title: 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.
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.
  
  
  METHODS
  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).
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  Current controlled trials ISRCTN40313497.
authors.affiliation: Psychological Services, Oxford Health NHS Foundation Trust, Fulbrook Centre, Oxford OX3 7JU, United Kingdom. jane.stafford@oxfordhealth.nhs.uk.
authors.forename: Rhiannon
authors.initials: R
authors.lastname: Whitaker
authors.forename: Clive
authors.initials: C
authors.lastname: Ballard
authors.forename: Jane
authors.initials: J
authors.lastname: Stafford
authors.forename: Martin
authors.initials: M
authors.lastname: Orrell
authors.forename: Esme
authors.initials: E
authors.lastname: Moniz-Cook
authors.forename: Robert T
authors.initials: RT
authors.lastname: Woods
authors.forename: Joanna
authors.initials: J
authors.lastname: Murray
authors.forename: Martin
authors.initials: M
authors.lastname: Knapp
authors.forename: Barbara Woodward
authors.initials: BW
authors.lastname: Carlton
authors.forename: Jane
authors.initials: J
authors.lastname: Fossey
mesh_terms: D014150:Antipsychotic Agents / Q000191:economics / Q000627:therapeutic use*; D002985:Clinical Protocols; D003362:Cost-Benefit Analysis; D003704:Dementia / Q000175:diagnosis / Q000188:drug therapy / Q000191:economics / Q000523:psychology / Q000628:therapy*; D016527:Drug Costs; D005240:Feasibility Studies; D006299:Health Services for the Aged / Q000191:economics; D006707:Homes for the Aged / Q000191:economics; D006801:Humans; D007398:Interpersonal Relations; D008603:Mental Health; D009735:Nursing Homes / Q000191:economics; D018802:Patient-Centered Care / Q000191:economics; D010865:Pilot Projects; D011788:Quality of Life; D012107:Research Design; D013997:Time Factors; D016896:Treatment Outcome; D006113:United Kingdom
chemical_list: D014150:Antipsychotic Agents