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OpenTrials
Completed

NCT Number: NCT01901263

Patients With Behavioural Symptoms and Hospitalized in Cognitive and Behavioural Units

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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Key information

Conditions

Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CH Saint Jean de Dieu, Lyon, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Neuropsychiatric Inventory (NPI) score

    Time frame: one year

    impact of CBU effectiveness in reducing BPSD

Secondary outcomes

  1. CBU effectiveness in reducing BPSD

    Time frame: 6 months

  2. CBU effectiveness on quality of life of patients and caregivers, and on caregivers' burden

    Time frame: one year

  3. Psychotropic drugs (in particular neuroleptic drugs) consumption

    Time frame: one year

  4. rehospitalisation rate for BPSD of the patients in the year following their hospitalisation in CBU

    Time frame: one year

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Collaborators

  • Agence Régionale de Santé Rhône-Alpes

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Jul 17, 2013
Registry last updated
Dec 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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