NCT03989245

Brief 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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
588

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 14, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 18, 2019

Completed
7 months until next milestone

Study Start

First participant enrolled

January 20, 2020

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

April 25, 2024

Status Verified

April 1, 2024

Enrollment Period

5 years

First QC Date

June 14, 2019

Last Update Submit

April 24, 2024

Conditions

Keywords

Severe disruptive behaviour disordersCognitive Behavioural UnitGeriatric Follow-up and Rehabilitation Care Unit

Outcome Measures

Primary Outcomes (1)

  • Compare the rate of re-hospitalizations in relation to a disruptive behaviour disorder according Clinician Neuropsychaitric Inventury (NPI-Es) scaleaccording

    6 months

Secondary Outcomes (3)

  • 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

Study Arms (2)

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)

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • ≥ 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

You may not qualify if:

  • \< 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Psychiatric Geriatric Department, Bretonneau hospital

Paris, Île-de-France Region, 75018, France

RECRUITING

Study Officials

  • Olivier Drunat, MD

    Psychiatric Geriatric Department, Bretonneau hospital

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 14, 2019

First Posted

June 18, 2019

Study Start

January 20, 2020

Primary Completion

January 1, 2025

Study Completion

December 1, 2025

Last Updated

April 25, 2024

Record last verified: 2024-04

Locations