Citation

van Schooten KS, Callisaya ML, O'Dea B, Lung T, Anstey K, Lord SR, Christensen H, Brown A, Chow J, McInerney G, Miles L, Ngo M, Perram A, Delbaere K. BMJ Open 2021; 11(4): e051085.

Copyright

(Copyright © 2021, BMJ Publishing Group)

DOI

10.1136/bmjopen-2021-051085

PMID

unavailable

Abstract

INTRODUCTION: Falls have a multifactorial aetiology, which may limit the effectiveness of the common approach of exercise as the sole intervention strategy. Multifactorial interventions could be more effective in people at high risk of falling; however, the focus of such interventions has traditionally been quite narrow. This paper describes the design of a randomised controlled trial that will evaluate the effectiveness of an eHealth programme, which addresses cumulative effects of key fall-risk factors across the triad of physical, affective and cognitive functions on falls in older people.

METHODS AND ANALYSIS: 518 older people aged 65 years and over with high fall risk, defined as having a history of falls in the past 6 months, self-reported fear of falling or being aged 80 years or over, will be recruited via local advertisements, newsletters and presentations, and randomised to an intervention or health education control group. The intervention comprises balance exercise, cognitive-motor exercise and cognitive-behavioural therapy, with their dosage based on participant's baseline balance, executive function and mood. The primary outcome is the rate of falls in the 12 months after randomisation. Secondary outcomes at 6 and 12 months comprise programme adherence, healthcare use, physical activity, balance and mobility, cognitive function, psychological well-being, quality of life, health literacy and user experience and attitudes towards the programme. Data will be analysed following intention to treat to gauge real-world effectiveness. We will further determine complier averaged causal effects to correct for varying adherence and conduct economic analyses to gain insight into cost-effectiveness and cost-utility. ETHICS AND DISSEMINATION: Ethical approval was obtained from the University of New South Wales (UNSW) Human Research Ethics Committee in December 2017. Outcomes will be disseminated via peer-reviewed articles, conference presentations, community events and media releases. TRIAL REGISTRATION NUMBER: ACTRN12619000540112.

Language: en

Keywords

clinical trials; delirium & cognitive disorders; depression & mood disorders; telemedicine