NCT03485898

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2018

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 22, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 3, 2018

Completed
9 days until next milestone

Study Start

First participant enrolled

April 12, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2019

Completed
Last Updated

September 16, 2019

Status Verified

September 1, 2019

Enrollment Period

1.3 years

First QC Date

February 22, 2018

Last Update Submit

September 13, 2019

Conditions

Keywords

UCCmortalityalzheimer's diseaselongitudinal study

Outcome Measures

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

    12 months

Secondary Outcomes (8)

  • Mortality rate at 3 and 6 month after patient's discharge from UCC

    3 and 6 months

  • Assess the primary mortality risk factors regarding all the collected data.

    12 months

  • Create a predictive score for 6 and 12 month mortality

    6 and 12 months

  • Mortality rate during the hospitalization in the UCC

    12 months

  • Analysis of hospitalisation rate

    12 months

  • +3 more secondary outcomes

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The population correspond to all inpatient from the UCC of Toulon

You may qualify if:

  • Inpatient at the UCC of Toulon

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Intercommunal de Toulon La-Seyne-sur-Mer

Toulon, France

Location

Related Publications (8)

  • 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.

    PMID: 2386336BACKGROUND
  • 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.

    PMID: 3776457BACKGROUND
  • 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.

    PMID: 12374497BACKGROUND
  • 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.

    PMID: 15760618BACKGROUND
  • 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.

    PMID: 19716062BACKGROUND
  • 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.

    PMID: 15187055BACKGROUND
  • 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.

    PMID: 20621437BACKGROUND
  • 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.

    PMID: 21045099BACKGROUND

MeSH Terms

Conditions

Mental DisordersAlzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive Disorders

Study Officials

  • Romain Van overloop, doctor

    Centre Hospitalier Intercommunal Toulon La Seyne sur Mer

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2018

First Posted

April 3, 2018

Study Start

April 12, 2018

Primary Completion

July 31, 2019

Study Completion

July 31, 2019

Last Updated

September 16, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

There is no plan to share IPD

Locations