An individually randomised controlled multi-centre pragmatic trial with embedded economic and process evaluations of ear
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STUDY PROTOCOL
Open Access
An individually randomised controlled multi-centre pragmatic trial with embedded economic and process evaluations of early vocational rehabilitation compared with usual care for stroke survivors: study protocol for the RETurn to work After stroKE (RETAKE) trial Kathryn A. Radford1*, Kristelle Craven1, Vicki McLellan2, Tracey H. Sach3, Richard Brindle2, Ivana Holloway2, Suzanne Hartley2, Audrey Bowen4, Rory O’Connor5, Judith Stevens6, Julie Philips1, Marion Walker1, Jain Holmes1, Christopher McKevitt7, John Murray8, Caroline Watkins9, Katie Powers1, Angela Shone10 and Amanda Farrin2
Abstract Background: Return to work (RTW) is achieved by less than 50% of stroke survivors. The rising incidence of stroke among younger people, the UK economic forecast, and clinical drivers highlight the need for stroke survivors to receive support with RTW. However, evidence for this type of support is lacking. This randomised controlled trial (RCT) will investigate whether Early Stroke Specialist Vocational Rehabilitation (ESSVR) plus usual care (UC) (i.e. usual NHS rehabilitation) is more clinically and cost-effective for supporting post-stroke RTW, than UC alone. (Continued on next page)
* Correspondence: [email protected] 1 Division of Rehabilitation and Ageing, School of Medicine, Medical School Queen’s Medical Centre, B-Floor, Nottingham NG7 2UH, UK Full list of author information is available at the end of the article © The Author(s). 2020 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
Radford et al. Trials
(2020) 21:1010
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Methods: Seven hundred sixty stroke survivors and their carers will be recruited from approximately 20 NHS stroke services. A 5:4 allocation ratio will be employed to randomise participants to receive ESSVR plus UC, or UC alone. The individually tailored ESSVR intervention will commence within 12 weeks of stroke onset and be delivered for up to 12 months as necessary by trained RETAKE occupational therapists in the communit
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