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

Sponsor

NHS Tayside (Other)

Overall Status

Completed

CT.gov ID

NCT02178527

Collaborator

University of Stirling (Other), La Trobe University (Other), University of Toronto (Other), University of Dundee (Other)

Enrollment

Locations

Arms

28.9

Duration (Months)

5.2

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Accidental Falls	Other: Foot and ankle exercises, foot orthoses, footwear provision Other: Usual Care	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

47 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2013

Actual Primary Completion Date :

Jun 1, 2015

Actual Study Completion Date :

Jun 1, 2015

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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]
Physical Functioning: Barthel Index [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]
Foot and Ankle Strength [Baseline, 3 months from baseline measures, 6 months from baseline, 9 months from baseline]
Measured via hand held dynamometry
Falls efficacy: Nursing home falls self efficacy scale [Baseline, 3 months from baseline measures, 6 months from baseline, 9 months from baseline]

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Glencairn House Care Home	Auchterarder	United Kingdom	PH3 1AD
2	Ancaster Care Home	Crieff	United Kingdom	PH7 3JU
3	Harestane Care Home	Dundee	United Kingdom	DD3 0NY
4	Janet Brougham House	Dundee	United Kingdom	DD4 7TQ
5	Balcarres Care Home	Dundee	United Kingdom	DD5 1NW
6	Orchar Care Home	Dundee	United Kingdom	DD5 2BG
7	Rivendell Care Home	Dunkeld	United Kingdom	PH8 0BL
8	Craigieknowes Care Home	Perth	United Kingdom	PH2 0DG
9	Kincarrathie House Care Home	Perth	United Kingdom	PH2 7HX