Traumatic Brain Injury With Brief Loss of ConsciousnessNCT00869154
Multidisciplinary Treatment in Patients With Mild Traumatic Brain Injury
A study testing primary care follow up and Multidisciplinary follow up in people with Traumatic Brain Injury With Brief Loss of Consciousness, run by Haukeland University Hospital at 2 sites in Norway.
Trial summary
The aim of the study is to compare a multidisciplinary examination and follow up by rehabilitation program with a multidisciplinary examination, good advice and follow up by the family doctor. Read more about this study
- Who is it for?
- Ages 16 to 55 years
- Conditions the study is for
- Traumatic Brain Injury With Brief Loss of Consciousness
- What is being tested?
- primary care follow up and Multidisciplinary follow up
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 151 participants
- Where
- 2 sitesNorway
- Study dates
- 1 Mar 2009to 31 Mar 2015
- Phase
- Interventional
- 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 16 to 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patient admitted acute to Department of Neurosurgery ICD-10 diagnosed S06.0- S06.9
- Age 16 to 55 years
- Mild traumatic brain injury defined as Glasgow Coma Scale (GCS) between 13 and 15.
Who cannot join
- Earlier severe traumatic brain injury (GCS 8 or less).
- Serious psychiatric disease (ICD-10 diagnosed last two years).
- Known drug abuse (ICD-10 diagnosed last two years).
- Other serious illness which have a major impact of the outcome.
- Social client last two years as major income
Trial locations and contacts
2 sites in 1 country.
Norway2 sites
Haukeland University Hospital, Dept. physical medicine and rehabilitation
Bergen, N-5020
Oslo University Hospital, Ullevål
Oslo, N-0407
About this study
Official title: Effect of Multidisciplinary Treatment in Patients With Mild Traumatic Brain Injury - a Randomized Controlled Trial
The aim of the study is to compare a multidisciplinary examination and follow up by rehabilitation program with a multidisciplinary examination, good advice and follow up by the family doctor.
Further on we will examine if there were differing clinical characteristics between patients who attended a planned follow-up session and those that failed to and Prognostic factors in mild traumatic brain injury patients after discharge from hospital.
Read the detailed description
2 months after an acute mild traumatic brain injury (TBI) defined as Glasgow Coma Scale between 13 and 15. The patient will get a clinical examination by a specialist in rehabilitation medicine. Patient who wish or need a further follow up, are out of work or school, will be included and randomized to either a multidisciplinary follow up or primary care follow by their family doctor.
Both groups will got a multidisciplinary examination. The multidisciplinary team will work out a rehabilitation program and a report back to their family doctor.
Patient who got a multidisciplinary follow up will then get individual appointments and they will follow an educational program for 4 days. The topics are physical and psychical problems after TBI and problems in daily living and return to work. We will teach a way to accept and deal with their problems. A cognitive behavioural treatment or a psycho educative approach will be central in the treatment. The follow up period will be until 2 years if needed.
For booth groups we will make a registration of sick leave for 5 years. The Extended Glasgow Outcome Scale (GOS- E), Hospital Anxiety and Depression Scale (HAD), Rivermead post concussion symptoms questionnaire and Patient Global Impression of Change (PGIC) after 6 and 12 months.
Department of Economics at the University of Bergen will make cost-benefit analysis.
Further on we will examine if there were differing clinical characteristics between patients who attended a planned follow-up session and those that failed to, if sick leave or return to work could make a difference and Prognostic factors in mild traumatic brain injury patients after discharge from hospital. We also include demographic data, CT findings and clinical data based on information from the medical records, pain drawings and numeric rating scale for pain, Quality of Life and Subjective Health Complaints inventory. We got data about days on sick leave, diagnosis for sick leave and income for the first year before and after the injury from The Norwegian Labour and Welfare Service (NAV) through a third accredited agency Statistics Norway. From Statistics Norway we got additional information about education level and income.
- Being tested
- primary care follow up, Multidisciplinary follow up
- Keywords
- Mild TBI, TBI (Traumatic Brain Injury), Traumatic Brain Injury, Injury, Brain, Traumatic, Injuries, Acute Brain, Brain Injuries, Traumatic, Acute Brain Injuries
- Medical subject headings
- Brain Injuries, Traumatic, Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
primary care follow upBehavioural
Also called Bergen Mild Traumatic Brain Injury Study.
Multidisciplinary examination, good advice from rehabilitation specialists and follow up by the family doctor.
Multidisciplinary follow upBehavioural
Also called Bergen Mild Traumatic Brain Injury Study
Multidisciplinary examination and follow up by rehabilitation specialists, a multidisciplinary team following an individual rehabilitation programs.
| Study group | Role | What they receive |
|---|---|---|
| Primary care follow up | Active comparator | Multidisciplinary examination and follow up by the family doctor. Receives: Behavioral: primary care follow up |
| Multidisciplinary follow up | Experimental | Multidisciplinary examination and follow up by a multidisciplinary outpatient team. Receives: Behavioral: Multidisciplinary follow up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Return to work
Sick leave for 5 years after injury
Measured: 6 and 12 months after 1. multidisciplinary examination
Secondary outcomes (3)
GOSE
Glasgow Outcome Scale Extended
Measured: 6 and 12 months after 1. multidisciplinary examination
Post-commotio symptoms (RPQ)
The Rivermead Post concussion symptoms Questionnaire
Measured: 12 months
Patient's Global Impression of Change
Patient's Global Impression of Change
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2009 (estimated)
- Study start1 Mar 2009
- Primary completion31 Mar 2013
- Study completion31 Mar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain Injury With Brief Loss of ConsciousnessStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial. Multidisciplinary outpatient rehabilitation with individual contacts and a psycho-educational group intervention at two outpatient rehabilitation clinics compared to follow-up by a general practitioner after a multidisciplinary examination.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Stiftelsen Helse og Rehabilitering, Ullevaal University Hospital
- Responsible party
- Sponsor
- Investigators
- Jan Sture Skouen, MD, PhD, Study director, Haukeland University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00869154
- Sponsor's protocol ID
- NSD 20425
- Status last verified
- Aug 2017
- First submitted
- 24 Feb 2009
- Last updated
- 14 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Multidisciplinary Treatment in Patients With Mild Traumatic Brain Injury - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00869154
- Acronym / sponsor ID
- NSD 20425
- Keywords
- Mild TBI, TBI (Traumatic Brain Injury), Traumatic Brain Injury, Injury, Brain, Traumatic, Injuries, Acute Brain, Brain Injuries, Traumatic, Acute Brain Injuries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Collaborators
- Stiftelsen Helse og Rehabilitering, Ullevaal University Hospital
- Study start
- 1 Mar 2009 (actual)
- Primary completion
- 31 Mar 2013 (actual)
- Study completion
- 31 Mar 2015 (actual)
- First posted
- 25 Mar 2009 (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 aim of the study is to compare a multidisciplinary examination and follow up by rehabilitation program with a multidisciplinary examination, good advice and follow up by the family doctor.
Further on we will examine if there were differing clinical characteristics between patients who attended a planned follow-up session and those that failed to and Prognostic factors in mild traumatic brain injury patients after discharge from hospital.
Detailed description
2 months after an acute mild traumatic brain injury (TBI) defined as Glasgow Coma Scale between 13 and 15. The patient will get a clinical examination by a specialist in rehabilitation medicine. Patient who wish or need a further follow up, are out of work or school, will be included and randomized to either a multidisciplinary follow up or primary care follow by their family doctor.
Both groups will got a multidisciplinary examination. The multidisciplinary team will work out a rehabilitation program and a report back to their family doctor.
Patient who got a multidisciplinary follow up will then get individual appointments and they will follow an educational program for 4 days. The topics are physical and psychical problems after TBI and problems in daily living and return to work. We will teach a way to accept and deal with their problems. A cognitive behavioural treatment or a psycho educative approach will be central in the treatment. The follow up period will be until 2 years if needed.
For booth groups we will make a registration of sick leave for 5 years. The Extended Glasgow Outcome Scale (GOS- E), Hospital Anxiety and Depression Scale (HAD), Rivermead post concussion symptoms questionnaire and Patient Global Impression of Change (PGIC) after 6 and 12 months.
Department of Economics at the University of Bergen will make cost-benefit analysis.
Further on we will examine if there were differing clinical characteristics between patients who attended a planned follow-up session and those that failed to, if sick leave or return to work could make a difference and Prognostic factors in mild traumatic brain injury patients after discharge from hospital. We also include demographic data, CT findings and clinical data based on information from the medical records, pain drawings and numeric rating scale for pain, Quality of Life and Subjective Health Complaints inventory. We got data about days on sick leave, diagnosis for sick leave and income for the first year before and after the injury from The Norwegian Labour and Welfare Service (NAV) through a third accredited agency Statistics Norway. From Statistics Norway we got additional information about education level and income.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Randomized controlled trial. Multidisciplinary outpatient rehabilitation with individual contacts and a psycho-educational group intervention at two outpatient rehabilitation clinics compared to follow-up by a general practitioner after a multidisciplinary examination.
| Arm | Type | Receives |
|---|---|---|
| Primary care follow up | Active comparator | Behavioral: primary care follow upMultidisciplinary examination and follow up by the family doctor. |
| Multidisciplinary follow up | Experimental | Behavioral: Multidisciplinary follow upMultidisciplinary examination and follow up by a multidisciplinary outpatient team. |
Who may qualify
- Ages
- 16 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Patient admitted acute to Department of Neurosurgery ICD-10 diagnosed S06.0- S06.9
- Age 16 to 55 years
- Mild traumatic brain injury defined as Glasgow Coma Scale (GCS) between 13 and 15.
Key exclusion criteria (5 listed)
- Earlier severe traumatic brain injury (GCS 8 or less).
- Serious psychiatric disease (ICD-10 diagnosed last two years).
- Known drug abuse (ICD-10 diagnosed last two years).
- Other serious illness which have a major impact of the outcome.
- Social client last two years as major income
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 |
|---|---|---|
| primary care follow upAlso: Bergen Mild Traumatic Brain Injury Study.Multidisciplinary examination, good advice from rehabilitation specialists and follow up by the family doctor. | Behavioural | Primary care follow up |
| Multidisciplinary follow upAlso: Bergen Mild Traumatic Brain Injury StudyMultidisciplinary examination and follow up by rehabilitation specialists, a multidisciplinary team following an individual rehabilitation programs. | Behavioural | Multidisciplinary follow up |
Primary outcome
Return to work
Time frame: 6 and 12 months after 1. multidisciplinary examination
Sick leave for 5 years after injury
3 secondary outcomes
GOSE
Time frame: 6 and 12 months after 1. multidisciplinary examination
Post-commotio symptoms (RPQ)
Time frame: 12 months
Patient's Global Impression of Change
Time frame: 12 months
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 Aug 2017.
- Publications from the project: Multidisciplinary outpatient treatment in patients with mild traumatic brain injury: A randomised controlled intervention study.Link provided by the sponsor.
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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.
Jan Sture Skouen, MD, PhD study director
Haukeland University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing primary care follow up and Multidisciplinary follow up in people with Traumatic Brain Injury With Brief Loss of Consciousness, run by Haukeland University Hospital at 2 sites in Norway.
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 3 inclusion and 5 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 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway. 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?
Return to work (time frame: 6 and 12 months after 1. multidisciplinary examination). 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 Aug 2017.