NCT02178527

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2013

Typical duration for not_applicable

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

June 17, 2014

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 30, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

October 12, 2015

Status Verified

October 1, 2015

Enrollment Period

2.4 years

First QC Date

June 17, 2014

Last Update Submit

October 7, 2015

Conditions

Accidental Falls

Keywords

GeriatricsAccidental FallsPodiatryExercise TherapyOrthotic DevicesFoot

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (6)

  • 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

  • +1 more secondary outcomes

Study Arms (2)

Mulitfaceted podiatry Intervention

EXPERIMENTAL

Foot and ankle exercises, foot orthoses, footwear provision

Other: Foot and ankle exercises, foot orthoses, footwear provision

Usual podiatry care

PLACEBO COMPARATOR

Continued provision of usual NHS (National Health Service) podiatry care

Other: Usual Care

Interventions

Foot and ankle exercises, foot orthoses, footwear provisionOTHER

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.

Mulitfaceted podiatry Intervention
Usual CareOTHER

Usual general podiatry care provded by UK National Health Service

Usual podiatry care

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Glencairn House Care Home

Auchterarder, PH3 1AD, United Kingdom

Location

Ancaster Care Home

Crieff, PH7 3JU, United Kingdom

Location

Harestane Care Home

Dundee, DD3 0NY, United Kingdom

Location

Janet Brougham House

Dundee, DD4 7TQ, United Kingdom

Location

Balcarres Care Home

Dundee, DD5 1NW, United Kingdom

Location

Orchar Care Home

Dundee, DD5 2BG, United Kingdom

Location

Rivendell Care Home

Dunkeld, PH8 0BL, United Kingdom

Location

Craigieknowes Care Home

Perth, PH2 0DG, United Kingdom

Location

Kincarrathie House Care Home

Perth, PH2 7HX, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 28701161DERIVED

MeSH Terms

Interventions

Foot Orthoses

Intervention Hierarchy (Ancestors)

Orthotic DevicesOrthopedic EquipmentSurgical EquipmentEquipment and Supplies

Study Officials

  • Gavin H Wylie, MSc

    NHS (National Health Service) Tayside / University of Dundee

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

June 17, 2014

First Posted

June 30, 2014

Study Start

January 1, 2013

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

October 12, 2015

Record last verified: 2015-10

Locations

GB(9)