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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03678077
Other study ID # mTBI-HJG-2018
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 20, 2018
Est. completion date March 13, 2019

Study information

Verified date March 2019
Source University of Copenhagen
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Mild traumatic brain injury (mTBI) accounts for 70-90% of all diagnosed traumatic brain injuries (TBI) affecting approximately 50-300 per 100.000 individuals annually. Persistent post-concussion symptoms are reported in 15-80% of hospital admitted and outpatient treated populations, affecting labour market attachment, academic achievement, income, socio-economic status, social interactions, home management, leisure activities and cohabitation status.

The association between mTBI and long-term trends in cohabitation status, income, academic achievement and socio-economic status has not been thoroughly explored. Previous studies focus on children's academic performance after severe TBI and only few studies include early adulthood and patients with mTBI. Trends in divorce rates are frequently conducted on severe injuries or populations consisting of veterans. Additionally, all studies have failed to apply a national register based design.

Aim The aim of the study is to examine the long-term associations between mTBI and trends in cohabitation status, academic achievement and socio-economic status between pre-injury rates and observed rates at 5 years post-injury. The hypothesis was that by 5 years mTBI would be associated with increased odds of marital breakdown, decreasing academic achievement, decreasing income, decreasing socio-economic status compared to the general population in Denmark.

Methods:

The study is a national register based cohort study with 5 years follow-up of patients with mild traumatic brain injury from 2008 - 2012 in Denmark.

Population:

Patients between 18-60 years diagnosed with concussion (ICD-10 S06.0) were extracted from the Danish National Patient Register between (2003-2007). Patients with major neurological injuries and previous concussions at the index date and 5 years before the index date (1998-2007) were excluded. Patients who were not resident in Denmark 5 years before and during the inclusion period were also excluded (1998-2007).

Data will be retrieved from several national databases, including: the Danish national patient register, Danish Civil Registration System (CRS), the Danish Education Registers, the Income Statistics Register and the Employment Classification Module (AKM).

One control of the general population were matched for each case on sex, age and municipality.

Outcome measures are: Cohabitation status, Education, income and socio-economic status.


Recruitment information / eligibility

Status Completed
Enrollment 45777
Est. completion date March 13, 2019
Est. primary completion date March 13, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

- Concussion (ICD-10 S06.0) (primary diagnosis)(2003-2007)

Exclusion Criteria:

- Major neurological injuries and previous concussions (1998-2007)

- Not resident in Denmark (1998-2007)

Study Design


Intervention

Other:
Mild traumatic brain injury
This is a register based observational study and does not include interventions. Exposure is mild traumatic brain injury.

Locations

Country Name City State
Denmark Department of Psychology, University of Copenhagen Copenhagen DK

Sponsors (4)

Lead Sponsor Collaborator
University of Copenhagen Aase and Ejnar Danielsens Foundation, Rigshospitalet, Denmark, Sygekassernes Helsefond

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Cohabitation status Data comprise four definitions of married couples, registered partnerships, couples living in consensual union, cohabiting couple or being single. Data were consolidated into married/cohabiting couple or single status. 5 years follow-up (2008-2012)
Secondary Education The highest completed qualifying education, given at the index date was used as a measure of academic achievement. Data were categorized into high education vs. low education. Low education encompasses basic schooling, high school, trade and craft educations and high educations encompass short education, medium length education, bachelor's degree, university degrees and Ph.D. 5 years follow-up (2008-2012)
Secondary Income To describe long-term trends in income, we analyze data on personal gross income including revenue and social transfer income and categorized data into two income groups: Low annually income (<200.000 DKK). and high annually income (>200.000 DKK). 5 years follow-up (2008-2012)
Secondary Socioeconomic status Based on occupation and income, socio-economic status determines whether the person is employed, unemployed or outside the labour force. To measure how mTBI influences socioeconomic status (employment status) regarding occupation and labour market attachment, data were categorized into (1) Self-employed/leaders/managers vs. wage earners/enrolled in education/not economically active and (2) Gainfully employed vs. not economically active. 5 years follow-up (2008-2012)
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