Multidisciplinary Treatment in Patients With Mild Traumatic Brain Injury

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Stiftelsen Helse og Rehabilitering
Ullevaal University Hospital
Information provided by (Responsible Party):
Eirik Vikane, Haukeland University Hospital
ClinicalTrials.gov Identifier:
NCT00869154
First received: February 24, 2009
Last updated: September 13, 2013
Last verified: September 2013
  Purpose

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 Intervention Phase
Traumatic Brain Injury With Brief Loss of Consciousness
Behavioral: primary care follow up
Behavioral: Multidisciplinary follow up
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Multidisciplinary Treatment in Patients With Mild Traumatic Brain Injury - a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Haukeland University Hospital:

Primary Outcome Measures:
  • Return to work [ Time Frame: 6 and 12 months after 1. multidisciplinary examination ] [ Designated as safety issue: No ]
    Sick leave for 5 years after injury


Secondary Outcome Measures:
  • GOSE [ Time Frame: 6 and 12 months after 1. multidisciplinary examination ] [ Designated as safety issue: No ]
    Glasgow Outcome Scale Extended


Estimated Enrollment: 160
Study Start Date: March 2009
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   16 Years to 55 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: Eirik Vikane, MD, Haukeland University Hospital
ClinicalTrials.gov Identifier: NCT00869154     History of Changes
Other Study ID Numbers: NSD 20425
Study First Received: February 24, 2009
Last Updated: September 13, 2013
Health Authority: Norway: Norwegian Social Science Data Services
Norway:National Committee for Medical and Health Research Ethics

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:
Unconsciousness
Brain Injuries
Wounds and Injuries
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Brain Diseases
Central Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System

ClinicalTrials.gov processed this record on July 20, 2014