Study of Patients Hospitalized in Specialized Cognitive-behavioral Unit (UCC)

Behavior Disorders Clinical Trial

— UCC  

Official title:

Patient Outcomes After an Hospitalization in the Specialized Cognitive-behavioral Unit (UCC) of Toulon

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03485898
• Other study ID #: 2017-CHITS-05
• Secondary ID: 2017-A03332-51
• Status: Terminated
• Start date: April 12, 2018
• Est. completion date: July 31, 2019

Study information

• Verified date: September 2019
• Source: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of the study is to assess the mortality of patient discharged from the specialized cognitive-behavioral unit (UCC) of Toulon.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 58
• Est. completion date: July 31, 2019
• Est. primary completion date: July 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Inpatient at the UCC of Toulon

Exclusion Criteria:

• 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)

Related Conditions & MeSH terms

• Behavior Disorders
• Mental Disorders

Locations

Country	Name	City	State
France	Centre Hospitalier Intercommunal de Toulon La-Seyne-sur-Mer	Toulon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

Country where clinical trial is conducted

France, 

References & Publications (8)

Edland 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. — View Citation

Fitzpatrick 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. Epub 2004 Dec 23. — View Citation

Lee 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. Review. — View Citation

Mitchell 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. — View Citation

Mitchell 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. — View Citation

Mitchell 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. — View Citation

Mölsä 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. — View Citation

Walsh JS, Welch HG, Larson EB. Survival of outpatients with Alzheimer-type dementia. Ann Intern Med. 1990 Sep 15;113(6):429-34. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	12 months
Secondary	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	3 and 6 months
Secondary	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	12 months
Secondary	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.	6 and 12 months
Secondary	Mortality rate during the hospitalization in the UCC	Number of all dead patient on the total number of patient included	12 months
Secondary	Analysis of hospitalisation rate	Descriptive analysis	12 months
Secondary	Analysis of the number of treatment taken during the study	Descriptive analysis	12 months
Secondary	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	12 months
Secondary	Analysis of the treatment's mode of delivery	Descriptive analysis	12 months