- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00817869
The HIP-HOP Flooring Study: Helping Injury Prevention in Hospitalised Older People
November 28, 2014 updated by: Martin Severs, University of Portsmouth
Pilot Cluster Randomised Controlled Trial of Flooring to Reduce Injuries From Falls in Elderly Care Units
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.
Study Overview
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
571
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Hampshire
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Portsmouth, Hampshire, United Kingdom, PO6 3LY
- Ward D1, Queen Alexandra Hospital
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Isle of Wight
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Newport, Isle of Wight, United Kingdom, PO30 5TG
- Newchurch Ward, St Mary's Hospital
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Merseyside
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Ellesmere Port, Merseyside, United Kingdom, CH65 6SG
- Ruby Ward, Ellesmere Port Hospital
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North East Lincolnshire
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Grimsby, North East Lincolnshire, United Kingdom, DN33 2BA
- Ward C5, Diana Princess of Wales Hospital
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North Yorkshire
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Harrogate, North Yorkshire, United Kingdom, HG2 7SX
- Granby Ward, Harrogate District Hospital
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Somerset
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Weston-super-Mare, Somerset, United Kingdom, BS23 4TQ
- Draycott Ward, Weston General Hospital
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Tyne and Wear
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Newcastle-upon-Tyne, Tyne and Wear, United Kingdom, NE7 7DN
- Ward 15, Newcastle Freeman Hospital
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Yorkshire
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York, Yorkshire, United Kingdom, YO31 8HE
- Ward 25, York District Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- all patients admitted to the study area on a participating elderly care ward
Exclusion Criteria:
- none.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: New Flooring
Will receive 8.3mm thick floor covering (Omnisports EXCEL) to replace previous floor covering.
|
8.3mm thick vinyl floor covering with foam backing, manufactured by Tarkett and installed by Tyndale Flooring Ltd.
Other Names:
|
|
No Intervention: Standard Flooring
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
fall-related injury
Time Frame: Study duration = 18 months. Outcome measured for each patient for duration of stay in ward (approx. 30 days).
|
Study duration = 18 months. Outcome measured for each patient for duration of stay in ward (approx. 30 days).
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Number of falls
Time Frame: Study duration = 18 months. Outcome measured for each patient for duration of stay in ward (approx. 30 days).
|
Study duration = 18 months. Outcome measured for each patient for duration of stay in ward (approx. 30 days).
|
|
Unexpected adverse events
Time Frame: Study duration = 18 months. Outcome measured for each patient for duration of stay in ward (approx. 30 days).
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Study duration = 18 months. Outcome measured for each patient for duration of stay in ward (approx. 30 days).
|
|
Slip resistance of flooring
Time Frame: Measured at 4 time-points over 1.5 years (1 month; 6 months; 12 months; 18 months)
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Measured at 4 time-points over 1.5 years (1 month; 6 months; 12 months; 18 months)
|
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Shock-absorbency of flooring
Time Frame: Measured at 4 time-points over 1.5 years (1 month; 6 months; 12 months; 18 months)
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Measured at 4 time-points over 1.5 years (1 month; 6 months; 12 months; 18 months)
|
|
Place of residence (for cost-effectiveness analysis)
Time Frame: Each patient followed-up 3 months post-discharge
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Each patient followed-up 3 months post-discharge
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Quality of life (for cost-effectiveness analysis)
Time Frame: Each patient followed-up 3 months post-discharge
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Each patient followed-up 3 months post-discharge
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Number of hospital re-admissions (for cost-effectiveness analysis)
Time Frame: Each patient followed-up 3 months post-discharge
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Each patient followed-up 3 months post-discharge
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User views (patients and staff)
Time Frame: Collected during 1 year follow-up of intervention sites (months 6 to 18)
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Collected during 1 year follow-up of intervention sites (months 6 to 18)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Chair: Martin Severs, University of Portsmouth
- Study Director: Amy K Drahota, University of Portsmouth
- Principal Investigator: Derek Ward, University of Portsmouth
- Principal Investigator: Julie Udell, University of Portsmouth
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2010
Primary Completion (Actual)
August 1, 2011
Study Completion (Actual)
August 1, 2011
Study Registration Dates
First Submitted
January 6, 2009
First Submitted That Met QC Criteria
January 6, 2009
First Posted (Estimate)
January 7, 2009
Study Record Updates
Last Update Posted (Estimate)
December 2, 2014
Last Update Submitted That Met QC Criteria
November 28, 2014
Last Verified
November 1, 2014
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 13247
- UKCRN ID: 5735
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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