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
2 other identifiers
observational
306
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2012
Typical duration for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2012
CompletedFirst Submitted
Initial submission to the registry
July 9, 2013
CompletedFirst Posted
Study publicly available on registry
July 17, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedDecember 2, 2015
July 1, 2015
3 years
July 9, 2013
November 30, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Neuropsychiatric Inventory (NPI) score
impact of CBU effectiveness in reducing BPSD
one year
Secondary Outcomes (4)
CBU effectiveness in reducing BPSD
6 months
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
rehospitalisation rate for BPSD of the patients in the year following their hospitalisation in CBU
one year
Study Arms (1)
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
Interventions
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.
Eligibility Criteria
Patients with Alzheimer's disease or associated disorders and BDSP and hospitalized in a CBU
You may qualify if:
- 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
You may not qualify if:
- Patient living alone at home
- Patient with risk of death within one year
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
CH Saint Jean de Dieu
Lyon, 69373, France
CHU de Saint Etienne
Saint-Etienne, 42000, France
Hospices Civils de Lyon
Villeurbanne, 69100, France
Related Publications (1)
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.
PMID: 25398578DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Isabelle ROUCH, PhD
CHU de Saint-Etienne
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 3 Years
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 9, 2013
First Posted
July 17, 2013
Study Start
October 1, 2012
Primary Completion
October 1, 2015
Study Completion
October 1, 2015
Last Updated
December 2, 2015
Record last verified: 2015-07