Dataset Information

RECREATE: a study protocol for a multicentre pilot cluster randomised controlled trial (cRCT) in UK stroke services evaluating an intervention to reduce sedentary behaviour in stroke survivors (Get Set Go) with embedded process and economic evaluations.

ABSTRACT:

Introduction

Sedentary behaviour (sitting or lying during waking hours without being otherwise active) is strongly associated with adverse health outcomes, including all-cause, cancer and cardiovascular mortality in adults. Stroke survivors are consistently reported as being more sedentary than healthy age-matched controls, spending more hours sedentary daily and sustaining longer unbroken bouts of sedentary time. An evidence-based and clinically feasible intervention ('Get Set Go') was developed. A pragmatic definitive trial to evaluate Get Set Go was planned; however, due to the unprecedented effects of the COVID-19 pandemic on National Health Service (NHS) services this study was reduced in size and scope to become an external pilot trial. We report the protocol for this external pilot trial, which aims to undertake a preliminary exploration of whether Get Set Go is likely to improve ability to complete extended activities of daily living in the first year post-stroke and inform future trial designs in stroke rehabilitation.

Methods and analysis

This study is a pragmatic, multicentre, two-arm, external pilot cluster randomised controlled trial with embedded process and economic evaluations. UK-based stroke services will be randomised 1:1 to the intervention (usual care plus Get Set Go) or control (usual care) arm. Fifteen stroke services will recruit 300-400 stroke inpatient and carer participants, with follow-up at 6, 12 and 24 months. The proposed primary endpoint is stroke survivor self-reported Nottingham Extended Activities of Daily Living scale at 12 months. Endpoint analyses will be exploratory and provide preliminary estimates of intervention effect. The process evaluation will provide valuable information on intervention fidelity, acceptability and how it can be optimised.

Ethics and dissemination

The study has been approved by Yorkshire and The Humber - Bradford-Leeds Research Ethics Committee (Ref: 19/YH/0403). Results will be disseminated through journal publications and conference presentations.

Trial registration number

This trial was registered prospectively on 01 April 2020 (ISRCTN ref: ISRCTN82280581).

SUBMITTER: Airlie J

PROVIDER: S-EPMC10387637 | biostudies-literature | 2023 Jul

REPOSITORIES: biostudies-literature

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Publications

RECREATE: a study protocol for a multicentre pilot cluster randomised controlled trial (cRCT) in UK stroke services evaluating an intervention to reduce sedentary behaviour in stroke survivors (Get Set Go) with embedded process and economic evaluations.

Airlie Jennifer J Burton Louisa-Jane LJ Copsey Bethan B English Coralie C Farrin Amanda A Fitzsimons Claire F CF Holloway Ivana I Horrocks Judith J Johansson Jessica Faye JF Mead Gillian G Moreau Lauren A LA Ozer Seline S Patel Anita A Yaziji Nahel N Forster Anne A

BMJ open 20230730 7

<h4>Introduction</h4>Sedentary behaviour (sitting or lying during waking hours without being otherwise active) is strongly associated with adverse health outcomes, including all-cause, cancer and cardiovascular mortality in adults. Stroke survivors are consistently reported as being more sedentary than healthy age-matched controls, spending more hours sedentary daily and sustaining longer unbroken bouts of sedentary time. An evidence-based and clinically feasible intervention ('Get Set Go') was ...[more]

PMID: 37518078

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Project description:IntroductionStroke survivors spend long periods of time engaging in sedentary behaviour (SB) even when their functional recovery is good. In the RECREATE programme, an intervention aimed at reducing SB ('Get Set Go') will be implemented and evaluated in a pragmatic external pilot cluster randomised controlled trial with embedded process and economic evaluations. We report the protocol for the process evaluation which will address the following objectives: (1) describe and clarify causal assumptions about the intervention, and its mechanisms of impact; (2) assess implementation fidelity; (3) explore views, perceptions and acceptability of the intervention to staff, stroke survivors and their carers; (4) establish the contextual factors that influence implementation, intervention mechanisms and outcomes.Methods and analysisThis pilot trial will be conducted in 15 UK-based National Health Service stroke services. This process evaluation study, underpinned by the Medical Research Council guidance, will be undertaken in six of the randomised services (four intervention, two control). Data collection includes the following: observations of staff training sessions, non-participant observations in inpatient and community settings, semi-structured interviews with staff, patients and carers, and documentary analysis of key intervention components. Additional quantitative implementation data will be collected in all sites. Training observations and documentary analysis data will be summarised, with other observational and interview data analysed using thematic analysis. Relevant theories will be used to interpret the findings, including the theoretical domains framework, normalisation process theory and the theoretical framework of acceptability. Anticipated outputs include the following: recommendations for intervention refinements (both content and implementation); a revised implementation plan and a refined logic model.Ethics and disseminationThe study was approved by Yorkshire & The Humber - Bradford Leeds Research Ethics Committee (REC reference: 19/YH/0403). Findings will be disseminated via peer review publications, and national and international conference presentations.Trial registration numberISRCTN82280581.

Project description:IntroductionStroke survivors usually experience long-lasting functional, emotional and social consequences that might contribute to sedentary behaviour and participation restrictions, which are important targets to address during rehabilitation. However, the trajectory and inter-relationship between these factors are unknown.Methods and analysisPart&Sed is a research project based on an observational study design with 6 and 12 months of follow-ups in stroke survivors. In addition, a qualitative analysis of the impact of the stroke on the stroke survivor, validation of the Satisfaction with Daily Occupation-Occupational Balance assessment tool and analysis of the reliability of the Fitbit Inspire 2 activity tracker wristband will be carried out. Participants will be chronic stroke survivors with independent walking capacity. Sociodemographic and clinical data, physical activity, ambulation, sleep, quality of life, anxiety and depression, community participation, and occupational satisfaction and balance, as well as data provided by the activity tracker wristband, will be collected. In addition, if the participant has a primary caregiver, the caregiver will also be monitored. A minimum of 130 participants will be recruited to conduct a random-effects multiple regression model. Mixed models for repeated measures will assess the variation over time of the different variables associated with participation and sedentary behaviour. Psychometric properties (eg, internal consistency, construct validity, test-retest reliability) of the Satisfaction with Daily Occupation-Occupational Balance will be determined. Additionally, intraclass correlation coefficients and minimum detectable change will be calculated to assess intrasubject reliability of physical activity and sleep parameters recorded by the Fitbit Inspire 2. The qualitative analysis process will be carried out using the analysis proposed by Giorgi.Ethics and disseminationThe study received ethical approval from the Spanish Regional Ethics Committee 'Comité de Ética de la Investigación de la Comunidad de Aragón' (PI21/333). The results will be made available via peer-reviewed publications, international conferences and official channels.

Project description:BackgroundStroke survivors are more sedentary than healthy, age-matched controls, independent of functional capacity. Interventions are needed to encourage a reduction in overall sedentary time, and regular breaks in prolonged periods of sedentary behaviour. This study captured the views and experiences of stroke survivors and their caregivers related to sedentary behaviour after stroke, to inform the development of an intervention to reduce sedentary behaviour.MethodsMixed-methods qualitative study. Non-participant observations were completed in two stroke services, inclusive of inpatient and community settings in the United Kingdom. Semi-structured interviews were conducted with stroke survivors and their caregivers (if available) at six- or nine-months post-stroke. Underpinned by the capability, opportunity and motivation (COM-B) model of behaviour change, observational data (132 h) were analysed thematically and interview data (n = 31 stroke survivors, n = 12 caregivers) were analysed using the Framework approach.ResultsObservation participants differed in functional ability whereas stroke survivor interviewees were all ambulant. Six themes related to sedentary behaviour after stroke were generated: (1) sedentary behaviour levels and patterns after stroke; (2) the physical and social environment in the stroke service and in the home; (3) standing and movement capability after stroke; (4) emotion and motivation after stroke; (5) caregivers' influence on, and role in influencing stroke survivors' sedentary behaviour; and (6) intervening to reduce sedentary behaviour after stroke. Capability, opportunity and motivation were influenced by the impact of the stroke and caregivers' inclination to support sedentary behaviour reduction. Stroke survivors reported being more sedentary than they were pre-stroke due to impaired balance and co-ordination, increased fatigue, and reduced confidence in mobilising. Caregivers inclination to support stroke survivors to reduce sedentary behaviour depended on factors including their willingness to withdraw from the caregiver role, and their perception of whether the stroke survivor would act on their encouragement.ConclusionsMany stroke survivors indicate being open to reducing sedentary behaviour, with appropriate support from stroke service staff and caregivers. The findings from this study have contributed to an intervention development process using the Behaviour Change Wheel (BCW) approach to develop strategies to reduce sedentary behaviour after stroke.

Project description:BackgroundReturn 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.MethodsSeven 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 community, participants' homes or workplaces, and outpatient/inpatient therapy settings, via telephone, email, or SMS text message. Outcome data will be collected via self-report questionnaires administered by post or online at 3, 6, and 12 months follow-up. The primary outcome will be self-reported RTW and job retention at 12 months (minimum 2 h/week). Secondary outcomes will include mood, function, participation, health-related quality of life, confidence, intervention compliance, health and social care resource use, and mortality. An embedded economic evaluation will estimate cost-effectiveness and cost-utility analyses from National Health Service (NHS) and Personal Social Services (PSS) perspectives. An embedded process evaluation will employ a mixed methods approach to explore ESSVR implementation, contextual factors linked to outcome variation, and factors affecting NHS roll-out.DiscussionThis article describes the protocol for a multi-centre RCT evaluating the clinical- and cost-effectiveness of an early vocational rehabilitation intervention aimed at supporting adults to return to work following a stroke. Evidence favouring the ESSVR intervention would support its roll-out in NHS settings.Trial registrationISRCTN, ISRCTN12464275 . Registered on 26 February 2018.

Project description:BackgroundInertial motion capture systems are used in many applications such as measuring the movement quality in stroke survivors. The absence of clinical effectiveness and usability evidence in these assistive technologies into rehabilitation has delayed the transition of research into clinical practice. Recently, a new inertial motion capture system was developed in a project, called INTERACTION, to objectively measure the quality of movement (QoM) in stroke survivors during daily-life activity. With INTERACTION, we are to be able to investigate into what happens with patients after discharge from the hospital. Resulting QoM metrics, where a metric is defined as a measure of some property, are subsequently presented to care professionals. Metrics include for example: reaching distance, walking speed, and hand distribution plots. The latter shows a density plot of the hand position in the transversal plane. The objective of this study is to investigate the opinions of care professionals in using these metrics obtained from INTERACTION and its usability.MethodsBy means of a semi-structured interview, guided by a presentation, presenting two patient reports. Each report includes several QoM metric (like reaching distance, hand position density plots, shoulder abduction) results obtained during daily-life measurements and in clinic and were evaluated by care professionals not related to the project. The results were compared with care professionals involved within the INTERACTION project. Furthermore, two questionnaires (5-point Likert and open questionnaire) were handed over to rate the usability of the metrics and to investigate if they would like such a system in their clinic.ResultsEleven interviews were conducted, where each interview included either two or three care professionals as a group, in Switzerland and The Netherlands. Evaluation of the case reports (CRs) by participants and INTERACTION members showed a high correlation for both lower and upper extremity metrics. Participants were most in favor of hand distribution plots during daily-life activities. All participants mentioned that visualizing QoM of stroke survivors over time during daily-life activities has more possibilities compared to current clinical assessments. They also mentioned that these metrics could be important for self-evaluation of stroke survivors.DiscussionThe results showed that most participants were able to understand the metrics presented in the CRs. For a few metrics, it remained difficult to assess the underlying cause of the QoM. Hence, a combination of metrics is needed to get a better insight of the patient. Furthermore, it remains important to report the state (e.g., how the patient feels), its surroundings (outside, inside the house, on a slippery surface), and detail of specific activities (does the patient grasps a piece of paper or a heavy cooking pan but also dual tasks). Altogether, it remains a questions how to determine what the patient is doing and where the patient is doing his or her activities.

Project description:BackgroundSedentary behaviour is associated with disease, but the molecular mechanisms are not understood. Valid biomarkers with predictive and explanatory properties are required. Therefore, we have investigated traditional and novel biomarkers of inflammation and immune modulation and their association to objectively measured sedentary behaviour in an ischemic stroke population.MethodsPatients admitted to hospital with acute ischemic stroke were included in the multicentre Norwegian Cognitive Impairment After Stroke (Nor-COAST) study (n = 815). For this sub-study (n = 257), sedentary behaviour was registered 3 months after stroke using position transition data from the body-worn sensor, ActivPal®. Blood samples were analysed for high sensitive C-reactive protein (hsCRP), the cytokines interleukin-6 (IL-6) and 10 (IL-10), neopterin, tryptophan (Trp), kynurenine (kyn), kynurenic acid (KA), and three B6 vitamers, pyridoxal 5'-phosphate (PLP), pyridoxal (PL), and pyridoxic acid (PA). The kynurenine/tryptophan ratio (KTR) and the pyridoxic acid ratio index (PAr = PA: PL + PLP) were calculated.ResultsOf the 815 patients included in the main study, 700 attended the three-month follow-up, and 257 fulfilled the inclusion criteria for this study. Sedentary time was significantly associated with levels of hsCRP, IL-6, neopterin, PAr-index, and KA adjusted for age, sex, waist circumference, and creatinine. In a fully adjusted model including all the significant biomarkers except hsCRP (because of missing values), sedentary time was independently positively associated with the PAr-index and negatively with KA. We did not find an association between sedentary behaviour, IL-10, and KTR.ConclusionsThe PAr-index is known to capture several modes of inflammation and has previously shown predictive abilities for future stroke. This novel result indicates that the PAr-index could be a useful biomarker in future studies on sedentary behaviour and disease progression. KA is an important modulator of inflammation, and this finding opens new and exciting pathways to understand the hazards of sedentary behaviour.Trial registrationThe study was registered at Clinicaltrials.gov ( NCT02650531 ). First posted 08/01/2016.

Dataset Information

RECREATE: a study protocol for a multicentre pilot cluster randomised controlled trial (cRCT) in UK stroke services evaluating an intervention to reduce sedentary behaviour in stroke survivors (Get Set Go) with embedded process and economic evaluations.

Introduction

Methods and analysis

Ethics and dissemination

Trial registration number

Publications

RECREATE: a study protocol for a multicentre pilot cluster randomised controlled trial (cRCT) in UK stroke services evaluating an intervention to reduce sedentary behaviour in stroke survivors (Get Set Go) with embedded process and economic evaluations.

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