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Clinical Trials/NCT03092713
NCT03092713
Completed
Not Applicable

The Effect Evaluation of Combined Cognitive and Vocational Interventions After Mild-to-moderate Traumatic Brain Injury: a Randomized Controlled Trial and Qualitative Process Evaluation

Oslo University Hospital1 site in 1 country121 target enrollmentJanuary 2, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Brain Injuries, Traumatic
Sponsor
Oslo University Hospital
Enrollment
121
Locations
1
Primary Endpoint
Return to work
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

A considerable number of patients with mild and moderate traumatic brain injury (TBI) experience long-lasting somatic, cognitive, and emotional symptoms that may hamper their capacity to return to work (RTW). Although several studies have described medical, psychological and work-related factors that predict RTW after TBI, well-controlled intervention studies regarding RTW in this group are scarce. Furthermore, there have traditionally been weak collaborations among rehabilitation services in the health sector, the Labor and Welfare Administration (NAV), and the work-places.

The current project proposal describes an innovative randomized controlled trial (RCT) which will explore the effect of combined manualized cognitive rehabilitation efforts and supported employment in real-life competitive work settings for patients who have not returned to work 8 weeks post-injury. The project combines the rehabilitation and vocational science perspectives; it involves multidisciplinary collaboration, and explores the efficacy of increased cross-sectorial collaboration between specialized health care services and the welfare system. If the intervention proves efficient, the project will further describe the cost-effectiveness and utility of the program, and thereby provide important information of use for policy makers. In addition, the study aims at generating knowledge on the RTW-process both for the persons with TBI, and their workplaces, and to disseminate this knowledge in order to create new multidisciplinary and collaborative practices. The project has potential to generate knowledge of relevance for other patients with neurological deficit.

Detailed Description

Please, see protocol article: https://www.ncbi.nlm.nih.gov/pubmed/29041954

Registry
clinicaltrials.gov
Start Date
January 2, 2017
End Date
June 30, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Oslo University Hospital
Responsible Party
Principal Investigator
Principal Investigator

Nada Andelic

MD, PhD

Oslo University Hospital

Eligibility Criteria

Inclusion Criteria

  • reside in Oslo and Akershus counties in Norway
  • mild-to-moderate TBI (Glasgow Coma scale score 10-15 at injury site). Confirmation of diagnosis of mild TBI will be done through documenting that acute symptoms adhere to the American Congress of Rehabilitation Medicine's (ACRM) definition of mild TBI.
  • loss of consciousness \<24 hours
  • posttraumatic amnesia (PTA) \<7 days
  • employed in a minimum 50% position at the time of injury
  • sick listed at the 50% or higher level due to post-concussive symptoms 2 months post-injury

Exclusion Criteria

  • history of severe psychiatric or neurological illness
  • active substance abuse
  • inability to speak and read Norwegian

Outcomes

Primary Outcomes

Return to work

Time Frame: 18 months post injury

The effect of the intervention on return to work rates throughout the follow-up period

Work stability

Time Frame: 18 months post injury

The effect of the intervention on work stability rates throughout the follow-up period

Secondary Outcomes

  • Euro-Qol - 5D (EQ-5D)(18 months)
  • Quality of life after brain injury (Qolibri)(18 months)
  • Rivermead post-concussion questionnaire(18 months)

Study Sites (1)

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