Patients With Behavioural Symptoms and Hospitalized in Cognitive and Behavioural Units

NCT01901263 — Completed, 306 participants, Centre Hospitalier Universitaire de Saint Etienne

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

RegistryNCT01901263
StatusCompleted
Study typeObservational
Enrollment306 (Actual)
SponsorCentre Hospitalier Universitaire de Saint Etienne (Other); collaborators: Agence Régionale de Santé Rhône-Alpes
ConditionsAlzheimer Disease
Interventionspatients with alzheimer's disease (Behavioral)
Datesstart 2012-10-01, primary completion 2015-10-01, completion 2015-10-01, first posted 2013-07-17, last updated 2015-12-02
Locations3 sites in France

Related Papers Related Patents Related Grants Related Experts
All trials for Alzheimer Disease All trials of patients with alzheimer's disease

-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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
patient with alzheimer's diseaseBehavioral: patients with alzheimer's diseaseCohort 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 (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.

+Outcome measures

Primary outcomes

  • Neuropsychiatric Inventory (NPI) score [one year]: impact of CBU effectiveness in reducing BPSD

Secondary outcomes

  • 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]

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (3)

FacilityCityCountryStatus
CH Saint Jean de DieuLyonFrance
CHU de Saint EtienneSaint-EtienneFrance
Hospices Civils de LyonVilleurbanneFrance

+Publications

  • Results publication: 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 25398578

+Investigators

  • Isabelle ROUCH, PhD, Principal investigator, CHU de Saint-Etienne