Behavior DisordersUCCNCT03485898
Study of Patients Hospitalized in Specialized Cognitive-behavioral Unit (UCC)
An observational study of Behavior Disorders, run by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer at 1 site in France.
Trial summary
The purpose of the study is to assess the mortality of patient discharged from the specialized cognitive-behavioral unit (UCC) of Toulon. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Behavior Disorders
- How many people
- 58 participants
- Where
- 1 siteFrance
- Study dates
- 12 Apr 2018to 31 Jul 2019
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The population correspond to all inpatient from the UCC of Toulon
Who may be able to join
- Inpatient at the UCC of Toulon
Who cannot join
- Patient already included in the study ( a patient cannot be included twice during the study)
- Non-affiliated to a social security regimen
- Objection of the patient, the trusted person, the legal representative, the relative or the member of the family (depending on the overall condition of the patient)
Trial locations and contacts
1 site in 1 country.
France1 site
Centre Hospitalier Intercommunal de Toulon La-Seyne-sur-Mer
Toulon
About this study
Official title: Patient Outcomes After an Hospitalization in the Specialized Cognitive-behavioral Unit (UCC) of Toulon
The purpose of the study is to assess the mortality of patient discharged from the specialized cognitive-behavioral unit (UCC) of Toulon.
Read the detailed description
The purpose of specialized cognitive-behavioral unit is to take care of patients demented, valid and with disruptive behavior disorders. The hypothesis is that analyzing the healthcare of these discharged patients might provide a view of the benefices of these units.
The study will be explained to the eligible subjects if they are able to understand it, or to their trusted person, primary caregiver or legal representative.
Medical information will be collected during and after the hospitalization in the specialized cognitive-behavioral unit. The investigator will call the medical staff and the primary caregiver at 3, 6, and 12 months after the patient's discharge, in order to collect study data.
- Conditions
- Behavior Disorders
- Keywords
- UCC, mortality, alzheimer's disease, longitudinal study
- Medical subject headings
- Mental Disorders, Alzheimer Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality rate at 12 month after patient's discharge from UCC
Number of dead patient at 12 month on the total number of patient included
Measured: 12 months
Secondary outcomes (8)
Mortality rate at 3 and 6 month after patient's discharge from UCC
Number of dead patient at 3 and 6 month on the total number of patient included
Measured: 3 and 6 months
Assess the primary mortality risk factors regarding all the collected data.
correlation analysis of collected data and survival data will lead to prediction of survival model with the most relevant survival variable
Measured: 12 months
Create a predictive score for 6 and 12 month mortality
all the survival variable will have a score according to the survival prediction model - this endpoint is adressed in order to create a predictive scale/score.
Measured: 6 and 12 months
Mortality rate during the hospitalization in the UCC
Number of all dead patient on the total number of patient included
Measured: 12 months
Analysis of hospitalisation rate
Descriptive analysis
Measured: 12 months
Analysis of the number of treatment taken during the study
Descriptive analysis
Measured: 12 months
Analysis of the different classes of treatment taken during the study
Descriptive analysis of the rate of different classes of treatment taken by patient during the study
Measured: 12 months
Analysis of the treatment's mode of delivery
Descriptive analysis
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2018
- Study start12 Apr 2018
- Primary completion31 Jul 2019
- Study completion31 Jul 2019
Why it stopped: study director job transfer in another departement
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Behavior 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
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Romain Van overloop, doctor, Principal investigator, Centre Hospitalier Intercommunal Toulon La Seyne sur Mer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03485898
- Sponsor's protocol ID
- 2017-CHITS-05
- Other IDs
- 2017-A03332-51
- Acronym
- UCC
- Status last verified
- Sep 2019
- First submitted
- 22 Feb 2018
- Last updated
- 16 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share IPD
Publications
Walsh JS, Welch HG, Larson EB. Survival of outpatients with Alzheimer-type dementia. Ann Intern Med. 1990 Sep 15;113(6):429-34. doi: 10.7326/0003-4819-113-6-429.
PubMed 2386336Molsa PK, Marttila RJ, Rinne UK. Survival and cause of death in Alzheimer's disease and multi-infarct dementia. Acta Neurol Scand. 1986 Aug;74(2):103-7. doi: 10.1111/j.1600-0404.1986.tb04634.x.
PubMed 3776457Edland SD, Rocca WA, Petersen RC, Cha RH, Kokmen E. Dementia and Alzheimer disease incidence rates do not vary by sex in Rochester, Minn. Arch Neurol. 2002 Oct;59(10):1589-93. doi: 10.1001/archneur.59.10.1589.
PubMed 12374497Fitzpatrick AL, Kuller LH, Lopez OL, Kawas CH, Jagust W. Survival following dementia onset: Alzheimer's disease and vascular dementia. J Neurol Sci. 2005 Mar 15;229-230:43-9. doi: 10.1016/j.jns.2004.11.022. Epub 2004 Dec 23.
PubMed 15760618Lee M, Chodosh J. Dementia and life expectancy: what do we know? J Am Med Dir Assoc. 2009 Sep;10(7):466-71. doi: 10.1016/j.jamda.2009.03.014. Epub 2009 Jun 27.
PubMed 19716062Mitchell SL, Kiely DK, Hamel MB, Park PS, Morris JN, Fries BE. Estimating prognosis for nursing home residents with advanced dementia. JAMA. 2004 Jun 9;291(22):2734-40. doi: 10.1001/jama.291.22.2734.
PubMed 15187055Mitchell SL, Miller SC, Teno JM, Davis RB, Shaffer ML. The advanced dementia prognostic tool: a risk score to estimate survival in nursing home residents with advanced dementia. J Pain Symptom Manage. 2010 Nov;40(5):639-51. doi: 10.1016/j.jpainsymman.2010.02.014.
PubMed 20621437Mitchell SL, Miller SC, Teno JM, Kiely DK, Davis RB, Shaffer ML. Prediction of 6-month survival of nursing home residents with advanced dementia using ADEPT vs hospice eligibility guidelines. JAMA. 2010 Nov 3;304(17):1929-35. doi: 10.1001/jama.2010.1572.
PubMed 21045099
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Outcomes After an Hospitalization in the Specialized Cognitive-behavioral Unit (UCC) of Toulon
- ClinicalTrials.gov ID
- NCT03485898
- Acronym / sponsor ID
- UCC / 2017-CHITS-05
- Conditions
- Behavior Disorders
- Keywords
- UCC, mortality, alzheimer's disease, longitudinal study
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: study director job transfer in another departement
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Centre Hospitalier Intercommunal de Toulon La Seyne sur MerUniversity, hospital or other
- Study start
- 12 Apr 2018 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 3 Apr 2018 (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 the study is to assess the mortality of patient discharged from the specialized cognitive-behavioral unit (UCC) of Toulon.
Detailed description
The purpose of specialized cognitive-behavioral unit is to take care of patients demented, valid and with disruptive behavior disorders. The hypothesis is that analyzing the healthcare of these discharged patients might provide a view of the benefices of these units.
The study will be explained to the eligible subjects if they are able to understand it, or to their trusted person, primary caregiver or legal representative.
Medical information will be collected during and after the hospitalization in the specialized cognitive-behavioral unit. The investigator will call the medical staff and the primary caregiver at 3, 6, and 12 months after the patient's discharge, in order to collect study data.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The population correspond to all inpatient from the UCC of Toulon
Key inclusion criteria (1 listed)
- Inpatient at the UCC of Toulon
Key exclusion criteria (3 listed)
- Patient already included in the study ( a patient cannot be included twice during the study)
- Non-affiliated to a social security regimen
- Objection of the patient, the trusted person, the legal representative, the relative or the member of the family (depending on the overall condition of the patient)
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
Mortality rate at 12 month after patient's discharge from UCC
Time frame: 12 months
Number of dead patient at 12 month on the total number of patient included
8 secondary outcomes
Mortality rate at 3 and 6 month after patient's discharge from UCC
Time frame: 3 and 6 months
Assess the primary mortality risk factors regarding all the collected data.
Time frame: 12 months
Create a predictive score for 6 and 12 month mortality
Time frame: 6 and 12 months
Mortality rate during the hospitalization in the UCC
Time frame: 12 months
Analysis of hospitalisation rate
Time frame: 12 months
Analysis of the number of treatment taken during the study
Time frame: 12 months
Analysis of the different classes of treatment taken during the study
Time frame: 12 months
Analysis of the treatment's mode of delivery
Time frame: 12 months
Results and safety
The study was stopped early (reason given: study director job transfer in another departement). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2019.
- Background: PubMed 2386336Walsh JS, Welch HG, Larson EB. Survival of outpatients with Alzheimer-type dementia. Ann Intern Med. 1990 Sep 15;113(6):429-34. doi: 10.7326/0003-4819-113-6-429.
- Background: PubMed 3776457Molsa PK, Marttila RJ, Rinne UK. Survival and cause of death in Alzheimer's disease and multi-infarct dementia. Acta Neurol Scand. 1986 Aug;74(2):103-7. doi: 10.1111/j.1600-0404.1986.tb04634.x.
- Background: PubMed 12374497Edland SD, Rocca WA, Petersen RC, Cha RH, Kokmen E. Dementia and Alzheimer disease incidence rates do not vary by sex in Rochester, Minn. Arch Neurol. 2002 Oct;59(10):1589-93. doi: 10.1001/archneur.59.10.1589.
- Background: PubMed 15760618Fitzpatrick AL, Kuller LH, Lopez OL, Kawas CH, Jagust W. Survival following dementia onset: Alzheimer's disease and vascular dementia. J Neurol Sci. 2005 Mar 15;229-230:43-9. doi: 10.1016/j.jns.2004.11.022. Epub 2004 Dec 23.
- Background: PubMed 19716062Lee M, Chodosh J. Dementia and life expectancy: what do we know? J Am Med Dir Assoc. 2009 Sep;10(7):466-71. doi: 10.1016/j.jamda.2009.03.014. Epub 2009 Jun 27.
- Background: PubMed 15187055Mitchell SL, Kiely DK, Hamel MB, Park PS, Morris JN, Fries BE. Estimating prognosis for nursing home residents with advanced dementia. JAMA. 2004 Jun 9;291(22):2734-40. doi: 10.1001/jama.291.22.2734.
- Background: PubMed 20621437Mitchell SL, Miller SC, Teno JM, Davis RB, Shaffer ML. The advanced dementia prognostic tool: a risk score to estimate survival in nursing home residents with advanced dementia. J Pain Symptom Manage. 2010 Nov;40(5):639-51. doi: 10.1016/j.jpainsymman.2010.02.014.
- Background: PubMed 21045099Mitchell SL, Miller SC, Teno JM, Kiely DK, Davis RB, Shaffer ML. Prediction of 6-month survival of nursing home residents with advanced dementia using ADEPT vs hospice eligibility guidelines. JAMA. 2010 Nov 3;304(17):1929-35. doi: 10.1001/jama.2010.1572.
- Individual participant dataSharing planned: No. There is no plan to share IPD
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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.
Romain Van overloop, doctor principal investigator
Centre Hospitalier Intercommunal Toulon La Seyne sur Mer
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 Behavior Disorders, run by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer 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 1 inclusion and 3 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: stopped early, as of the sponsor's last update on 16 Sep 2019. 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?
The study was stopped early (reason given: study director job transfer in another departement). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality rate at 12 month after patient's discharge from UCC (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03485898, which also lists 8 linked publications.
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 16 Sep 2019.