Clinical trial NCT00869154: Multidisciplinary Treatment in Patients With Mild Traumatic Brain Injury
Official title: Effect of Multidisciplinary Treatment in Patients With Mild Traumatic Brain Injury - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Traumatic Brain Injury With Brief Loss of Consciousness
Keywords: Mild TBI
TBI (Traumatic Brain Injury)
Traumatic Brain Injury
Injury, Brain, Traumatic
Injuries, Acute Brain
Brain Injuries, Traumatic
Acute Brain Injuries
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
Collaborators: name: Stiftelsen Helse og Rehabilitering
name: Ullevaal University Hospital
First posted: 2009-03-25
Enrollment: 151
Sex: ALL
Minimum age (years): 16
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Return to work
timeFrame: 6 and 12 months after 1. multidisciplinary examination
Secondary outcomes:
measure: GOSE
timeFrame: 6 and 12 months after 1. multidisciplinary examination
measure: Post-commotio symptoms (RPQ)
timeFrame: 12 months
measure: Patient's Global Impression of Change
timeFrame: 12 months
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Haukeland University Hospital, Dept. physical medicine and rehabilitation
city: Oslo
country: Norway
facility: Oslo University Hospital, Ullevål
Study officials:
affiliation: Haukeland University Hospital
name: Jan Sture Skouen, MD, PhD
role: STUDY_DIRECTOR
References: