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Randomized Controlled Trial
. 2017 Jan 20;12(1):e0168712.
doi: 10.1371/journal.pone.0168712. eCollection 2017.

Cohort Randomised Controlled Trial of a Multifaceted Podiatry Intervention for the Prevention of Falls in Older People (The REFORM Trial)

Sarah Cockayne  1 , Joy Adamson  1 , Arabella Clarke  1 , Belen Corbacho  1 , Caroline Fairhurst  1 , Lorraine Green  2 , Catherine E Hewitt  1 , Kate Hicks  1 , Anne-Maree Kenan  2 , Sarah E Lamb  3 , Caroline McIntosh  4 , Hylton B Menz  5 , Anthony C Redmond  2 , Zoe Richardson  1 , Sara Rodgers  1 , Wesley Vernon  6 , Judith Watson  1 , David J Torgerson  1 ; REFORM study
Affiliations
Randomized Controlled Trial

Cohort Randomised Controlled Trial of a Multifaceted Podiatry Intervention for the Prevention of Falls in Older People (The REFORM Trial)

Sarah Cockayne et al. PLoS One. .

Abstract

Background: Falls are a major cause of morbidity among older people. A multifaceted podiatry intervention may reduce the risk of falling. This study evaluated such an intervention.

Design: Pragmatic cohort randomised controlled trial in England and Ireland. 1010 participants were randomised (493 to the Intervention group and 517 to Usual Care) to either: a podiatry intervention, including foot and ankle exercises, foot orthoses and, if required, new footwear, and a falls prevention leaflet or usual podiatry treatment plus a falls prevention leaflet. The primary outcome was the incidence rate of self-reported falls per participant in the 12 months following randomisation. Secondary outcomes included: proportion of fallers and those reporting multiple falls, time to first fall, fear of falling, Frenchay Activities Index, Geriatric Depression Scale, foot pain, health related quality of life, and cost-effectiveness.

Results: In the primary analysis were 484 (98.2%) intervention and 507 (98.1%) control participants. There was a small, non statistically significant reduction in the incidence rate of falls in the intervention group (adjusted incidence rate ratio 0.88, 95% CI 0.73 to 1.05, p = 0.16). The proportion of participants experiencing a fall was lower (49.7 vs 54.9%, adjusted odds ratio 0.78, 95% CI 0.60 to 1.00, p = 0.05) as was the proportion experiencing two or more falls (27.6% vs 34.6%, adjusted odds ratio 0.69, 95% CI 0.52 to 0.90, p = 0.01). There was an increase (p = 0.02) in foot pain for the intervention group. There were no statistically significant differences in other outcomes. The intervention was more costly but marginally more beneficial in terms of health-related quality of life (mean quality adjusted life year (QALY) difference 0.0129, 95% CI -0.0050 to 0.0314) and had a 65% probability of being cost-effective at a threshold of £30,000 per QALY gained.

Conclusion: There was a small reduction in falls. The intervention may be cost-effective.

Trial registration: ISRCTN ISRCTN68240461.

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Conflict of interest statement

The authors have declared that no competing interests exist.

Figures

Fig 1
Fig 1. CONSORT flow diagram of participants in the REFORM study.
Fig 2
Fig 2. Kaplan-Meier curves by randomised group for time to first fall.
See this image and copyright information in PMC

References

    1. Iglesias C.P., Manca A., Torgerson DJ. The health-related quality of life and cost implications of falls in elderly women. Osteoporosis Int 2009. 20:869–78. - PubMed
    1. Prudham D, Grimley-Evans J. Factors associated with falls in the elderly: a community study. Age Ageing 1981;17:141–146. - PubMed
    1. Gill T, Taylor AW, Pengelly A. A population-based survey of factors relating to the prevalence of falls in older people. Gerontology. 2005. Sep-Oct;51(5):340–5 10.1159/000086372 - DOI - PubMed
    1. Mickle KJ, Munro BJ, Lord SR, Menz HB, Steele JR. Foot pain, plantar pressures, and falls in older people: a prospective study. J Am Geriatr Soc. 2010. October;58(10):1936–40 10.1111/j.1532-5415.2010.03061.x - DOI - PubMed
    1. Menz HB, Morris ME, Lord SR. Foot and ankle risk factors for falls in older people: a prospective study. J Gerontol A Biol Sci Med Sci. 2006. August;61(8):866–70. - PubMed

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