NCT00817869

Brief Summary

In hospitals, older people can fall and hurt themselves. The investigators want to see if a new type of flooring can help stop people hurting themselves as badly, if they accidentally fall.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
571

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2010

Geographic Reach
1 country

8 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

First Submitted

Initial submission to the registry

January 6, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 7, 2009

Completed
1.2 years until next milestone

Study Start

First participant enrolled

April 1, 2010

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

December 2, 2014

Status Verified

November 1, 2014

Enrollment Period

1.3 years

First QC Date

January 6, 2009

Last Update Submit

November 28, 2014

Conditions

Accidental Falls

Keywords

Floors and FloorcoveringsHealth Services for the AgedFractures, boneDelirium, Dementia, Amnestic, Cognitive DisordersFrail ElderlyAged, 80 and over

Outcome Measures

Primary Outcomes (1)

  • fall-related injury

    Study duration = 18 months. Outcome measured for each patient for duration of stay in ward (approx. 30 days).

Secondary Outcomes (8)

  • Number of falls

    Study duration = 18 months. Outcome measured for each patient for duration of stay in ward (approx. 30 days).

  • Unexpected adverse events

    Study duration = 18 months. Outcome measured for each patient for duration of stay in ward (approx. 30 days).

  • Slip resistance of flooring

    Measured at 4 time-points over 1.5 years (1 month; 6 months; 12 months; 18 months)

  • Shock-absorbency of flooring

    Measured at 4 time-points over 1.5 years (1 month; 6 months; 12 months; 18 months)

  • Place of residence (for cost-effectiveness analysis)

    Each patient followed-up 3 months post-discharge

  • +3 more secondary outcomes

Study Arms (2)

New Flooring

EXPERIMENTAL

Will receive 8.3mm thick floor covering (Omnisports EXCEL) to replace previous floor covering.

Other: New flooring

Standard Flooring

NO INTERVENTION

Ward will remain with standard floor covering. The overlay will have a comparable slip resistance rating to the new flooring. The sub-floor will also be comparable.

Interventions

New flooringOTHER

8.3mm thick vinyl floor covering with foam backing, manufactured by Tarkett and installed by Tyndale Flooring Ltd.

Also known as: Omnisports EXCEL
New Flooring

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • all patients admitted to the study area on a participating elderly care ward

You may not qualify if:

  • none.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Ward D1, Queen Alexandra Hospital

Portsmouth, Hampshire, PO6 3LY, United Kingdom

Location

Newchurch Ward, St Mary's Hospital

Newport, Isle of Wight, PO30 5TG, United Kingdom

Location

Ruby Ward, Ellesmere Port Hospital

Ellesmere Port, Merseyside, CH65 6SG, United Kingdom

Location

Ward C5, Diana Princess of Wales Hospital

Grimsby, North East Lincolnshire, DN33 2BA, United Kingdom

Location

Granby Ward, Harrogate District Hospital

Harrogate, North Yorkshire, HG2 7SX, United Kingdom

Location

Draycott Ward, Weston General Hospital

Weston-super-Mare, Somerset, BS23 4TQ, United Kingdom

Location

Ward 15, Newcastle Freeman Hospital

Newcastle upon Tyne, Tyne and Wear, NE7 7DN, United Kingdom

Location

Ward 25, York District Hospital

York, Yorkshire, YO31 8HE, United Kingdom

Location

Related Publications (3)

  • Drahota A, Gal D, Windsor J, Dixon S, Udell J, Ward D, Soilemezi D, Dean T, Severs M. Pilot cluster randomised controlled trial of flooring to reduce injuries from falls in elderly care units: study protocol. Inj Prev. 2011 Dec;17(6):e7. doi: 10.1136/injuryprev-2011-040154. Epub 2011 Sep 2.

    PMID: 21890580BACKGROUND

  • Drahota AK, Ward D, Udell JE, Soilemezi D, Ogollah R, Higgins B, Dean TP, Severs M. Pilot cluster randomised controlled trial of flooring to reduce injuries from falls in wards for older people. Age Ageing. 2013 Sep;42(5):633-40. doi: 10.1093/ageing/aft067. Epub 2013 Jul 17.

    PMID: 23868093RESULT

  • Latimer N, Dixon S, Drahota AK, Severs M. Cost--utility analysis of a shock-absorbing floor intervention to prevent injuries from falls in hospital wards for older people. Age Ageing. 2013 Sep;42(5):641-5. doi: 10.1093/ageing/aft076. Epub 2013 Jul 9.

    PMID: 23838763RESULT

MeSH Terms

Conditions

Fractures, BoneNeurocognitive Disorders

Condition Hierarchy (Ancestors)

Wounds and InjuriesMental Disorders

Study Officials

  • Martin Severs

    University of Portsmouth

    STUDY CHAIR

  • Amy K Drahota

    University of Portsmouth

    STUDY DIRECTOR

  • Derek Ward

    University of Portsmouth

    PRINCIPAL INVESTIGATOR

  • Julie Udell

    University of Portsmouth

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 6, 2009

First Posted

January 7, 2009

Study Start

April 1, 2010

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

December 2, 2014

Record last verified: 2014-11

Locations

GB(8)