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Trial record 1 of 29 for:    DREAM | Denmark
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Return to Work After Mild Traumatic Brain Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03214432
Recruitment Status : Completed
First Posted : July 11, 2017
Last Update Posted : July 6, 2018
Sponsor:
Collaborators:
Rigshospitalet, Denmark
Sygekassernes Helsefond
Information provided by (Responsible Party):
Heidi Jeannet Graff, University of Copenhagen

Tracking Information
First Submitted Date July 5, 2017
First Posted Date July 11, 2017
Last Update Posted Date July 6, 2018
Actual Study Start Date July 1, 2017
Actual Primary Completion Date July 4, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 4, 2018)
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.
Original Primary Outcome Measures
 (submitted: July 10, 2017)
Return to work [ Time Frame: 5 years follow up ]
Return to work up till 5 years post-injury. Return to Work is defined as not receiving any social transfer payments for more than 50% of the weeks in the follow-up period.
Change History Complete list of historical versions of study NCT03214432 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: May 7, 2018)
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures
 (submitted: July 10, 2017)
  • Sickness absence [ Time Frame: 5 years follow up ]
    Sickness absence is defined as at least eight consecutive weeks of sickness absence during follow-up.
  • Long-term sickness absence [ Time Frame: 5 years follow up ]
    Long-term sickness absence is defined as more than 52 consecutive weeks (12 months) of sickness benefits.
  • Disability pension [ Time Frame: 5 years follow up ]
    Disability pension in Denmark could be granted all persons between 18-60 years who had considerable permanent reduced ability to work. Disability pension in this study is defined as a registration with the code 793 in the DREAM database.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Return to Work After Mild Traumatic Brain Injury
Official Title Return to Work After Mild Traumatic Brain Injury
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.

Condition
  • Mild Traumatic Brain Injury
  • Concussion, Mild
Intervention Not Provided
Study Groups/Cohorts
  • 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.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 4, 2018)
38372
Original Estimated Enrollment
 (submitted: July 10, 2017)
20000
Actual Study Completion Date July 4, 2018
Actual Primary Completion Date July 4, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Denmark
Removed Location Countries  
 
Administrative Information
NCT Number NCT03214432
Other Study ID Numbers mTBI-HJG-2017
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Heidi Jeannet Graff, University of Copenhagen
Study Sponsor University of Copenhagen
Collaborators
  • Rigshospitalet, Denmark
  • Sygekassernes Helsefond
Investigators
Study Director: Hana M Rytter Department of Psychology
PRS Account University of Copenhagen
Verification Date July 2018