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Patients With Behavioural Symptoms and Hospitalized in Cognitive and Behavioural Units

NCT ID: NCT01901263

Last Updated: 2015-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

306 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-10-31

Study Completion Date

2015-10-31

Brief Summary

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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

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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.

Conditions

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Alzheimer Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

patients with alzheimer's disease

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Agence Régionale de Santé Rhône-Alpes

OTHER

Sponsor Role collaborator

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Isabelle ROUCH, PhD

Role: PRINCIPAL_INVESTIGATOR

CHU de Saint-Etienne

Locations

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CH Saint Jean de Dieu

Lyon, , France

Site Status

CHU de Saint Etienne

Saint-Etienne, , France

Site Status

Hospices Civils de Lyon

Villeurbanne, , France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 25398578 (View on PubMed)

Other Identifiers

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13.069bis

Identifier Type: OTHER

Identifier Source: secondary_id

1208125

Identifier Type: -

Identifier Source: org_study_id