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Completed

NCT Number: NCT00869154

Multidisciplinary Treatment in Patients With Mild Traumatic Brain Injury

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.

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Key information

Age range

16 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Haukeland University Hospital, Dept. physical medicine and rehabilitation, Bergen, Norway

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

primary care follow up

Behavioral

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

Other names: Bergen Mild Traumatic Brain Injury Study.

Multidisciplinary follow up

Behavioral

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

Other names: Bergen Mild Traumatic Brain Injury Study

Primary outcomes

  1. Return to work

    Time frame: 6 and 12 months after 1. multidisciplinary examination

    Sick leave for 5 years after injury

Secondary outcomes

  1. GOSE

    Time frame: 6 and 12 months after 1. multidisciplinary examination

    Glasgow Outcome Scale Extended

  2. Post-commotio symptoms (RPQ)

    Time frame: 12 months

    The Rivermead Post concussion symptoms Questionnaire

  3. Patient's Global Impression of Change

    Time frame: 12 months

    Patient's Global Impression of Change

Sponsors and collaborators

Lead sponsor

Haukeland University Hospital

Other

Collaborators

  • Stiftelsen Helse og Rehabilitering
  • Ullevaal University Hospital

Registry information

Official study title

Effect of Multidisciplinary Treatment in Patients With Mild Traumatic Brain Injury - a Randomized Controlled Trial

Important dates

Study start
2009
Primary completion
2013
Study completion
2015
First posted
Mar 25, 2009
Registry last updated
Aug 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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