title: 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.
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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  Current Controlled Trials ISRCTN10748953 Date of registration: 18 September 2014.
authors: Division of Psychiatry, Faculty of Brain Sciences, University College London, London, UK. j.wenborn@ucl.ac.uk.|Research & Development Department, Goodmayes Hospital, North East London NHS Foundation Trust, Essex, IG3 8XJ, UK. j.wenborn@ucl.ac.uk.
authors: Jennifer
authors: J
authors: Wenborn
authors: Department of Occupational Therapy, National University of Ireland, Galway, Ireland. sinead.hynes@nuigalway.ie.
authors: Sinéad
authors: S
authors: Hynes
authors: Faculty of Health and Social Care, University of Hull, Hull, UK. e.d.moniz-cook@hull.ac.uk.
authors: Esme
authors: E
authors: Moniz-Cook
authors: School of Health and Related Research, University of Sheffield, Sheffield, UK. g.a.mountain@sheffield.ac.uk.
authors: Gail
authors: G
authors: Mountain
authors: School of Health Sciences, University of East Anglia, Norwich, UK. f.poland@uea.ac.uk.
authors: Fiona
authors: F
authors: Poland
authors: Priment Clinical Trials Unit, Division of Psychiatry, Faculty of Brain Sciences, University College London, London, UK. michael.king@ucl.ac.uk.
authors: Michael
authors: M
authors: King
authors: Department of Statistical Science and Priment Clinical Trials Unit, University College London, London, UK. r.omar@ucl.ac.uk.
authors: Rumana
authors: R
authors: Omar
authors: Department of Applied Health Research, University College London, London, UK. steve.morris@ucl.ac.uk.
authors: Steven
authors: S
authors: Morris
authors: Department of IQ Healthcare; Kalorama Foundation, Radboud University Medical Center (Radboudumc), Nijmegen, The Netherlands. m.vernooij-dassen@iq.umcn.nl.
authors: Myrra
authors: M
authors: Vernooij-Dassen
authors: PSSRU, Faculty of Medical and Human Sciences, University of Manchester, Manchester, UK. david.j.challis@manchester.ac.uk.
authors: David
authors: D
authors: Challis
authors: Department of Clinical, Educational and Health Psychology, University College London, London, UK. s.michie@ucl.ac.uk.
authors: Susan
authors: S
authors: Michie
authors: Swansea Trials Unit, College of Medicine, Swansea University, Swansea, UK. i.t.russell@swansea.ac.uk.
authors: Ian
authors: I
authors: Russell
authors: Division of Health and Social Care Research, King's College, London, UK. catherine.sackley@kcl.ac.uk.
authors: Catherine
authors: C
authors: Sackley
authors: 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. m.graff@iq.umcn.nl.
authors: Maud
authors: M
authors: Graff
authors: Department of Statistical Science and Priment Clinical Trials Unit, University College London, London, UK. a.o'keeffe@ucl.ac.uk.
authors: Aidan
authors: A
authors: O'Keeffe
authors: Research & Development Department, Goodmayes Hospital, North East London NHS Foundation Trust, Essex, IG3 8XJ, UK. nadia.crellin@nelft.nhs.uk.
authors: Nadia
authors: N
authors: Crellin
authors: Institute of Mental Health, University of Nottingham, Nottingham, UK. m.orrell@nottingham.ac.uk.
authors: Martin
authors: M
authors: Orrell
mesh_terms: D017028:Caregivers; D002985:Clinical Protocols; D003627:Data Interpretation, Statistical; D003704:Dementia / Q000523:psychology / Q000628:therapy*; D006801:Humans; D007258:Informed Consent; D009788:Occupational Therapy / Q000379:methods*; D017063:Outcome Assessment, Health Care; D011788:Quality of Life; D012111:Residence Characteristics; D018401:Sample Size; D016037:Single-Blind Method