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Patients With Behavioural Symptoms and Hospitalized in Cognitive and Behavioural Units

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01901263
Enrollment
306
Registered
2013-07-17
Start date
2012-10-31
Completion date
2015-10-31
Last updated
2015-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer Disease

Keywords

Cognitive and behavioral units, Alzheimer Disease, Dementia

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.

Interventions

BEHAVIORALpatients 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.

Sponsors

Agence Régionale de Santé Rhône-Alpes
CollaboratorOTHER
Centre Hospitalier Universitaire de Saint Etienne
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Neuropsychiatric Inventory (NPI) scoreone yearimpact of CBU effectiveness in reducing BPSD

Secondary

MeasureTime frame
CBU effectiveness in reducing BPSD6 months
CBU effectiveness on quality of life of patients and caregivers, and on caregivers' burdenone year
Psychotropic drugs (in particular neuroleptic drugs) consumptionone year
rehospitalisation rate for BPSD of the patients in the year following their hospitalisation in CBUone year

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 19, 2026