Accidental FallsNCT00817869
The HIP-HOP Flooring Study: Helping Injury Prevention in Hospitalised Older People
A study testing New flooring in people with Accidental Falls, run by University of Portsmouth at 8 sites in United Kingdom.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Accidental Falls
- What is being tested?
- New flooring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 571 participants
- Where
- 8 sitesUnited Kingdom
- Study dates
- Apr 2010to Aug 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- all patients admitted to the study area on a participating elderly care ward
Who cannot join
- none.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United Kingdom8 sites
Ruby Ward, Ellesmere Port Hospital
Ellesmere Port, Merseyside, CH65 6SG
Ward C5, Diana Princess of Wales Hospital
Grimsby, North East Lincolnshire, DN33 2BA
Granby Ward, Harrogate District Hospital
Harrogate, North Yorkshire, HG2 7SX
Ward 15, Newcastle Freeman Hospital
Newcastle upon Tyne, Tyne and Wear, NE7 7DN
Newchurch Ward, St Mary's Hospital
Newport, Isle of Wight, PO30 5TG
Ward D1, Queen Alexandra Hospital
Portsmouth, Hampshire, PO6 3LY
Draycott Ward, Weston General Hospital
Weston-super-Mare, Somerset, BS23 4TQ
Ward 25, York District Hospital
York, Yorkshire, YO31 8HE
About this study
Official title: 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.
Read the 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.
- Conditions
- Accidental Falls
- Being tested
- New flooring
- Keywords
- Floors and Floorcoverings, Health Services for the Aged, Fractures, bone, Delirium, Dementia, Amnestic, Cognitive Disorders, Frail Elderly, Aged, 80 and over
- Medical subject headings
- Fractures, Bone, Neurocognitive Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
New flooringOther
Also called Omnisports EXCEL
8.3mm thick vinyl floor covering with foam backing, manufactured by Tarkett and installed by Tyndale Flooring Ltd.
| Study group | Role | What they receive |
|---|---|---|
| New Flooring | Experimental | Will receive 8.3mm thick floor covering (Omnisports EXCEL) to replace previous floor covering. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
fall-related injury
Measured: Study duration = 18 months. Outcome measured for each patient for duration of stay in ward (approx. 30 days).
Secondary outcomes (8)
Number of falls
Measured: Study duration = 18 months. Outcome measured for each patient for duration of stay in ward (approx. 30 days).
Unexpected adverse events
Measured: Study duration = 18 months. Outcome measured for each patient for duration of stay in ward (approx. 30 days).
Slip resistance of flooring
Measured: Measured at 4 time-points over 1.5 years (1 month; 6 months; 12 months; 18 months)
Shock-absorbency of flooring
Measured: Measured at 4 time-points over 1.5 years (1 month; 6 months; 12 months; 18 months)
Place of residence (for cost-effectiveness analysis)
Measured: Each patient followed-up 3 months post-discharge
Quality of life (for cost-effectiveness analysis)
Measured: Each patient followed-up 3 months post-discharge
Number of hospital re-admissions (for cost-effectiveness analysis)
Measured: Each patient followed-up 3 months post-discharge
User views (patients and staff)
Measured: Collected during 1 year follow-up of intervention sites (months 6 to 18)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2009 (estimated)
- Study startApr 2010
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Accidental FallsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 571 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Portsmouth
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Principal investigator, Martin Severs, University of Portsmouth
- Investigators
- Martin Severs, Study chair, University of PortsmouthAmy K Drahota, Study director, University of PortsmouthDerek Ward, Principal investigator, University of PortsmouthJulie Udell, Principal investigator, University of Portsmouth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00817869
- Sponsor's protocol ID
- 13247
- Other IDs
- UKCRN ID: 5735
- Status last verified
- Nov 2014
- First submitted
- 6 Jan 2009
- Last updated
- 2 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 21890580Drahota 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.
PubMed 23868093Latimer 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.
PubMed 23838763
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Cluster Randomised Controlled Trial of Flooring to Reduce Injuries From Falls in Elderly Care Units
- ClinicalTrials.gov ID
- NCT00817869
- Acronym / sponsor ID
- 13247
- Conditions
- Accidental Falls
- Keywords
- Floors and Floorcoverings, Health Services for the Aged, Fractures, bone, Delirium, Dementia, Amnestic, Cognitive Disorders, Frail Elderly, Aged, 80 and over
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 571 participants (actual)
- Lead sponsor
- University of PortsmouthUniversity, hospital or other
- 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
- Study start
- Apr 2010
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 7 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| New Flooring | Experimental | Other: New flooringWill receive 8.3mm thick floor covering (Omnisports EXCEL) to replace previous floor covering. |
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- all patients admitted to the study area on a participating elderly care ward
Key exclusion criteria (1 listed)
- none.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| New flooringAlso: Omnisports EXCEL8.3mm thick vinyl floor covering with foam backing, manufactured by Tarkett and installed by Tyndale Flooring Ltd. | Other | New Flooring |
Primary outcome
fall-related injury
Time frame: Study duration = 18 months. Outcome measured for each patient for duration of stay in ward (approx. 30 days).
8 secondary outcomes
Number of falls
Time frame: 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).
Slip resistance of flooring
Time frame: Measured at 4 time-points over 1.5 years (1 month; 6 months; 12 months; 18 months)
Shock-absorbency of flooring
Time frame: 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
Quality of life (for cost-effectiveness analysis)
Time frame: Each patient followed-up 3 months post-discharge
Number of hospital re-admissions (for cost-effectiveness analysis)
Time frame: Each patient followed-up 3 months post-discharge
User views (patients and staff)
Time frame: Collected during 1 year follow-up of intervention sites (months 6 to 18)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2014.
- Background: PubMed 21890580Drahota 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.
- Results publication: PubMed 23868093Drahota 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.
- Results publication: PubMed 23838763Latimer 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Severs study chair
University of Portsmouth
Amy K Drahota study director
University of Portsmouth
Derek Ward principal investigator
University of Portsmouth
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing New flooring in people with Accidental Falls, run by University of Portsmouth at 8 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fall-related injury (time frame: Study duration = 18 months. Outcome measured for each patient for duration of stay in ward (approx. 30 days).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00817869, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2014.