Brain InjuriesNCT01801969
Return to Work and QOL Following TBI. Impact of Rehabilitation Service.
An observational study of Brain Injuries and Return to Work, run by University of Aarhus at 1 site in Denmark.
Trial summary
The proportion of patients who return to work after surviving severe traumatic brain injury (TBI) has been estimated in number of studies but results do not agree.This may be due to complex interaction between many factors, including available rehabilitation services. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Brain Injuries, Return to Work, Quality of Life
- What is being tested?
- Rehabilitation service
- How many people
- 653 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2013to Dec 2016
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
Study population: Individuals suffering from severe TBI (GCS<9) from the Danish Head Trauma Database
Who may be able to join
- age 18-64
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
The proportion of patients who return to work after surviving severe traumatic brain injury (TBI) has been estimated in number of studies but results do not agree.This may be due to complex interaction between many factors, including available rehabilitation services.
In Denmark rehabilitation services vary been regions and municipalities. Hospital based rehabilitation is organized by the regions. Rehabilitation outside the hospitals is organized by the municipalities
Read more
The first purpose of this study is to investigate a possible link between centralized hospital based rehabilitation and better return to work / quality of life.
The second purpose is to investigate whether municipality size affects quality of life and return to work after severe TBI.
Data on return to work are derived from a national register on labor market attachment. Data on quality of life are derived from a questionnaire.
The study population is identified from the Danish Head Trauma Database. The completeness and accuracy of the database will be investigated as the first part of the project.
- Conditions
- Brain Injuries, Return to Work, Quality of Life
- Being tested
- Rehabilitation service
- Keywords
- Brain injuries, Rehabilitation services, Return to Work, Quality of life
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rehabilitation serviceOther
- Centralized/ decentralized hospital based rehabilitation defined as hospital based rehabilitation in a single or in multiple locations, respectively.
- Size of the municipality responsible for providing rehabilitation services after discharge from hospital
| Study group | Role | What they receive |
|---|---|---|
| Rehabilitation service | * Centralized or Decentralized rehabilitation
* Size of municipality Receives: Other: Rehabilitation service |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to return to work
Data Source: Register (DREAM)
Measured: up to 11 years post-injury
Secondary outcomes (1)
Quality of life
Data Source: Questionnaire (QUOLIBRI)
Measured: 1-10 years post-injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2013 (estimated)
- Study startFeb 2013
- Primary completionMar 2015
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain InjuriesStudies of the same condition, open and under way.
- More trials run by University of AarhusThe 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
- 653 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lene Odgaard, Principal investigator, Research Unit (Forskningsenheden), Hammel Neurorehabilitation and Research Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01801969
- Sponsor's protocol ID
- hovedtraume
- Status last verified
- Mar 2016
- First submitted
- 6 Feb 2013
- Last updated
- 18 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Return to Work and QOL Following TBI. Impact of Rehabilitation Service.
- ClinicalTrials.gov ID
- NCT01801969
- Acronym / sponsor ID
- hovedtraume
- Conditions
- Brain Injuries, Return to Work, Quality of Life
- Keywords
- Brain injuries, Rehabilitation services, Return to Work, Quality of life
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 653 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Mar 2015 (actual)
- Study completion
- Dec 2016 (estimated)
- First posted
- 1 Mar 2013 (estimated)
- 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.
The proportion of patients who return to work after surviving severe traumatic brain injury (TBI) has been estimated in number of studies but results do not agree.This may be due to complex interaction between many factors, including available rehabilitation services.
In Denmark rehabilitation services vary been regions and municipalities. Hospital based rehabilitation is organized by the regions. Rehabilitation outside the hospitals is organized by the municipalities
The first purpose of this study is to investigate a possible link between centralized hospital based rehabilitation and better return to work / quality of life.
The second purpose is to investigate whether municipality size affects quality of life and return to work after severe TBI.
Data on return to work are derived from a national register on labor market attachment. Data on quality of life are derived from a questionnaire.
The study population is identified from the Danish Head Trauma Database. The completeness and accuracy of the database will be investigated as the first part of the project.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rehabilitation service | – | Other: Rehabilitation service* Centralized or Decentralized rehabilitation * Size of municipality |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Individuals suffering from severe TBI (GCS<9) from the Danish Head Trauma Database
Key inclusion criteria (1 listed)
- age 18-64
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Rehabilitation service* Centralized/ decentralized hospital based rehabilitation defined as hospital based rehabilitation in a single or in multiple locations, respectively. * Size of the municipality responsible for providing rehabilitation services after discharge from hospital | Other | Rehabilitation service |
Primary outcome
time to return to work
Time frame: up to 11 years post-injury
Data Source: Register (DREAM)
1 secondary outcome
Quality of life
Time frame: 1-10 years post-injury
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2016.
- 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.
Lene Odgaard principal investigator
Research Unit (Forskningsenheden), Hammel Neurorehabilitation and Research Centre
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 Brain Injuries and Return to Work, run by University of Aarhus 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 1 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: status not confirmed, as of the sponsor's last update on 18 Mar 2016. 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?
Results are not available in the source record.
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?
time to return to work (time frame: up to 11 years post-injury). 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 18 Mar 2016.