Severe Disruptive Behaviour DisordersIMPACTUCCNCT03989245
Measuring the Impact of Care in the Cognitive Behavioural Unit
An observational study of Severe Disruptive Behaviour Disorders, run by Gérond'if at 1 site in France.
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). Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Severe Disruptive Behaviour Disorders
- How many people
- 588 participants
- Where
- 1 siteFrance
- Study dates
- 20 Jan 2020to Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients receiving care in Cognitive Behavioural Unit (UCC ) and Geriatric Follow-up and Rehabilitation Unit (SSR)
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Psychiatric Geriatric Department, Bretonneau hospital
Paris, Île-de-France Region, 75018
Olivier Drunat, MD, +33 (0) 153111710, olivier.drunat@aphp.fr
About this study
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).
Read the 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.
- Conditions
- Severe Disruptive Behaviour Disorders
- Keywords
- Severe disruptive behaviour disorders, Cognitive Behavioural Unit, Geriatric Follow-up and Rehabilitation Care Unit
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Compare the rate of re-hospitalizations in relation to a disruptive behaviour disorder according Clinician Neuropsychaitric Inventury (NPI-Es) scaleaccording
Measured: 6 months
Secondary outcomes (3)
Measuring cognitive impairment according Mini-Mental State Examination (MMSE) score
Measured: 6 months
Screening for a nutritional disorder according Body Mass Index (BMI) score
Measured: 1 month
Assessment of somatic-comorbidities according Charlson scale
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2019
- Study start20 Jan 2020
- Primary completionJan 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Disruptive Behaviour DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 588 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gérond'if
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier Drunat, MD, Study chair, Psychiatric Geriatric Department, Bretonneau hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03989245
- Sponsor's protocol ID
- 2018-A02869-46
- Acronym
- IMPACTUCC
- Status last verified
- Apr 2024
- First submitted
- 14 Jun 2019
- Last updated
- 25 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring the Impact of Care in the Cognitive Behavioural Unit
- ClinicalTrials.gov ID
- NCT03989245
- Acronym / sponsor ID
- IMPACTUCC / 2018-A02869-46
- Conditions
- Severe Disruptive Behaviour Disorders
- Keywords
- Severe disruptive behaviour disorders, Cognitive Behavioural Unit, Geriatric Follow-up and Rehabilitation Care Unit
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 588 participants (estimated)
- Lead sponsor
- Gérond'ifUniversity, hospital or other
- Study start
- 20 Jan 2020 (actual)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 18 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients receiving care in Cognitive Behavioural Unit (UCC ) and Geriatric Follow-up and Rehabilitation Unit (SSR)
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Compare the rate of re-hospitalizations in relation to a disruptive behaviour disorder according Clinician Neuropsychaitric Inventury (NPI-Es) scaleaccording
Time frame: 6 months
3 secondary outcomes
Measuring cognitive impairment according Mini-Mental State Examination (MMSE) score
Time frame: 6 months
Screening for a nutritional disorder according Body Mass Index (BMI) score
Time frame: 1 month
Assessment of somatic-comorbidities according Charlson scale
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olivier Drunat, MD study chair
Psychiatric Geriatric Department, Bretonneau hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Disruptive Behaviour Disorders, run by Gérond'if at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Isabelle Dufour (+33 (0) 185781010, isabelle.dufour@gerondif.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare the rate of re-hospitalizations in relation to a disruptive behaviour disorder according Clinician Neuropsychaitric Inventury (NPI-Es) scaleaccording (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2024.