A podiatry intervention to reduce falls in care home residents is feasible and demonstrates benefits: results from PIRFECT, a feasibility randomised controlled trial

Gavin Wylie, Zoe Young, Brian Williams, Francis Sullivan, Hylton B. Menz, Simon Ogston, Jacqui Morris

Research output: Contribution to journalMeeting abstract

Abstract

Background: Previous research has demonstrated effectiveness of a podiatry intervention in reducing falls among community dwelling older people. The purpose of this project was to (i) establish the feasibility of implementing and testing this existing podiatry intervention in the CH setting, (ii) remodel the intervention and subsequent trial in light of the feasibility findings to suit the CH context, and (iii) estimate the effect size of the remodelled intervention on falls in a pilot rando- mised controlled trial (RCT). Here, we report the findings from the pilot RCT.

Methods: The pre-RCT feasibility work has been reported elsewhere. The re- modelled multifaceted podiatry intervention (MPI) consists of: foot orthoses provision (Formthotics™, Christchurch, New Zealand), foot-wear assessment and provision, ankle dorsiflexion/plantarflexion exercises, and toe flexor exercises. We subsequently conducted a two armed, rater blinded, pilot randomised controlled trial of the MPI with outcome assessment at 3, 6 and 9 months.

Results: Forty-three CH residents were randomly allocated to receive either the MPI or usual care. Median time to first fall (days) was longer in the MPI group compared to the control group (91 + 5.9 vs. 64 + 27.1), however this did not reach significance (Log Rank test, p = .41). A significant difference in the number of falls was found between the 2
groups, groups, favouring the MPI, directly after the 3 month intervention (p = .05, 95 % CI −1.59 to .36; mean falls MPI group 0.62 + 1.1 vs. mean falls control group 1.24 + 1.8) which translated to a medium effect size on the number of falls (Cohen’sd= .43). This significance disappeared following multiple imputation for missing data (p = .08, 95 % CI −1.39 to .31). There was no significant difference between the groups in the number of falls at the end of the 6-month follow up (p = .89, 95 % CI −1.26 to 1.22; mean falls MPI group 0.77 + 1.6 vs. mean falls control group 0.83 + 1.6). This translated to a small effect size (Cohen’s d = 0.06). Documented adherence to the exercise component of the MPI was poor, with 35 % of participants attempting the exercises 3 times per week.

Conclusion: Despite poor documented adherence, this work demonstrates a beneficial effect of the MPI on the time to first fall, and a beneficial effect size at the end of the intervention period. Our results suggest that participants adhering and completing the intervention protocol will benefit most from the intervention. If documented adherence can be improved the MPI has the potential to reduce falls in the CH setting. Based on these findings, a definitive multicentre RCT using the intervention and methods developed in this study is feasible and warranted.
Original languageEnglish
Article numberB7.6
Pages (from-to)11
Number of pages1
JournalJournal of Foot and Ankle Research
Volume9
Issue numberSuppl 1
DOIs
Publication statusPublished - 27 Apr 2016
EventThe College of Podiatry Annual Conference 2015 - Harrogate, United Kingdom
Duration: 19 Nov 201521 Nov 2015

Fingerprint

Podiatry
Home Care Services
Randomized Controlled Trials
Control Groups
Foot Orthoses
Independent Living
Toes
New Zealand
Ankle

Cite this

@article{ccb308b5d628421880579bc6cfe66db0,
title = "A podiatry intervention to reduce falls in care home residents is feasible and demonstrates benefits: results from PIRFECT, a feasibility randomised controlled trial",
abstract = "Background: Previous research has demonstrated effectiveness of a podiatry intervention in reducing falls among community dwelling older people. The purpose of this project was to (i) establish the feasibility of implementing and testing this existing podiatry intervention in the CH setting, (ii) remodel the intervention and subsequent trial in light of the feasibility findings to suit the CH context, and (iii) estimate the effect size of the remodelled intervention on falls in a pilot rando- mised controlled trial (RCT). Here, we report the findings from the pilot RCT.Methods: The pre-RCT feasibility work has been reported elsewhere. The re- modelled multifaceted podiatry intervention (MPI) consists of: foot orthoses provision (Formthotics™, Christchurch, New Zealand), foot-wear assessment and provision, ankle dorsiflexion/plantarflexion exercises, and toe flexor exercises. We subsequently conducted a two armed, rater blinded, pilot randomised controlled trial of the MPI with outcome assessment at 3, 6 and 9 months.Results: Forty-three CH residents were randomly allocated to receive either the MPI or usual care. Median time to first fall (days) was longer in the MPI group compared to the control group (91 + 5.9 vs. 64 + 27.1), however this did not reach significance (Log Rank test, p = .41). A significant difference in the number of falls was found between the 2groups, groups, favouring the MPI, directly after the 3 month intervention (p = .05, 95 {\%} CI −1.59 to .36; mean falls MPI group 0.62 + 1.1 vs. mean falls control group 1.24 + 1.8) which translated to a medium effect size on the number of falls (Cohen’sd= .43). This significance disappeared following multiple imputation for missing data (p = .08, 95 {\%} CI −1.39 to .31). There was no significant difference between the groups in the number of falls at the end of the 6-month follow up (p = .89, 95 {\%} CI −1.26 to 1.22; mean falls MPI group 0.77 + 1.6 vs. mean falls control group 0.83 + 1.6). This translated to a small effect size (Cohen’s d = 0.06). Documented adherence to the exercise component of the MPI was poor, with 35 {\%} of participants attempting the exercises 3 times per week.Conclusion: Despite poor documented adherence, this work demonstrates a beneficial effect of the MPI on the time to first fall, and a beneficial effect size at the end of the intervention period. Our results suggest that participants adhering and completing the intervention protocol will benefit most from the intervention. If documented adherence can be improved the MPI has the potential to reduce falls in the CH setting. Based on these findings, a definitive multicentre RCT using the intervention and methods developed in this study is feasible and warranted.",
author = "Gavin Wylie and Zoe Young and Brian Williams and Francis Sullivan and Menz, {Hylton B.} and Simon Ogston and Jacqui Morris",
year = "2016",
month = "4",
day = "27",
doi = "10.1186/s13047-016-0141-x",
language = "English",
volume = "9",
pages = "11",
journal = "Journal of Foot and Ankle Research",
issn = "1757-1146",
publisher = "Springer Verlag",
number = "Suppl 1",

}

A podiatry intervention to reduce falls in care home residents is feasible and demonstrates benefits: results from PIRFECT, a feasibility randomised controlled trial. / Wylie, Gavin; Young, Zoe; Williams, Brian; Sullivan, Francis; Menz, Hylton B.; Ogston, Simon; Morris, Jacqui.

In: Journal of Foot and Ankle Research, Vol. 9, No. Suppl 1, B7.6, 27.04.2016, p. 11.

Research output: Contribution to journalMeeting abstract

TY - JOUR

T1 - A podiatry intervention to reduce falls in care home residents is feasible and demonstrates benefits: results from PIRFECT, a feasibility randomised controlled trial

AU - Wylie, Gavin

AU - Young, Zoe

AU - Williams, Brian

AU - Sullivan, Francis

AU - Menz, Hylton B.

AU - Ogston, Simon

AU - Morris, Jacqui

PY - 2016/4/27

Y1 - 2016/4/27

N2 - Background: Previous research has demonstrated effectiveness of a podiatry intervention in reducing falls among community dwelling older people. The purpose of this project was to (i) establish the feasibility of implementing and testing this existing podiatry intervention in the CH setting, (ii) remodel the intervention and subsequent trial in light of the feasibility findings to suit the CH context, and (iii) estimate the effect size of the remodelled intervention on falls in a pilot rando- mised controlled trial (RCT). Here, we report the findings from the pilot RCT.Methods: The pre-RCT feasibility work has been reported elsewhere. The re- modelled multifaceted podiatry intervention (MPI) consists of: foot orthoses provision (Formthotics™, Christchurch, New Zealand), foot-wear assessment and provision, ankle dorsiflexion/plantarflexion exercises, and toe flexor exercises. We subsequently conducted a two armed, rater blinded, pilot randomised controlled trial of the MPI with outcome assessment at 3, 6 and 9 months.Results: Forty-three CH residents were randomly allocated to receive either the MPI or usual care. Median time to first fall (days) was longer in the MPI group compared to the control group (91 + 5.9 vs. 64 + 27.1), however this did not reach significance (Log Rank test, p = .41). A significant difference in the number of falls was found between the 2groups, groups, favouring the MPI, directly after the 3 month intervention (p = .05, 95 % CI −1.59 to .36; mean falls MPI group 0.62 + 1.1 vs. mean falls control group 1.24 + 1.8) which translated to a medium effect size on the number of falls (Cohen’sd= .43). This significance disappeared following multiple imputation for missing data (p = .08, 95 % CI −1.39 to .31). There was no significant difference between the groups in the number of falls at the end of the 6-month follow up (p = .89, 95 % CI −1.26 to 1.22; mean falls MPI group 0.77 + 1.6 vs. mean falls control group 0.83 + 1.6). This translated to a small effect size (Cohen’s d = 0.06). Documented adherence to the exercise component of the MPI was poor, with 35 % of participants attempting the exercises 3 times per week.Conclusion: Despite poor documented adherence, this work demonstrates a beneficial effect of the MPI on the time to first fall, and a beneficial effect size at the end of the intervention period. Our results suggest that participants adhering and completing the intervention protocol will benefit most from the intervention. If documented adherence can be improved the MPI has the potential to reduce falls in the CH setting. Based on these findings, a definitive multicentre RCT using the intervention and methods developed in this study is feasible and warranted.

AB - Background: Previous research has demonstrated effectiveness of a podiatry intervention in reducing falls among community dwelling older people. The purpose of this project was to (i) establish the feasibility of implementing and testing this existing podiatry intervention in the CH setting, (ii) remodel the intervention and subsequent trial in light of the feasibility findings to suit the CH context, and (iii) estimate the effect size of the remodelled intervention on falls in a pilot rando- mised controlled trial (RCT). Here, we report the findings from the pilot RCT.Methods: The pre-RCT feasibility work has been reported elsewhere. The re- modelled multifaceted podiatry intervention (MPI) consists of: foot orthoses provision (Formthotics™, Christchurch, New Zealand), foot-wear assessment and provision, ankle dorsiflexion/plantarflexion exercises, and toe flexor exercises. We subsequently conducted a two armed, rater blinded, pilot randomised controlled trial of the MPI with outcome assessment at 3, 6 and 9 months.Results: Forty-three CH residents were randomly allocated to receive either the MPI or usual care. Median time to first fall (days) was longer in the MPI group compared to the control group (91 + 5.9 vs. 64 + 27.1), however this did not reach significance (Log Rank test, p = .41). A significant difference in the number of falls was found between the 2groups, groups, favouring the MPI, directly after the 3 month intervention (p = .05, 95 % CI −1.59 to .36; mean falls MPI group 0.62 + 1.1 vs. mean falls control group 1.24 + 1.8) which translated to a medium effect size on the number of falls (Cohen’sd= .43). This significance disappeared following multiple imputation for missing data (p = .08, 95 % CI −1.39 to .31). There was no significant difference between the groups in the number of falls at the end of the 6-month follow up (p = .89, 95 % CI −1.26 to 1.22; mean falls MPI group 0.77 + 1.6 vs. mean falls control group 0.83 + 1.6). This translated to a small effect size (Cohen’s d = 0.06). Documented adherence to the exercise component of the MPI was poor, with 35 % of participants attempting the exercises 3 times per week.Conclusion: Despite poor documented adherence, this work demonstrates a beneficial effect of the MPI on the time to first fall, and a beneficial effect size at the end of the intervention period. Our results suggest that participants adhering and completing the intervention protocol will benefit most from the intervention. If documented adherence can be improved the MPI has the potential to reduce falls in the CH setting. Based on these findings, a definitive multicentre RCT using the intervention and methods developed in this study is feasible and warranted.

U2 - 10.1186/s13047-016-0141-x

DO - 10.1186/s13047-016-0141-x

M3 - Meeting abstract

VL - 9

SP - 11

JO - Journal of Foot and Ankle Research

JF - Journal of Foot and Ankle Research

SN - 1757-1146

IS - Suppl 1

M1 - B7.6

ER -