Return to Work After Mild Traumatic Brain Injury

July 4, 2018 updated by: Heidi Jeannet Graff, University of Copenhagen

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 Overview

Status

Completed

Study Type

Observational

Enrollment (Actual)

38372

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Copenhagen K
      • Copenhagen, Copenhagen K, Denmark, 1353
        • Department of psychology, University of Copenhagen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
5 years follow up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health related nRTW
Time Frame: 5 years follow up
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.
5 years follow up
Limited nRTW
Time Frame: 5 years follow up
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.
5 years follow up
Permanently nRTW
Time Frame: 5 years follow up
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.
5 years follow up
Mortality
Time Frame: 5 years follow up
Data on mortality was retrieved from the DREAM register and the proportion of mortality will be assessed during the 5 year follow-up period.
5 years follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 1, 2017

Primary Completion (ACTUAL)

July 4, 2018

Study Completion (ACTUAL)

July 4, 2018

Study Registration Dates

First Submitted

July 5, 2017

First Submitted That Met QC Criteria

July 10, 2017

First Posted (ACTUAL)

July 11, 2017

Study Record Updates

Last Update Posted (ACTUAL)

July 6, 2018

Last Update Submitted That Met QC Criteria

July 4, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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