Dementia, Mild to moderately severe, New diagnosis, Prevention of behavioural problems

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Social worker

Control

Arm Description

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

Outcomes

Primary Outcome Measures

NeuroPsychiatric Inventory (NPI)
Evaluation of frequency, severity and repercussion of several behavioural problems

Secondary Outcome Measures

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

Full Information

First Posted
March 4, 2010
Last Updated
August 25, 2017
Sponsor
Institut de Sante Publique, d'Epidemiologie et de Developpement
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1. Study Identification

Unique Protocol Identification Number
NCT01081743
Brief Title
Effectiveness of Care Management in Alzheimer Patients
Acronym
AIDALZ
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
November 24, 2009 (Actual)
Primary Completion Date
October 2, 2013 (Actual)
Study Completion Date
October 2, 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut de Sante Publique, d'Epidemiologie et de Developpement

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease or Associated Disorder, Mild to Moderately Severe Dementia
Keywords
Alzheimer, Dementia, Mild to moderately severe, New diagnosis, Prevention of behavioural problems

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
270 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Social worker
Arm Type
Experimental
Arm Title
Control
Arm Type
No Intervention
Arm Description
Control group is followed-up as usually (usual care)
Intervention Type
Other
Intervention Name(s)
Intervention of the social worker
Intervention Description
Systematic home visits and regular follow-ups by phone from a social worker
Primary Outcome Measure Information:
Title
NeuroPsychiatric Inventory (NPI)
Description
Evaluation of frequency, severity and repercussion of several behavioural problems
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Cohen-Mansfield Agitation Inventory (CMAI)
Time Frame
1 year
Title
Apathy Inventory
Time Frame
1 year
Title
Disablement Assessment for Dementia (DAD)
Time Frame
1 year
Title
Mini Mental State Examination (MMSE)
Time Frame
1 year
Title
Global Deterioration Scale (GDS)
Time Frame
1 year
Title
Montgomery-Asberg Depression Rating Scale (MADRS)
Time Frame
1 year
Title
Questionnaire Quality of Life - Alzheimer's Disease (QoL-AD)
Time Frame
1 year
Title
Burden Interview of Zarit
Time Frame
1 year
Title
Resource utilization in dementia scale (RUD Lite)
Time Frame
1 year
Title
Medical Outcome Study Short Form 36-item health survey (MOS SF-36)
Time Frame
1 year
Title
Institutionalization
Time Frame
1 year
Title
Tiredness scale
Time Frame
1 year

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
ISPED (Institut de Santé Publique, d'Epidémiologie et de Développement)
City
Bordeaux
ZIP/Postal Code
33076
Country
France

12. IPD Sharing Statement

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Effectiveness of Care Management in Alzheimer Patients

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