Twenty five million people worldwide have dementia, including 700,000 in the UK , of whom an estimated 250,000 live in care homes [1, 2]. Older people with dementia in care homes have complex needs; for example, cognitive and functional impairment often coexists with additional mental health problems such as aggression, agitation, depression and psychosis . These difficulties are further compounded by the widespread prescription of antipsychotic drugs [2, 4]. The cost of prescription of antipsychotic medication is estimated to be £84 million a year for 140,000 people in the UK, who are unlikely to benefit and may be harmed by them .
Dementia has a vast impact on Health and Social Care Services. The direct cost of Alzheimer’s disease is £17 billion per year , greater than for stroke, heart disease and cancer combined. The high level of unmet need and the management of key health and mental health issues are matters for serious concern both nationally , and internationally . In the UK this led to the National Dementia Strategy (NDS) , which was developed as a partnership between the Department of Health (DH) and key stakeholders such as the Alzheimer’s Society. It is a unique vision for people with dementia and provides a five-year plan to ‘develop services for people with dementia and their carers that are fit for the 21st century and that meet the needs of everyone’. Key goals include objective number 11 ‘Improving the quality of care for people with dementia in care homes’, achieved through a variety of measures, including visits from specialist mental health teams, and objective 13, the development of an ‘informed and effective workforce for people with dementia’, whereby health and social care staff will receive the right training and have the right skills to deliver the best care.
The National Service Framework (NSF) for older people , the National Institute for Clinical Excellence (NICE) dementia guidelines  and a market analysis [11, 12] also highlight the importance of training for care staff and the need to improve access to effective non-pharmacological therapies. The DH has also conducted a review of antipsychotic prescribing [13, 14] for people with dementia, which recommends a substantial reduction in unnecessary prescribing. This adds further weight to the recommendations of the NDS, the NSF and the NICE dementia guidelines to improve the treatment and care for people with dementia in care homes. Care home regulators in the US have launched initiatives to tackle the same key issues . The NDS vision of enabling people with dementia in care homes to live well with dementia needs to be underpinned by effective, evidence-based interventions that are standardized, consistent, practical and can be delivered as part of the National Health Service (NHS).
Improving the care of mental health problems, reducing antipsychotic use and improving quality of life for people with dementia in care homes are all key NHS priorities. There is strong evidence that staff training, promoting person-centred care (PCC) and utilising non-pharmacological interventions improve some key health outcomes and can reduce antipsychotic drug use [10, 16]. However, the breadth of benefit conferred by most of these interventions is modest; none have directly improved the quality of life (QoL) for care home residents with dementia, and importantly, none have achieved widespread implementation in a health or care setting as part of routine NHS practice.
Further research is therefore urgently needed to address these key issues. There is a need for an optimised therapy combining the most effective elements of currently available evidence-based interventions that are conceptually integrated, cost-effective and practical to implement in a range of settings. To achieve these objectives there is a need to evaluate the key components of effective interventions to enable the development of an optimised intervention.
Overcoming the barriers to implementation, which is rare in dementia care research and has never been achieved for any therapy in a care home setting, is also a major challenge. Research is needed to tailor an optimised therapy to the needs of mental health practitioners, care home staff and people with dementia in care homes. In addition, research should identify and overcome the potential obstacles to implementation, and refine the intervention model through in-depth field testing. This programme aims to provide an effective, simple and practical intervention that improves mental health and reduces sedative drug use for people with dementia in care homes, and which is replicable and scalable to enable it to be widely used in the UK and internationally. The current paper describes the pilot study and qualitative evaluation, setting the foundation for the full-scale multicentre randomised controlled clinical trial to evaluate an optimised intervention ‘welding together’ the most effective elements of the best currently available intervention programmes and a standardised manual and training programme (WHELD).
The pilot study follows a factorial randomised controlled clinical trial design. Evaluations will be undertaken to understand the breadth of additional benefits conferred by three interventions, namely, antipsychotic review (discontinuation and safety); social interaction and pleasant activities; and exercise, compared with PCC alone.
Each intervention will significantly improve several key outcomes but none when used alone will improve all outcomes. This pilot randomised trial is not powered to provide a definitive answer but to guide the analysis and to generate firm hypotheses for testing in a definitive large-scale cluster randomised trial.
Specifically the hypotheses are that compared to person-centred care alone are:
PCC plus antipsychotic review will result in the reduction of antipsychotic prescribing.
PCC and social interaction with pleasant activities will result in reductions in agitation/aggression, especially in individuals already experiencing these symptoms at the baseline evaluation.
PCC and exercise will improve mood and reduce falls.
Secondary objectives and qualitative evaluation
To inform subsequent work, the key secondary objectives are to determine the specific impact of each therapy on a range of outcomes including, mental health, psychotropic drug use, physical health and QoL, as well as the impact on potentially important mediating factors such as activities, social interaction, staff attitudes and the quality of the interaction between care staff and people with dementia.
The purpose of the qualitative research is to develop understanding of the process of implementation within the care environment. Staff beliefs, attitudes and behaviour in their work with people with dementia are key components. Recognition and acknowledgement of staff perspectives is also essential to negotiating the implementation of the interventions.