Physiotherapy-led telehealth and exercise intervention to improve mobility in older people receiving aged care services (TOP UP): protocol for a randomised controlled type 1 hybrid effectiveness-implementation trial

Abstract

IntroductionDeteriorating mobility and falls reduce independence and quality of life for older people receiving aged care services. This trial aims to establish effectiveness on the mobility of older people, and explore cost-effectiveness and implementation of a telehealth physiotherapy programme.Method and analysisThis type 1 hybrid effectiveness-implementation randomised controlled trial will involve 240 people aged 65+ years receiving aged care services in community or residential settings. Participants will be randomised to either: (1) the Telehealth Physiotherapy for Older People (TOP UP) Program or (2) a wait-list control group. The 6-month intervention includes 10 physiotherapy sessions delivered by videocall (Zoom). The intervention will include the local support of an aged care worker and online exercise resources. Primary outcome is mobility at 6 months post randomisation measured by the Short Physical Performance Battery. Secondary outcomes include rate of falls, sit-to-stand, quality of life, and goal attainment at 6 months after randomisation. Regression models will assess the effect of group allocation on mobility and the other continuously scored secondary outcomes, adjusting for baseline scores. The number of falls per person over 6 months will be analysed using negative binomial regression models to estimate between-group differences. An economic analysis will explore the cost-effectiveness of the TOP UP programme compared with usual care. Implementation outcomes and determinants relating to the intervention’s reach, fidelity, exercise dose delivered, adoption, feasibility, acceptability, barriers and facilitators will be explored using mixed methods.ConclusionThis is the first trial to investigate the effectiveness, cost-effectiveness and implementation of a physiotherapy intervention in aged care delivered solely by telehealth internationally. The study has strong aged care co-design and governance and is guided by steering and advisory committees that include staff from aged care service providers and end-users. Trial results will be disseminated via peer-reviewed articles, conference presentations and lay summaries.Trial registration numberThe trial is registered with the Australian New Zealand Clinical Trials Registry (ACTRN 12621000734864).