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Published in: Trials 1/2017

Open Access 01-12-2017 | Study protocol

A manual-based vocational rehabilitation program for patients with an acquired brain injury: study protocol of a pragmatic randomized controlled trial (RCT)

Authors: Louise K. Hoeffding, Maria Haahr Nielsen, Morten A. Rasmussen, Anne Norup, Juan Carlos Arango-Lasprilla, Ulrikka K. Kjær, Kristoffer Sølvsten Burgdorf, Kirsten Jensen Quas, Trine Schow

Published in: Trials | Issue 1/2017

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Abstract

Background

An acquired brain injury (ABI) is a complex injury often followed by a broad range of cognitive, physical, emotional, and behavioral disabilities. Because of these disabilities, vocational rehabilitation (VR) is a challenging task, however, of great importance, since approximately 75% of the patients with ABI are of working age. Thus, standardized clinically effective and cost-effective methodologies regarding VR for patients with ABI are highly needed. Therefore, the aim of this study is to evaluate the effect of an individually targeted manual-based VR for patient with ABI compared to conventional VR (usual care).

Methods

This study is an interventional, two-arm, six-month follow-up, cluster randomized controlled trial involving four municipalities in the Zealand Region and the Capital Region of Denmark. A total of 84 patients with ABI evenly distributed across four municipalities will be included in the study. The patients will randomly be allocated in a 1:1 ratio to the VR intervention provided by a specialized Brain Injury Centre or the conventional VR provided by the municipalities (usual care). The six- to nine-month intervention will consist of individual and group therapies as well as a work placement program including supported employment. Furthermore, the intervention will include a family intervention program followed up by support to one individual family caregiver. The primary outcomes are increased work or study rate at six-month follow-up. Moreover, a budget impact analysis and possibly a cost-utility analysis of the intervention will be performed.

Discussion

This study consists of a comprehensive multidiciplinary VR intervention involving several parties such as the municipalities, a specialized rehabilitation team, and patients’ own family caregivers. If this intervention is proven successful when compared to the conventional VR, it will provide evidence for a manual-based individualized holistic approach in returning to work after an ABI. Furthermore, the study will contribute with novel knowledge regarding feasibility and clinical effectiveness of the VR intervention relevant to clinicians, researchers, and policymakers.

Trial registration

ClinicalTrials.gov, NCT03086031. Registered on 21 March 2017.
Appendix
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Metadata
Title
A manual-based vocational rehabilitation program for patients with an acquired brain injury: study protocol of a pragmatic randomized controlled trial (RCT)
Authors
Louise K. Hoeffding
Maria Haahr Nielsen
Morten A. Rasmussen
Anne Norup
Juan Carlos Arango-Lasprilla
Ulrikka K. Kjær
Kristoffer Sølvsten Burgdorf
Kirsten Jensen Quas
Trine Schow
Publication date
01-12-2017
Publisher
BioMed Central
Published in
Trials / Issue 1/2017
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-017-2115-0

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