Clinical trial NCT03989245: Measuring the Impact of Care in the Cognitive Behavioural Unit
Official title: Measuring the Impact of Care in the Cognitive Behavioural Unit
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Severe Disruptive Behaviour Disorders
Keywords: Severe disruptive behaviour disorders
Cognitive Behavioural Unit
Geriatric Follow-up and Rehabilitation Care Unit
Lead sponsor: Gérond'if
Sponsor class: OTHER
First posted: 2019-06-18
Enrollment: 588
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients receiving care in Cognitive Behavioural Unit (UCC ) and Geriatric Follow-up and Rehabilitation Unit (SSR)

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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Compare the rate of re-hospitalizations in relation to a disruptive behaviour disorder according Clinician Neuropsychaitric Inventury (NPI-Es) scaleaccording
timeFrame: 6 months
Secondary outcomes:
measure: Measuring cognitive impairment according Mini-Mental State Examination (MMSE) score
timeFrame: 6 months
measure: Screening for a nutritional disorder according Body Mass Index (BMI) score
timeFrame: 1 month
measure: Assessment of somatic-comorbidities according Charlson scale
timeFrame: 6 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Psychiatric Geriatric Department, Bretonneau hospital
state: Ile-de-France
Study officials:
affiliation: Psychiatric Geriatric Department, Bretonneau hospital
name: Olivier Drunat, MD
role: STUDY_CHAIR
References: