A digital programme 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 whom around 50% experience a fall each year. 'Keep On Keep Up' (KOKU) is a National Health Service-approved gamified, digital health programme designed to maintain function and reduce falls through strength and balance exercises (Fitness and Mobility Exercise/OTAGO Exercise Programme (OTAGO)), and health literacy games. KOKU has been adapted to the needs of people living with dementia 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 ANALYSIS: A two-arm, parallel, non-blinded feasibility randomised controlled trial will be conducted using mixed methods. Participants aged ≥55 years with any type but varying levels of dementia from mild to moderate stages (ratings 1 and 2 on clinical dementia rating (CDR) scale) and meeting the eligibility criteria will be recruited from patient organisations across Greater Manchester, UK. The target sample size is 60 for the trial. Participants randomised into the intervention arm will use the KOKU-LITE programme for 30 min, 3 times a week for 6 weeks plus dementia-specific falls prevention leaflet and participants randomised into the control arm will receive dementia-specific falls prevention leaflet. OUTCOME MEASURES: primary outcomes: recruitment, retention and adherence rates; secondary outcomes: quality of life, participants' activities of daily living, physical activity levels, functional ability, lower limb strength, concerns about falling, falls risk, mood and user's experience of the technology. Post-intervention interviews or focus groups with participants and health and social care professionals will explore the feasibility of trial processes and technology and evaluate the usability and acceptability of the intervention, respectively. Analyses will be descriptive. TRIAL STATUS: the first participants were recruited on 20 March 2024. Data collection is currently ongoing. ETHICS AND DISSEMINATION: This 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 and KOKU websites. TRIAL REGISTRATION NUMBER: NCT06149702.