Trends in Cohabitation Status, Academic Achievement and Socio-economic Indicators After Mild Traumatic Brain Injury

Sponsor
University of Copenhagen (Other)
Overall Status
Completed
CT.gov ID
NCT03678077
Collaborator
Rigshospitalet, Denmark (Other), Sygekassernes Helsefond (Other), Aase and Ejnar Danielsens Foundation (Other)
45,777
1
5.7
8007.7

Study Details

Study Description

Brief 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.

Study Design

Study Type:
Observational
Actual Enrollment :
45777 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
5-year Trend in Cohabitation Status, Academic Achievement and Socio-economic Indicators After Mild Traumatic Brain Injury: a National Register Study
Actual Study Start Date :
Sep 20, 2018
Actual Primary Completion Date :
Mar 13, 2019
Actual Study Completion Date :
Mar 13, 2019

Arms and Interventions

Arm Intervention/Treatment
Mild traumatic brain injury

Patients between 18-60 years, who were hospital admitted, emergency or outpatient treated with mild traumatic brain injury (ICD-10 S06.0). Data were extracted from the Danish national patient register from January 2003 - December 2007. Patients who were not resident in Denmark 5 years before and during the inclusion period were excluded (1998-2007).

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

Matching controls

Matching controls without concussion of the same age, from the same municipality and of same gender as the included cases. Controls were included during 2003 - 2007. Data were extracted from the population register. Controls who were not resident in Denmark 5 years before and during the inclusion period were excluded (1998-2007).

Outcome Measures

Primary Outcome Measures

  1. Cohabitation status [5 years follow-up (2008-2012)]

    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.

Secondary Outcome Measures

  1. Education [5 years follow-up (2008-2012)]

    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.

  2. Income [5 years follow-up (2008-2012)]

    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).

  3. Socioeconomic status [5 years follow-up (2008-2012)]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Psychology, University of Copenhagen Copenhagen DK Denmark 1353

Sponsors and Collaborators

  • University of Copenhagen
  • Rigshospitalet, Denmark
  • Sygekassernes Helsefond
  • Aase and Ejnar Danielsens Foundation

Investigators

  • Study Director: Hana M Rytter, Department of Psychology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Heidi Jeannet Graff, Phd student, University of Copenhagen
ClinicalTrials.gov Identifier:
NCT03678077
Other Study ID Numbers:
  • mTBI-HJG-2018
First Posted:
Sep 19, 2018
Last Update Posted:
Mar 14, 2019
Last Verified:
Mar 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 14, 2019