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Measuring the Impact of Care in the Cognitive Behavioural Unit (IMPACTUCC)

G

Gérond'if

Status

Enrolling

Conditions

Severe Disruptive Behaviour Disorders

Study type

Observational

Funder types

Other

Identifiers

NCT03989245
2018-A02869-46

Details and patient eligibility

About

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).

Full description

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.

Enrollment

588 estimated patients

Sex

All

Ages

70+ years old

Volunteers

No Healthy Volunteers

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

Trial design

588 participants in 2 patient groups

Target arm: UCC (Cognitive Behavioural Unit)
Description:
Patients receiving care in Cognitive Behavioural Unit (UCC )
Control arm: SSR (Geriatric Follow-up and Rehabilitation Unit)
Description:
Patients receiving care in Geriatric Follow-up and Rehabilitation Care Unit (SSR)

Trial contacts and locations

1

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Central trial contact

Prisca Lucas, PhD; Isabelle Dufour

Data sourced from clinicaltrials.gov

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