Randomised controlled trials to evaluate clinical and cost effectiveness of the Stroke Action Falls rehabilitation programme

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PA Logan1,2;E Doig1;V Booth2;F Allen2;A Arjunan1;M Chatfield3;T Comans3;L Connell4; E Cox2;R Durairaj4;N Foster1;R Gee6;R Grimley7;H Gullo3;R Haydock2;K Harding8;F Higton6;A Hill8;T Hepburn2;S Isbel9;M James2;N Lannin10;P Leighton2;J Liddle3;N Mahendran1;

1.STARS Education and Research Alliance, University of Queensland and Metro North Health;2.University of Nottingham;3.The University of Queensland;4.Cairns Hospital;5.University of Lancaster;6.Stroke Survivor;7.Sunshine Coast University Hospital;8.Latrobe

Scientific Research

SP - Stroke

Rehabilitation

View DOI

Abstract

Background

Falls are one of the most common secondary complications after stroke. Clinical guidelines do not include a falls prevention programme addressing the specific needs of stroke survivors. A falls prevention intervention called Action Falls has reduced fall rates in care home residents and could be effective for stroke survivors. The FISS trials in Australia and the UK aim to evaluate whether implementing the Stroke Action Falls programme helps in reducing fall rates among stroke survivors at home in the 12 months after discharge from hospital, and if it is more cost-effective compared to usual care.

Method

The randomised controlled trials are due to start recruitment of participants in Q1 2026. 476 stroke patients in each country will be either allocated to receive the intervention (Stroke Action Falls plus usual care) or usual care alone. The intervention is consumer driven, guided by collaborative action planning between stroke survivors and care providers targeted toward identified falls risk factors. The primary outcome is falls rate over a 12-month period. The secondary outcomes are number of falls, injuries due to falls, fear of falling, activities of daily living, psychological stress, quality of life and resource use. An economic evaluation and process evaluation will run independently.

Results

The UK and Australian teams have met monthly and have succeeded in achieving: Funding secured from NHMRC and NIHR; Ethical and organisational approvals; A joint protocol has been produced, Each plan to have 10, stroke services ready to commence recruitment; Developed a Stroke Action falls manual, aphasia friendly (adapted for tele-delivery in the Australian context); Trials Steering and Data monitoring Committees; parallel REDCap data bases; A network of trust and shared learning.

Conclusion

Falls prevention trials across countries are possible and we should consider establishing platforms to enable timely set up and sharing knowledge.