title: The REFORM study protocol: a cohort randomised controlled trial of a multifaceted podiatry intervention for the prevention of falls in older people.
abstract: BACKGROUND
  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
  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.
  
  
  BACKGROUND
  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.
  
  
  BACKGROUND
  Current Controlled Trials ISRCTN68240461 assigned 01/07/2011.
authors.affiliation: York Trials Unit, Department of Health Sciences, University of York, York, UK.
authors.forename: Sarah
authors.initials: S
authors.lastname: Cockayne
authors.affiliation: York Trials Unit, Department of Health Sciences, University of York, York, UK.
authors.forename: Joy
authors.initials: J
authors.lastname: Adamson
authors.affiliation: York Trials Unit, Department of Health Sciences, University of York, York, UK.
authors.forename: Belen
authors.initials: B
authors.lastname: Corbacho Martin
authors.affiliation: York Trials Unit, Department of Health Sciences, University of York, York, UK.
authors.forename: Caroline
authors.initials: C
authors.lastname: Fairhurst
authors.affiliation: York Trials Unit, Department of Health Sciences, University of York, York, UK.
authors.forename: Catherine
authors.initials: C
authors.lastname: Hewitt
authors.affiliation: York Trials Unit, Department of Health Sciences, University of York, York, UK.
authors.forename: Kate
authors.initials: K
authors.lastname: Hicks
authors.affiliation: Podiatry Services, Harrogate and District NHS Foundation Trust, Harrogate District Hospital, Harrogate, UK.
authors.forename: Robin
authors.initials: R
authors.lastname: Hull
authors.affiliation: NIHR Leeds Musculoskeletal Biomedical Research Unit, Chapel Allerton Hospital, Leeds, UK Leeds Institute of Rheumatology and Musculoskeletal Medicine, University of Leeds, Leeds, UK.
authors.forename: Anne Maree
authors.initials: AM
authors.lastname: Keenan
authors.affiliation: Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Kadoorie Critical Care Research Centre, John Radcliffe Hospital, University of Oxford, Oxford, UK.
authors.forename: Sarah E
authors.initials: SE
authors.lastname: Lamb
authors.affiliation: York Trials Unit, Department of Health Sciences, University of York, York, UK NIHR Leeds Musculoskeletal Biomedical Research Unit, Chapel Allerton Hospital, Leeds, UK.
authors.forename: Lorraine
authors.initials: L
authors.lastname: Loughrey
authors.affiliation: National University of Ireland, Galway, Republic of Ireland.
authors.forename: Caroline
authors.initials: C
authors.lastname: McIntosh
authors.affiliation: Faculty of Health Sciences, Lower Extremity and Gait Studies Program, La Trobe University, Bundoora, Victoria, Australia.
authors.forename: Hylton B
authors.initials: HB
authors.lastname: Menz
authors.affiliation: NIHR Leeds Musculoskeletal Biomedical Research Unit, Chapel Allerton Hospital, Leeds, UK Leeds Institute of Rheumatology and Musculoskeletal Medicine, University of Leeds, Leeds, UK.
authors.forename: Anthony C
authors.initials: AC
authors.lastname: Redmond
authors.affiliation: York Trials Unit, Department of Health Sciences, University of York, York, UK.
authors.forename: Sara
authors.initials: S
authors.lastname: Rodgers
authors.affiliation: Podiatry Services, Sheffield Teaching Hospitals NHS Foundation Trust, Jordanthorpe Health Centre, Sheffield, UK.
authors.forename: Wesley
authors.initials: W
authors.lastname: Vernon
authors.affiliation: York Trials Unit, Department of Health Sciences, University of York, York, UK.
authors.forename: Judith
authors.initials: J
authors.lastname: Watson
authors.affiliation: York Trials Unit, Department of Health Sciences, University of York, York, UK.
authors.forename: David
authors.initials: D
authors.lastname: Torgerson
mesh_terms: D000058:Accidental Falls / Q000517:prevention & control*; D000368:Aged; D000369:Aged, 80 and over; D015331:Cohort Studies; D004739:England; D005260:Female; D061826:Foot Orthoses; D006801:Humans; D007494:Ireland; D008297:Male; D010353:Patient Education as Topic; D011032:Podiatry / Q000379:methods*; D012775:Shoes
keywords: HEALTH ECONOMICS; QUALITATIVE RESEARCH; STATISTICS & RESEARCH METHODS