Overview

This trial is active, not recruiting.

Condition traumatic brain injury with brief loss of consciousness
Treatments primary care follow up, multidisciplinary follow up
Phase phase 2
Sponsor Haukeland University Hospital
Collaborator Stiftelsen Helse og Rehabilitering
Start date March 2009
End date October 2015
Trial size 151 participants
Trial identifier NCT00869154, NSD 20425

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Multidisciplinary examination and follow up by the family doctor.
primary care follow up Bergen Mild Traumatic Brain Injury Study.
Multidisciplinary examination, good advice from rehabilitation specialists and follow up by the family doctor.
(Experimental)
Multidisciplinary examination and follow up by a multidisciplinary outpatient team.
multidisciplinary follow up Bergen Mild Traumatic Brain Injury Study
Multidisciplinary examination and follow up by rehabilitation specialists, a multidisciplinary team following an individual rehabilitation programs.

Primary Outcomes

Measure
Return to work
time frame: 6 and 12 months after 1. multidisciplinary examination

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants from 16 years up to 55 years old.

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

Additional Information

Official title Effect of Multidisciplinary Treatment in Patients With Mild Traumatic Brain Injury - a Randomized Controlled Trial
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2015.
Information provided to ClinicalTrials.gov by Haukeland University Hospital.