Skip to main content
OpenTrials
Completed

NCT Number: NCT01081743

Effectiveness of Care Management in Alzheimer Patients

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.

Completed

Looking for future studies?

Notify Me

Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Bordeaux, 33076, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intervention of the social worker

Other

Systematic home visits and regular follow-ups by phone from a social worker

Primary outcomes

  1. NeuroPsychiatric Inventory (NPI)

    Time frame: 1 year

    Evaluation of frequency, severity and repercussion of several behavioural problems

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Institut de Sante Publique, d'Epidemiologie et de Developpement

Other

Registry information

Official study 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

Acronym: AIDALZ

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Mar 5, 2010
Registry last updated
Aug 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.