Ignite Creation Date:
2025-12-24 @ 10:30 PM
Ignite Modification Date:
2026-02-09 @ 6:03 AM
Study NCT ID:
NCT00665535
Status:
COMPLETED
Last Update Posted:
2012-03-21
First Post:
2008-04-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pressure Ulcer Prevention: Turning for Ulcer Reduction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003668', 'term': 'Pressure Ulcer'}], 'ancestors': [{'id': 'D012883', 'term': 'Skin Ulcer'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 967}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-03-20', 'studyFirstSubmitDate': '2008-04-22', 'studyFirstSubmitQcDate': '2008-04-23', 'lastUpdatePostDateStruct': {'date': '2012-03-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-04-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pressure ulcers, present (stage)or absent', 'timeFrame': 'End of 3rd week or conclusion of participation'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Pressure ulcers', 'Nursing facilities', 'Elderly', 'At risk for pressure ulcers'], 'conditions': ['Pressure Ulcers']}, 'referencesModule': {'references': [{'pmid': '26066791', 'type': 'DERIVED', 'citation': 'Yap TL, Kennerly SM, Bergstrom N, Hudak SL, Horn SD. An Evidence-Based Cue-Selection Guide and Logic Model to Improve Pressure Ulcer Prevention in Long-term Care. J Nurs Care Qual. 2016 Jan-Mar;31(1):75-83. doi: 10.1097/NCQ.0000000000000128.'}, {'pmid': '23426413', 'type': 'DERIVED', 'citation': 'Omolayo T, Brown K, Rapp MP, Li J, Barrett R, Horn S, Bergstrom N. Construct validity of the moisture subscale of the Braden Scale for Predicting Pressure Sore Risk. Adv Skin Wound Care. 2013 Mar;26(3):122-7. doi: 10.1097/01.ASW.0000427921.74379.c5.'}], 'seeAlsoLinks': [{'url': 'http://www.bradenscale.com', 'label': 'Home of the Braden Scale and source of official copies of the tool and the location for obtaining permission to use the tool.'}, {'url': 'http://www.npuap.org/', 'label': 'Home of the National Pressure Ulcer Advisory Panel with information regarding staging and policies regarding pressure ulcers'}, {'url': 'http://www.wocn.org/', 'label': 'Home page of the Wound Ostomy and Continence Nurses Organization, the experts in wound healing.'}, {'url': 'http://www.henniscarecentre.com/volunteers.htm', 'label': 'Hennis Care Center of Dover, Ohio is a data collection site'}, {'url': 'http://www.gurwin.org/', 'label': 'Gurwin Jewish Nursing and Rehabilitation Center, Commack, NY, is a data collection site'}, {'url': 'http://www.monroehosp.org/', 'label': 'Monro Community Hospital, Rochester, NY, is a data collection sites'}, {'url': 'http://www.specialty-care.com/index.php/mississauga-road', 'label': 'Specialty Care Mississauga Road, Mississauga, Ontario, Canada is a data collection site'}, {'url': 'http://www.specialty-care.com/index.php/villa-leonardo-gambin', 'label': 'Villa Leonardo Gambin, Woodbridge, Ontario, Canada is a data collection site'}, {'url': 'http://www.oprs.org/breckenridge_village/', 'label': 'Fairmount at Breckenridge Village is a data collection site'}, {'url': 'http://www.jaxhealth.com/AboutUs/default.asp?ENOrgID=B8AD2776B8C74351ABCD7349B0C8D30D', 'label': 'St. Catherine Laboure Manor is a data collection site'}, {'url': 'http://www.bremenhealthcare.com/BuildPageC.asp?IFacID=156&PageID=H', 'label': 'Kindred Bremen Health Care Center'}, {'url': 'http://www.miamijewishhealthsystems.org', 'label': 'Miami Jewish Home \\& Hospital will be a data collection site'}, {'url': 'http://www.fairparkhc.com/BuildPageC.asp?IFacID=77&PageID=H', 'label': 'Kindred Fairpark Health Care Center is a data collection site'}, {'url': 'http://www.loudonhealthcare.com/BuildPageC.asp?IFacID=80&PageID=H', 'label': 'Kindred Loudon Healthcare Center is a data collection site'}, {'url': 'http://www.bremenhealthcare.com', 'label': 'Related Info'}, {'url': 'http://www.miamijewishhealthsystems.org/', 'label': 'Related Info'}, {'url': 'http://www.signaturehealthcarellc.com/Facility/FacilityInfo.aspx', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to determine the optimal frequency of repositioning nursing facility residents with limited mobility who are cared for on a high density foam mattress in order to prevent bed sores. It is hypothesized that participants at moderate risk (Braden Scale Scores 13-14) who are turned every 3 or 4 hours and participants at high risk (Braden Scores 10-12) turned every 3 or 4 hours will not have a higher incidence of ulcers than those residents turned every 2 hours.', 'detailedDescription': 'The purpose of this multi-site, randomized, controlled trial is to determine the optimal frequency of repositioning nursing facility residents with mobility limitations who are at moderate and high risk for pressure ulcer development who are cared for on high density foam mattresses for the purpose of preventing pressure ulcers. Pressure ulcers result primarily from pressure over a bony prominence that occludes blood flow to tissues. Traditionally, soft surfaces over mattress and repositioning individuals every 2 hours to relieve pressure have been the gold standard of care to prevent ulcers. Recent improvements in support surfaces may reduce the need for 2-hour repositioning. The specific aims of this study are to determine if: 1) there is a significant difference in the incidence of pressure ulcers among: a) moderate risk (Braden Scale Score, 13-14) residents randomly assigned to be repositioned every 2-, compared with every 3- or 4- hours; or b) high risk (Braden Scale Score, 10-12) residents who are turned every 2- compared with every 3- or 4-hours; 2) mobility (spontaneous or assisted) measured by actigraphy is a significant covariate with repositioning frequency in the incidence of pressure ulcers and 3) resident characteristics and resident influencing factors are significant covariates of repositioning schedules on pressure ulcer incidence. A 2 X 2/2 X 3 experimental design is used in which participants at two levels of risk (moderate or high) for pressure ulcer development are randomly assigned to one of 3 repositioning schedules every 2-hours (the current standard of care), contrasted with 3- or 4- hours carried out for 3 weeks. Actigraphs worn for 7 days (Tuesday to Tuesday) will determine if mobility is a significant covariate. Residents (1080) who are over 65 years, able to give consent or have a surrogate who can give consent and are at moderate or high risk for pressure ulcers will be invited to participate. Nursing facilities are selected because of their ability to follow a research protocol and submit data according to protocol requirements, and who have a reputation for good care are being selected for participation. Participants will be randomly assigned to a repositioning schedule that will be carried out by a Certified Nursing Assistants (CNA) who will document time of each repositioning. A CNA supervisor monitors repositioning and documentation frequently. Data are FAXED to and monitored by the investigators daily. With the exception of the repositioning intervention, participants will receive the same preventive care as all residents. The primary outcome of this study, pressure ulcers (yes/no) will be documented by a nurse assessor who will be masked to the repositioning timing. Data analysis and management will be performed by ISIS. The goal of this study is to shape Nursing Facility policy by defining how level of risk, mobility, and frequency of repositioning of residents can reduce the incidence of pressure ulcers and improve resident outcomes. Less frequent repositioning would allow residents longer periods of sleep, would reduce staff time for repositioning, and allow more efficient allocation of time.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: Participants will:\n\n* Be free of pressure ulcers upon admission to the study.\n* Have a Braden Scale Score between 10 - 12 (high risk) or 13 -14 (moderate risk) within one week of admission (new residents) or greater than 90 days (established residents) of study participation\n* Have a high-density foam replacement mattress in use or can be transferred to such a mattress.\n* Are 65 years or older. Younger residents are present in fewer numbers and may have different health issues and co-morbidities than older residents.\n* Can legally grant consent to participate or have available surrogates to grant consent. If able, participant should assent when a surrogate grants consent.\n* Expected to have a length of stay of 21 days or greater.\n\nExclusion Criteria:\n\n* Pressure ulcer is present upon initial examination.\n* The Braden Scale score is 15 or greater indicating mild risk or no risk, or 9 or below indicating very high risk.\n* The resident cannot be turned on 3 anatomical surfaces (side, back, side) or has a contraindication to repositioning.'}, 'identificationModule': {'nctId': 'NCT00665535', 'acronym': 'TURN', 'briefTitle': 'Pressure Ulcer Prevention: Turning for Ulcer Reduction', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center, Houston'}, 'officialTitle': 'Preventing Pressure Ulcers: A Multi-site RCT in Nursing Facilities', 'orgStudyIdInfo': {'id': '1R011NR009680-01A1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': '2. High Risk', 'description': 'High risk for pressure ulcers according to the Braden Scale for Predicting Pressure Sore Risk (Score 10-12)', 'interventionNames': ['Procedure: Turning or repositioning schedule']}, {'type': 'OTHER', 'label': '1. Moderate Risk', 'description': 'Moderate risk for pressure ulcers according to the Braden Scale for Predicting Pressure Sore Risk (Score 13 and 14)', 'interventionNames': ['Procedure: Turning or repositioning schedule']}], 'interventions': [{'name': 'Turning or repositioning schedule', 'type': 'PROCEDURE', 'description': 'Turning schedule randomly assigned at 2, 3, or 4 hours', 'armGroupLabels': ['1. Moderate Risk']}, {'name': 'Turning or repositioning schedule', 'type': 'PROCEDURE', 'description': 'Turning schedule randomly assigned at 2, 3 or 4 hours', 'armGroupLabels': ['2. High Risk']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85302', 'city': 'Glendale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Glencroft Care Center', 'geoPoint': {'lat': 33.53865, 'lon': -112.18599}}, {'zip': '92354', 'city': 'Loma Linda', 'state': 'California', 'country': 'United States', 'facility': 'Linda Valley Nursing Facility', 'geoPoint': {'lat': 34.04835, 'lon': -117.26115}}, {'zip': '90026', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Garden Crest Convalescent Hospital', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '32204', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'St. Catherine Laboure Manor', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '33137', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Miami Jewish Home & Hospital', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '32177', 'city': 'Palatka', 'state': 'Florida', 'country': 'United States', 'facility': 'Palatka Health Care Center', 'geoPoint': {'lat': 29.64858, 'lon': -81.63758}}, {'zip': '46506', 'city': 'Bremen', 'state': 'Indiana', 'country': 'United States', 'facility': 'Kindred Bremen Health Care Center', 'geoPoint': {'lat': 41.44644, 'lon': -86.14806}}, {'zip': '02021', 'city': 'Canton', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Tower Hill Center for Health and Rehabilitation', 'geoPoint': {'lat': 42.15843, 'lon': -71.14477}}, {'zip': '11725-4403', 'city': 'Commack', 'state': 'New York', 'country': 'United States', 'facility': 'Gurwin Jewish Nursing and Rehabilitation Center', 'geoPoint': {'lat': 40.84288, 'lon': -73.29289}}, {'zip': '14620', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'Monroe Community Hospital', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '27455', 'city': 'Greensboro', 'state': 'North Carolina', 'country': 'United States', 'facility': 'BlumenthalJewish Nursing and Rehabilitation', 'geoPoint': {'lat': 36.07264, 'lon': -79.79198}}, {'zip': '44622', 'city': 'Dover', 'state': 'Ohio', 'country': 'United States', 'facility': 'Hennis Care Center', 'geoPoint': {'lat': 40.52062, 'lon': -81.47401}}, {'zip': '45365', 'city': 'Sidney', 'state': 'Ohio', 'country': 'United States', 'facility': 'Dorothy Love Retirement Community', 'geoPoint': {'lat': 40.28422, 'lon': -84.1555}}, {'zip': '44504', 'city': 'Willoughby', 'state': 'Ohio', 'country': 'United States', 'facility': 'Fairmount at aBreckenridge Village', 'geoPoint': {'lat': 41.63977, 'lon': -81.4065}}, {'zip': '44094', 'city': 'Youngstown', 'state': 'Ohio', 'country': 'United States', 'facility': 'Park Vista Retirement Community', 'geoPoint': {'lat': 41.09978, 'lon': -80.64952}}, {'zip': '38401', 'city': 'Columbia', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Signature HealthCare of Columbia', 'geoPoint': {'lat': 35.61507, 'lon': -87.03528}}, {'zip': '37774', 'city': 'Loudon', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Kindred Loudon Healthcare Center', 'geoPoint': {'lat': 35.73285, 'lon': -84.33381}}, {'zip': '37802', 'city': 'Maryville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Kindred Fairpark Health Care Center', 'geoPoint': {'lat': 35.75647, 'lon': -83.97046}}, {'zip': '37804', 'city': 'Maryville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Asbury Place Maryville', 'geoPoint': {'lat': 35.75647, 'lon': -83.97046}}, {'zip': 'L4W 1K3', 'city': 'East Missassauga', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Tyndall Nursing Home'}, {'zip': 'L4T4M1', 'city': 'Mississauga', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Malton Village Long Term Care Center', 'geoPoint': {'lat': 43.5789, 'lon': -79.6583}}, {'zip': 'L5M 7C3', 'city': 'Mississauga', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Specialty Care of Mississauga Road', 'geoPoint': {'lat': 43.5789, 'lon': -79.6583}}, {'zip': 'M1S 5T7', 'city': 'Scarborough Village', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Yee Hong Scarborough', 'geoPoint': {'lat': 43.73899, 'lon': -79.22124}}, {'zip': 'M1T 3K9', 'city': 'Scarborough Village', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Shepherd Lodge', 'geoPoint': {'lat': 43.73899, 'lon': -79.22124}}, {'zip': 'M9N 3V4', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Leisure World Lawrence', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'L4L 9T3', 'city': 'Woodbridge', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Villa Leonardo Gambin Specialty Care', 'geoPoint': {'lat': 43.78341, 'lon': -79.59962}}], 'overallOfficials': [{'name': 'Nancy Bergstrom, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Texas Health Science Center, Houston'}, {'name': 'Susan Horn, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ISIS, Salt Lake City, UT'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Health Science Center, Houston', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}, {'name': 'National Institute of Nursing Research (NINR)', 'class': 'NIH'}, {'name': 'National Institute on Aging (NIA)', 'class': 'NIH'}, {'name': 'Ontario Ministry of Health and Long Term Care', 'class': 'OTHER_GOV'}, {'name': 'Toronto Health Economic Technology Assessment collaborative (THETA)', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Trumble Professor of Aging Research & Director, Center on Aging', 'investigatorFullName': 'Nancy Bergstrom', 'investigatorAffiliation': 'The University of Texas Health Science Center, Houston'}}}}