Measuring the Impact of Care in the Cognitive Behavioural Unit
NCT ID: NCT03989245
Last Updated: 2024-04-25
Study Results
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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RECRUITING
588 participants
OBSERVATIONAL
2020-01-20
2025-12-31
Brief Summary
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Detailed Description
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At Inclusion (Month 0) : Inclusion of patients admitted in UCC or in geriatric SSR units for less than 8 days after obtaining of their non opposition.
Following data: Socio-educational Level, somatic and psychiatric comorbidities, classification of the type of dementia, evolution of nutritional status, biology (hemoglobin, creatinine, albuminemia), cognitive evaluation, treatment, pain assessment, assessment of disruptive behaviour disorders, discharge modalities, assistance plan, legal protection (before and after hospitalization), types of restraints, measurement of fall rates and their consequences, pathology and/or symptoms observed ( incidents) during hospitalization and vital status will be collected at inclusion and follow-up (1, 3 and 6 months ).
At 1 month (M1), exit from hospitalization (M1): Data provided by Investigator .
At 3 months (M3) and 6 months (M6) after discharge from hospital in UCC or SSR: Sponsor's Clinical Research Associateall call patient (or his legal representative) or to the primary caregiver or attending physician or EHPAD coordinating physician for collection of questionnaires.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Target arm: UCC (Cognitive Behavioural Unit)
Patients receiving care in Cognitive Behavioural Unit (UCC )
No interventions assigned to this group
Control arm: SSR (Geriatric Follow-up and Rehabilitation Unit)
Patients receiving care in Geriatric Follow-up and Rehabilitation Care Unit (SSR)
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Patient with severe disruptive behaviour disorders with a score (Frequency X Severity) \>7 to at least one of the 7 items targeted on Clinician Neuropsychaitric Inventury (NPI-Es) scale
* Patient who was not cared for in Cognitive Behavioural Unit (UCC) within 6 months prior to admission
* Patient entered center less than 8 days
* Affiliation to a social security scheme
* Patient or legal representative has expressed his non-opposition
Exclusion Criteria
* Patient with no score (FXG) \>7 to at least one of the 7 items targeted on Clinician Neuropsychaitric Inventury NPI-ES scale
* Patient who was cared for in UCC within 6 months of admission
* Entered Centre for 8 days or more
* Not affiliated or entitled to a social security scheme
* Patient or legal representative has expressed his opposition
70 Years
ALL
No
Sponsors
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Gérond'if
OTHER
Responsible Party
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Principal Investigators
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Olivier Drunat, MD
Role: STUDY_CHAIR
Psychiatric Geriatric Department, Bretonneau hospital
Locations
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Psychiatric Geriatric Department, Bretonneau hospital
Paris, Île-de-France Region, France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2018-A02869-46
Identifier Type: -
Identifier Source: org_study_id
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