A multicentre pilot cluster randomised controlled trial evaluating an intervention to reduce sedentary behaviour in stroke survivors incorporating an embedded process evaluation
Stroke
Current interventions as of 25/04/2023: The 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 alongside current practice, whilst those randomised to the control group will continue to deliver only current practice. The intervention (‘Get Set Go’) aims to reduce sedentary behaviour after stroke. It was developed using coproduction methods, following significant systematic review and qualitative work, and is underpinned by behaviour change theory. It is intended to begin early after stroke (in the in-patient setting) and continue into the community, and designed to fit into existing rehabilitation and recovery pathways. Previous interventions: The 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 discharge home will be recruited by researchers based on the referring stroke units. Outcomes will be assessed at 6, 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.
Current participant inclusion criteria as of 25/04/2023: All stroke survivors with the following characteristics are eligible for this trial: 1. Are aged 16 years or over at the time of stroke 2. New or recurrent clinically diagnosed ischaemic or haemorrhagic (excluding subarachnoid haemorrhage) stroke 3. Require manual contact of no more than one person to stand to prevent falling. Manual contact consists of continuous or intermittent light touch to assist balance or coordination (i.e. not to support body weight) 4. Planned discharge to live in the community (not to a care home) 5. Provide written informed consent or Consultee agreement Thus, the study will include a range of abilities from people who need help with balance/coordination to stand to those able to walk independently anywhere. Family/friends /carer will be eligible for the study provided they are: 1. Aged 16 years or over 2. A family member/close friend/carer of a stroke survivor participating in the study and identified by the stroke survivor as someone they engage with on a regular basis (meet at least once a fortnight) 3. Able and willing to provide written informed consent Previous participant inclusion criteria: All stroke survivors with the following characteristics are eligible for this trial: 1. New or recurrent clinically diagnosed ischaemic or haemorrhagic (excluding subarachnoid haemorrhage) stroke 2. Requires manual contact of no more than one person to stand to prevent falling. Manual contact consists of continuous or intermittent light touch to assist balance or coordination in keeping with Functional Ambulatory Categories [Holden et al, 1984] (FAC) 3-6 3. Planned discharge to live in the community (not to a care home) 4. Provide written informed consent or Consultee agreement Thus, the study will include a range of abilities from people who need help with balance/coordination to walk (FAC score=3) to those able to walk independently anywhere (FAC score=6) Family/friends /carer
Current participant exclusion criteria as of 25/04/2023: Stroke survivors will be excluded from the trial if they: 1. Are in receipt of palliative care 2. Are discharged outside the defined geographical area supported by the associated community service(s) participating in the trial Family members/friends/carers will be excluded from the trial if the person with stroke does not consent to the trial Previous participant exclusion criteria: Stroke survivors will be excluded from the trial if they: 1. Are in receipt of palliative care 2. Have an FAC score of 1 (unable to stand without the help of a hoist or two people) or an FAC score of 2 (need continuous support to walk), as they will be unable to amend their behaviour without substantial help 3. Are discharged outside the area supported by the associated community service(s) participating in the trial Family members/friends/carers will be excluded from the trial if the person with stroke does not consent to the trial