Title: Promoting Activity, Independence and Stability in Early Dementia (PrAISED)
Funder: Department of Health and Social Care

Abstract: Background and rationale Falls 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 plan We propose seven work packages (WP), grouped according to the Medical Research Council (MRC) guidelines on complex intervention development and evaluation. THEORY AND INTERVENTION DEVELOPMENT WP1. Building on work already underway, we will develop a risk assessment and intervention programme, and options for its delivery. FEASIBILITY WP2. We will identify and overcome barriers to uptake of the intervention and long-term adherence WP3. 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. EVALUATION WP5. 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. IMPLEMENTATION WP7. 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. Analysis We 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 & dissemination Publications 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 experience The multidisciplinary team includes doctors, nurses, therapists, a service manager and researchers with expertise in falls, clinical and lived-experience aspects of dementia, intervention development and training, behaviour change, clinical trials, qualitative research, statistics, health economics, implementation and dissemination, and research PPI. The programme will be supported by the NWORTH Clinical Trials Unit, the leading dementia care CTU. Our group has an excellent track record delivering research for complex problems (>20 trials), leading to changes in clinical care. The programme is a partnership between Acute and Mental Health NHS Trusts, NHS community providers, NHS Trusts in neighbouring counties, and Nottingham and Bangor Universities. We worked closely with East Midlands Research Design Service and Clinical Research Network (CRN) in developing the proposal. Justification of costs Most of the costs are for staff and co-applicant time, budgets for PPI, travel and consumables. We have budgeted for dissemination and training materials for both professionals and public. Support costs will include the East Midlands CRN identifying and recruiting participants from Memory Assessment Services. Excess Treatment Costs for the intervention have been agreed by the Nottingham Clinical Commissioning Groups. The programme lasts 6 years, hence a total budget exceeding &pound;2.5M. Patient and public involvement We have an established PPI panel to support dementia and older people s research, which will meet quarterly to oversee involvement. A researcher experienced in PPI will facilitate this. Management and governance. A Programme Management Board (PMB) will meet monthly. Work package leads will convene meetings and report to the PMB. Oversight of progress will be undertaken by Programme Steering and Data Monitoring Committees.

Lay abstract: People with dementia are at high risk of falls, which accelerate decline in physical and mental health. We will develop and test a therapy programme, which promotes activity and reduces risk of falls, helping people to live well with dementia for longer. Dementia causes loss of memory, judgement, planning, normal walking pattern and balance. 60-80% of people with dementia fall each year, due to factors related to both dementia and general health. Falls cause injury, distress, disability, hospital and care home admissions, and are expensive to the patient, families and society. Nearly half of broken hips occur in someone with dementia. Current attempts to prevent these falls are thought to be ineffective. Recent research has identified possible new approaches. We are developing a falls prevention programme, based on exercise, gait re-education, dual-task training, analysis of daily activity and risks, and environmental assessment. These will be adapted and delivered to enable people with dementia to engage and persist with the programme. We will take account of their priorities and interests, retained abilities, physical and mental health problems and the availability (or not) of support from family or other carers. We will include people with mild dementia, who are at risk of deterioration, but who are able enough to participate. In a programme development study we recruited people with dementia and measured falls risk factors. Interviews with patients, carers, and professionals told us that we should focus on promoting independence and wellbeing through continuing activity, rather than emphasising falls. We drafted an intervention based on literature, practitioner-, patient- and carer-experience, and neuro-psychological expertise. We will study how we can make the programme achievable, including how much supervision is needed. We will evaluate whether it works, and represents value for money, in a randomised-controlled clinical trial. We will measure its success in changing disability, rate of falling, activity levels, memory and quality of life. We will learn what helped and hindered delivery in practice. Ethical issues are: research with people who are vulnerable; and suggesting restrictions to lifestyle to reduce risk of falling. We have experience in overcoming these. The research team includes expertise in falls, dementia, psychology, service development, behaviour change, clinical trials, health economics and interview-based research. We have an excellent record of delivering research for complex problems, leading to changes in clinical care. A successful outcome will maintain wellbeing and quality of life, and help reduce falls and fractures amongst people with dementia. This will reduce and delay disability, distress and the cost of disease progression, with a real prospect of cost saving to the NHS. An effective intervention would be an important addition to what can be offered following a dementia diagnosis.

Research activity codes: 3.1 PRIMARY PREVENTION INTERVENTIONS TO MODIFY BEHAVIOURS OR PROMOTE WELL-BEING
Health categories: INJURIES AND ACCIDENTS;NEUROLOGICAL