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The REFORM study protocol: a cohort randomised controlled trial of a multifaceted podiatry intervention for the prevention of falls in older people
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...
Autores principales: | , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BMJ Publishing Group
2014
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4275677/ https://www.ncbi.nlm.nih.gov/pubmed/25518875 http://dx.doi.org/10.1136/bmjopen-2014-006977 |
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author | Cockayne, Sarah Adamson, Joy Corbacho Martin, Belen Fairhurst, Caroline Hewitt, Catherine Hicks, Kate Hull, Robin Keenan, Anne Maree Lamb, Sarah E Loughrey, Lorraine McIntosh, Caroline Menz, Hylton B Redmond, Anthony C Rodgers, Sara Vernon, Wesley Watson, Judith Torgerson, David |
author_facet | Cockayne, Sarah Adamson, Joy Corbacho Martin, Belen Fairhurst, Caroline Hewitt, Catherine Hicks, Kate Hull, Robin Keenan, Anne Maree Lamb, Sarah E Loughrey, Lorraine McIntosh, Caroline Menz, Hylton B Redmond, Anthony C Rodgers, Sara Vernon, Wesley Watson, Judith Torgerson, David |
author_sort | Cockayne, Sarah |
collection | PubMed |
description | 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 ISRCTN68240461assigned 01/07/2011. |
format | Online Article Text |
id | pubmed-4275677 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2014 |
publisher | BMJ Publishing Group |
record_format | MEDLINE/PubMed |
spelling | pubmed-42756772014-12-31 The REFORM study protocol: a cohort randomised controlled trial of a multifaceted podiatry intervention for the prevention of falls in older people Cockayne, Sarah Adamson, Joy Corbacho Martin, Belen Fairhurst, Caroline Hewitt, Catherine Hicks, Kate Hull, Robin Keenan, Anne Maree Lamb, Sarah E Loughrey, Lorraine McIntosh, Caroline Menz, Hylton B Redmond, Anthony C Rodgers, Sara Vernon, Wesley Watson, Judith Torgerson, David BMJ Open Health Services Research 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 ISRCTN68240461assigned 01/07/2011. BMJ Publishing Group 2014-12-17 /pmc/articles/PMC4275677/ /pubmed/25518875 http://dx.doi.org/10.1136/bmjopen-2014-006977 Text en Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/ |
spellingShingle | Health Services Research Cockayne, Sarah Adamson, Joy Corbacho Martin, Belen Fairhurst, Caroline Hewitt, Catherine Hicks, Kate Hull, Robin Keenan, Anne Maree Lamb, Sarah E Loughrey, Lorraine McIntosh, Caroline Menz, Hylton B Redmond, Anthony C Rodgers, Sara Vernon, Wesley Watson, Judith Torgerson, David The REFORM study protocol: a cohort randomised controlled trial of a multifaceted podiatry intervention for the prevention of falls in older people |
title | The REFORM study protocol: a cohort randomised controlled trial of a multifaceted podiatry intervention for the prevention of falls in older people |
title_full | The REFORM study protocol: a cohort randomised controlled trial of a multifaceted podiatry intervention for the prevention of falls in older people |
title_fullStr | The REFORM study protocol: a cohort randomised controlled trial of a multifaceted podiatry intervention for the prevention of falls in older people |
title_full_unstemmed | The REFORM study protocol: a cohort randomised controlled trial of a multifaceted podiatry intervention for the prevention of falls in older people |
title_short | The REFORM study protocol: a cohort randomised controlled trial of a multifaceted podiatry intervention for the prevention of falls in older people |
title_sort | reform study protocol: a cohort randomised controlled trial of a multifaceted podiatry intervention for the prevention of falls in older people |
topic | Health Services Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4275677/ https://www.ncbi.nlm.nih.gov/pubmed/25518875 http://dx.doi.org/10.1136/bmjopen-2014-006977 |
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