Multiple TraumaNCT02602405
Return to Work After Potential Severe Injury
An observational study of Multiple Trauma, run by Norwegian University of Science and Technology at 8 sites in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Multiple Trauma
- How many people
- 1,741 participants
- Where
- 8 sitesNorway
- Study dates
- Dec 2015to Aug 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- exposed to traumatic injuries
- received by trauma team attendance
- received by trauma team activation protocol
Who cannot join
None listed.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Norway8 sites
Ålesund Hospital
Ålesund
Kristiansund Hospital
Kristiansund
Levanger Hospital
Levanger
Molde Hospital
Molde
Namsos Hospital
Namsos
Orkanger Hospital
Orkanger
St Olavs Hospital
Trondheim
Volda Hospital
Volda
About this study
Official title: Return to Work After Potential Severe Injury; a Population Based Observational Study
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.
- Conditions
- Multiple Trauma
- Keywords
- Outcome Assessment (Health Care), Return to work, Registries, Norway
- Medical subject headings
- Multiple Trauma
What is being measured
The primary outcome is the main question the study is designed to answer.
Return to work
Measured: up to 8 years
Return to education
Measured: up to 8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2015 (estimated)
- Study startDec 2015
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple TraumaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,741 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital, Statistics Norway, Namsos Hospital, Helse Nord-Trøndelag HF, Alesund Hospital, Molde Hospital, Kristiansund Hospital
- Responsible party
- Sponsor
- Investigators
- Pål Klepstad, md prof, Study director, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02602405
- Sponsor's protocol ID
- 2015/1582
- Status last verified
- Dec 2017
- First submitted
- 9 Nov 2015
- Last updated
- 21 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 30221344
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Return to Work After Potential Severe Injury; a Population Based Observational Study
- ClinicalTrials.gov ID
- NCT02602405
- Acronym / sponsor ID
- 2015/1582
- Conditions
- Multiple Trauma
- Keywords
- Outcome Assessment (Health Care), Return to work, Registries, Norway
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,741 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- St. Olavs Hospital, Statistics Norway, Namsos Hospital, Helse Nord-Trøndelag HF, Alesund Hospital, Molde Hospital, Kristiansund Hospital
- Study start
- Dec 2015 (actual)
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 11 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- exposed to traumatic injuries
- received by trauma team attendance
- received by trauma team activation protocol
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Return to work
Time frame: up to 8 years
Return to education
Time frame: up to 8 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2017.
- Derived from this study: PubMed 30221344Uleberg 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pål Klepstad, md prof study director
Norwegian University of Science and Technology
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Trauma, run by Norwegian University of Science and Technology at 8 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Return to work (time frame: up to 8 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02602405, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2017.