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Multidisciplinary Treatment in Patients With Mild Traumatic Brain Injury

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ClinicalTrials.gov Identifier: NCT00869154
Recruitment Status : Completed
First Posted : March 25, 2009
Last Update Posted : August 14, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief 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.

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.


Condition or disease Intervention/treatment
Traumatic Brain Injury With Brief Loss of Consciousness Behavioral: primary care follow up Behavioral: Multidisciplinary follow up

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 151 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Investigator)
Masking Description:
The baseline data were collected before randomization. The data collection at 12 months was conducted by postal self-report questionnaires, and for GOSE, an assistant who was blinded to the group allocation performed a telephone interview. Two independent persons, who were blinded for the groups and were unfamiliar with the aim and content of the study, entered the data into the SPSS database. A statistician, who did not participate in the treatment program and was blinded to the group allocation when the data were analyzed, controlled the data and performed the statistical analyses for RTW and the secondary outcomes.
Primary Purpose: Treatment
Official Title: Effect of Multidisciplinary Treatment in Patients With Mild Traumatic Brain Injury - a Randomized Controlled Trial
Actual Study Start Date : March 1, 2009
Primary Completion Date : March 31, 2013
Study Completion Date : March 31, 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Primary care follow up
Multidisciplinary examination and follow up by the family doctor.
Behavioral: primary care follow up
Multidisciplinary examination, good advice from rehabilitation specialists and follow up by the family doctor.
Other Name: Bergen Mild Traumatic Brain Injury Study.
Experimental: Multidisciplinary follow up
Multidisciplinary examination and follow up by a multidisciplinary outpatient team.
Behavioral: Multidisciplinary follow up
Multidisciplinary examination and follow up by rehabilitation specialists, a multidisciplinary team following an individual rehabilitation programs.
Other Name: Bergen Mild Traumatic Brain Injury Study


Outcome Measures

Primary Outcome Measures :
  1. Return to work [ Time Frame: 6 and 12 months after 1. multidisciplinary examination ]
    Sick leave for 5 years after injury


Secondary Outcome Measures :
  1. GOSE [ Time Frame: 6 and 12 months after 1. multidisciplinary examination ]
    Glasgow Outcome Scale Extended

  2. Post-commotio symptoms (RPQ) [ Time Frame: 12 months ]
    The Rivermead Post concussion symptoms Questionnaire

  3. Patient's Global Impression of Change [ Time Frame: 12 months ]
    Patient's Global Impression of Change


Eligibility Criteria

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Ages Eligible for Study:   16 Years to 55 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00869154


Locations
Norway
Haukeland University Hospital, Dept. physical medicine and rehabilitation
Bergen, Norway, N-5020
Oslo University Hospital, Ullevål
Oslo, Norway, N-0407
Sponsors and Collaborators
Haukeland University Hospital
Stiftelsen Helse og Rehabilitering
Ullevaal University Hospital
Investigators
Study Director: Jan Sture Skouen, MD, PhD Haukeland University Hospital
More Information

Additional Information:
Responsible Party: Haukeland University Hospital
ClinicalTrials.gov Identifier: NCT00869154     History of Changes
Other Study ID Numbers: NSD 20425
First Posted: March 25, 2009    Key Record Dates
Last Update Posted: August 14, 2017
Last Verified: August 2017

Keywords provided by Haukeland University Hospital:
Mild TBI
TBI (Traumatic Brain Injury)
Traumatic Brain Injury
Injury, Brain, Traumatic
Injuries, Acute Brain
Brain Injuries, Traumatic
Acute Brain Injuries

Additional relevant MeSH terms:
Wounds and Injuries
Brain Injuries
Brain Injuries, Traumatic
Brain Concussion
Brain Diseases
Craniocerebral Trauma
Trauma, Nervous System
Head Injuries, Closed
Wounds, Nonpenetrating
Unconsciousness
Central Nervous System Diseases
Nervous System Diseases
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms