Clinical trial NCT02178527: Podiatry Intervention to Reduce Falls in Elderly Care Trial (PIRFECT)
Official title: A Podiatry Intervention to Reduce Falls in Care Home Residents: Development, Feasibility and Acceptability Study With Exploratory Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Accidental Falls
Keywords: Geriatrics
Accidental Falls
Podiatry
Exercise Therapy
Orthotic Devices
Foot
Lead sponsor: NHS Tayside
Sponsor class: OTHER_GOV
Collaborators: name: University of Stirling
name: La Trobe University
name: University of Toronto
name: University of Dundee
First posted: 2014-06-30
Enrollment: 47
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in falls rate
timeFrame: 3 months from baseline measures, 6 months from baseline, 9 months from baseline
Secondary outcomes:
measure: Functional Balance: Berg Balance Scale
timeFrame: Baseline, 3 months from baseline measures, 6 months from baseline, 9 months from baseline
measure: Mobility: Timed up and go test
timeFrame: Baseline, 3 months from baseline measures, 6 months from baseline, 9 months from baseline
measure: Physical Functioning: Barthel Index
timeFrame: Baseline, 3 months from baseline measures, 6 months from baseline, 9 months from baseline
measure: Health Related Quality of Life: EQ-5D
timeFrame: Baseline, 3 months from baseline measures, 6 months from baseline, 9 months from baseline
measure: Foot and Ankle Strength
timeFrame: Baseline, 3 months from baseline measures, 6 months from baseline, 9 months from baseline
measure: Falls efficacy: Nursing home falls self efficacy scale
timeFrame: Baseline, 3 months from baseline measures, 6 months from baseline, 9 months from baseline
Other outcomes:
Locations:
city: Auchterarder
country: United Kingdom
facility: Glencairn House Care Home
city: Crieff
country: United Kingdom
facility: Ancaster Care Home
city: Dundee
country: United Kingdom
facility: Harestane Care Home
city: Dundee
country: United Kingdom
facility: Janet Brougham House
city: Dundee
country: United Kingdom
facility: Balcarres Care Home
city: Dundee
country: United Kingdom
facility: Orchar Care Home
city: Dunkeld
country: United Kingdom
facility: Rivendell Care Home
city: Perth
country: United Kingdom
facility: Craigieknowes Care Home
city: Perth
country: United Kingdom
facility: Kincarrathie House Care Home
Study officials:
affiliation: NHS (National Health Service) Tayside / University of Dundee
name: Gavin H Wylie, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wylie G, Menz HB, McFarlane S, Ogston S, Sullivan F, Williams B, Young Z, Morris J. Podiatry intervention versus usual care to prevent falls in care homes: pilot randomised controlled trial (the PIRFECT study). BMC Geriatr. 2017 Jul 12;17(1):143. doi: 10.1186/s12877-017-0541-1.