Clinical effectiveness and cost-effectiveness of a multifaceted podiatry intervention for falls prevention in older people

Description

Aims: To examine the clinical and cost-effectiveness of the multifaceted podiatry intervention for falls prevention

Method

A cohort randomised control trial where 2,600 participants will be recruited to the REFORM cohort.  From this cohort, a total of 890 participants aged 65 years and over with an increased risk of falling will be randomised to the REFORM trial.  They will be allocated to a control or intervention group.  The control group will receive routine podiatry care and a falls prevention leaflet.   The intervention group will receive routine podiatry care, a falls prevention leaflet and as clinically indicated a multifaceted podiatry intervention consisting of (i) footwear assessment with provision of new footwear if current footwear is deemed inappropriate; (ii) an orthotic device (iii) a home-based foot and ankle exercise programme. The primary outcome is the rate of falls (i.e. falls/person/time) recorded by a falls diary over 12 months. Secondary outcome measures assessed at 12 months include the proportion of fallers (single and multiple), self-reported time to first fall over a 12 month period,  Short Falls Efficacy Scale - International, fear of falling in the past four weeks, Frenchay Activities Index, Geriatric Depression Scale,  fracture rate, health-related quality of life (EQ5D 3-L) and health service utilisation data. A nested qualitative study will be carried out to examine the acceptability of the package of care to trial participants and podiatrists delivering the intervention.

Background

Falls and fall related injuries are a serious cause of morbidity and cost to society. There is some evidence to suggest that foot problems and inappropriate footwear may increase the risk of falls, therefore podiatric interventions may have a role to play in falls prevention. We are undertaking a pragmatic randomised controlled trial to evaluate the clinical and cost effectiveness of a multifaceted podiatry intervention in reducing falls in people over the age of 65 years attending routine podiatry clinics.

People

Primary Investigator: Professor David Torgeson, York Trials Unit, Department of Health Sciences, University of York

Leeds Collaborators
Professor Anne-Maree Keenan, School of Healthcare, University of Leeds, NIHR Leeds
Musculoskeletal Biomedical Research Unit, Leeds Teaching Hospitals Trust
Professor Anthony Redmond, Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds and NIHR Leeds Musculoskeletal Biomedical Research Unit Leeds Teaching Hospitals Trust
Lorraine Green, Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of
Leeds and NIHR Leeds Musculoskeletal Biomedical Research Unit Leeds Teaching
Hospitals Trust

York Trials Unit, Department of Health Sciences, University of York
Sarah Cockayne, 
Sara Rodgers, 
Caroline Fairhurst
Dr Joy Adamson
Arabella Clarke
Belen Corbacho
Professor Catherine E Hewitt
Dr Kate Hicks
Zoe Richardson
Dr Judith Waston

Other Collaborators 
Professor Hylton B Menz, School of Allied Health, College of Science, Health and
Engineering, La Trobe University
Robin Hull, Harrogate and District NHS Foundation Trust
Professor Sarah E Lamb, Oxford NIHR Biomedical Research Unit
Professor Caroline McIntosh, Discipline of Podiatric Medicine, National University of
Ireland Galway
Professor Wesley Vernon, Sheffield Teaching Hospitals NHS Foundation Trust

Funding body: National Institute for Health Research (HTA Programme) £1,241,128

Contact: (For Leeds):  Anne-Maree Keenan