CClinicalTrials.gg
TerminatedNCT03485898UCCUpdated Sep 16, 2019

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

An observational study in Behavior Disorders, sponsored by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer. Terminated at 1 site in France. Per ClinicalTrials.gov, last updated 2019-09-16.

Sponsored by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer · Observational

Why this study was terminated
study director job transfer in another departement
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
58
Sex
All
01

Study summary

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.

02

Conditions studied

  • Behavior Disorders

Browse trials for

Keywords

  • UCC
  • mortality
  • alzheimer's disease
  • longitudinal study
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

The population correspond to all inpatient from the UCC of Toulon

Inclusion criteria

  • Inpatient at the UCC of Toulon

Exclusion criteria

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)
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
58 participants (actual)
Patient registry
No
05

What researchers measure

Primary outcomes

  1. 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

    Time frame: 12 months

Secondary outcomes

  1. 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

    Time frame: 3 and 6 months

  2. 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

    Time frame: 12 months

  3. 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.

    Time frame: 6 and 12 months

  4. Mortality rate during the hospitalization in the UCC

    Number of all dead patient on the total number of patient included

    Time frame: 12 months

  5. Analysis of hospitalisation rate

    Descriptive analysis

    Time frame: 12 months

  6. Analysis of the number of treatment taken during the study

    Descriptive analysis

    Time frame: 12 months

  7. 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

    Time frame: 12 months

  8. Analysis of the treatment's mode of delivery

    Descriptive analysis

    Time frame: 12 months

06

Study locations

1 site
  • Centre Hospitalier Intercommunal de Toulon La-Seyne-sur-Mer
    Toulon, France
07

References and documents

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 2386336 ↗
  • 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. PubMed 3776457 ↗
  • 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. PubMed 12374497 ↗
  • 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. PubMed 15760618 ↗
  • 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. PubMed 19716062 ↗
  • 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. PubMed 15187055 ↗
  • 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. PubMed 20621437 ↗
  • 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. PubMed 21045099 ↗

Individual participant data

Plan to share: No — There is no plan to share IPD

08

Registry details

Key details

Study ID
NCT03485898
Lead sponsor
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Responsible party
Sponsor
First posted
Apr 3, 2018
Start date
Apr 12, 2018
Primary completion
Jul 31, 2019
Completion
Jul 31, 2019
Last update
Sep 16, 2019

Study contacts

Romain Van overloop, doctor
principal investigator · Centre Hospitalier Intercommunal Toulon La Seyne sur Mer

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion