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      PATCH: posture and mobility training for care staff versus usual care in care homes: study protocol for a randomised controlled trial

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          Abstract

          Background

          Residents of care homes have high levels of disability and poor mobility, but the promotion of health and wellbeing within care homes is poorly realised. Residents spend the majority of their time sedentary which leads to increased dependency and, coupled with poor postural management, can have many adverse outcomes including pressure sores, pain and reduced social interaction. The intervention being tested in this project (the Skilful Care Training Package) aims to increase the awareness and skills of care staff in relation to poor posture in the older, less mobile adult and highlight the benefits of activity, and how to skilfully assist activity, in this group to enable mobility and reduce falls risk. Feasibility work will be undertaken to inform the design of a definitive cluster randomised controlled trial.

          Methods

          This is a cluster randomised controlled feasibility trial, aiming to recruit at least 12–15 residents at each of 10 care homes across Yorkshire. Care homes will be randomly allocated on a 1:1 basis to receive either the Skilful Care Training Package alongside usual care or to continue to provide usual care alone. Assessments will be undertaken by blinded researchers with participating residents at baseline (before care home randomisation) and at three and six months post randomisation. Data relating to changes in physical activity, mobility, posture, mood and quality of life will be collected. Data at the level of the home will also be collected and will include staff experience of care and changes in the numbers and types of adverse events residents experience (for example, hospital admissions, falls). Details of NHS service usage will be collected to inform the economic analysis. An embedded process evaluation will explore intervention delivery and its acceptability to staff and residents.

          Discussion

          Participant uptake, engagement and retention are key feasibility outcomes. Exploration of barriers and facilitators to intervention delivery will inform intervention optimisation. Study results will inform progression to a definitive trial and add to the body of evidence for good practice in care home research.

          Trial registration

          ISRCTN Registry, ISRCTN50080330. Registered on 27 March 2017.

          Electronic supplementary material

          The online version of this article (10.1186/s13063-018-2863-5) contains supplementary material, which is available to authorized users.

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          Most cited references17

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          Qualitative research sample design and sample size: resolving and unresolved issues and inferential imperatives.

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            Methods and processes for development of a CONSORT extension for reporting pilot randomized controlled trials

            Background Feasibility and pilot studies are essential components of planning or preparing for a larger randomized controlled trial (RCT). They are intended to provide useful information about the feasibility of the main RCT—with the goal of reducing uncertainty and thereby increasing the chance of successfully conducting the main RCT. However, research has shown that there are serious inadequacies in the reporting of pilot and feasibility studies. Reasons for this include a lack of explicit publication policies for pilot and feasibility studies in many journals, unclear definitions of what constitutes a pilot or feasibility RCT/study, and a lack of clarity in the objectives and methodological focus. All these suggest that there is an urgent need for new guidelines for reporting pilot and feasibility studies. Objectives The aim of this paper is to describe the methods and processes in our development of an extension to the Consolidated Standards of Reporting Trials (CONSORT) Statement for reporting pilot and feasibility RCTs, that are executed in preparation for a future, more definitive RCT. Methods/design There were five overlapping parts to the project: (i) the project launch—which involved establishing a working group and conducting a review of the literature; (ii) stakeholder engagement—which entailed consultation with the CONSORT group, journal editors and publishers, the clinical trials community, and funders; (iii) a Delphi process—used to assess the agreement of experts on initial definitions and to generate a reporting checklist for pilot RCTs, based on the 2010 CONSORT statement extension applicable to reporting pilot studies; (iv) a consensus meeting—to discuss, add, remove, or modify checklist items, with input from experts in the field; and (v) write-up and implementation—which included a guideline document which gives an explanation and elaboration (E&E) and which will provide advice for each item, together with examples of good reporting practice. This final part also included a plan for dissemination and publication of the guideline. Conclusions We anticipate that implementation of our guideline will improve the reporting completeness, transparency, and quality of pilot RCTs, and hence benefit several constituencies, including authors of journal manuscripts, funding agencies, educators, researchers, and end-users.
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              Valuing health-related quality of life: An EQ-5D-5L value set for England

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                Author and article information

                Contributors
                liz.graham@bthft.nhs.uk
                r.cicero@leeds.ac.uk
                d.j.clarke@leeds.ac.uk
                b.e.cundill@leeds.ac.uk
                alison.ellwood@bthft.nhs.uk
                a.j.farrin@leeds.ac.uk
                practice@leedsneurophysiotherapy.co.uk
                m.e.l.goodwin@leeds.ac.uk
                r.hawkins@leeds.ac.uk
                practice@leedsneurophysiotherapy.co.uk
                c.t.hulme@leeds.ac.uk
                trepeld@tcd.ie
                rachel.williams@bthft.nhs.uk
                a.forster@leeds.ac.uk
                Journal
                Trials
                Trials
                Trials
                BioMed Central (London )
                1745-6215
                24 September 2018
                24 September 2018
                2018
                : 19
                : 521
                Affiliations
                [1 ]ISNI 0000 0004 0379 5398, GRID grid.418449.4, Academic Unit of Elderly Care and Rehabilitation, , Bradford Teaching Hospitals NHS Foundation Trust, ; Bradford, UK
                [2 ]ISNI 0000 0004 1936 8403, GRID grid.9909.9, Clinical Trials Research Unit, , University of Leeds, ; Leeds, UK
                [3 ]ISNI 0000 0004 0379 5398, GRID grid.418449.4, Academic Unit of Elderly Care and Rehabilitation, , Bradford Teaching Hospitals NHS Foundation Trust and University of Leeds, ; Bradford, UK
                [4 ]Leeds Neurophysiotherapy, Rawdon, Leeds, UK
                [5 ]ISNI 0000 0004 1936 8403, GRID grid.9909.9, Academic Unit of Health Economics, Leeds Institute of Health Sciences, , University of Leeds, ; Leeds, UK
                [6 ]ISNI 0000 0004 1936 9705, GRID grid.8217.c, Trinity College Dublin, ; Dublin, Ireland
                Article
                2863
                10.1186/s13063-018-2863-5
                6154918
                fdbfc2a3-7ff3-4a88-bd85-d2708cf409ea
                © The Author(s). 2018

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                History
                : 23 February 2018
                : 17 August 2018
                Funding
                Funded by: Chartered Society of Physiotherapy Charitable Trust (GB)
                Award ID: OPA/14/03
                Award Recipient :
                Categories
                Study Protocol
                Custom metadata
                © The Author(s) 2018

                Medicine
                care homes,nursing homes,older people,feasibility,cluster randomised controlled trial,staff training,physiotherapy,posture,mobility,process evaluation

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