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

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
571

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United Kingdom
    • Hampshire
      • Portsmouth, Hampshire, United Kingdom, PO6 3LY
        • Ward D1, Queen Alexandra Hospital
    • Isle of Wight
      • Newport, Isle of Wight, United Kingdom, PO30 5TG
        • Newchurch Ward, St Mary's Hospital
    • Merseyside
      • Ellesmere Port, Merseyside, United Kingdom, CH65 6SG
        • Ruby Ward, Ellesmere Port Hospital
    • North East Lincolnshire
      • Grimsby, North East Lincolnshire, United Kingdom, DN33 2BA
        • Ward C5, Diana Princess of Wales Hospital
    • North Yorkshire
      • Harrogate, North Yorkshire, United Kingdom, HG2 7SX
        • Granby Ward, Harrogate District Hospital
    • Somerset
      • Weston-super-Mare, Somerset, United Kingdom, BS23 4TQ
        • Draycott Ward, Weston General Hospital
    • Tyne and Wear
      • Newcastle-upon-Tyne, Tyne and Wear, United Kingdom, NE7 7DN
        • Ward 15, Newcastle Freeman Hospital
    • Yorkshire
      • York, Yorkshire, United Kingdom, YO31 8HE
        • Ward 25, York District Hospital

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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).
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)
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)
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
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
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
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)
Collected during 1 year follow-up of intervention sites (months 6 to 18)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Portsmouth

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Sheffield
University of Bath
Portsmouth Hospitals NHS Trust
The Dunhill Medical Trust
Department of Health, United Kingdom
National Osteoporosis Society
Health & Safety Laboratory
National Patient Safety Agency

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 6, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 6, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 7, 2009

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 2, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 28, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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