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Intervention to reduce sedentary behaviour and improve outcomes after stroke (Get Set Go): a study protocol for the process evaluation of a pilot cluster randomised controlled trial (RECREATE)
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 analysis This pilot trial will be conducted in 15 UK-based National Health Service stroke services. This process evaluation study, underpinned by the Medical Research C...
Source: BMJ Open - September 12, 2023 Category: General Medicine Authors: Johansson, J. F., Shannon, R., Mossabir, R., Airlie, J., Ozer, S., Moreau, L. A., Farrin, A., Mead, G., English, C., Fitzsimons, C. F., Clarke, D. J., Forster, A., on behalf of the RECREATE Programme Management Group, RECREATE Programme Management Group, Tags: Open access, Rehabilitation medicine Source Type: research

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
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....
Source: BMJ Open - July 30, 2023 Category: General Medicine Authors: Airlie, J., Burton, L.-J., Copsey, B., English, C., Farrin, A., Fitzsimons, C. F., Holloway, I., Horrocks, J., Johansson, J. F., Mead, G., Moreau, L. A., Ozer, S., Patel, A., Yaziji, N., Forster, A., on behalf of the RECREATE Programme Management Group, A Tags: Open access, Rehabilitation medicine Source Type: research

Efficacy and safety of carbon dioxide insufflation for brain protection for patients undergoing planned left-sided open heart valve surgery: protocol for a multicentre, placebo-controlled, blinded, randomised controlled trial (the CO2 Study)
Introduction Brain injury is common following open heart valve surgery. Carbon dioxide insufflation (CDI) has been proposed to reduce the incidence of brain injury by reducing the number of air microemboli entering the bloodstream in surgery. The CO2 Study will evaluate the efficacy and safety of CDI in patients undergoing planned left-sided open heart valve surgery. Methods and analysis The CO2 Study is a multicentre, blinded, placebo-controlled, randomised controlled trial. Seven-hundred and four patients aged 50 years and over undergoing planned left-sided heart valve surgery will be recruited to the study, from at lea...
Source: BMJ Open - May 17, 2023 Category: General Medicine Authors: Todd, R., Rogers, C. A., Pufulete, M., Culliford, L., Pretorius, P., Voets, N., Akowuah, E., Sayeed, R., Lazaroo, M., Kaur, S., Angelini, G. D., Gibbison, B. Tags: Open access, Surgery Source Type: research

AlzEye: longitudinal record-level linkage of ophthalmic imaging and hospital admissions of 353 157 patients in London, UK
Purpose Retinal signatures of systemic disease (‘oculomics’) are increasingly being revealed through a combination of high-resolution ophthalmic imaging and sophisticated modelling strategies. Progress is currently limited not mainly by technical issues, but by the lack of large labelled datasets, a sine qua non for deep learning. Such data are derived from prospective epidemiological studies, in which retinal imaging is typically unimodal, cross-sectional, of modest number and relates to cohorts, which are not enriched with subpopulations of interest, such as those with systemic disease. We thus linked longitu...
Source: BMJ Open - March 16, 2022 Category: General Medicine Authors: Wagner, S. K., Hughes, F., Cortina-Borja, M., Pontikos, N., Struyven, R., Liu, X., Montgomery, H., Alexander, D. C., Topol, E., Petersen, S. E., Balaskas, K., Hindley, J., Petzold, A., Rahi, J. S., Denniston, A. K., Keane, P. A. Tags: Open access, Ophthalmology Source Type: research

Community-based Rehabilitation Training after stroke: protocol of a pilot randomised controlled trial (ReTrain)
Introduction The Rehabilitation Training (ReTrain) intervention aims to improve functional mobility, adherence to poststroke exercise guidelines and quality of life for people after stroke. A definitive randomised controlled trial (RCT) is required to assess the clinical and cost-effectiveness of ReTrain, which is based on Action for Rehabilitation from Neurological Injury (ARNI). The purpose of this pilot study is to assess the feasibility of such a definitive trial and inform its design. Methods and analysis A 2-group, assessor-blinded, randomised controlled external pilot trial with parallel mixed-methods process evalu...
Source: BMJ Open - October 2, 2016 Category: Journals (General) Authors: Dean, S. G., Poltawski, L., Forster, A., Taylor, R. S., Spencer, A., James, M., Allison, R., Stevens, S., Norris, M., Shepherd, A. I., Calitri, R. Tags: Open access, Health services research, Rehabilitation medicine, Sports and exercise medicine Protocol Source Type: research

ESCAPS study protocol: a feasibility randomised controlled trial of 'Early electrical stimulation to the wrist extensors and wrist flexors to prevent the post-stroke complications of pain and contractures in the paretic arm
This study aims to evaluate the feasibility of a randomised controlled trial to test the efficacy and cost-effectiveness of delivering early intensive electrical stimulation (ES) to prevent post-stroke complications in the paretic upper limb. Methods and analysis This is a feasibility randomised controlled trial (n=40) with embedded qualitative studies (patient/carer interviews and therapist focus groups) and feasibility economic evaluation. Patients will be recruited from the Stroke Unit at the Nottingham University Hospitals National Health Service (NHS) Trust within 72 h after stroke. Participants will be randomis...
Source: BMJ Open - January 4, 2016 Category: Journals (General) Authors: Fletcher-Smith, J. C., Walker, D.-M., Sprigg, N., James, M., Walker, M. F., Allatt, K., Mehta, R., Pandyan, A. D. Tags: Open access, Neurology, Rehabilitation medicine Protocol Source Type: research

'HeART of Stroke (HoS)', a community-based Arts for Health group intervention to support self-confidence and psychological well-being following a stroke: protocol for a randomised controlled feasibility study
Introduction Over 152 000 people in the UK have strokes annually and a third experience residual disability. Low mood also affects a third of stroke survivors; yet psychological support is poor. While Arts for Health interventions have been shown to improve well-being in people with mild-to-moderate depression post-stroke, their role in helping people regain sense of self, well-being and confidence has yet to be evaluated. The main aim of this study is to explore the feasibility of conducting a pragmatic multicentre randomised controlled trial to assess the effectiveness and cost-effectiveness of an Arts for Health gr...
Source: BMJ Open - August 4, 2015 Category: Journals (General) Authors: Ellis-Hill, C., Gracey, F., Thomas, S., Lamont-Robinson, C., Thomas, P. W., Marques, E. M. R., Grant, M., Nunn, S., Cant, R. P. I., Galvin, K. T., Reynolds, F., Jenkinson, D. F. Tags: Open access, Health services research, Neurology Protocol Source Type: research