NCT02602405

Brief Summary

In Norway an estimated 10 % of the population is injured annually. Of these 36.000 sustain permanent functional impairment, 1.200 receive disability pension, and approximately 2.500 die because of their injuries. Mortality is the most common variable measuring trauma outcome. However, measuring only trauma mortality may be looking merely at the tip of the iceberg. For every trauma death, there are ten-folds suffering long term functional impairment. Mortality is therefore a too crude variable to describe the impact of injuries - both for the individual trauma patient and for society as a whole. There is a need for variables describing long-term outcomes on a functional level. The aim of this study is to use the rate of return to work and education as an alternative outcome measure. The ability of returning to work after injury is a central indicator of individual functional outcome, combining both physical and mental skills in performing complex and compound tasks. Previous studies on return to work after injury are limited by a combination of short follow-up times, the use of patient reported outcomes and having mainly been focusing on only severely injured patients (ISS \> 15). This a population-based study including all patients in working age (16 - 65 years) received by a trauma team in any of the eight hospitals within the region of Central Norway in the time period from June 1st,2007 to May 30th, 2010. Already collected trauma registry data will be linked with national register data on sickness and disability benefits, employment and education.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,741

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2015

Shorter than P25 for all trials

Geographic Reach
1 country

8 active sites

Status
completed

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

November 9, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 11, 2015

Completed
20 days until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

December 21, 2017

Status Verified

December 1, 2017

Enrollment Period

8 months

First QC Date

November 9, 2015

Last Update Submit

December 20, 2017

Conditions

Multiple Trauma

Keywords

Outcome Assessment (Health Care)Return to workRegistriesNorway

Outcome Measures

Primary Outcomes (2)

  • Return to work

    up to 8 years

  • Return to education

    up to 8 years

Eligibility Criteria

Age16 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients in working age received by a trauma team in any of the eight hospitals within the region of Central Norway in the period from June 1st, 2007 to May 30th, 2010

You may qualify if:

  • exposed to traumatic injuries
  • received by trauma team attendance
  • received by trauma team activation protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Ålesund Hospital

Ålesund, Norway

Location

Kristiansund Hospital

Kristiansund, Norway

Location

Levanger Hospital

Levanger, Norway

Location

Molde Hospital

Molde, Norway

Location

Namsos Hospital

Namsos, Norway

Location

Orkanger Hospital

Orkanger, Norway

Location

St Olavs Hospital

Trondheim, Norway

Location

Volda Hospital

Volda, Norway

Location

Related Publications (1)

  • Uleberg O, Pape K, Kristiansen T, Romundstad PR, Klepstad P. Population-based analysis of the impact of trauma on longer-term functional outcomes. Br J Surg. 2019 Jan;106(1):65-73. doi: 10.1002/bjs.10965. Epub 2018 Sep 17.

    PMID: 30221344DERIVED

MeSH Terms

Conditions

Multiple Trauma

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Pål Klepstad, md prof

    Norwegian University of Science and Technology

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

November 9, 2015

First Posted

November 11, 2015

Study Start

December 1, 2015

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

December 21, 2017

Record last verified: 2017-12

Locations

NO(8)