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
Lay summary of study results: Too much time spent in sedentary behaviours (sitting/lying down) is linked with ill health and mortality. Stroke survivors are particularly sedentary, spending up to 80% of their waking day sitting or lying down. We developed and evaluated an intervention to reduce sedentary behaviour for stroke survivors through a series of projects.
We updated reviews of previous and current research, and interviewed staff and observed what happens on stroke units and during therapy sessions in patients’ homes. We also interviewed stroke survivors and their carers, to explore their thoughts and perceptions on sedentary behaviour, and what might help or hinder this.
Through a series of meetings, using information from the work described above, ideas and action plans (an intervention) for reducing time spent sitting/lying were produced. The intervention (called Get Set Go (GSG)) was further refined by working with three stroke services. The intervention included training for staff and stroke survivors, and materials for staff and stroke survivors to encourage them to undertake and monitor their own standing and moving,
In this work we undertook a preliminary exploration of the developed intervention in 15 stroke services; eight were randomly allocated to deliver GSG and the other seven continued providing their usual care to all stroke survivors. We aimed to explore whether GSG was likely to improve stroke survivors’ ability to complete extended activities of daily living in the first year after stroke. A total of 334 stroke survivors were included in the trial. No significant differences between groups were found in any of the measured outcomes.
Participants and staff appreciated the relevance of the work and components of the intervention. The exploratory findings from this external pilot study suggest that the GSG intervention is unlikely to be cost-effective, although the scale of our work was impacted by the pandemic.
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