Measuring the Impact of Care in the Cognitive Behavioural Unit

NCT ID: NCT03989245

Last Updated: 2024-04-25

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

RECRUITING

Total Enrollment

588 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-20

Study Completion Date

2025-12-31

Brief Summary

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The purpose of this study is to compare the rate of re-hospitalizations in relation to a disruptive behaviour disorder (at 3 and 6 months) between patients who have received care in Cognitive Behavioural Unity (UCC ) and those who have received care in Geriatric Follow-up and Rehabilitation Care Unit (SSR).

Detailed Description

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The purpose of this muliticentric non-interventional study is to compare the rate of re-hospitalization in relation to a disruptive behaviour disorder between patients receiving care in Cognitive Behavioural Unity UCC (target arm) and those who have received care in Geriatric Care Unit and Rehabilitation SSR (Control arm ).

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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Severe Disruptive Behaviour Disorders

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

* 70 ≥ years of age
* 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

* 70 \< years of age
* 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
Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gérond'if

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status RECRUITING

Countries

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France

Central Contacts

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Isabelle Dufour

Role: CONTACT

+33 (0) 185781010

Prisca Lucas, PhD

Role: CONTACT

+33 (0) 185781010

Facility Contacts

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Olivier Drunat, MD

Role: primary

+33 (0) 153111710

Other Identifiers

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2018-A02869-46

Identifier Type: -

Identifier Source: org_study_id

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