Clinical trial NCT01901263: Patients With Behavioural Symptoms and Hospitalized in Cognitive and Behavioural Units
Official title: Initial and Long-term Evaluation of Patients With Behavioural Symptoms and Hospitalized in Cognitive and Behavioural Units
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alzheimer Disease
Keywords: Cognitive and behavioral units
Alzheimer Disease
Dementia
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
Collaborators: name: Agence Régionale de Santé Rhône-Alpes
First posted: 2013-07-17
Enrollment: 306
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Alzheimer's disease or associated disorders and BDSP and hospitalized in a CBU

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.

Eligibility criteria: 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

Primary outcomes:
measure: Neuropsychiatric Inventory (NPI) score
timeFrame: one year
Secondary outcomes:
measure: CBU effectiveness in reducing BPSD
timeFrame: 6 months
measure: CBU effectiveness on quality of life of patients and caregivers, and on caregivers' burden
timeFrame: one year
measure: Psychotropic drugs (in particular neuroleptic drugs) consumption
timeFrame: one year
measure: rehospitalisation rate for BPSD of the patients in the year following their hospitalisation in CBU
timeFrame: one year
Other outcomes:
Locations:
city: Lyon
country: France
facility: CH Saint Jean de Dieu
city: Saint Etienne
country: France
facility: CHU de Saint Etienne
city: Villeurbanne
country: France
facility: Hospices Civils de Lyon
Study officials:
affiliation: CHU de Saint-Etienne
name: Isabelle ROUCH, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pongan E, Freulon M, Delphin-Combe F, Dibie-Racoupeau F, Martin-Gaujard G, Federico D, Waissi A, Richard G, Jacqueline S, Fabre F, Trombert-Paviot B, Krolak-Salmon P, Laurent B, Rouch I. Initial and long-term evaluation of patients with Alzheimer's after hospitalization in cognitive and behavioural units: the EVITAL study design. BMC Psychiatry. 2014 Nov 15;14:308. doi: 10.1186/s12888-014-0308-6.