Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2025-12-29 @ 9:51 PM
Study NCT ID:
NCT01350557
Status:
COMPLETED
Last Update Posted:
2017-02-03
First Post:
2011-05-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Three Care Models for Elderly Patients With Hip Fracture
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006620', 'term': 'Hip Fractures'}], 'ancestors': [{'id': 'D005264', 'term': 'Femoral Fractures'}, {'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D025981', 'term': 'Hip Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003191', 'term': 'Comprehensive Health Care'}, {'id': 'D019467', 'term': 'Subacute Care'}], 'ancestors': [{'id': 'D010346', 'term': 'Patient Care Management'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 299}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-02', 'studyFirstSubmitDate': '2011-05-06', 'studyFirstSubmitQcDate': '2011-05-09', 'lastUpdatePostDateStruct': {'date': '2017-02-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-05-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Self-care ability', 'timeFrame': '1, 3, 6, 12 months after hospital discharge', 'description': 'Measured by the Chinese Barthel Index (CBI) as ability to perform activities of daily living (ADLs), with scores ranging from 0 to 100.'}], 'secondaryOutcomes': [{'measure': 'Depressive symptoms', 'timeFrame': '1, 3, 6, 12 months after hospital discharge', 'description': 'Depressive symptoms were assessed using the Chinese version of the Geriatric Depression Scale, short form (GDS-s). Patients with a score ≥ 5 were categorized as at risk for clinical depression.'}, {'measure': 'Nutritional status', 'timeFrame': '1, 3, 6, 12 months after hospital discharge', 'description': 'Nutritional status was assessed using the Mini Nutritional Assessment (MNA). MNA scores categorize each person as well-nourished (≥24 points), at risk of malnutrition (17-23.5 points), and malnourished (\\<17 points).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Elderly', 'Hip fracture', 'Intervention program'], 'conditions': ['Hip Fracture']}, 'referencesModule': {'references': [{'pmid': '34766330', 'type': 'DERIVED', 'citation': 'Handoll HH, Cameron ID, Mak JC, Panagoda CE, Finnegan TP. Multidisciplinary rehabilitation for older people with hip fractures. Cochrane Database Syst Rev. 2021 Nov 12;11(11):CD007125. doi: 10.1002/14651858.CD007125.pub3.'}, {'pmid': '26936194', 'type': 'DERIVED', 'citation': 'Tseng MY, Liang J, Shyu YI, Wu CC, Cheng HS, Chen CY, Yang SF. Effects of interventions on trajectories of health-related quality of life among older patients with hip fracture: a prospective randomized controlled trial. BMC Musculoskelet Disord. 2016 Mar 3;17:114. doi: 10.1186/s12891-016-0958-2.'}, {'pmid': '22960477', 'type': 'DERIVED', 'citation': 'Shyu YI, Liang J, Tseng MY, Li HJ, Wu CC, Cheng HS, Yang CT, Chou SW, Chen CY. Comprehensive care improves health outcomes among elderly Taiwanese patients with hip fracture. J Gerontol A Biol Sci Med Sci. 2013 Feb;68(2):188-97. doi: 10.1093/gerona/gls164. Epub 2012 Sep 7.'}]}, 'descriptionModule': {'briefSummary': 'Hip fracture in the elderly is associated with excess mortality of 5 to 20%, and mobility problems that usually results in costly hospital stays and lengthy rehabilitation procedures. The purpose of this study is to compare the costs and effectiveness of three care models- acute/sub-acute, comprehensive, and routine care models for hip fractured elders in Taiwan.', 'detailedDescription': 'Hip fracture in the elderly is associated with excess mortality of 5 to 20%, and mobility problems that usually results in costly hospital stays and lengthy rehabilitation procedures. With this increase in the aging population, hip fracture represents a major and a fast growing health care problem in Taiwan. Currently, the incidence rate of hip fractures is 10 times of the incidence rate for the general population. Despite the use of advanced treatment, the one-year mortality rate (15.4%) remains significant, and many of the patients never recover completely in terms of activities of daily living functions. Many studies in the United States have proved that elderly patients with hip fracture can benefit from post-operative rehabilitation, early discharge planning programs, or transitional care programs. However, little is known about what intervention should be attempted for these patients and their families in Taiwan.\n\nThe purpose of this study is to compare the costs and effectiveness of three care models- acute/sub-acute, comprehensive, and routine care models for hip fractured elders in Taiwan.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 60 years or older\n* Admitted to hospital for an accidental single-side hip fracture\n* Receiving hip arthroplasty or internal fixation\n* Able to perform full range of motion against gravity and against some or full resistance, and have a pre-fracture Chinese Barthel Index (CBI) score \\>70\n* Living in northern Taiwan\n\nExclusion Criteria:\n\n* Severely cognitively impaired and completely unable to follow orders (determined by a Chinese Mini-Mental State Examination \\[MMSE\\] score \\<10), or\n* Terminally ill'}, 'identificationModule': {'nctId': 'NCT01350557', 'briefTitle': 'Three Care Models for Elderly Patients With Hip Fracture', 'organization': {'class': 'OTHER', 'fullName': 'Chang Gung Memorial Hospital'}, 'officialTitle': 'Three Care Models for Elderly Patients With Hip Fracture', 'orgStudyIdInfo': {'id': 'NHRI-EX98-9404PI'}, 'secondaryIdInfos': [{'id': 'HMRPD180015', 'type': 'OTHER', 'domain': 'Chang Gung Memorial Hospital'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Patients receive only usual hospital care'}, {'type': 'OTHER', 'label': 'Subacute care group', 'description': 'Patients receive hospital usual care and subacute care. Subacute care consisted of geriatric consultation, a rehabilitation program, and early discharge planning.', 'interventionNames': ['Other: Subacute care']}, {'type': 'EXPERIMENTAL', 'label': 'Comprehensive care group', 'description': 'Patients receive not only the subacute care (geriatric consultation, rehabilitation program, and discharge planning), but also health-maintenance interventions to prevent falls, consult on nutrition, and manage depression.', 'interventionNames': ['Other: Comprehensive care']}], 'interventions': [{'name': 'Comprehensive care', 'type': 'OTHER', 'description': 'Comprehensive care consisted of subacute care plus health-maintenance interventions to manage depressive symptoms, manage malnutrition, and prevent falls.', 'armGroupLabels': ['Comprehensive care group']}, {'name': 'Subacute care', 'type': 'OTHER', 'description': 'Subacute care included geriatric consultation, continuous rehabilitation, and discharge planning.', 'armGroupLabels': ['Subacute care group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '333', 'city': 'Taoyuan District', 'country': 'Taiwan', 'facility': 'Chang Gung Memorial Hospital', 'geoPoint': {'lat': 24.9896, 'lon': 121.3187}}], 'overallOfficials': [{'name': 'Yea-Ing L Shyu, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chang Gung University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chang Gung Memorial Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Health Research Institutes, Taiwan', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Yea-Ing Lotus Shyu', 'investigatorAffiliation': 'Chang Gung University'}}}}