TY  - JOUR
PY  - 2014//
TI  - The REFORM study protocol: a cohort randomised controlled trial of a multifaceted podiatry intervention for the prevention of falls in older people
JO  - BMJ open
A1  - Cockayne, Sarah
A1  - Adamson, Joy
A1  - Corbacho Martin, Belen
A1  - Fairhurst, Caroline
A1  - Hewitt, Catherine
A1  - Hicks, Kate
A1  - Hull, Robin
A1  - Keenan, Anne Maree
A1  - Lamb, Sarah E.
A1  - Loughrey, Lorraine
A1  - McIntosh, Caroline
A1  - Menz, Hylton B.
A1  - Redmond, Anthony C.
A1  - Rodgers, Sara
A1  - Vernon, Wesley
A1  - Watson, Judith
A1  - Torgerson, David
SP  - e006977
EP  - e006977
VL  - 4
IS  - 12
N2  - 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. <br><br>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.<p />  <p>Language: en</p>
LA  - en
SN  - 2044-6055
UR  - http://dx.doi.org/10.1136/bmjopen-2014-006977
ID  - ref1
ER  -