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

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.

Study Overview

• Status: Terminated
• Conditions: Behavior Disorders

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 Type: Observational
• Enrollment (Actual): 58

Contacts and Locations

Study Locations

• France
  • Toulon, France
    • Centre Hospitalier Intercommunal de Toulon La-Seyne-sur-Mer

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The population correspond to all inpatient from the UCC of Toulon

Description

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)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Mortality rate during the hospitalization in the UCC	Number of all dead patient on the total number of patient included	12 months
Analysis of hospitalisation rate	Descriptive analysis	12 months
Analysis of the number of treatment taken during the study	Descriptive analysis	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	12 months
Analysis of the treatment's mode of delivery	Descriptive analysis	12 months

Collaborators and Investigators

• Sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
• Investigators: Principal Investigator: Romain Van overloop, doctor, Centre Hospitalier Intercommunal Toulon La Seyne sur Mer

Publications and helpful links

General 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.
• Molsa 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.
• 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. doi: 10.1001/archneur.59.10.1589.
• 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. doi: 10.1016/j.jns.2004.11.022. Epub 2004 Dec 23.
• 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.
• 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. doi: 10.1001/jama.291.22.2734.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 12, 2018
• Primary Completion (Actual): July 31, 2019
• Study Completion (Actual): July 31, 2019

Study Registration Dates

• First Submitted: February 22, 2018
• First Submitted That Met QC Criteria: March 26, 2018
• First Posted (Actual): April 3, 2018

Study Record Updates

• Last Update Posted (Actual): September 16, 2019
• Last Update Submitted That Met QC Criteria: September 13, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: mortality; longitudinal study; alzheimer's disease; UCC
• Additional Relevant MeSH Terms: Mental Disorders
• Other Study ID Numbers: 2017-CHITS-05; 2017-A03332-51 (Other Identifier: Id-RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to share IPD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No