Patients With Behavioural Symptoms and Hospitalized in Cognitive and Behavioural Units

November 30, 2015 updated by: Centre Hospitalier Universitaire de Saint Etienne

Initial and Long-term Evaluation of Patients With Behavioural Symptoms and Hospitalized in Cognitive and Behavioural Units

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

306

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lyon, France, 69373
        • CH Saint Jean de Dieu
      • Saint Etienne, France, 42000
        • CHU de Saint Etienne
      • Villeurbanne, France, 69100
        • Hospices Civils de Lyon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with Alzheimer's disease or associated disorders and BDSP and hospitalized in a CBU

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
patient with alzheimer's disease

Cohort of patients with psychological symptoms of dementia hospitalised in Cognitive and Behaviorial Units (CBUs)

Evaluation of these units through the observation of the behavioral and psychological symptoms of dementia evolution : NPI score, caregivers quality of life, caregivers burden, collection of psychotropic drugs, the rehospitalisation rate
Behavioral: patients with alzheimer's disease
the Neuropsychiatric Inventory (NPI), is uded to assess 10 behavioral disturbances occurring in dementia patients: delusions, hallucinations, dysphoria, anxiety, agitation/aggression, euphoria, disinhibition, irritability/lability, apathy, and aberrant motor activity. The NPI uses a screening strategy to minimize administration time, examining and scoring only those behavioral domains with positive responses to screening questions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neuropsychiatric Inventory (NPI) score
Time Frame: one year
impact of CBU effectiveness in reducing BPSD
one year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Collaborators

Agence Régionale de Santé Rhône-Alpes

Investigators

  • Principal Investigator: Isabelle ROUCH, PhD, CHU de Saint-Etienne

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

July 9, 2013

First Submitted That Met QC Criteria

July 15, 2013

First Posted (Estimate)

July 17, 2013

Study Record Updates

Last Update Posted (Estimate)

December 2, 2015

Last Update Submitted That Met QC Criteria

November 30, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1208125
  • 13.069bis (Other Identifier: CCTIRS)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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