Patients With Behavioural Symptoms and Hospitalized in Cognitive and Behavioural Units

Completed

• Conditions: Alzheimer Disease

• Registration Number: NCT01901263
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Brief Summary

Cognitive and behavioral units (CBUs) have been created between 2008 and 2012 French National Alzheimer plan for the management of behavior problems of patients suffering from Alzheimer's disease or other related disorders and necessitating hospitalisation. This Alzheimer plan is promoting the evaluation of these units through the observation of the behavioral and psychological symptoms of dementia (BPSD) evolution. As these units are new, it appears important to assess their long-term impact on patients care.

Detailed Description

EXPECTED RESULTS The present study should allow to better understand the long-term impact of CBU on care of patients with Alzheimer disease and BPSD. Moreover, it should allow to identify patients improved by CBU.

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2013-07-09
• Study First Submitted QC: 2013-07-15
• Study First Posted: 2013-07-17
• Status Verified: 2015-07
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Last Update Submitted: 2015-11-30
• Last Update Posted: 2015-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 306

Inclusion Criteria

• patient hospitalized on CBUs
• patient with the diagnostic criteria for disease related to dementia stage with a Clinical Demential Rating ≥ 1
• patient with a caregiver who is fairly frequent contact with the patient in order to observe the appearance of behavior changes

Exclusion Criteria

• Patient living alone at home
• Patient with risk of death within one year

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Neuropsychiatric Inventory (NPI) score	one year	impact of CBU effectiveness in reducing BPSD

Secondary Outcome Measures

Name	Time	Method
CBU effectiveness in reducing BPSD	6 months
rehospitalisation rate for BPSD of the patients in the year following their hospitalisation in CBU	one year
CBU effectiveness on quality of life of patients and caregivers, and on caregivers' burden	one year
Psychotropic drugs (in particular neuroleptic drugs) consumption	one year

Trial Locations

Locations (3)

CH Saint Jean de Dieu; 🇫🇷 Lyon, France

CHU de Saint Etienne; 🇫🇷 Saint Etienne, France

Hospices Civils de Lyon; 🇫🇷 Villeurbanne, France