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Multidisciplinary Treatment in Patients With Mild Traumatic Brain Injury

Primary Purpose

Traumatic Brain Injury With Brief Loss of Consciousness

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
primary care follow up
Multidisciplinary follow up
Sponsored by
Haukeland University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Traumatic Brain Injury With Brief Loss of Consciousness focused on measuring Mild TBI, TBI (Traumatic Brain Injury), Traumatic Brain Injury, Injury, Brain, Traumatic, Injuries, Acute Brain, Brain Injuries, Traumatic, Acute Brain Injuries

Eligibility Criteria

16 Years - 55 Years (Child, Adult)All SexesDoes not accept 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.

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

Sites / Locations

  • Haukeland University Hospital, Dept. physical medicine and rehabilitation
  • Oslo University Hospital, Ullevål

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Primary care follow up

Multidisciplinary follow up

Arm Description

Multidisciplinary examination and follow up by the family doctor.

Multidisciplinary examination and follow up by a multidisciplinary outpatient team.

Outcomes

Primary Outcome Measures

Return to work
Sick leave for 5 years after injury

Secondary Outcome Measures

GOSE
Glasgow Outcome Scale Extended
Post-commotio symptoms (RPQ)
The Rivermead Post concussion symptoms Questionnaire
Patient's Global Impression of Change
Patient's Global Impression of Change

Full Information

First Posted
February 24, 2009
Last Updated
August 11, 2017
Sponsor
Haukeland University Hospital
Collaborators
Stiftelsen Helse og Rehabilitering, Ullevaal University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00869154
Brief Title
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

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
March 1, 2009 (Actual)
Primary Completion Date
March 31, 2013 (Actual)
Study Completion Date
March 31, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Haukeland University Hospital
Collaborators
Stiftelsen Helse og Rehabilitering, Ullevaal University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
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.
Allocation
Randomized
Enrollment
151 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Primary care follow up
Arm Type
Active Comparator
Arm Description
Multidisciplinary examination and follow up by the family doctor.
Arm Title
Multidisciplinary follow up
Arm Type
Experimental
Arm Description
Multidisciplinary examination and follow up by a multidisciplinary outpatient team.
Intervention Type
Behavioral
Intervention Name(s)
primary care follow up
Other Intervention Name(s)
Bergen Mild Traumatic Brain Injury Study.
Intervention Description
Multidisciplinary examination, good advice from rehabilitation specialists and follow up by the family doctor.
Intervention Type
Behavioral
Intervention Name(s)
Multidisciplinary follow up
Other Intervention Name(s)
Bergen Mild Traumatic Brain Injury Study
Intervention Description
Multidisciplinary examination and follow up by rehabilitation specialists, a multidisciplinary team following an individual rehabilitation programs.
Primary Outcome Measure Information:
Title
Return to work
Description
Sick leave for 5 years after injury
Time Frame
6 and 12 months after 1. multidisciplinary examination
Secondary Outcome Measure Information:
Title
GOSE
Description
Glasgow Outcome Scale Extended
Time Frame
6 and 12 months after 1. multidisciplinary examination
Title
Post-commotio symptoms (RPQ)
Description
The Rivermead Post concussion symptoms Questionnaire
Time Frame
12 months
Title
Patient's Global Impression of Change
Description
Patient's Global Impression of Change
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan Sture Skouen, MD, PhD
Organizational Affiliation
Haukeland University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Haukeland University Hospital, Dept. physical medicine and rehabilitation
City
Bergen
ZIP/Postal Code
N-5020
Country
Norway
Facility Name
Oslo University Hospital, Ullevål
City
Oslo
ZIP/Postal Code
N-0407
Country
Norway

12. IPD Sharing Statement

Links:
URL
https://www.ncbi.nlm.nih.gov/pubmed/?term=vikane+e+not+diabetes
Description
Publications from the project: Multidisciplinary outpatient treatment in patients with mild traumatic brain injury: A randomised controlled intervention study.

Learn more about this trial

Multidisciplinary Treatment in Patients With Mild Traumatic Brain Injury

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