Podiatry Intervention to Reduce Falls in Elderly Care Trial (PIRFECT) (PIRFECT)

October 7, 2015 updated by: Gavin Wylie, NHS Tayside

A Podiatry Intervention to Reduce Falls in Care Home Residents: Development, Feasibility and Acceptability Study With Exploratory Randomised Controlled Trial

This is an exploratory pilot Randomised Controlled Trial (RCT) to investigate the effects of a multifaceted podiatry intervention designed to reduce falls in care homes. The investigators hypothesise that the intervention will reduce the high falls rates present in care homes for older people, compared to usual care.

The results will inform the sample size calculation for a full-scale definitive RCT

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background: Falls are a problem in care homes where it is estimated that half of all residents will fall at least once in a year. There is now strong empirical evidence that weakness of the foot muscles and painful foot problems such as corns and/or callus are a contributing factor to falls in this population. These problems are common and reversible; however there have been no trials of podiatry interventions that address these problems to establish whether or not this approach can be effective at reducing falls in care home populations.

Methods: Care home residents meeting the inclusion criteria will be assigned to receive either the intervention (specific foot and ankle exercises, orthoses, footwear). We will then conduct an exploratory randomised controlled trial (RCT) with the aim of acquiring data that will inform the design of a subsequent full scale RCT. The groups will then be compared on a number of balance and falls related outcomes.

Main Outcome: The results will indicate the effect size to allow a sample size calculation for a later definitive trial to be conducted.

Study Type

Interventional

Enrollment (Actual)

47

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Auchterarder, United Kingdom, PH3 1AD
        • Glencairn House Care Home
      • Crieff, United Kingdom, PH7 3JU
        • Ancaster Care Home
      • Dundee, United Kingdom, DD3 0NY
        • Harestane Care Home
      • Dundee, United Kingdom, DD4 7TQ
        • Janet Brougham House
      • Dundee, United Kingdom, DD5 1NW
        • Balcarres Care Home
      • Dundee, United Kingdom, DD5 2BG
        • Orchar Care Home
      • Dunkeld, United Kingdom, PH8 0BL
        • Rivendell Care Home
      • Perth, United Kingdom, PH2 0DG
        • Craigieknowes Care Home
      • Perth, United Kingdom, PH2 7HX
        • Kincarrathie House Care Home

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 65 Years or older permanently living in care homes for older people
  • One or more falls in the previous year.
  • Foot problem that is within the scope of podiatry care

Exclusion Criteria:

  • Residents who are terminally unwell or too frail to be included
  • Residents who are only able to mobilise with the use of a wheelchair
  • Temporary residents (for example, those in respite care)
  • Unable to provide informed consent
  • Lower limb Amputees

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mulitfaceted podiatry Intervention
Foot and ankle exercises, foot orthoses, footwear provision
Other: Foot and ankle exercises, foot orthoses, footwear provision
Participants in the intervention group will receive orthoses and footwear as part of the study. The research team will train care home staff in the provision of foot and ankle exercises. The exercise protocol states that exercises will be carried out 3 times per week for 12 weeks.
Placebo Comparator: Usual podiatry care
Continued provision of usual NHS (National Health Service) podiatry care
Other: Usual Care
Usual general podiatry care provded by UK National Health Service

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in falls rate
Time Frame: 3 months from baseline measures, 6 months from baseline, 9 months from baseline
A fall will be defined as "an unexpected event in which the participant comes to rest on the ground, floor, or lower level"
3 months from baseline measures, 6 months from baseline, 9 months from baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional Balance: Berg Balance Scale
Time Frame: Baseline, 3 months from baseline measures, 6 months from baseline, 9 months from baseline
Baseline, 3 months from baseline measures, 6 months from baseline, 9 months from baseline
Mobility: Timed up and go test
Time Frame: Baseline, 3 months from baseline measures, 6 months from baseline, 9 months from baseline
Baseline, 3 months from baseline measures, 6 months from baseline, 9 months from baseline
Physical Functioning: Barthel Index
Time Frame: Baseline, 3 months from baseline measures, 6 months from baseline, 9 months from baseline
Baseline, 3 months from baseline measures, 6 months from baseline, 9 months from baseline
Health Related Quality of Life: EQ-5D
Time Frame: Baseline, 3 months from baseline measures, 6 months from baseline, 9 months from baseline
Baseline, 3 months from baseline measures, 6 months from baseline, 9 months from baseline
Foot and Ankle Strength
Time Frame: Baseline, 3 months from baseline measures, 6 months from baseline, 9 months from baseline
Measured via hand held dynamometry
Baseline, 3 months from baseline measures, 6 months from baseline, 9 months from baseline
Falls efficacy: Nursing home falls self efficacy scale
Time Frame: Baseline, 3 months from baseline measures, 6 months from baseline, 9 months from baseline
Baseline, 3 months from baseline measures, 6 months from baseline, 9 months from baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NHS Tayside

Collaborators

University of Toronto
University of Dundee
University of Stirling
La Trobe University

Investigators

  • Principal Investigator: Gavin H Wylie, MSc, NHS (National Health Service) Tayside / University of Dundee

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

June 17, 2014

First Submitted That Met QC Criteria

June 27, 2014

First Posted (Estimate)

June 30, 2014

Study Record Updates

Last Update Posted (Estimate)

October 12, 2015

Last Update Submitted That Met QC Criteria

October 7, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2010GR10
  • CZH/4/701 (Other Grant/Funding Number: Chief Scientist Office, Scottish Goverment)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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