Mild Traumatic Brain InjuryNCT03214432
Return to Work After Mild Traumatic Brain Injury
An observational study of Mild Traumatic Brain Injury and Concussion, Mild, run by University of Copenhagen at 1 site in Denmark.
Trial summary
Background: Patients with mild traumatic brain injury can to some extend experience long-term physical, cognitive, social and behavioral deficits, which have serious implications for employment trajectories and financial independence. These deficits have shown to be more pronounced in women. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Mild Traumatic Brain Injury, Concussion, Mild
- How many people
- 38,372 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jul 2017to 4 Jul 2018
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients with mild traumatic brain injury were hospital admitted, emergency or outpatient treated and identified on the basis of ICD-10 codes in the National Patient Register from the 1st of January 2003 - 31st of December 2007. Patients were included if they were registered in the national patient register database with concussion (ICD-10 S06.0) as primary diagnosis.
Who may be able to join
- ICD-10 code for concussion as action diagnosis (ICD-10: S06.0)
- Working age adults between 18-60 years old at the time of injury
- Gainfully occupied or deemed available for work the week preceding the time of injury
Who cannot join
- Patients were excluded if they were hospital treated and diagnosed with other major neurological injuries such as spinal cord and column injuries and traumatic brain injuries (TBI) besides the concussion at baseline.
- Patients were excluded, who 5 years prior to baseline (1st of January 1998 - 31st of December 2002) had sustained major neurological impairments including concussions.
- Patients outside of the age limit
- Patients not resident in Denmark
- Patients on unemployment benefits and not economically active at the time of injury
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Psychology, University of Copenhagen
Copenhagen, Copenhagen K, 1353
About this study
Background:
Patients with mild traumatic brain injury can to some extend experience long-term physical, cognitive, social and behavioral deficits, which have serious implications for employment trajectories and financial independence. These deficits have shown to be more pronounced in women. High socio-economic position such as income, level of education and employment status before the accident have shown to affect return to work. But also cohabitation status, ethnicity and health are important factors. Previously studies are typically self-report studies, and are often small and may suffer from selection bias due to patient nonresponse.
Read more
Aim:
The aim of this study is to describe no return to work among patients with mild traumatic brain injury in Denmark and to examine how factors such as age, gender, cohabitation status, socio-economic and pre-injury health factors affect no return to work up to 5 years post-injury.
Hypothesis:
We hypothesize that most patients with mild traumatic brain injury return to work within work 6 months post-injury, and that patients with mild traumatic brain injury injury receive more social transfer payments compared to the general population.
Additionally, we hypothesize that low socio economic position, comorbidities and being single are associated with prolonged no return to work.
Methods:
The present study is an observational national register-based cohort study with long-term follow up of patients with mild traumatic brain injury from 1st of January 2008 - 31st of December 2012 in Denmark. Patients aged 18-60 years diagnosed with concussion from 1st of January 2003-31st of December 2007 in the national patient register will be included in the study. Data will be retrieved from several national databases, including the DREAM database containing data on social benefits and reimbursements.
Primary outcome is no-return to work (nRTW) due to any cause and the following four secondary outcomes are graded and should be regarded as a continuum ranging from health related nRTW, limited nRTW, permanently nRTW and mortality.
The results will be published as two separate scientific articles.
- Conditions
- Mild Traumatic Brain Injury, Concussion, Mild
- Keywords
- Mild traumatic brain injury, Concussion, Labour market affiliation, Return to work, Sickness absence, Long-term sickness absence, Disability pension
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| mild traumatic brain injury cohort | Patients with mild traumatic brain injury were defined as hospital admitted, emergency or outpatient treated, who were assigned the ICD-10 code for concussion (ICD-10 S06.0) in the national patient register at hospital discharge from the 1st of January 2003 - 31st of December 2007. Patients were working age adults between 18-60 years old and gainfully occupied or deemed available for work the week before the injury. | |
| non-injured control group | Controls were randomly selected from the Population register who were between 18-60 years old, had no diagnosis of mild traumatic brain injury during the period 1st of January 2003 - 31st of December 2007 and were gainfully occupied or deemed available for work the week preceding the time of injury. One control was matched for each mTBI case on gender, municipality and age (year of birth +/- 0,5 years). In case of no matching control the age criterion was expanded to (year of birth +/- 1 year), if still no matching control the age criterion was further expanded to (year of birth +/- 2 year). Additionally, controls were excluded according to the same criteria as the included cases. |
What is being measured
The primary outcome is the main question the study is designed to answer.
nRTW
No-return to work up to 5 years post-injury. nRTW is defined as receiving social transfer payments in any given week during the follow-up period. If no social benefit is given in the DREAM register, it is assumed the patient is gainfully occupied or self-supporting.
Measured: 5 years follow up
Secondary outcomes (4)
Health related nRTW
Health related nRTW is defined as a combined effect of social transfer payments given in case of short or long-term sickness absence. If social transfer payments are granted due to illness it is assumed that the patient is not gainfully working or job seeking.
Measured: 5 years follow up
Limited nRTW
Limited nRTW is defined as a joint effect of several outcome measures granted citizens with permanent reduced work capacity. If no social transfer payments are given, it is assumed that the patients are gainfully occupied or self-supporting.
Measured: 5 years follow up
Permanently nRTW
Individuals between 18-60 years who have permanently reduced work capacity and unable to return to work after injury can be granted disability pension (DP) after an extensive municipal assessment. DP would only be granted persons who have no work capacity left. This outcome includes disability pension and mortality and is regarded as a permanent exit from the labour market.
Measured: 5 years follow up
Mortality
Data on mortality was retrieved from the DREAM register and the proportion of mortality will be assessed during the 5 year follow-up period.
Measured: 5 years follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2017
- Study start1 Jul 2017
- Primary completion4 Jul 2018
- Study completion4 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Mild Traumatic Brain InjuryStudies 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
- 38,372 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet, Sygekassernes Helsefond
- Responsible party
- Principal investigator, Heidi Jeannet Graff, University of Copenhagen
- Investigators
- Hana M Rytter, Study director, Department of Psychology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03214432
- Sponsor's protocol ID
- mTBI-HJG-2017
- Status last verified
- Jul 2018
- First submitted
- 5 Jul 2017
- Last updated
- 6 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Graff HJ, Siersma V, Moller A, Kragstrup J, Andersen LL, Egerod I, Mala Rytter H. Premorbid risk factors influencing labour market attachment after mild traumatic brain injury: a national register study with long-term follow-up. BMJ Open. 2019 Apr 11;9(4):e027297. doi: 10.1136/bmjopen-2018-027297.
PubMed 30975684Graff HJ, Siersma V, Moller A, Kragstrup J, Andersen LL, Egerod I, Mala Rytter H. Labour market attachment after mild traumatic brain injury: nationwide cohort study with 5-year register follow-up in Denmark. BMJ Open. 2019 Apr 11;9(4):e026104. doi: 10.1136/bmjopen-2018-026104.
PubMed 30975680
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Return to Work After Mild Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT03214432
- Acronym / sponsor ID
- mTBI-HJG-2017
- Conditions
- Mild Traumatic Brain Injury, Concussion, Mild
- Keywords
- Mild traumatic brain injury, Concussion, Labour market affiliation, Return to work, Sickness absence, Long-term sickness absence, Disability pension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38,372 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet, Sygekassernes Helsefond
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 4 Jul 2018 (actual)
- Study completion
- 4 Jul 2018 (actual)
- First posted
- 11 Jul 2017 (actual)
- 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.
Background:
Patients with mild traumatic brain injury can to some extend experience long-term physical, cognitive, social and behavioral deficits, which have serious implications for employment trajectories and financial independence. These deficits have shown to be more pronounced in women. High socio-economic position such as income, level of education and employment status before the accident have shown to affect return to work. But also cohabitation status, ethnicity and health are important factors. Previously studies are typically self-report studies, and are often small and may suffer from selection bias due to patient nonresponse.
Aim:
The aim of this study is to describe no return to work among patients with mild traumatic brain injury in Denmark and to examine how factors such as age, gender, cohabitation status, socio-economic and pre-injury health factors affect no return to work up to 5 years post-injury.
Hypothesis:
We hypothesize that most patients with mild traumatic brain injury return to work within work 6 months post-injury, and that patients with mild traumatic brain injury injury receive more social transfer payments compared to the general population.
Additionally, we hypothesize that low socio economic position, comorbidities and being single are associated with prolonged no return to work.
Methods:
The present study is an observational national register-based cohort study with long-term follow up of patients with mild traumatic brain injury from 1st of January 2008 - 31st of December 2012 in Denmark. Patients aged 18-60 years diagnosed with concussion from 1st of January 2003-31st of December 2007 in the national patient register will be included in the study. Data will be retrieved from several national databases, including the DREAM database containing data on social benefits and reimbursements.
Primary outcome is no-return to work (nRTW) due to any cause and the following four secondary outcomes are graded and should be regarded as a continuum ranging from health related nRTW, limited nRTW, permanently nRTW and mortality.
The results will be published as two separate scientific articles.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mild traumatic brain injury cohort | – | –Patients with mild traumatic brain injury were defined as hospital admitted, emergency or outpatient treated, who were assigned the ICD-10 code for concussion (ICD-10 S06.0) in the national patient register at hospital discharge from the 1st of January 2003 - 31st of December 2007. Patients were working age adults between 18-60 years old and gainfully occupied or deemed available for work the week before the injury. |
| non-injured control group | – | –Controls were randomly selected from the Population register who were between 18-60 years old, had no diagnosis of mild traumatic brain injury during the period 1st of January 2003 - 31st of December 2007 and were gainfully occupied or deemed available for work the week preceding the time of injury. One control was matched for each mTBI case on gender, municipality and age (year of birth +/- 0,5 years). In case of no matching control the age criterion was expanded to (year of birth +/- 1 year), if still no matching control the age criterion was further expanded to (year of birth +/- 2 year). Additionally, controls were excluded according to the same criteria as the included cases. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients with mild traumatic brain injury were hospital admitted, emergency or outpatient treated and identified on the basis of ICD-10 codes in the National Patient Register from the 1st of January 2003 - 31st of December 2007. Patients were included if they were registered in the national patient register database with concussion (ICD-10 S06.0) as primary diagnosis.
Key inclusion criteria (3 listed)
- ICD-10 code for concussion as action diagnosis (ICD-10: S06.0)
- Working age adults between 18-60 years old at the time of injury
- Gainfully occupied or deemed available for work the week preceding the time of injury
Key exclusion criteria (5 listed)
- Patients were excluded if they were hospital treated and diagnosed with other major neurological injuries such as spinal cord and column injuries and traumatic brain injuries (TBI) besides the concussion at baseline.
- Patients were excluded, who 5 years prior to baseline (1st of January 1998 - 31st of December 2002) had sustained major neurological impairments including concussions.
- Patients outside of the age limit
- Patients not resident in Denmark
- Patients on unemployment benefits and not economically active at the time of injury
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
nRTW
Time frame: 5 years follow up
No-return to work up to 5 years post-injury. nRTW is defined as receiving social transfer payments in any given week during the follow-up period. If no social benefit is given in the DREAM register, it is assumed the patient is gainfully occupied or self-supporting.
4 secondary outcomes
Health related nRTW
Time frame: 5 years follow up
Limited nRTW
Time frame: 5 years follow up
Permanently nRTW
Time frame: 5 years follow up
Mortality
Time frame: 5 years follow up
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 6 Jul 2018.
- Derived from this study: PubMed 30975684Graff HJ, Siersma V, Moller A, Kragstrup J, Andersen LL, Egerod I, Mala Rytter H. Premorbid risk factors influencing labour market attachment after mild traumatic brain injury: a national register study with long-term follow-up. BMJ Open. 2019 Apr 11;9(4):e027297. doi: 10.1136/bmjopen-2018-027297.
- Derived from this study: PubMed 30975680Graff HJ, Siersma V, Moller A, Kragstrup J, Andersen LL, Egerod I, Mala Rytter H. Labour market attachment after mild traumatic brain injury: nationwide cohort study with 5-year register follow-up in Denmark. BMJ Open. 2019 Apr 11;9(4):e026104. doi: 10.1136/bmjopen-2018-026104.
- Individual participant dataSharing planned: No
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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.
Hana M Rytter study director
Department of Psychology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mild Traumatic Brain Injury and Concussion, Mild, run by University of Copenhagen at 1 site in Denmark.
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 5 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 6 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. 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?
nRTW (time frame: 5 years follow up). 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 NCT03214432, which also lists 2 linked publications.
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 6 Jul 2018; AzTrials last refreshed its copy on 27 Oct 2026.