Non-fatal Outcome After Trauma

NCT02508675 | Unknown

• 1 other identifier: NL50258.028.14
• Study Type: observational
• Target: 6,500
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Trauma

Keywords

injury; risk factors; outcome; costs

Outcome Measures

Primary Outcomes (5)

• Short and longterm HRQoL

  self-reported questionnaire

  2 years

• Functional outcome

  self-reported questionnaire

  2 years

• Healthcare and societal costs

  self-reported questionnaire and information from registries

  2 years

• Psychological outcome

  self-reported questionnaire

  2 years

• Social outcome

  self-reported questionnaire

  2 years

Secondary Outcomes (2)

• Return to work (RtW)

  2 years

• Health care consumption

  2 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Network Emergency Care Brabant: lead
• Elisabeth-TweeSteden Ziekenhuis: collaborator
• Erasmus Medical Center: collaborator
• Tilburg University: collaborator
• Amphia Hospital: collaborator
• Catharina Ziekenhuis Eindhoven: collaborator
• Bravis Hospital: collaborator
• Elkerliek Hospital: collaborator
• Maas Hospital Pantein: collaborator
• St. Anna Ziekenhuis, Geldrop, Netherlands: collaborator
• Jeroen Bosch Ziekenhuis: collaborator
• Maxima Medical Center: collaborator
• Twee Steden Hospital: collaborator
• Bernhoven Hospital: collaborator
• Maasstad Hospital: collaborator

Related Publications (8)

• de Munter L, van de Ree CLP, van der Jagt OP, Gosens T, Maas HAAM, de Jongh MAC. Trajectories and prognostic factors for recovery after hip fracture: a longitudinal cohort study. Int Orthop. 2022 Dec;46(12):2913-2926. doi: 10.1007/s00264-022-05561-4. Epub 2022 Sep 6.

  PMID: 36066616 DERIVED

• de Munter L, Polinder S, Havermans RJM, Steyerberg EW, de Jongh MAC. Prognostic factors for recovery of health status after injury: a prospective multicentre cohort study. BMJ Open. 2021 Jan 6;11(1):e038707. doi: 10.1136/bmjopen-2020-038707.

  PMID: 33408198 DERIVED

• Brouwers L, de Jongh MAC, de Munter L, Edwards M, Lansink KWW. Prognostic factors and quality of life after pelvic fractures. The Brabant Injury Outcome Surveillance (BIOS) study. PLoS One. 2020 Jun 11;15(6):e0233690. doi: 10.1371/journal.pone.0233690. eCollection 2020.

  PMID: 32525901 DERIVED

• Kruithof N, Polinder S, de Munter L, van de Ree CLP, Lansink KWW, de Jongh MAC; BIOS-group. Health status and psychological outcomes after trauma: A prospective multicenter cohort study. PLoS One. 2020 Apr 21;15(4):e0231649. doi: 10.1371/journal.pone.0231649. eCollection 2020.

  PMID: 32315373 DERIVED

• de Munter L, Polinder S, Haagsma JA, Kruithof N, van de Ree CLP, Steyerberg EW, de Jongh M. Prevalence and Prognostic Factors for Psychological Distress After Trauma. Arch Phys Med Rehabil. 2020 May;101(5):877-884. doi: 10.1016/j.apmr.2019.10.196. Epub 2019 Dec 23.

  PMID: 31874154 DERIVED

• van de Ree CLP, Landers MJF, Kruithof N, de Munter L, Slaets JPJ, Gosens T, de Jongh MAC. Effect of frailty on quality of life in elderly patients after hip fracture: a longitudinal study. BMJ Open. 2019 Jul 18;9(7):e025941. doi: 10.1136/bmjopen-2018-025941.

  PMID: 31324679 DERIVED

• Kruithof N, Haagsma JA, Karabatzakis M, Cnossen MC, de Munter L, van de Ree CLP, de Jongh MAC, Polinder S. Validation and reliability of the Abbreviated World Health Organization Quality of Life Instrument (WHOQOL-BREF) in the hospitalized trauma population. Injury. 2018 Oct;49(10):1796-1804. doi: 10.1016/j.injury.2018.08.016. Epub 2018 Aug 23.

  PMID: 30154022 DERIVED

• de Jongh MA, Kruithof N, Gosens T, van de Ree CL, de Munter L, Brouwers L, Polinder S, Lansink KW; BIOS-group. Prevalence, recovery patterns and predictors of quality of life and costs after non-fatal injury: the Brabant Injury Outcome Surveillance (BIOS) study. Inj Prev. 2017 Feb;23(1):59. doi: 10.1136/injuryprev-2016-042032. Epub 2016 May 6.

  PMID: 27154507 DERIVED

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

• Koen W Lansink, MD

  St. Elisabeth Hospital, Tilburg, The Netherlands

  PRINCIPAL INVESTIGATOR

• Mariska A de Jongh, PhD

  Network Emergency Care Brabant

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2015
• First Posted: July 27, 2015
• Study Start: August 1, 2015
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: March 29, 2018

Record last verified: 2018-03