A digital program to prevent falls and improve well-being in people living with dementia in the community: the KOKU-LITE feasibility Randomised Controlled Trial protocol

IntroductionAround 885,000 people live with dementia in the UK of which around 50% experience a fall each year. Keep On Keep Up (KOKU) is an NHS approved gamified, digital health program designed to maintain function and reduce falls through strength & balance exercises (FaME/OTAGO), and health literacy games. KOKU has been adapted to the needs of people living with Dementia (PLwD) in the community, known as KOKU-LITE. This trial aims to test the feasibility and acceptability of trial processes and usability of KOKU-LITE. Methods and analysisA two-arm, mixed methods, feasibility randomised controlled trial will be conducted. Participants aged [≥]55 years meeting the eligibility criteria will be recruited from patient organisations across Greater Manchester, UK. Participants randomised into the intervention arm will receive 6 weeks KOKU-LITE program plus dementia specific falls prevention leaflet and participants randomised into the control arm will receive dementia specific falls prevention leaflet. Outcome measures include: recruitment rate, adherence, quality of life, participants Activities of Daily Living, physical activity levels, functional ability, lower limb strength, fear of falling, falls risk, mood, and users experience of the technology. Post-intervention interviews or focus groups with participants and health and social care professionals will explore feasibility of trial processes & technology and evaluate the usability and acceptability of the intervention respectively. Analyses will be descriptive. Ethics and disseminationThis feasibility trial has been reviewed and received favourable ethical approval from Yorkshire & The Humber - Bradford Leeds Research Ethics Committee, Newcastle upon Tyne (REC reference 23/YH/0262). The findings of the study will be disseminated through peer-reviewed scientific journals, at conferences, publication on University of Manchester, Applied Research Collaboration Greater Manchester (ARC-GM) and KOKU websites. Trial registration numberNCT06149702 Strengths and Limitations of this studyO_LIThis is one of the first studies to test the feasibility and acceptability of trial processes and usability of a gamified digital health program for falls prevention and to improve well-being in people living with dementia in the community known as KOKU-LITE. C_LIO_LIRecruiting and retaining people living with dementia can be very challenging and therefore this feasibility study will explore and evaluate different strategies to recruit participants and estimate the time required for recruitment. C_LIO_LIThe barriers and facilitators identified in the recruitment and retention phase of the trial will help us to design a robust definitive trial. C_LIO_LIWe have involved people with lived experience of dementia extensively in the development of KOKU-LITE and will continue to do so in feasibility testing of KOKU-LITE to inform a larger study that will test effectiveness. C_LIO_LIThis is a feasibility trial and is not powered to determine the effectiveness of the intervention. C_LI