RESUMO
Introduction Falls have major implications for quality-of-life, independence and cost to health services. Strength and balance training has been found to be effective in reducing the rate/risk of falls, as long as there is adequate fidelity to the evidence-based programme. The aims of this study were to: (1) assess the feasibility of using the 'Motivate Me' and 'My Activity Programme' intervention to support falls rehabilitation when delivered in practice (2) assess study design and trial procedures for the evaluation of the intervention. Methods A two-arm, pragmatic feasibility randomised controlled trial was conducted with five health service providers in the UK. Patients aged 50+ years eligible for a falls rehabilitation exercise programme from community services were recruited and received either: (1) standard service with a smartphone for outcome measurement only or (2) standard service plus the 'Motivate Me' and 'My Activity Programme' apps. The primary outcome was feasibility of the intervention, study design and procedures (including recruitment rate, adherence and drop-out). Outcome measures include balance, function, falls, strength, fear of falling, health related quality of life, resource use and adherence, measured at baseline, three and six month post-randomisation. Blinded assessors collected the outcome measures. Results 24 patients were randomised to control group, 26 to intervention group, mean age 77.6 (Range 62 to 92) years. We recruited 37.5% of eligible participants across the five clinical sites. 77% in the intervention group completed their full exercise programme (including the use of the app). Response rate for outcome measures at six months were 77%-80% across outcome measures, but this was effected by the COVID19 pandemic. There was a mean 2.6 ± 1.9 point difference between groups in change in BERG balance score from baseline to three months and mean 4.4 ± 2.7 point difference from baseline to six months in favour of the intervention group. Less falls (1.8 ± 2.8 vs 9.1 ± 32.6) and less injurious falls (0.1 ± 0.5 vs 0.4 ± 0.6) in the intervention group and higher adherence scores at three (17.7 ± 6.8 vs 13.1 ± 6.5) and six months (15.3 ± 7.8 vs 14.9 ± 7.8). There were no related adverse events. Health professionals and patients had few technical issues with the apps. Conclusions The motivational apps and trial procedures were feasible for health professionals and patients. There are positive indications from outcome measures in the feasibility trial and key criteria for progression to full trial were met.
RESUMO
INTRODUCTION: One in three people aged 65 years and over fall each year. The health, economic and personal impact of falls will grow substantially in the coming years due to population ageing. Developing and implementing cost-effective strategies to prevent falls and mobility problems among older people is therefore an urgent public health challenge. StandingTall is a low-cost, unsupervised, home-based balance exercise programme delivered through a computer or tablet. StandingTall has a simple user-interface that incorporates physical and behavioural elements designed to promote compliance. A large randomised controlled trial in 503 community-dwelling older people has shown that StandingTall is safe, has high adherence rates and is effective in improving balance and reducing falls. The current project targets a major need for older people and will address the final steps needed to scale this innovative technology for widespread use by older people across Australia and internationally. METHODS AND ANALYSIS: This project will endeavour to recruit 300 participants across three sites in Australia and 100 participants in the UK. The aim of the study is to evaluate the implementation of StandingTall into the community and health service settings in Australia and the UK. The nested process evaluation will use both quantitative and qualitative methods to explore uptake and acceptability of the StandingTall programme and associated resources. The primary outcome is participant adherence to the StandingTall programme over 6 months. ETHICS AND DISSEMINATION: Ethical approval has been obtained from the South East Sydney Local Health District Human Research Ethics Committee (HREC reference 18/288) in Australia and the North West- Greater Manchester South Research Ethics Committee (IRAS ID: 268954) in the UK. Dissemination will be via publications, conferences, newsletter articles, social media, talks to clinicians and consumers and meetings with health departments/managers. TRIAL REGISTRATION NUMBER: ACTRN12619001329156.