Non-fatal Outcome After Trauma

NCT ID: NCT02508675

Last Updated: 2018-03-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

6500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-08-31

Study Completion Date

2018-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Trauma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Elisabeth-TweeSteden Ziekenhuis

OTHER

Sponsor Role collaborator

Erasmus Medical Center

OTHER

Sponsor Role collaborator

Tilburg University

OTHER

Sponsor Role collaborator

Amphia Hospital

OTHER

Sponsor Role collaborator

Catharina Ziekenhuis Eindhoven

OTHER

Sponsor Role collaborator

Bravis Hospital

OTHER

Sponsor Role collaborator

Elkerliek Hospital

OTHER

Sponsor Role collaborator

Maas Hospital Pantein

OTHER

Sponsor Role collaborator

St. Anna Ziekenhuis, Geldrop, Netherlands

OTHER

Sponsor Role collaborator

Jeroen Bosch Ziekenhuis

OTHER

Sponsor Role collaborator

Maxima Medical Center

OTHER

Sponsor Role collaborator

Twee Steden Hospital

UNKNOWN

Sponsor Role collaborator

Bernhoven Hospital

OTHER

Sponsor Role collaborator

Maasstad Hospital

OTHER

Sponsor Role collaborator

Network Emergency Care Brabant

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Koen W Lansink, MD

Role: PRINCIPAL_INVESTIGATOR

St. Elisabeth Hospital, Tilburg, The Netherlands

Mariska A de Jongh, PhD

Role: PRINCIPAL_INVESTIGATOR

Network Emergency Care Brabant

References

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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.

Reference Type DERIVED
PMID: 36066616 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33408198 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32525901 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32315373 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31874154 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31324679 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30154022 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27154507 (View on PubMed)

Other Identifiers

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NL50258.028.14

Identifier Type: -

Identifier Source: org_study_id

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