Ignite Creation Date:
2025-12-24 @ 11:03 PM
Ignite Modification Date:
2025-12-25 @ 8:34 PM
Study NCT ID:
NCT00817869
Status:
COMPLETED
Last Update Posted:
2014-12-02
First Post:
2009-01-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The HIP-HOP Flooring Study: Helping Injury Prevention in Hospitalised Older People
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2019-07-22', 'releaseDate': '2019-05-13'}], 'estimatedResultsFirstSubmitDate': '2019-05-13'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 571}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-11-28', 'studyFirstSubmitDate': '2009-01-06', 'studyFirstSubmitQcDate': '2009-01-06', 'lastUpdatePostDateStruct': {'date': '2014-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-01-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'fall-related injury', 'timeFrame': 'Study duration = 18 months. Outcome measured for each patient for duration of stay in ward (approx. 30 days).'}], 'secondaryOutcomes': [{'measure': 'Number of falls', 'timeFrame': 'Study duration = 18 months. Outcome measured for each patient for duration of stay in ward (approx. 30 days).'}, {'measure': 'Unexpected adverse events', 'timeFrame': 'Study duration = 18 months. Outcome measured for each patient for duration of stay in ward (approx. 30 days).'}, {'measure': 'Slip resistance of flooring', 'timeFrame': 'Measured at 4 time-points over 1.5 years (1 month; 6 months; 12 months; 18 months)'}, {'measure': 'Shock-absorbency of flooring', 'timeFrame': 'Measured at 4 time-points over 1.5 years (1 month; 6 months; 12 months; 18 months)'}, {'measure': 'Place of residence (for cost-effectiveness analysis)', 'timeFrame': 'Each patient followed-up 3 months post-discharge'}, {'measure': 'Quality of life (for cost-effectiveness analysis)', 'timeFrame': 'Each patient followed-up 3 months post-discharge'}, {'measure': 'Number of hospital re-admissions (for cost-effectiveness analysis)', 'timeFrame': 'Each patient followed-up 3 months post-discharge'}, {'measure': 'User views (patients and staff)', 'timeFrame': 'Collected during 1 year follow-up of intervention sites (months 6 to 18)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Floors and Floorcoverings', 'Health Services for the Aged', 'Fractures, bone', 'Delirium, Dementia, Amnestic, Cognitive Disorders', 'Frail Elderly', 'Aged, 80 and over'], 'conditions': ['Accidental Falls']}, 'referencesModule': {'references': [{'pmid': '21890580', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '23868093', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '23838763', 'type': 'RESULT', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* all patients admitted to the study area on a participating elderly care ward\n\nExclusion Criteria:\n\n* none.'}, 'identificationModule': {'nctId': 'NCT00817869', 'briefTitle': 'The HIP-HOP Flooring Study: Helping Injury Prevention in Hospitalised Older People', 'organization': {'class': 'OTHER', 'fullName': 'University of Portsmouth'}, 'officialTitle': 'Pilot Cluster Randomised Controlled Trial of Flooring to Reduce Injuries From Falls in Elderly Care Units', 'orgStudyIdInfo': {'id': '13247'}, 'secondaryIdInfos': [{'id': 'UKCRN ID: 5735'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'New Flooring', 'description': 'Will receive 8.3mm thick floor covering (Omnisports EXCEL) to replace previous floor covering.', 'interventionNames': ['Other: New flooring']}, {'type': 'NO_INTERVENTION', 'label': 'Standard Flooring', 'description': '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.'}], 'interventions': [{'name': 'New flooring', 'type': 'OTHER', 'otherNames': ['Omnisports EXCEL'], 'description': '8.3mm thick vinyl floor covering with foam backing, manufactured by Tarkett and installed by Tyndale Flooring Ltd.', 'armGroupLabels': ['New Flooring']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'PO6 3LY', 'city': 'Portsmouth', 'state': 'Hampshire', 'country': 'United Kingdom', 'facility': 'Ward D1, Queen Alexandra Hospital', 'geoPoint': {'lat': 50.79899, 'lon': -1.09125}}, {'zip': 'PO30 5TG', 'city': 'Newport', 'state': 'Isle of Wight', 'country': 'United Kingdom', 'facility': "Newchurch Ward, St Mary's Hospital", 'geoPoint': {'lat': 51.58774, 'lon': -2.99835}}, {'zip': 'CH65 6SG', 'city': 'Ellesmere Port', 'state': 'Merseyside', 'country': 'United Kingdom', 'facility': 'Ruby Ward, Ellesmere Port Hospital', 'geoPoint': {'lat': 53.27875, 'lon': -2.90134}}, {'zip': 'DN33 2BA', 'city': 'Grimsby', 'state': 'North East Lincolnshire', 'country': 'United Kingdom', 'facility': 'Ward C5, Diana Princess of Wales Hospital', 'geoPoint': {'lat': 53.56539, 'lon': -0.07553}}, {'zip': 'HG2 7SX', 'city': 'Harrogate', 'state': 'North Yorkshire', 'country': 'United Kingdom', 'facility': 'Granby Ward, Harrogate District Hospital', 'geoPoint': {'lat': 53.99078, 'lon': -1.5373}}, {'zip': 'BS23 4TQ', 'city': 'Weston-super-Mare', 'state': 'Somerset', 'country': 'United Kingdom', 'facility': 'Draycott Ward, Weston General Hospital', 'geoPoint': {'lat': 51.34603, 'lon': -2.97665}}, {'zip': 'NE7 7DN', 'city': 'Newcastle upon Tyne', 'state': 'Tyne and Wear', 'country': 'United Kingdom', 'facility': 'Ward 15, Newcastle Freeman Hospital', 'geoPoint': {'lat': 54.97328, 'lon': -1.61396}}, {'zip': 'YO31 8HE', 'city': 'York', 'state': 'Yorkshire', 'country': 'United Kingdom', 'facility': 'Ward 25, York District Hospital', 'geoPoint': {'lat': 53.95763, 'lon': -1.08271}}], 'overallOfficials': [{'name': 'Martin Severs', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Portsmouth'}, {'name': 'Amy K Drahota', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Portsmouth'}, {'name': 'Derek Ward', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Portsmouth'}, {'name': 'Julie Udell', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Portsmouth'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Portsmouth', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Dunhill Medical Trust', 'class': 'OTHER'}, {'name': 'National Osteoporosis Society', 'class': 'OTHER'}, {'name': 'University of Sheffield', 'class': 'OTHER'}, {'name': 'Health & Safety Laboratory', 'class': 'OTHER'}, {'name': 'National Patient Safety Agency', 'class': 'OTHER_GOV'}, {'name': 'Department of Health, United Kingdom', 'class': 'OTHER_GOV'}, {'name': 'Portsmouth Hospitals NHS Trust', 'class': 'OTHER_GOV'}, {'name': 'University of Bath', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Martin Severs', 'investigatorAffiliation': 'University of Portsmouth'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2019-05-13', 'type': 'RELEASE'}, {'date': '2019-07-22', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Dr. Amy Drahota, Dr., University of Portsmouth'}}}}