NCT03214432

Return to Work After Mild Traumatic Brain Injury

Completed Last updated 6 July 2018

What this trial tests

trial in Mild Traumatic Brain Injury in 38,372 participants. Completed in 4 July 2018.

Timeline

1 July 2017

Primary endpoint
4 July 2018

4 July 2018

Quick facts

Lead sponsor	University of Copenhagen
Status	Completed
Study type	OBSERVATIONAL
Enrollment	38,372
Start date	1 July 2017
Primary completion	4 July 2018
Estimated completion	4 July 2018
Sites	1 location across Denmark

Conditions studied

• Mild Traumatic Brain Injury — all drugs for Mild Traumatic Brain Injury →
• Concussion, Mild — all drugs for Concussion, Mild →

Sponsor

University of Copenhagen

Who can join

Adults 18 to 60, any sex, with Mild Traumatic Brain Injury or Concussion, Mild. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Labour market attachment after mild traumatic brain injury: nationwide cohort study with 5-year register follow-up in Denmark.
   Graff HJ, Siersma V, Møller A, Kragstrup J, et al · · 2019 · cited 23× · PMID 30975680 · DOI 10.1136/bmjopen-2018-026104
2. Premorbid risk factors influencing labour market attachment after mild traumatic brain injury: a national register study with long-term follow-up.
   Graff HJ, Siersma V, Møller A, Kragstrup J, et al · · 2019 · cited 6× · PMID 30975684 · DOI 10.1136/bmjopen-2018-027297