RECREATE: a cluster randomised trial
Research type
Research Study
Full title
A multicentre cluster randomised controlled trial evaluating the clinical and cost-effectiveness of an intervention to reduce sedentary behaviour in stroke survivors incorporating an internal pilot phase and embedded process evaluation
IRAS ID
271111
Contact name
Anne Forster
Contact email
Sponsor organisation
Bradford Teaching Hospitals NHS Foundation Trust
Duration of Study in the UK
4 years, 6 months, 15 days
Research summary
This study is the fifth of five workstreams in a National Institute for Health Research funded seven year research programme, which seeks to develop and evaluate strategies for reducing sedentary behaviour in people after stroke to improve outcomes. We are developing and evaluating a complex intervention to target sedentary behaviour after stroke.\n\nBuilding on the intervention developed through a co-production process in Workstream 3 and tested for feasibility in Workstream 4, we will undertake a multicentre cluster randomised controlled trial evaluating the clinical and cost-effectiveness of the intervention incorporating an internal pilot phase and embedded process evaluation.\n\nThe intervention will be delivered by NHS stroke services across the UK. NHS stroke services randomised to the intervention group will be trained to deliver the intervention, whilst those randomised to the control group will continue to deliver current practice. The trial aims to recruit 1,156 patients in 34 NHS stroke services. Patients with planned discharged home will be recruited by researchers based on the referring stroke units. Outcomes will be assessed at six, 12 and 24 months after stroke survivors recruitment and registration to the trial. The primary outcome is ability in extended activities of daily living (ADL) measured using the Nottingham Extended ADL Scale at 12 months following participant recruitment. The key secondary outcome is measurement of sedentary behaviour in total sitting time at 12 months (measured by the activity monitor activPAL). Other secondary outcomes include cost-effectiveness, health status and occurrence of major vascular events. A parallel and embedded process evaluation will explore and understand the implementation of the intervention and how it is experienced and understood by providers and recipients.\n
REC name
Yorkshire & The Humber - Bradford Leeds Research Ethics Committee
REC reference
19/YH/0403
Date of REC Opinion
3 Dec 2019
REC opinion
Favourable Opinion