The HIP-HOP Flooring Study: Helping Injury Prevention in Hospitalised Older People - Full Text View

Sponsors and Collaborators:	University of Portsmouth Dunhill Medical Trust National Osteoporosis Society University of Sheffield Health & Safety Laboratory National Patient Safety Agency Estates & Facilities Division, Department of Health Portsmouth Hospitals NHS Trust University of Bath
Information provided by:	University of Portsmouth
ClinicalTrials.gov Identifier:	NCT00817869

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

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	Pilot Cluster Randomised Controlled Trial of Flooring Underlay to Reduce Injuries From Falls in Elderly Care Units

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 ]
"Stiction" of flooring (pushing force along floor) [ 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 2009
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
New Flooring: Experimental Will receive 9mm floor covering (6mm 'shock-absorbing' underlay with 3mm rubber flooring overlay) to replace previous floor covering.	Other: New flooring 6mm visco-elastic polymer underlay (Leyland Rubber Ltd.) with 3mm rubber flooring overlay (The Rubber Flooring Company).
Standard Flooring: No Intervention Ward will remain with standard floor covering (no 'shock-absorbing' underlay). The overlay will have a comparable slip resistance rating to the new flooring. Sub-flooring 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 a 'shock-absorbent' underlay. 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

Contacts

Contact: Amy K Drahota, PhD

+442392848484 ext 4432

amy.drahota@port.ac.uk

Sponsors and Collaborators

University of Portsmouth

Dunhill Medical Trust

National Osteoporosis Society

University of Sheffield

Health & Safety Laboratory

National Patient Safety Agency

Estates & Facilities Division, Department of Health

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

No publications provided

Responsible Party:	University of Portsmouth ( Prof. Martin Severs )
Study ID Numbers:	13247, UKCRN ID: 5735
Study First Received:	January 6, 2009
Last Updated:	January 6, 2009
ClinicalTrials.gov Identifier:	NCT00817869
Health Authority:	United Kingdom: Department of Health; United Kingdom: National Health Service; United Kingdom: Research Ethics Committee

Keywords provided by University of Portsmouth:

Health Services for the Aged
Fractures, bone
Delirium, Dementia, Amnestic, Cognitive Disorders
Frail Elderly
Aged, 80 and over

Study placed in the following topic categories:

Delirium, Dementia, Amnestic, Cognitive Disorders
Fractures, Bone
Dementia
Cognition Disorders
Delirium

ClinicalTrials.gov processed this record on February 12, 2009