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

Accidental Falls Clinical Trial

— PIRFECT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02178527
• Other study ID #: 2010GR10
• Secondary ID: CZH/4/701
• Status: Completed
• Phase: N/A
• First received: June 17, 2014
• Last updated: October 7, 2015
• Start date: January 2013
• Est. completion date: June 2015

Study information

• Verified date: October 2015
• Source: NHS Tayside
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Accidental Falls

Intervention

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.
• Usual Care
Usual general podiatry care provded by UK National Health Service

Locations

Country	Name	City	State
United Kingdom	Glencairn House Care Home	Auchterarder
United Kingdom	Ancaster Care Home	Crieff
United Kingdom	Balcarres Care Home	Dundee
United Kingdom	Harestane Care Home	Dundee
United Kingdom	Janet Brougham House	Dundee
United Kingdom	Orchar Care Home	Dundee
United Kingdom	Rivendell Care Home	Dunkeld
United Kingdom	Craigieknowes Care Home	Perth
United Kingdom	Kincarrathie House Care Home	Perth

Sponsors (5)

Lead Sponsor	Collaborator
NHS Tayside	La Trobe University, University of Dundee, University of Stirling, University of Toronto

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in falls rate	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	Yes
Secondary	Functional Balance: Berg Balance Scale		Baseline, 3 months from baseline measures, 6 months from baseline, 9 months from baseline	No
Secondary	Mobility: Timed up and go test		Baseline, 3 months from baseline measures, 6 months from baseline, 9 months from baseline	No
Secondary	Physical Functioning: Barthel Index		Baseline, 3 months from baseline measures, 6 months from baseline, 9 months from baseline	No
Secondary	Health Related Quality of Life: EQ-5D		Baseline, 3 months from baseline measures, 6 months from baseline, 9 months from baseline	No
Secondary	Foot and Ankle Strength	Measured via hand held dynamometry	Baseline, 3 months from baseline measures, 6 months from baseline, 9 months from baseline	No
Secondary	Falls efficacy: Nursing home falls self efficacy scale		Baseline, 3 months from baseline measures, 6 months from baseline, 9 months from baseline	No