Non-fatal Outcome After Trauma (βioς)

March 28, 2018 updated by: Network Emergency Care Brabant

Prevalence, Recovery Patterns and Risk Factors of Non-fatal Outcome and Costs After Trauma; a Prospective Follow up Study

The major aim of this project is to investigate the prevalence, recovery patterns and risk factors for health related quality of life functional, psychological, societal and economic outcome after trauma. Another aim is to validate the WHO Quality Of Life-bref (WHOQOL-Bref) questionnaire for the trauma population.

Study Overview

Status

Unknown

Conditions

Detailed Description

Patients aged 18 years and older admitted in a hospital in Brabant after a trauma, independent of severity or type of injury are included in the study. Patients who decease during hospital stay or transferred to another hospital outside the borders of trauma region Brabant will be excluded. Socio-demographic characteristics, functional and psychological outcome and Health Related Quality of Life (HRQoL) shortly after trauma will be measured. Subsequently the same items will be measured after 1, 3, 6, 12 and 24 months. Outcomes will be assessed using questionnaires. The primary outcome parameters are: short and long term HRQoL, functional and psychological outcome, and Healthcare and societal costs in injured patients. Secondary outcome measures are Return to Work and health care consumption.

Study Type

Observational

Enrollment (Anticipated)

6500

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients seen at the Emergency Department (ED) which are admitted to the Intensive Care Unit (ICU) or ward after getting injured, with a minimal age of 18 years old.

Description

Inclusion Criteria:

  • patients seen at the ED which are admitted to the ICU or ward after getting injured
  • all types and severities of injury (Injury Severity Score (ISS) 1-75)
  • a minimal age of 18 years old
  • sufficient knowledge of the Dutch language

Exclusion Criteria:

  • patients who are dead on arrival or decease in the ED
  • pathological fracture (i.e., the bones are weakened by disease, for example by a tumor)
  • patients who die in the hospital will drop out the study and will not be included in the analyses

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Short and longterm HRQoL
Time Frame: 2 years
self-reported questionnaire
2 years
Functional outcome
Time Frame: 2 years
self-reported questionnaire
2 years
Healthcare and societal costs
Time Frame: 2 years
self-reported questionnaire and information from registries
2 years
Psychological outcome
Time Frame: 2 years
self-reported questionnaire
2 years
Social outcome
Time Frame: 2 years
self-reported questionnaire
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Return to work (RtW)
Time Frame: 2 years
self-reported questionnaire
2 years
Health care consumption
Time Frame: 2 years
self-reported questionnaire and information from registries
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Network Emergency Care Brabant

Collaborators

Erasmus Medical Center
Catharina Ziekenhuis Eindhoven
Tilburg University
Maxima Medical Center
Elisabeth-TweeSteden Ziekenhuis
Maasstad Hospital
Jeroen Bosch Ziekenhuis
Bernhoven Hospital
St. Anna Ziekenhuis, Geldrop, Netherlands
Bravis Hospital
Elkerliek Hospital
Amphia Hospital
Maas Hospital Pantein
Twee Steden Hospital

Investigators

  • Principal Investigator: Koen W Lansink, MD, St. Elisabeth Hospital, Tilburg, The Netherlands
  • Principal Investigator: Mariska A de Jongh, PhD, Network Emergency Care Brabant

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Anticipated)

July 1, 2018

Study Completion (Anticipated)

July 1, 2018

Study Registration Dates

First Submitted

July 23, 2015

First Submitted That Met QC Criteria

July 24, 2015

First Posted (Estimate)

July 27, 2015

Study Record Updates

Last Update Posted (Actual)

March 29, 2018

Last Update Submitted That Met QC Criteria

March 28, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL50258.028.14

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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