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Open Access Study protocol

Feasibility study of an optimised person-centred intervention to improve mental health and reduce antipsychotics amongst people with dementia in care homes: study protocol for a randomised controlled trial

Rhiannon Whitaker1, Clive Ballard2, Jane Stafford3*, Martin Orrell4, Esme Moniz-Cook5, Robert T Woods6, Joanna Murray7, Martin Knapp8, Barbara Woodward Carlton9 and Jane Fossey3

Author Affiliations

1 North Wales Organisation for Randomised Trials in Health, Bangor University, Holyhead Road, Bangor LL57 2PZ Gwynedd, United Kingdom

2 Wolfson Centre for Age Related Diseases, King's College London, Guy's Campus, London SE1 1UL, United Kingdom

3 Psychological Services, Oxford Health NHS Foundation Trust, Fulbrook Centre, Oxford OX3 7JU, United Kingdom

4 University College London, 67-73 Riding House Street, London, W1W 7EJ, United Kingdom

5 Institute of Rehabilitation: Dementia Applied Research Centre, University of Hull, Health House, Grange Park Lane, East Yorkshire HU10 6DT, United Kingdom

6 Dementia Services Development Centre, Wales, Institute of Medical and Social Care Research, Bangor University, Holyhead Road, Bangor LL57 2PX Gwynedd, United Kingdom

7 Section of Mental Health and Ageing, Health Service and Population Research Department, The Institute of Psychiatry at King's College London, PO26, The David Goldberg Centre, De Crespigny Park, London, SE5 8AF, United Kingdom

8 London School of Economics and Political Science, Houghton Street, London WC2A 2AE, United Kingdom

9 Alzheimer's Society, Devon House, 58 St Katharine's Way, London E1W 1LB, United Kingdom

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Trials 2013, 14:13  doi:10.1186/1745-6215-14-13

Published: 10 January 2013

Abstract

Background

People living in care homes often have complex mental and physical health problems, disabilities and social needs which are compounded by the use of psychiatric and other drugs. In the UK dementia care is a national priority with a vast impact on services. WHELD combines the most effective elements of existing approaches to develop a comprehensive but practical intervention. This will be achieved by training care staff to provide care that is focused on an understanding of the individual and their needs; and by using additional components such as exercise, activities and social interaction to improve mental health and quality of life (QoL) and reduce the use of sedative drugs.

Design

Work Package 3 (WP3) is the pilot randomised trial and qualitative evaluation to help develop a future definitive randomised controlled clinical trial. The study design is a cluster randomised 2x2x2 factorial design with two replications in 16 care homes. Each care home is randomized to receive one of the eight possible permutations of the four key interventions, with each possible combination delivered in two of the 16 homes. Each cluster includes a minimum of 12 participants (depending upon size of the care home, the number of people with dementia and the number consenting).

Discussion

The overarching goal of the programme is to provide an effective, simple and practical intervention which improves the mental health of, and reduces sedative drug use in, people with dementia in care homes and which can be implemented nationally in all UK care homes as an NHS intervention.

Trial Registration

Current controlled trials ISRCTN40313497

Keywords:
Dementia; Care homes; Quality of life; Antipsychotic medication; Behavioural symptoms; Cost-effectiveness; Implementation; Person-centred care; Exercise; Social interaction