NCT00869154

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
151

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 24, 2009

Completed
5 days until next milestone

Study Start

First participant enrolled

March 1, 2009

Completed
24 days until next milestone

First Posted

Study publicly available on registry

March 25, 2009

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2013

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2015

Completed
Last Updated

August 14, 2017

Status Verified

August 1, 2017

Enrollment Period

4.1 years

First QC Date

February 24, 2009

Last Update Submit

August 11, 2017

Conditions

Traumatic Brain Injury With Brief Loss of Consciousness

Keywords

Mild TBITBI (Traumatic Brain Injury)Traumatic Brain InjuryInjury, Brain, TraumaticInjuries, Acute BrainBrain Injuries, TraumaticAcute Brain Injuries

Outcome Measures

Primary Outcomes (1)

  • Return to work

    Sick leave for 5 years after injury

    6 and 12 months after 1. multidisciplinary examination

Secondary Outcomes (3)

  • GOSE

    6 and 12 months after 1. multidisciplinary examination

  • Post-commotio symptoms (RPQ)

    12 months

  • Patient's Global Impression of Change

    12 months

Study Arms (2)

Primary care follow up

ACTIVE COMPARATOR

Multidisciplinary examination and follow up by the family doctor.

Behavioral: primary care follow up

Multidisciplinary follow up

EXPERIMENTAL

Multidisciplinary examination and follow up by a multidisciplinary outpatient team.

Behavioral: Multidisciplinary follow up

Interventions

primary care follow upBEHAVIORAL

Multidisciplinary examination, good advice from rehabilitation specialists and follow up by the family doctor.

Also known as: Bergen Mild Traumatic Brain Injury Study.
Primary care follow up
Multidisciplinary follow upBEHAVIORAL

Multidisciplinary examination and follow up by rehabilitation specialists, a multidisciplinary team following an individual rehabilitation programs.

Also known as: Bergen Mild Traumatic Brain Injury Study
Multidisciplinary follow up

Eligibility Criteria

Age16 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Haukeland University Hospital, Dept. physical medicine and rehabilitation

Bergen, N-5020, Norway

Location

Oslo University Hospital, Ullevål

Oslo, N-0407, Norway

Location

Related Links

MeSH Terms

Conditions

Brain Injuries, TraumaticBrain Injuries

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Jan Sture Skouen, MD, PhD

    Haukeland University Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 24, 2009

First Posted

March 25, 2009

Study Start

March 1, 2009

Primary Completion

March 31, 2013

Study Completion

March 31, 2015

Last Updated

August 14, 2017

Record last verified: 2017-08

Locations

NO(2)