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

Not Applicable

Completed

• Conditions: Accidental Falls
• Interventions: Other: Usual Care; Other: Foot and ankle exercises, foot orthoses, footwear provision

• Registration Number: NCT02178527
• Lead Sponsor: NHS Tayside

Brief Summary

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

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 Timeline

• Study Start: 2013-01
• Study First Submitted: 2014-06-17
• Study First Submitted QC: 2014-06-27
• Study First Posted: 2014-06-30
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-07
• Last Update Posted: 2015-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual podiatry care	Usual Care	Continued provision of usual NHS (National Health Service) podiatry care
Mulitfaceted podiatry Intervention	Foot and ankle exercises, foot orthoses, footwear provision	Foot and ankle exercises, foot orthoses, footwear provision

Primary Outcome Measures

Name	Time	Method
Change in falls rate	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"

Secondary Outcome Measures

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

Trial Locations

Locations (9)

Ancaster Care Home; 🇬🇧 Crieff, United Kingdom

Harestane Care Home; 🇬🇧 Dundee, United Kingdom

Glencairn House Care Home; 🇬🇧 Auchterarder, United Kingdom

Balcarres Care Home; 🇬🇧 Dundee, United Kingdom

Craigieknowes Care Home; 🇬🇧 Perth, United Kingdom

Rivendell Care Home; 🇬🇧 Dunkeld, United Kingdom

Kincarrathie House Care Home; 🇬🇧 Perth, United Kingdom

Orchar Care Home; 🇬🇧 Dundee, United Kingdom

Janet Brougham House; 🇬🇧 Dundee, United Kingdom