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Randomized Controlled Trial
. 2014 Dec 17;4(12):e006977.
doi: 10.1136/bmjopen-2014-006977.

The REFORM study protocol: a cohort randomised controlled trial of a multifaceted podiatry intervention for the prevention of falls in older people

Sarah Cockayne  1 , Joy Adamson  1 , Belen Corbacho Martin  1 , Caroline Fairhurst  1 , Catherine Hewitt  1 , Kate Hicks  1 , Robin Hull  2 , Anne Maree Keenan  3 , Sarah E Lamb  4 , Lorraine Loughrey  5 , Caroline McIntosh  6 , Hylton B Menz  7 , Anthony C Redmond  3 , Sara Rodgers  1 , Wesley Vernon  8 , Judith Watson  1 , David Torgerson  1 ; REFORM study
Affiliations
Randomized Controlled Trial

The REFORM study protocol: a cohort randomised controlled trial of a multifaceted podiatry intervention for the prevention of falls in older people

Sarah Cockayne et al. BMJ Open. .

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 ISRCTN68240461 assigned 01/07/2011.

Keywords: HEALTH ECONOMICS; QUALITATIVE RESEARCH; STATISTICS & RESEARCH METHODS.

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Figures

Figure 1
Figure 1
Formthotic orthotic device (colour for on-line version/monochrome for other format).
Figure 2
Figure 2
X-line orthotic device (colour for on-line version/monochrome for other format).
See this image and copyright information in PMC

References

    1. Iglesias CP, Manca A, Torgerson DJ. The health-related quality of life and cost implications of falls in elderly women. Osteoporos Int 2009;20:869–78. 10.1007/s00198-008-0753-5 - DOI - PubMed
    1. Department of Health (DH). National service framework for older people. London: Department of Health, 2001. https://www.gov.uk/government/publications/quality-standards-for-care-se... (accessed 20 Oct 2014).
    1. Lord S, Sherrington C, Menz H et al. . Falls in older people: risk factors and strategies for prevention. 2nd edn Cambridge, UK: Cambridge University Press, 2007.
    1. Dunn JE, Link CL, Felson DT et al. . Prevalence of foot and ankle conditions in a multiethnic community sample of older adults. Am J Epidemiol 2004;159:491–8. 10.1093/aje/kwh071 - DOI - PubMed
    1. Benvenuti F, Ferrucci L, Guralnik J et al. . Foot pain and disability in older persons: an epidemiologic survey. J Am Geriatr Soc 1995;43:479–84. - PubMed

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