Background
Return to work is a major goal for many stroke survivors but achieved by fewer than half of working people. There is a lack of evidence on how best to support stroke survivors wanting to RTW.
A new therapy has been developed ‘Early Stroke Specific Vocational Rehabilitation’ (ESSVR). This is delivered by occupational therapists and includes matching survivors’ abilities to job demands and negotiating return to work with an existing employer.
Design and methods
We are conducting a definitive 20 centre multicentre randomised controlled trial to test the clinical effectiveness of ESSVR and usual care (compared to usual care alone) at returning stroke survivors to work and keeping them there 12 months after stroke.
Alongside the trial we are conducting an economic evaluation (to test for cost effectiveness) and a process evaluation to examine what was actually delivered during the trial and to elicit stroke survivors and staff’s views. We aim to recruit 760 stroke survivors, aged 18 or over and employed at the time of stroke, from 20 NHS centres. Approximately half will be randomly allocated to ESSVR in addition to their usual NHS rehabilitation (usual Care), and half to usual care alone. We will follow up participants with postal questionnaires at three, six and 12 months and offer help over the telephone when needed.
The trial has an eight site internal pilot in the first year to check that we are recruiting to target across multiple sites and are collecting the expected number of questionnaires.
The trial is led by Dr Kate Radford, Associate Professor in Rehabilitation Research at the University of Nottingham and managed by the Leeds Clinical Trial Unit.
Timeframe
The trial opened to recruitment in May 2018 and will now complete by the end of December 2023 due to an extension.
Research team
- Dr Kate Radford
- Dame Professor Caroline Watkins
- Ms Suzanne Hartley
- Professor Rory O'Connor
- Mrs Ivana Holloway
- Professor Amanda Farrin
- Dr Judith Stevens
- Mr John Duncan Murray
- Professor Christopher McKevitt
- Professor Marion Fraser Walker
- Professor Tracey Sach
- Mrs Kate Hooban
- Professor Audrey Bowen
- Dr Les Stuart Smith
Funding
The RETAKE study is a definitive national randomised control trial funded by the National Institute for Health Research (NIHR) Health Technology Assessment Programme (HTA 15/130/1).
ISRCTN12464275 https://doi.org/10.1186/ISRCTN12464275