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

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).

Study Overview

• Status: Recruiting
• Conditions: Severe Disruptive Behaviour Disorders

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 588

Contacts and Locations

• Study Contact: Name: Isabelle Dufour; Phone Number: +33 (0) 185781010; Email: isabelle.dufour@gerondif.org
• Study Contact Backup: Name: Prisca Lucas, PhD; Phone Number: +33 (0) 185781010; Email: prisca.lucas@gerondif.org

Study Locations

• France
  • Ile-de-France
    • Paris, Ile-de-France, France, 75018
      • Recruiting
      • Psychiatric Geriatric Department, Bretonneau hospital
      • Contact: Olivier Drunat, MD; Phone Number: +33 (0) 153111710; Email: olivier.drunat@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients receiving care in Cognitive Behavioural Unit (UCC ) and Geriatric Follow-up and Rehabilitation Unit (SSR)

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Compare the rate of re-hospitalizations in relation to a disruptive behaviour disorder according Clinician Neuropsychaitric Inventury (NPI-Es) scaleaccording	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Measuring cognitive impairment according Mini-Mental State Examination (MMSE) score	6 months
Screening for a nutritional disorder according Body Mass Index (BMI) score	1 month
Assessment of somatic-comorbidities according Charlson scale	6 months

Collaborators and Investigators

• Sponsor: Gérond'if
• Investigators: Study Chair: Olivier Drunat, MD, Psychiatric Geriatric Department, Bretonneau hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2020
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: June 14, 2019
• First Submitted That Met QC Criteria: June 14, 2019
• First Posted (Actual): June 18, 2019

Study Record Updates

• Last Update Posted (Actual): April 25, 2024
• Last Update Submitted That Met QC Criteria: April 24, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Severe disruptive behaviour disorders; Cognitive Behavioural Unit; Geriatric Follow-up and Rehabilitation Care Unit
• Additional Relevant MeSH Terms: Behavioral Symptoms; Neurodevelopmental Disorders; Problem Behavior; Mental Disorders; Attention Deficit and Disruptive Behavior Disorders
• Other Study ID Numbers: 2018-A02869-46

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No