Flooring for Injury Prevention Trial

NCT01618786 | Completed DMC

• 2 other identifiers: TIPS-001TIR 103945
• Study Type: interventional
• Target: 151
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

Falls; Fall injuries; Bone fracture; Hip fracture; Skull fracture; Wounds; Closed head injury; Traumatic brain injury; Concussion; Spinal cord injury; Trauma; Older adults; Long-term care; Compliant flooring; Safety floors; Balance; Injury biomechanics; Biomedical engineering; Environmental hazards; Environmental interventions; Fall prevention; Gerontology

Outcome Measures

Primary Outcomes (1)

• Fall-related injuries

  Moderate and serious injuries that result from falls in resident rooms. Assessed from incident and follow-up reports at participating long-term care facility.

  4 years

Secondary Outcomes (4)

• Falls

  4 years

• Fractures

  4 years

• Health resource utilization

  4 years

• Musculoskeletal injuries

  4 years

Study Arms (2)

Compliant Flooring (CF)

EXPERIMENTAL

Compliant flooring

Other: SmartCell flooring

Control (CON)

PLACEBO COMPARATOR

Non-compliant flooring

Other: Plywood flooring

Interventions

SmartCell flooring 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.

Compliant Flooring (CF)

Plywood flooring OTHER

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

Control (CON)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Dr. Stephen Robinovitch: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• AGE-WELL, Inc: collaborator
• Fraser Health Authority: collaborator
• Centre for Hip Health and Mobility: collaborator
• New Vista Society Care Home: collaborator
• Michael Smith Foundation for Health Research: collaborator
• Canada Research Chair Program: collaborator
• Natural Sciences and Engineering Research Council, Canada: collaborator

Study Sites (1)

New Vista Care Home

Burnaby, British Columbia, V5E 3Z3, Canada

Location

Related Publications (2)

• 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.

  PMID: 27044272 BACKGROUND

• 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.

  PMID: 31233541 DERIVED

Related Links

• Technology for Injury Prevention in Seniors (TIPS)

MeSH Terms

Conditions

Fractures, Bone; Brain Injuries, Traumatic; Head Injuries, Closed; Hip Fractures; Skull Fractures; Wounds and Injuries; Brain Concussion; Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds, Nonpenetrating; Femoral Fractures; Hip Injuries; Leg Injuries; Spinal Cord Diseases

Study Officials

• Dawn C Mackey, PhD

  Simon Fraser University

  PRINCIPAL INVESTIGATOR

• Fabio Feldman, PhD

  Fraser Health Authority

  PRINCIPAL INVESTIGATOR

• Andrew C Laing, PhD

  University of Waterloo

  PRINCIPAL INVESTIGATOR

• Stephen N Robinovitch, PhD

  Simon Fraser University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Department of Biomedical Physiology and Kinesiology

Study Record Dates

• First Submitted: June 11, 2012
• First Posted: June 13, 2012
• Study Start: September 1, 2013
• Primary Completion: August 31, 2017
• Study Completion: August 1, 2019
• Last Updated: May 4, 2022

Record last verified: 2019-01

Locations

CA (1)