Effect of Multidisciplinary Treatment in Patients With Mild Traumatic Brain Injury - a Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 151
- Locations
- 4
- Primary Endpoint
- Return to work
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- 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.
Eligibility Criteria
- Ages
- 16 Years to 55 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Primary care follow up
Multidisciplinary examination and follow up by the family doctor.
Intervention: primary care follow up (Behavioral)
Multidisciplinary follow up
Multidisciplinary examination and follow up by a multidisciplinary outpatient team.
Intervention: Multidisciplinary follow up (Behavioral)
Outcomes
Primary Outcomes
Return to work
Time Frame: 6 and 12 months after 1. multidisciplinary examination
Sick leave for 5 years after injury
Secondary Outcomes
- GOSE(6 and 12 months after 1. multidisciplinary examination)
- Patient's Global Impression of Change(12 months)
- Post-commotio symptoms (RPQ)(12 months)