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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00817869
Other study ID # 13247
Secondary ID UKCRN ID: 5735
Status Completed
Phase N/A
First received January 6, 2009
Last updated November 28, 2014
Start date April 2010
Est. completion date August 2011

Study information

Verified date November 2014
Source University of Portsmouth
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Department of HealthUnited Kingdom: National Health ServiceUnited Kingdom: Research Ethics Committee
Study type Interventional

Clinical Trial 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.


Description:

We will carry out the study in eight elderly care wards across England. We will first study the wards for up to 6 months. Then, half of the wards will have the new floor laid. Wards will be chosen to receive the new floor, or remain with a standard floor, by chance. The new floor has 'shock-absorbent' properties. We will study all the wards for another 12 months. This will allow us to compare the new flooring with the normal flooring.


Recruitment information / eligibility

Status Completed
Enrollment 571
Est. completion date August 2011
Est. primary completion date August 2011
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United Kingdom Ruby Ward, Ellesmere Port Hospital Ellesmere Port Merseyside
United Kingdom Ward C5, Diana Princess of Wales Hospital Grimsby North East Lincolnshire
United Kingdom Granby Ward, Harrogate District Hospital Harrogate North Yorkshire
United Kingdom Ward 15, Newcastle Freeman Hospital Newcastle-upon-Tyne Tyne and Wear
United Kingdom Newchurch Ward, St Mary's Hospital Newport Isle of Wight
United Kingdom Ward D1, Queen Alexandra Hospital Portsmouth Hampshire
United Kingdom Draycott Ward, Weston General Hospital Weston-super-Mare Somerset
United Kingdom Ward 25, York District Hospital York Yorkshire

Sponsors (9)

Lead Sponsor Collaborator
University of Portsmouth Department of Health, United Kingdom, Health & Safety Laboratory, National Osteoporosis Society, National Patient Safety Agency, Portsmouth Hospitals NHS Trust, The Dunhill Medical Trust, University of Bath, University of Sheffield

Country where clinical trial is conducted

United Kingdom, 

References & 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. — View Citation

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/aft06 — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary fall-related injury Study duration = 18 months. Outcome measured for each patient for duration of stay in ward (approx. 30 days). Yes
Secondary Number of falls Study duration = 18 months. Outcome measured for each patient for duration of stay in ward (approx. 30 days). Yes
Secondary Unexpected adverse events Study duration = 18 months. Outcome measured for each patient for duration of stay in ward (approx. 30 days). Yes
Secondary Slip resistance of flooring Measured at 4 time-points over 1.5 years (1 month; 6 months; 12 months; 18 months) Yes
Secondary Shock-absorbency of flooring Measured at 4 time-points over 1.5 years (1 month; 6 months; 12 months; 18 months) Yes
Secondary Place of residence (for cost-effectiveness analysis) Each patient followed-up 3 months post-discharge No
Secondary Quality of life (for cost-effectiveness analysis) Each patient followed-up 3 months post-discharge No
Secondary Number of hospital re-admissions (for cost-effectiveness analysis) Each patient followed-up 3 months post-discharge No
Secondary User views (patients and staff) Collected during 1 year follow-up of intervention sites (months 6 to 18) No
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