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      Community occupational therapy for people with dementia and family carers (COTiD-UK) versus treatment as usual (Valuing Active Life in Dementia [VALID] programme): study protocol for a randomised controlled trial

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          Abstract

          Background

          A community-based occupational therapy intervention for people with mild to moderate dementia and their family carers (Community Occupational Therapy in Dementia (COTiD)) was found clinically and cost effective in the Netherlands but not in Germany. This highlights the need to adapt and implement complex interventions to specific national contexts. The current trial aims to evaluate the United Kingdom-adapted occupational therapy intervention for people with mild to moderate dementia and their family carers living in the community (COTiD-UK) compared with treatment as usual.

          Methods/Design

          This study is a multi-centre, parallel-group, pragmatic randomised trial with internal pilot. We aim to allocate 480 pairs, with each pair comprising a person with mild to moderate dementia and a family carer, who provides at least 4 hours of practical support per week, at random between COTiD-UK and treatment as usual. We shall assess participants at baseline, 12 and 26 weeks, and by telephone at 52 and 78 weeks (first 40 % of recruits only) after randomisation. The primary outcome measure is the Bristol Activities of Daily Living Scale (BADLS) at 26 weeks. Secondary outcome measures will include quality of life, mood, and resource use. To assess intervention delivery, and client experience, we shall collect qualitative data via audio recordings of COTiD-UK sessions and conduct semi-structured interviews with pairs and occupational therapists.

          Discussion

          COTiD-UK is an evidence-based person-centred intervention that reflects the current priority to enable people with dementia to remain in their own homes by improving their capabilities whilst reducing carer burden. If COTiD-UK is clinically and cost effective, this has major implications for the future delivery of dementia services across the UK.

          Trial registration

          Current Controlled Trials ISRCTN10748953

          Date of registration: 18 September 2014.

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          Most cited references50

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          "Mini-mental state". A practical method for grading the cognitive state of patients for the clinician.

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            The Hospital Anxiety and Depression Scale

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                Author and article information

                Contributors
                j.wenborn@ucl.ac.uk , jennifer.wenborn@nelft.nhs.uk
                sinead.hynes@nuigalway.ie
                e.d.moniz-cook@hull.ac.uk
                g.a.mountain@sheffield.ac.uk
                f.poland@uea.ac.uk
                michael.king@ucl.ac.uk
                r.omar@ucl.ac.uk
                steve.morris@ucl.ac.uk
                m.vernooij-dassen@iq.umcn.nl
                david.j.challis@manchester.ac.uk
                s.michie@ucl.ac.uk
                i.t.russell@swansea.ac.uk
                catherine.sackley@kcl.ac.uk
                m.graff@iq.umcn.nl
                a.o'keeffe@ucl.ac.uk
                nadia.crellin@nelft.nhs.uk
                m.orrell@nottingham.ac.uk
                Journal
                Trials
                Trials
                Trials
                BioMed Central (London )
                1745-6215
                3 February 2016
                3 February 2016
                2016
                : 17
                : 65
                Affiliations
                [ ]Division of Psychiatry, Faculty of Brain Sciences, University College London, London, UK
                [ ]Research & Development Department, Goodmayes Hospital, North East London NHS Foundation Trust, Essex, IG3 8XJ UK
                [ ]Department of Occupational Therapy, National University of Ireland, Galway, Ireland
                [ ]Faculty of Health and Social Care, University of Hull, Hull, UK
                [ ]School of Health and Related Research, University of Sheffield, Sheffield, UK
                [ ]School of Health Sciences, University of East Anglia, Norwich, UK
                [ ]Priment Clinical Trials Unit, Division of Psychiatry, Faculty of Brain Sciences, University College London, London, UK
                [ ]Department of Statistical Science and Priment Clinical Trials Unit, University College London, London, UK
                [ ]Department of Applied Health Research, University College London, London, UK
                [ ]Department of IQ Healthcare; Kalorama Foundation, Radboud University Medical Center (Radboudumc), Nijmegen, The Netherlands
                [ ]PSSRU, Faculty of Medical and Human Sciences, University of Manchester, Manchester, UK
                [ ]Department of Clinical, Educational and Health Psychology, University College London, London, UK
                [ ]Swansea Trials Unit, College of Medicine, Swansea University, Swansea, UK
                [ ]Division of Health and Social Care Research, King’s College, London, UK
                [ ]Department of Rehabilitation and Scientific Institute for Quality of Healthcare-Radboudumc Alzheimer Centre, Radboud University Medical Center (Radboudumc), Donders Institute for Cognition, Brain and Behaviour, Nijmegen, The Netherlands
                [ ]Institute of Mental Health, University of Nottingham, Nottingham, UK
                Article
                1150
                10.1186/s13063-015-1150-y
                4739339
                26841799
                0d0b39ea-4485-47a7-962e-01922594cc57
                © Wenborn et al. 2016

                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
                : 2 November 2015
                : 30 December 2015
                Funding
                Funded by: FundRef http://dx.doi.org/10.13039/501100000272, National Institute for Health Research;
                Award ID: RP-PG-0610-10108
                Award Recipient :
                Categories
                Study Protocol
                Custom metadata
                © The Author(s) 2016

                Medicine
                occupational therapy,dementia,caregiver,community,psychosocial,activities of daily living,social participation,quality of life,cost-effectiveness

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