The HIP-HOP Flooring Study: Helping Injury Prevention in Hospitalised Older People
This study is enrolling participants by invitation only.
Sponsor:
University of Portsmouth
Collaborators:
The Dunhill Medical Trust
National Osteoporosis Society
University of Sheffield
Health & Safety Laboratory
National Patient Safety Agency
Department of Health, United Kingdom
Portsmouth Hospitals NHS Trust
University of Bath
Information provided by:
University of Portsmouth
ClinicalTrials.gov Identifier:
NCT00817869
First received: January 6, 2009
Last updated: July 13, 2010
Last verified: July 2010
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Aged Accidental Falls |
Other: New flooring |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Pilot Cluster Randomised Controlled Trial of Flooring to Reduce Injuries From Falls in Elderly Care Units |
Resource links provided by NLM:
Further study details as provided by University of Portsmouth:
Primary Outcome Measures:
- fall-related injury [ Time Frame: Study duration = 18 months. Outcome measured for each patient for duration of stay in ward (approx. 30 days). ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Number of falls [ Time Frame: Study duration = 18 months. Outcome measured for each patient for duration of stay in ward (approx. 30 days). ] [ Designated as safety issue: Yes ]
- Unexpected adverse events [ Time Frame: Study duration = 18 months. Outcome measured for each patient for duration of stay in ward (approx. 30 days). ] [ Designated as safety issue: Yes ]
- Slip resistance of flooring [ Time Frame: Measured at 4 time-points over 1.5 years (1 month; 6 months; 12 months; 18 months) ] [ Designated as safety issue: Yes ]
- Shock-absorbency of flooring [ Time Frame: Measured at 4 time-points over 1.5 years (1 month; 6 months; 12 months; 18 months) ] [ Designated as safety issue: Yes ]
- Place of residence (for cost-effectiveness analysis) [ Time Frame: Each patient followed-up 3 months post-discharge ] [ Designated as safety issue: No ]
- Quality of life (for cost-effectiveness analysis) [ Time Frame: Each patient followed-up 3 months post-discharge ] [ Designated as safety issue: No ]
- Number of hospital re-admissions (for cost-effectiveness analysis) [ Time Frame: Each patient followed-up 3 months post-discharge ] [ Designated as safety issue: No ]
- User views (patients and staff) [ Time Frame: Collected during 1 year follow-up of intervention sites (months 6 to 18) ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 800 |
| Study Start Date: | April 2010 |
| Estimated Study Completion Date: | August 2011 |
| Estimated Primary Completion Date: | August 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: New Flooring
Will receive 8.3mm thick floor covering (Omnisports EXCEL) to replace previous floor covering.
|
Other: New flooring
8.3mm thick vinyl floor covering with foam backing, manufactured by Tarkett and installed by Tyndale Flooring Ltd.
Other Name: Omnisports EXCEL
|
|
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.
|
Detailed Description:
We will carry out the study in eight elderly care wards across England. We will first study the wards for 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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- all patients admitted to the study area on a participating elderly care ward
Exclusion Criteria:
- none.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00817869
Locations
| United Kingdom | |
| Ward D1, Queen Alexandra Hospital | |
| Portsmouth, Hampshire, United Kingdom, PO6 3LY | |
| Newchurch Ward, St Mary's Hospital | |
| Newport, Isle of Wight, United Kingdom, PO30 5TG | |
| Ruby Ward, Ellesmere Port Hospital | |
| Ellesmere Port, Merseyside, United Kingdom, CH65 6SG | |
| Ward C5, Diana Princess of Wales Hospital | |
| Grimsby, North East Lincolnshire, United Kingdom, DN33 2BA | |
| Granby Ward, Harrogate District Hospital | |
| Harrogate, North Yorkshire, United Kingdom, HG2 7SX | |
| Draycott Ward, Weston General Hospital | |
| Weston-super-Mare, Somerset, United Kingdom, BS23 4TQ | |
| Ward 15, Newcastle Freeman Hospital | |
| Newcastle-upon-Tyne, Tyne and Wear, United Kingdom, NE7 7DN | |
| Ward 25, York District Hospital | |
| York, Yorkshire, United Kingdom, YO31 8HE | |
Sponsors and Collaborators
University of Portsmouth
The Dunhill Medical Trust
National Osteoporosis Society
University of Sheffield
Health & Safety Laboratory
National Patient Safety Agency
Department of Health, United Kingdom
Portsmouth Hospitals NHS Trust
University of Bath
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 |
More Information
Additional Information:
No publications provided by University of Portsmouth
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Prof. Martin Severs, University of Portsmouth |
| ClinicalTrials.gov Identifier: | NCT00817869 History of Changes |
| Other Study ID Numbers: | 13247, UKCRN ID: 5735 |
| Study First Received: | January 6, 2009 |
| Last Updated: | July 13, 2010 |
| Health Authority: | United Kingdom: Department of Health United Kingdom: National Health Service United Kingdom: Research Ethics Committee |
Keywords provided by University of Portsmouth:
|
Floors and Floorcoverings Health Services for the Aged Fractures, bone |
Delirium, Dementia, Amnestic, Cognitive Disorders Frail Elderly Aged, 80 and over |
ClinicalTrials.gov processed this record on May 23, 2013