NCT03214432

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38,372

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

July 1, 2017

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

July 5, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 11, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 4, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 4, 2018

Completed
Last Updated

July 6, 2018

Status Verified

July 1, 2018

Enrollment Period

1 year

First QC Date

July 5, 2017

Last Update Submit

July 4, 2018

Conditions

Keywords

Mild traumatic brain injuryConcussionLabour market affiliationReturn to workSickness absenceLong-term sickness absenceDisability pension

Outcome Measures

Primary Outcomes (1)

  • 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.

    5 years follow up

Secondary Outcomes (4)

  • Health related nRTW

    5 years follow up

  • Limited nRTW

    5 years follow up

  • Permanently nRTW

    5 years follow up

  • Mortality

    5 years follow up

Study Arms (2)

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.

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Psychology, University of Copenhagen

Copenhagen, Copenhagen K, 1353, Denmark

Location

Related Publications (2)

  • 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.

  • Graff 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.

MeSH Terms

Conditions

Brain Concussion

Condition Hierarchy (Ancestors)

Brain Injuries, TraumaticBrain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemHead Injuries, ClosedWounds and InjuriesWounds, Nonpenetrating

Study Officials

  • Hana M Rytter

    Department of Psychology

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ph.d. student

Study Record Dates

First Submitted

July 5, 2017

First Posted

July 11, 2017

Study Start

July 1, 2017

Primary Completion

July 4, 2018

Study Completion

July 4, 2018

Last Updated

July 6, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

Locations