Patients With Behavioural Symptoms and Hospitalized in Cognitive and Behavioural Units

Alzheimer Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01901263
• Other study ID #: 1208125
• Secondary ID: 13.069bis
• Status: Completed
• Phase: N/A
• First received: July 9, 2013
• Last updated: November 30, 2015
• Start date: October 2012
• Est. completion date: October 2015

Study information

• Verified date: July 2015
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: French Data Protection Authority
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 306
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

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.

Locations

Country	Name	City	State
France	CH Saint Jean de Dieu	Lyon
France	CHU de Saint Etienne	Saint Etienne
France	Hospices Civils de Lyon	Villeurbanne

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne	Agence Régionale de Santé Rhône-Alpes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neuropsychiatric Inventory (NPI) score	impact of CBU effectiveness in reducing BPSD	one year	No
Secondary	CBU effectiveness in reducing BPSD		6 months	No
Secondary	CBU effectiveness on quality of life of patients and caregivers, and on caregivers' burden		one year	No
Secondary	Psychotropic drugs (in particular neuroleptic drugs) consumption		one year	No
Secondary	rehospitalisation rate for BPSD of the patients in the year following their hospitalisation in CBU		one year	No