Promoting Activity, Independence and Stability in Early Dementia (PrAISED)

Background and rationaleFalls are common, harmful, costly and a major threat to continuing independence and quality of life for older people. People with dementia are at high risk of falling, even at the early stages, and have distinctive risk factors, causing existing falls prevention efforts to be ineffective. Problems associated with population ageing are putting pressure on health services. We need new ways to maintain good health and independence in older age. Intervening at an early stage of disease offers hope of doing this cost-effectively. We propose to develop and test acceptable and practicable interventions to reduce falls in people in the early stages of dementia, to maintain activity and independence, in partnership with families and carers. Research planWe propose seven work packages (WP), grouped according to the Medical Research Council (MRC) guidelines on complex intervention development and evaluation. THEORY AND INTERVENTION DEVELOPMENTWP1. Building on work already underway, we will develop a risk assessment and intervention programme, and options for its delivery. FEASIBILITYWP2. We will identify and overcome barriers to uptake of the intervention and long-term adherenceWP3. We will examine the feasibility of a multi-centred randomised trial, the impact of tailoring and different levels of supervision on adherence, and persistence with the intervention. We will determine acceptability, impact on carers, and changes in strength and balance, enabling us to finalise the intervention for the main trial. We will test trial procedures including data collection, falls ascertainment, and longer-term follow-up for persistence with the intervention. WP4. We will undertake a process evaluation as part of the feasibility study and main trial. EVALUATIONWP5. We will do a pragmatic, multi-centred, randomised, controlled, trial to test clinical effectiveness in 4 centres. Primary end-point is disability. Power is sufficient to detect a clinically important change in the Disability Assessment in Dementia scale. We will also measure falls rate, activity, cognition, quality of life and carer strain.WP6. An economic analysis and modelling study to estimate cost-effectiveness and likely costs and benefits over participants remaining lifespan. IMPLEMENTATIONWP7. We will maximise patient benefit by communicating findings with clinical, academic, policy and public partners. We will investigate how the programme might be delivered both within or outside the NHS. AnalysisWe will use standard statistical and qualitative methods. We will compare disability, rate of falling, and quality of life between groups receiving and not receiving the intervention. We will calculate cost-effectiveness. Study of adherence and process will use mixed quantitative and qualitative methods. Outputs & disseminationPublications on: 1. Falls prevention intervention development, and manual 2. Clinical and cost-effectiveness 3. Practical and contextual factors that should be addressed for delivery, maintenance and implementation of the programme, including motivation and behaviour change. Outputs will include materials to support future implementation including educational materials for the public, for mental health and falls prevention staff, and an instruction video. We will produce knowledge summaries for health, social and third sector organisations, made available via multiple approaches to maximise reach, including university and dementia education portals, East Midlands CLAHRC and AHSN, and PPI contacts. In our previous PGfAR we successfully engaged traditional national media (broadcast, newspapers) and social media (Twitter, blogs) to enhance dissemination, and speed and extent of impact. Relevant expertise and experienceThe multidisciplinary team includes doctors, nurses, therapists, a service manager and researchers with expertise in falls, clinical and lived-experience aspects of dementia, intervention devel