Measuring the Impact of Care in the Cognitive Behavioural Unit

Severe Disruptive Behaviour Disorders Clinical Trial

— IMPACTUCC  

Official title:

Measuring the Impact of Care in the Cognitive Behavioural Unit

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03989245
• Other study ID #: 2018-A02869-46
• Status: Recruiting
• Start date: January 20, 2020
• Est. completion date: December 2025

Study information

• Verified date: April 2024
• Source: Gérond'if
• Contact: Isabelle Dufour
• Phone: +33 (0) 185781010
• Email: isabelle.dufour[@]gerondif.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 588
• Est. completion date: December 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Attention Deficit and Disruptive Behavior Disorders
• Mental Disorders
• Problem Behavior
• Severe Disruptive Behaviour Disorders

Locations

Country	Name	City	State
France	Psychiatric Geriatric Department, Bretonneau hospital	Paris	Ile-de-France

Sponsors (1)

Lead Sponsor	Collaborator
Gérond'if

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare the rate of re-hospitalizations in relation to a disruptive behaviour disorder according Clinician Neuropsychaitric Inventury (NPI-Es) scaleaccording		6 months
Secondary	Measuring cognitive impairment according Mini-Mental State Examination (MMSE) score		6 months
Secondary	Screening for a nutritional disorder according Body Mass Index (BMI) score		1 month
Secondary	Assessment of somatic-comorbidities according Charlson scale		6 months