Mild Traumatic Brain InjuryNCT03678077
Trends in Cohabitation Status, Academic Achievement and Socio-economic Indicators After Mild Traumatic Brain Injury
An observational study of Mild Traumatic Brain Injury and Concussion, Mild, run by University of Copenhagen at 1 site in Denmark.
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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Mild Traumatic Brain Injury, Concussion, Mild, Academic Achievement
- What is being tested?
- Mild traumatic brain injury
- How many people
- 45,777 participants
- Where
- 1 siteDenmark
- Study dates
- 20 Sep 2018to 13 Mar 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Hospital admitted, emergency or outpatient treated patients between 18-60 years diagnosed with concussion (ICD-10 S06.0) are extracted from the Danish National Patient Registre between (2003-2007).
Who may be able to join
- Concussion (ICD-10 S06.0) (primary diagnosis)(2003-2007)
Who cannot join
- Major neurological injuries and previous concussions (1998-2007)
- Not resident in Denmark (1998-2007)
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Psychology, University of Copenhagen
Copenhagen, DK, 1353
About this study
Official title: 5-year Trend in Cohabitation Status, Academic Achievement and Socio-economic Indicators After Mild Traumatic Brain Injury: a National Register Study
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.
Read more
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.
- Conditions
- Mild Traumatic Brain Injury, Concussion, Mild, Academic Achievement, Specific Academic or Work Inhibition, Marriage, Marital Status
- Being tested
- Mild traumatic brain injury
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mild traumatic brain injuryOther
This is a register based observational study and does not include interventions. Exposure is mild traumatic brain injury.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 years follow-up (2008-2012)
Secondary outcomes (3)
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.
Measured: 5 years follow-up (2008-2012)
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).
Measured: 5 years follow-up (2008-2012)
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.
Measured: 5 years follow-up (2008-2012)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2018
- Study start20 Sep 2018
- Primary completion13 Mar 2019
- Study completion13 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 45,777 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet, Sygekassernes Helsefond, Aase and Ejnar Danielsens Foundation
- Responsible party
- Principal investigator, Heidi Jeannet Graff, University of Copenhagen
- Investigators
- Hana M Rytter, Study director, Department of Psychology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03678077
- Sponsor's protocol ID
- mTBI-HJG-2018
- Status last verified
- Mar 2019
- First submitted
- 18 Sep 2018
- Last updated
- 14 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 5-year Trend in Cohabitation Status, Academic Achievement and Socio-economic Indicators After Mild Traumatic Brain Injury: a National Register Study
- ClinicalTrials.gov ID
- NCT03678077
- Acronym / sponsor ID
- mTBI-HJG-2018
- Conditions
- Mild Traumatic Brain Injury, Concussion, Mild, Academic Achievement, Specific Academic or Work Inhibition, Marriage, Marital Status
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45,777 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet, Sygekassernes Helsefond, Aase and Ejnar Danielsens Foundation
- Study start
- 20 Sep 2018 (actual)
- Primary completion
- 13 Mar 2019 (actual)
- Study completion
- 13 Mar 2019 (actual)
- First posted
- 19 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mild traumatic brain injury | – | Other: Mild traumatic brain injuryPatients 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). |
| 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). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Hospital admitted, emergency or outpatient treated patients between 18-60 years diagnosed with concussion (ICD-10 S06.0) are extracted from the Danish National Patient Registre between (2003-2007).
Key inclusion criteria (1 listed)
- Concussion (ICD-10 S06.0) (primary diagnosis)(2003-2007)
Key exclusion criteria (2 listed)
- Major neurological injuries and previous concussions (1998-2007)
- Not resident in Denmark (1998-2007)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mild traumatic brain injuryThis is a register based observational study and does not include interventions. Exposure is mild traumatic brain injury. | Other | Mild traumatic brain injury |
Primary outcome
Cohabitation status
Time frame: 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.
3 secondary outcomes
Education
Time frame: 5 years follow-up (2008-2012)
Income
Time frame: 5 years follow-up (2008-2012)
Socioeconomic status
Time frame: 5 years follow-up (2008-2012)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hana M Rytter study director
Department of Psychology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mild Traumatic Brain Injury and Concussion, Mild, run by University of Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cohabitation status (time frame: 5 years follow-up (2008-2012)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2019.