Multidisciplinary Treatment in Patients With Mild Traumatic Brain Injury

Sponsor

Haukeland University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT00869154

Collaborator

Stiftelsen Helse og Rehabilitering (Other), Ullevaal University Hospital (Other)

151

Enrollment

Locations

Arms

Actual Duration (Months)

75.5

Patients Per Site

Patients Per Site Per Month

Study Details

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	Phase
Traumatic Brain Injury With Brief Loss of Consciousness	Behavioral: primary care follow up Behavioral: Multidisciplinary follow up	N/A

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

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.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 :

Mar 1, 2009

Actual Primary Completion Date :

Mar 31, 2013

Actual Study Completion Date :

Mar 31, 2015

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 Names: 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 Names: Bergen Mild Traumatic Brain Injury Study

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 Names:

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 Names:

Bergen Mild Traumatic Brain Injury Study

Outcome Measures

Primary Outcome Measures

Return to work [6 and 12 months after 1. multidisciplinary examination]
Sick leave for 5 years after injury

Secondary Outcome Measures

GOSE [6 and 12 months after 1. multidisciplinary examination]
Glasgow Outcome Scale Extended
Post-commotio symptoms (RPQ) [12 months]
The Rivermead Post concussion symptoms Questionnaire
Patient's Global Impression of Change [12 months]
Patient's Global Impression of Change

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.