Podiatry intervention versus usual care to prevent falls in care homes: pilot randomised controlled trial (the PIRFECT study)

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

Research output: Contribution to journalArticle

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Abstract

Background: Common foot problems are independent risk factors for falls in older people. There is evidence that podiatry can prevent falls in community-dwelling populations. The feasibility of implementing a podiatry intervention and trial in the care home population is unknown. To inform a potential future definitive trial, we performed a pilot randomised controlled trial to assess: (i) the feasibility of a trial of a podiatry intervention to reduce care home falls, and (ii) the potential direction and magnitude of the effect of the intervention in terms of number of falls in care home residents.

Methods: Informed by Medical Research Council guidance on developing and evaluating complex interventions, we conducted a single blind, pilot randomised controlled trial in six care homes in the East of Scotland. Participants were randomised to either: (i) a three month podiatry intervention comprising core podiatry care, foot and ankle exercises, orthoses and footwear provision or (ii) usual care. Falls-related outcomes (number of falls, time to first fall) and feasibility-related outcomes (recruitment, retention, adherence, data collection rates) were collected. Secondary outcomes included: generic health status, balance, mobility, falls efficacy, and ankle joint strength.

Results: 474 care home residents were screened. 43 (9.1%) participants were recruited: 23 to the intervention, 20 to control. Nine (21%) participants were lost to follow-up due to declining health or death. It was feasible to deliver the trial elements in the care home setting. 35% of participants completed the exercise programme. 48% reported using the orthoses 'all or most of the time'. Completion rates of the outcome measures were between 93% and 100%. No adverse events were reported. At the nine month follow-up period, the intervention group per-person fall rate was 0.77 falls vs. 0.83 falls in the control group.

Conclusions: A podiatry intervention to reduce falls can be delivered to care home residents within a pilot randomised controlled trial of the intervention. Although not powered to determine effectiveness, these preliminary data provide justification for a larger trial, incorporating a full process evaluation, to determine whether this intervention can significantly reduce falls in this high-risk population.

Trial Registration: ClinicalTrials.gov identifier: NCT02178527 ; Date of registration: 17 June 2014.

Original languageEnglish
Article number143
Pages (from-to)1-13
Number of pages13
JournalBMC Geriatrics
Volume17
Issue number143
DOIs
Publication statusPublished - 12 Jul 2017

Fingerprint

Podiatry
Home Care Services
Randomized Controlled Trials
Orthotic Devices
Foot
Population
Independent Living
Ankle Joint
Lost to Follow-Up
Scotland
Ankle
Health Status
Biomedical Research
Outcome Assessment (Health Care)
Control Groups
Health

Keywords

  • Older people
  • Falls
  • Podiatry
  • Care homes

Cite this

Wylie, Gavin ; Menz, Hylton B. ; McFarlane, Sarah ; Ogston, Simon ; Sullivan, Frank ; Williams, Brian ; Young, Zoe ; Morris, Jacqui. / Podiatry intervention versus usual care to prevent falls in care homes : pilot randomised controlled trial (the PIRFECT study). In: BMC Geriatrics. 2017 ; Vol. 17, No. 143. pp. 1-13.
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abstract = "Background: Common foot problems are independent risk factors for falls in older people. There is evidence that podiatry can prevent falls in community-dwelling populations. The feasibility of implementing a podiatry intervention and trial in the care home population is unknown. To inform a potential future definitive trial, we performed a pilot randomised controlled trial to assess: (i) the feasibility of a trial of a podiatry intervention to reduce care home falls, and (ii) the potential direction and magnitude of the effect of the intervention in terms of number of falls in care home residents.Methods: Informed by Medical Research Council guidance on developing and evaluating complex interventions, we conducted a single blind, pilot randomised controlled trial in six care homes in the East of Scotland. Participants were randomised to either: (i) a three month podiatry intervention comprising core podiatry care, foot and ankle exercises, orthoses and footwear provision or (ii) usual care. Falls-related outcomes (number of falls, time to first fall) and feasibility-related outcomes (recruitment, retention, adherence, data collection rates) were collected. Secondary outcomes included: generic health status, balance, mobility, falls efficacy, and ankle joint strength.Results: 474 care home residents were screened. 43 (9.1{\%}) participants were recruited: 23 to the intervention, 20 to control. Nine (21{\%}) participants were lost to follow-up due to declining health or death. It was feasible to deliver the trial elements in the care home setting. 35{\%} of participants completed the exercise programme. 48{\%} reported using the orthoses 'all or most of the time'. Completion rates of the outcome measures were between 93{\%} and 100{\%}. No adverse events were reported. At the nine month follow-up period, the intervention group per-person fall rate was 0.77 falls vs. 0.83 falls in the control group.Conclusions: A podiatry intervention to reduce falls can be delivered to care home residents within a pilot randomised controlled trial of the intervention. Although not powered to determine effectiveness, these preliminary data provide justification for a larger trial, incorporating a full process evaluation, to determine whether this intervention can significantly reduce falls in this high-risk population.Trial Registration: ClinicalTrials.gov identifier: NCT02178527 ; Date of registration: 17 June 2014.",
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Podiatry intervention versus usual care to prevent falls in care homes : pilot randomised controlled trial (the PIRFECT study). / Wylie, Gavin; Menz, Hylton B.; McFarlane, Sarah; Ogston, Simon; Sullivan, Frank; Williams, Brian; Young, Zoe; Morris, Jacqui.

In: BMC Geriatrics, Vol. 17, No. 143, 143, 12.07.2017, p. 1-13.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Podiatry intervention versus usual care to prevent falls in care homes

T2 - pilot randomised controlled trial (the PIRFECT study)

AU - Wylie, Gavin

AU - Menz, Hylton B.

AU - McFarlane, Sarah

AU - Ogston, Simon

AU - Sullivan, Frank

AU - Williams, Brian

AU - Young, Zoe

AU - Morris, Jacqui

N1 - This study was funded by the Chief Scientist Office, Scottish Government Health Department (reference: CZH/4/701).

PY - 2017/7/12

Y1 - 2017/7/12

N2 - Background: Common foot problems are independent risk factors for falls in older people. There is evidence that podiatry can prevent falls in community-dwelling populations. The feasibility of implementing a podiatry intervention and trial in the care home population is unknown. To inform a potential future definitive trial, we performed a pilot randomised controlled trial to assess: (i) the feasibility of a trial of a podiatry intervention to reduce care home falls, and (ii) the potential direction and magnitude of the effect of the intervention in terms of number of falls in care home residents.Methods: Informed by Medical Research Council guidance on developing and evaluating complex interventions, we conducted a single blind, pilot randomised controlled trial in six care homes in the East of Scotland. Participants were randomised to either: (i) a three month podiatry intervention comprising core podiatry care, foot and ankle exercises, orthoses and footwear provision or (ii) usual care. Falls-related outcomes (number of falls, time to first fall) and feasibility-related outcomes (recruitment, retention, adherence, data collection rates) were collected. Secondary outcomes included: generic health status, balance, mobility, falls efficacy, and ankle joint strength.Results: 474 care home residents were screened. 43 (9.1%) participants were recruited: 23 to the intervention, 20 to control. Nine (21%) participants were lost to follow-up due to declining health or death. It was feasible to deliver the trial elements in the care home setting. 35% of participants completed the exercise programme. 48% reported using the orthoses 'all or most of the time'. Completion rates of the outcome measures were between 93% and 100%. No adverse events were reported. At the nine month follow-up period, the intervention group per-person fall rate was 0.77 falls vs. 0.83 falls in the control group.Conclusions: A podiatry intervention to reduce falls can be delivered to care home residents within a pilot randomised controlled trial of the intervention. Although not powered to determine effectiveness, these preliminary data provide justification for a larger trial, incorporating a full process evaluation, to determine whether this intervention can significantly reduce falls in this high-risk population.Trial Registration: ClinicalTrials.gov identifier: NCT02178527 ; Date of registration: 17 June 2014.

AB - Background: Common foot problems are independent risk factors for falls in older people. There is evidence that podiatry can prevent falls in community-dwelling populations. The feasibility of implementing a podiatry intervention and trial in the care home population is unknown. To inform a potential future definitive trial, we performed a pilot randomised controlled trial to assess: (i) the feasibility of a trial of a podiatry intervention to reduce care home falls, and (ii) the potential direction and magnitude of the effect of the intervention in terms of number of falls in care home residents.Methods: Informed by Medical Research Council guidance on developing and evaluating complex interventions, we conducted a single blind, pilot randomised controlled trial in six care homes in the East of Scotland. Participants were randomised to either: (i) a three month podiatry intervention comprising core podiatry care, foot and ankle exercises, orthoses and footwear provision or (ii) usual care. Falls-related outcomes (number of falls, time to first fall) and feasibility-related outcomes (recruitment, retention, adherence, data collection rates) were collected. Secondary outcomes included: generic health status, balance, mobility, falls efficacy, and ankle joint strength.Results: 474 care home residents were screened. 43 (9.1%) participants were recruited: 23 to the intervention, 20 to control. Nine (21%) participants were lost to follow-up due to declining health or death. It was feasible to deliver the trial elements in the care home setting. 35% of participants completed the exercise programme. 48% reported using the orthoses 'all or most of the time'. Completion rates of the outcome measures were between 93% and 100%. No adverse events were reported. At the nine month follow-up period, the intervention group per-person fall rate was 0.77 falls vs. 0.83 falls in the control group.Conclusions: A podiatry intervention to reduce falls can be delivered to care home residents within a pilot randomised controlled trial of the intervention. Although not powered to determine effectiveness, these preliminary data provide justification for a larger trial, incorporating a full process evaluation, to determine whether this intervention can significantly reduce falls in this high-risk population.Trial Registration: ClinicalTrials.gov identifier: NCT02178527 ; Date of registration: 17 June 2014.

KW - Older people

KW - Falls

KW - Podiatry

KW - Care homes

U2 - 10.1186/s12877-017-0541-1

DO - 10.1186/s12877-017-0541-1

M3 - Article

C2 - 28701161

VL - 17

SP - 1

EP - 13

JO - BMC Geriatrics

JF - BMC Geriatrics

SN - 1471-2318

IS - 143

M1 - 143

ER -