Flooring for Injury Prevention Trial

NCT ID: NCT01618786

Last Updated: 2022-05-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

151 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-01

Study Completion Date

2019-08-31

Brief Summary

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This study will evaluate the efficacy of novel compliant flooring in reducing injuries due to falls in a long-term care facility, determine the cost effectiveness of this intervention, and assess perceptions about compliant flooring among staff, residents, and families.

The investigators hypothesize that compliant flooring will (1) reduce the incidence of injuries due to falls in long-term care residents; (2) represent an overall cost-savings when material and implementation costs are considered relative to direct and indirect costs associated with injuries due to falls; and (3) be received positively by staff, residents, and their family members.

Detailed Description

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Falls are the number one cause of unintentional injury among older adults in Canada, and are responsible for economic costs in excess of $1 billion CAD annually. In high-risk environments, such as long-term care (LTC) facilities, 60% of residents will experience at least one fall each year. Moreover, approximately 30% of falls in LTC residents result in injury, and 3 to 5% cause fractures.

A promising strategy for reducing the incidence of fall-related injuries in LTC facilities is to decrease the stiffness of the ground surface, and the subsequent force applied to the body parts at impact. Purpose-designed compliant flooring can reduce the force applied to the hip during a fall by up to 35 % (to allow a raw egg to be successfully bounced without cracking). Yet, few LTC facilities have flooring designed to reduce the impact of falls. This study will address this gap.

Resident rooms at a local LTC facility will be randomly assigned to installation of compliant flooring or control (non-compliant) flooring. Following installation, primary and secondary outcomes, including fall-related injuries and falls, will be monitored for 4 years and compared between resident rooms with and without compliant flooring. In addition, health resource utilization and their costs will be compared between resident rooms with and without compliant flooring. Perceptions about compliant flooring will be assessed among staff, residents, and their families.

Conditions

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Accidental Falls Bone Fracture Traumatic Brain Injury Head Injuries, Closed Nursing Homes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Compliant Flooring (CF)

Compliant flooring

Group Type EXPERIMENTAL

SmartCell flooring

Intervention Type OTHER

SmartCell (SATECH Inc., Chehalis, WA, USA) is a continuous rubber surface layer supported by an array of cylindrical rubber columns 14 mm in diameter, and spaced at 19 mm intervals. It has a surface hardness of 50 durometer. It has been reported to provide approximately 35% peak force attenuation during mechanical tests that simulate falls on the hip. It has also been reported to have minimal effect on balance and mobility of older women during activities of daily living. It will be covered with hospital-grade vinyl and will be inspected regularly for maintenance requirements.

Control (CON)

Non-compliant flooring

Group Type PLACEBO_COMPARATOR

Plywood flooring

Intervention Type OTHER

Plywood flooring covered with the same hospital-grade vinyl as the SmartCell flooring.

Interventions

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SmartCell flooring

SmartCell (SATECH Inc., Chehalis, WA, USA) is a continuous rubber surface layer supported by an array of cylindrical rubber columns 14 mm in diameter, and spaced at 19 mm intervals. It has a surface hardness of 50 durometer. It has been reported to provide approximately 35% peak force attenuation during mechanical tests that simulate falls on the hip. It has also been reported to have minimal effect on balance and mobility of older women during activities of daily living. It will be covered with hospital-grade vinyl and will be inspected regularly for maintenance requirements.

Intervention Type OTHER

Plywood flooring

Plywood flooring covered with the same hospital-grade vinyl as the SmartCell flooring.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Resident rooms across four units at New Vista Society Care Home, a long-term care facility in Burnaby, BC, Canada

Exclusion Criteria

* Resident rooms across four units at New Vista Society Care Home in which new flooring cannot be installed
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role collaborator

AGE-WELL, Inc

UNKNOWN

Sponsor Role collaborator

Fraser Health Authority

UNKNOWN

Sponsor Role collaborator

Centre for Hip Health and Mobility

UNKNOWN

Sponsor Role collaborator

New Vista Society Care Home

UNKNOWN

Sponsor Role collaborator

Michael Smith Foundation for Health Research

OTHER

Sponsor Role collaborator

Canada Research Chair Program

UNKNOWN

Sponsor Role collaborator

Natural Sciences and Engineering Research Council, Canada

OTHER

Sponsor Role collaborator

Dr. Stephen Robinovitch

OTHER

Sponsor Role lead

Responsible Party

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Dr. Stephen Robinovitch

Professor, Department of Biomedical Physiology and Kinesiology

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Dawn C Mackey, PhD

Role: PRINCIPAL_INVESTIGATOR

Simon Fraser University

Fabio Feldman, PhD

Role: PRINCIPAL_INVESTIGATOR

Fraser Health Authority

Andrew C Laing, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Waterloo

Stephen N Robinovitch, PhD

Role: PRINCIPAL_INVESTIGATOR

Simon Fraser University

Locations

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New Vista Care Home

Burnaby, British Columbia, Canada

Site Status

Countries

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Canada

References

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Lachance CC, Feldman F, Laing AC, Leung PM, Robinovitch SN, Mackey DC. Study protocol for the Flooring for Injury Prevention (FLIP) Study: a randomised controlled trial in long-term care. Inj Prev. 2016 Dec;22(6):453-460. doi: 10.1136/injuryprev-2016-042008. Epub 2016 Apr 4.

Reference Type BACKGROUND
PMID: 27044272 (View on PubMed)

Mackey DC, Lachance CC, Wang PT, Feldman F, Laing AC, Leung PM, Hu XJ, Robinovitch SN. The Flooring for Injury Prevention (FLIP) Study of compliant flooring for the prevention of fall-related injuries in long-term care: A randomized trial. PLoS Med. 2019 Jun 24;16(6):e1002843. doi: 10.1371/journal.pmed.1002843. eCollection 2019 Jun.

Reference Type DERIVED
PMID: 31233541 (View on PubMed)

Related Links

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http://www.sfu.ca/tips

Technology for Injury Prevention in Seniors (TIPS)

Other Identifiers

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TIR 103945

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

TIPS-001

Identifier Type: -

Identifier Source: org_study_id

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