The REFORM study protocol: a cohort randomised controlled trial of a multifaceted podiatry intervention for the prevention of falls in older people

Sarah Cockayne; Joy Ann Adamson; Belén Corbacho Martín; Caroline Marie Fairhurst; Catherine Elizabeth Hewitt; Kate Hicks; Robin Hull; Anne Maree Keenan; Sarah E Lamb; Lorraine Ruth Loughrey; Caroline McIntosh; Hylton B Menz; Anthony C Redmond; Sara Anita Rodgers; Wesley Vernon; Jude Watson; David John Torgerson; REFORM study

doi:10.1136/bmjopen-2014-006977

The REFORM study protocol: a cohort randomised controlled trial of a multifaceted podiatry intervention for the prevention of falls in older people

Sarah Cockayne, Joy Ann Adamson, Belén Corbacho Martín, Caroline Marie Fairhurst, Catherine Elizabeth Hewitt, Kate Hicks, Robin Hull, Anne Maree Keenan, Sarah E Lamb, Lorraine Ruth Loughrey, Caroline McIntosh, Hylton B Menz, Anthony C Redmond, Sara Anita Rodgers, Wesley Vernon, Jude Watson, David John Torgerson, REFORM study

Health Sciences

Research output: Contribution to journal › Article › peer-review

Abstract

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.

Original language	English
Article number	e006977
Number of pages	12
Journal	BMJ Open
Volume	4
Issue number	12
DOIs	https://doi.org/10.1136/bmjopen-2014-006977
Publication status	Published - 2014

Bibliographical note

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.

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10.1136/bmjopen-2014-006977

Cite this

Cockayne, S., Adamson, J. A., Corbacho Martín, B., Fairhurst, C. M., Hewitt, C. E., Hicks, K., Hull, R., Keenan, A. M., Lamb, S. E., Loughrey, L. R., McIntosh, C., Menz, H. B., Redmond, A. C., Rodgers, S. A., Vernon, W., Watson, J., Torgerson, D. J., & REFORM study (2014). The REFORM study protocol: a cohort randomised controlled trial of a multifaceted podiatry intervention for the prevention of falls in older people. BMJ Open, 4(12), Article e006977. https://doi.org/10.1136/bmjopen-2014-006977

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title = "The REFORM study protocol: a cohort randomised controlled trial of a multifaceted podiatry intervention for the prevention of falls in older people",

abstract = "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.",

author = "Sarah Cockayne and Adamson, {Joy Ann} and {Corbacho Mart{\'i}n}, Bel{\'e}n and Fairhurst, {Caroline Marie} and Hewitt, {Catherine Elizabeth} and Kate Hicks and Robin Hull and Keenan, {Anne Maree} and Lamb, {Sarah E} and Loughrey, {Lorraine Ruth} and Caroline McIntosh and Menz, {Hylton B} and Redmond, {Anthony C} and Rodgers, {Sara Anita} and Wesley Vernon and Jude Watson and Torgerson, {David John} and {REFORM study}",

note = "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.",

year = "2014",

doi = "10.1136/bmjopen-2014-006977",

language = "English",

volume = "4",

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Cockayne, S , Adamson, JA , Corbacho Martín, B , Fairhurst, CM , Hewitt, CE , Hicks, K, Hull, R, Keenan, AM, Lamb, SE, Loughrey, LR, McIntosh, C, Menz, HB, Redmond, AC, Rodgers, SA, Vernon, W, Watson, J , Torgerson, DJ & REFORM study 2014, 'The REFORM study protocol: a cohort randomised controlled trial of a multifaceted podiatry intervention for the prevention of falls in older people', BMJ Open, vol. 4, no. 12, e006977. https://doi.org/10.1136/bmjopen-2014-006977

TY - JOUR

T1 - The REFORM study protocol

T2 - a cohort randomised controlled trial of a multifaceted podiatry intervention for the prevention of falls in older people

AU - Cockayne, Sarah

AU - Adamson, Joy Ann

AU - Corbacho Martín, Belén

AU - Fairhurst, Caroline Marie

AU - Hewitt, Catherine Elizabeth

AU - Hicks, Kate

AU - Hull, Robin

AU - Keenan, Anne Maree

AU - Lamb, Sarah E

AU - Loughrey, Lorraine Ruth

AU - McIntosh, Caroline

AU - Menz, Hylton B

AU - Redmond, Anthony C

AU - Rodgers, Sara Anita

AU - Vernon, Wesley

AU - Watson, Jude

AU - Torgerson, David John

AU - REFORM study

N1 - 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.

PY - 2014

Y1 - 2014

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.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.

AB - 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.

U2 - 10.1136/bmjopen-2014-006977

DO - 10.1136/bmjopen-2014-006977

M3 - Article

C2 - 25518875

SN - 2044-6055

VL - 4

JO - BMJ Open

JF - BMJ Open

IS - 12

M1 - e006977

ER -