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CompletedNCT01901263Updated Dec 2, 2015

Patients With Behavioural Symptoms and Hospitalized in Cognitive and Behavioural Units

An observational study in Alzheimer Disease, sponsored by Centre Hospitalier Universitaire de Saint Etienne. Completed at 3 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-12-02.

Sponsored by Centre Hospitalier Universitaire de Saint Etienne · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
306
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Alzheimer Disease

Keywords

  • Cognitive and behavioral units
  • Alzheimer Disease
  • Dementia
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In context

Alzheimer Disease

3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.

This study's enrollment of 306 is above the median of 200 across 751 observational studies indexed under Alzheimer Disease.

Browse Alzheimer Disease studies →

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne is the lead sponsor of 578 studies on the registry; 128 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with Alzheimer's disease or associated disorders and BDSP and hospitalized in a CBU

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

Exclusion Criteria:

  • Patient living alone at home
  • Patient with risk of death within one year
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
306 participants (actual)
Target follow-up
3 Years
Patient registry
Yes

Groups and cohorts

  • 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

    Behavioral: patients with alzheimer's disease

Interventions

  • Behavioralpatients 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.

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What researchers measure

Primary outcomes

  1. Neuropsychiatric Inventory (NPI) score

    impact of CBU effectiveness in reducing BPSD

    Time frame: one year

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

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Study locations

3 sites
  • CH Saint Jean de Dieu
    Lyon, 69373, France
  • CHU de Saint Etienne
    Saint Etienne, 42000, France
  • Hospices Civils de Lyon
    Villeurbanne, 69100, France
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References and documents

Publications

  • 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. PubMed 25398578 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 2, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01901263
Lead sponsor
Centre Hospitalier Universitaire de Saint Etienne
Collaborators
Agence Régionale de Santé Rhône-Alpes
Responsible party
Sponsor
First posted
Jul 17, 2013
Start date
Oct 2012
Primary completion
Oct 2015
Completion
Oct 2015
Last update
Dec 2, 2015

Study contacts

Isabelle ROUCH, PhD
principal investigator · CHU de Saint-Etienne

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.

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