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The REFORM study protocol: a cohort randomised controlled trial of a multifaceted podiatry intervention for the prevention of falls in older people
  1. Sarah Cockayne1,
  2. Joy Adamson1,
  3. Belen Corbacho Martin1,
  4. Caroline Fairhurst1,
  5. Catherine Hewitt1,
  6. Kate Hicks1,
  7. Robin Hull2,
  8. Anne Maree Keenan3,4,
  9. Sarah E Lamb5,
  10. Lorraine Loughrey1,3,
  11. Caroline McIntosh6,
  12. Hylton B Menz7,
  13. Anthony C Redmond3,4,
  14. Sara Rodgers1,
  15. Wesley Vernon8,
  16. Judith Watson1,
  17. David Torgerson1
  18. on behalf of the REFORM study
  1. 1York Trials Unit, Department of Health Sciences, University of York, York, UK
  2. 2Podiatry Services, Harrogate and District NHS Foundation Trust, Harrogate District Hospital, Harrogate, UK
  3. 3NIHR Leeds Musculoskeletal Biomedical Research Unit, Chapel Allerton Hospital, Leeds, UK
  4. 4Leeds Institute of Rheumatology and Musculoskeletal Medicine, University of Leeds, Leeds, UK
  5. 5Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Kadoorie Critical Care Research Centre, John Radcliffe Hospital, University of Oxford, Oxford, UK
  6. 6National University of Ireland, Galway, Republic of Ireland
  7. 7Faculty of Health Sciences, Lower Extremity and Gait Studies Program, La Trobe University, Bundoora, Victoria, Australia
  8. 8Podiatry Services, Sheffield Teaching Hospitals NHS Foundation Trust, Jordanthorpe Health Centre, Sheffield, UK
  1. Correspondence to Dr Sarah Cockayne; sarah.cockayne{at}york.ac.uk

Abstract

Introduction Falls and fall-related injuries are a serious cause of morbidity and cost to society. Foot problems and inappropriate footwear may increase the risk of falls; therefore podiatric interventions may play a role in reducing falls. Two Cochrane systematic reviews identified only one study of a podiatry intervention aimed to reduce falls, which was undertaken in Australia. The REFORM trial aims to evaluate the clinical and cost-effectiveness of a multifaceted podiatry intervention in reducing falls in people aged 65 years and over in a UK and Irish setting.

Methods and analysis This multicentre, cohort randomised controlled trial will recruit 2600 participants from routine podiatry clinics in the UK and Ireland to the REFORM cohort. In order to detect a 10% point reduction in falls from 50% to 40%, with 80% power 890 participants will be randomised to receive routine podiatry care and a falls prevention leaflet or routine podiatry care, a falls prevention leaflet and a multifaceted podiatry intervention. The primary outcome is rate of falls (falls/person/time) over 12 months assessed by patient self-report falls diary. Secondary self-report outcome measures include: the proportion of single and multiple fallers and time to first fall over a 12-month period; Short Falls Efficacy Scale—International; fear of falling in the past 4 weeks; Frenchay Activities Index; fracture rate; Geriatric Depression Scale; EuroQoL-five dimensional scale 3-L; health service utilisation at 6 and 12 months. A qualitative study will examine the acceptability of the package of care to participants and podiatrists.

Ethics and dissemination The trial has received a favourable opinion from the East of England—Cambridge East Research Ethics Committee and Galway Research Ethics Committee. The trial results will be published in peer-reviewed journals and at conference presentations.

Trial registration number Current Controlled Trials ISRCTN68240461assigned 01/07/2011.

  • HEALTH ECONOMICS
  • STATISTICS & RESEARCH METHODS
  • QUALITATIVE RESEARCH

This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/

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