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

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.

Keywords: Care homes; Falls; Older people; Podiatry.

Conflict of interest statement

Ethics approval and consent to participate

Ethics approval for this study was sought and obtained from the East of Scotland Research Ethics Service (EoSRES), reference number ES/12/0088. The decision to recruit was based on the ability of the prospective participant to explain back to the research podiatrist what was required by their participation in the study. Written consent to take part was obtained form each participant.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
CONSORT flow of participants through study

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