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Non-fatal Outcome After Trauma

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02508675
Acronym
βioς
Enrollment
6500
Registered
2015-07-27
Start date
2015-08-31
Completion date
2018-07-31
Last updated
2018-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Trauma

Keywords

injury, risk factors, outcome, costs

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.

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.

Interventions

None listed

Sponsors

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

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Functional outcome2 yearsself-reported questionnaire
Psychological outcome2 yearsself-reported questionnaire
Short and longterm HRQoL2 yearsself-reported questionnaire
Social outcome2 yearsself-reported questionnaire
Healthcare and societal costs2 yearsself-reported questionnaire and information from registries

Secondary

MeasureTime frameDescription
Return to work (RtW)2 yearsself-reported questionnaire
Health care consumption2 yearsself-reported questionnaire and information from registries

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026