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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Details
1 University College London, Division of Psychiatry, Faculty of Brain Sciences, London, UK (GRID:grid.83440.3b) (ISNI:0000000121901201); Research & Development Department, Goodmayes Hospital, North East London NHS Foundation Trust, Essex, UK (GRID:grid.439781.0)
2 National University of Ireland, Department of Occupational Therapy, Galway, Ireland (GRID:grid.6142.1) (ISNI:0000 0004 0488 0789)
3 University of Hull, Faculty of Health and Social Care, Hull, UK (GRID:grid.9481.4) (ISNI:0000000404128669)
4 University of Sheffield, School of Health and Related Research, Sheffield, UK (GRID:grid.11835.3e) (ISNI:0000000419369262)
5 University of East Anglia, School of Health Sciences, Norwich, UK (GRID:grid.8273.e) (ISNI:0000000110927967)
6 University College London, Priment Clinical Trials Unit, Division of Psychiatry, Faculty of Brain Sciences, London, UK (GRID:grid.83440.3b) (ISNI:0000000121901201)
7 University College London, Department of Statistical Science and Priment Clinical Trials Unit, London, UK (GRID:grid.83440.3b) (ISNI:0000000121901201)
8 University College London, Department of Applied Health Research, London, UK (GRID:grid.83440.3b) (ISNI:0000000121901201)
9 Radboud University Medical Center (Radboudumc), Department of IQ Healthcare; Kalorama Foundation, Nijmegen, The Netherlands (GRID:grid.10417.33) (ISNI:0000000404449382)
10 University of Manchester, PSSRU, Faculty of Medical and Human Sciences, Manchester, UK (GRID:grid.5379.8) (ISNI:0000000121662407)
11 University College London, Department of Clinical, Educational and Health Psychology, London, UK (GRID:grid.83440.3b) (ISNI:0000000121901201)
12 Swansea University, Swansea Trials Unit, College of Medicine, Swansea, UK (GRID:grid.4827.9) (ISNI:0000000106588800)
13 Division of Health and Social Care Research, King’s College, London, UK (GRID:grid.13097.3c) (ISNI:0000000123226764)
14 Radboud University Medical Center (Radboudumc), Donders Institute for Cognition, Brain and Behaviour, Department of Rehabilitation and Scientific Institute for Quality of Healthcare-Radboudumc Alzheimer Centre, Nijmegen, The Netherlands (GRID:grid.10417.33) (ISNI:0000000404449382)
15 Research & Development Department, Goodmayes Hospital, North East London NHS Foundation Trust, Essex, UK (GRID:grid.439781.0)
16 University of Nottingham, Institute of Mental Health, Nottingham, UK (GRID:grid.4563.4) (ISNI:0000000419368868)