Ignite Creation Date:
2025-12-25 @ 12:56 AM
Ignite Modification Date:
2026-03-03 @ 12:03 AM
Study NCT ID:
NCT05525793
Status:
COMPLETED
Last Update Posted:
2022-09-02
First Post:
2022-08-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of the Transitional Care Model in Total Knee Arthroplasty Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-02-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2021-11-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-30', 'studyFirstSubmitDate': '2022-08-25', 'studyFirstSubmitQcDate': '2022-08-30', 'lastUpdatePostDateStruct': {'date': '2022-09-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Western Ontario and McMaster Universities Osteoarthritis Index-WOMAC', 'timeFrame': 'up to 9 weeks', 'description': 'Assessments of functional status of patients were conducted at baseline, 2nd and 9th weeks after discharge.'}, {'measure': 'Arthritis Self-efficacy Scale (ASES)', 'timeFrame': 'up to 9 weeks', 'description': 'Assessments of self-efficacy of patients were conducted at baseline, 2nd and 9th weeks after discharge.'}], 'secondaryOutcomes': [{'measure': 'number of hospital visits', 'timeFrame': 'up to 12 weeks', 'description': 'Assessments of the number of hospital visits outside of routine control were conducted 2nd week, 6th week, 9th week, and 12th weeks after discharge.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Knee Osteoarthritis', 'Pain', 'Self Efficacy', 'Health Care Utilization']}, 'referencesModule': {'references': [{'pmid': '33074309', 'type': 'BACKGROUND', 'citation': 'An S, Li J, Xie W, Yin N, Li Y, Hu Y. Extracorporeal shockwave treatment in knee osteoarthritis: therapeutic effects and possible mechanism. Biosci Rep. 2020 Nov 27;40(11):BSR20200926. doi: 10.1042/BSR20200926.'}, {'pmid': '28870302', 'type': 'BACKGROUND', 'citation': 'Gaffney CJ, Pelt CE, Gililland JM, Peters CL. Perioperative Pain Management in Hip and Knee Arthroplasty. Orthop Clin North Am. 2017 Oct;48(4):407-419. doi: 10.1016/j.ocl.2017.05.001. Epub 2017 Jun 29.'}, {'pmid': '32950214', 'type': 'BACKGROUND', 'citation': 'Magan AA, Ahmed SS, Paton B, Konan S, Haddad FS. Does Multimodal Therapy Influence Functional Outcome After Total Knee Arthroplasty? Orthop Clin North Am. 2020 Oct;51(4):453-459. doi: 10.1016/j.ocl.2020.06.011.'}, {'pmid': '24493186', 'type': 'BACKGROUND', 'citation': "Hanusch BC, O'Connor DB, Ions P, Scott A, Gregg PJ. Effects of psychological distress and perceptions of illness on recovery from total knee replacement. Bone Joint J. 2014 Feb;96-B(2):210-6. doi: 10.1302/0301-620X.96B2.31136."}, {'pmid': '33154651', 'type': 'BACKGROUND', 'citation': 'Mardani A, Griffiths P, Vaismoradi M. The Role of the Nurse in the Management of Medicines During Transitional Care: A Systematic Review. J Multidiscip Healthc. 2020 Oct 30;13:1347-1361. doi: 10.2147/JMDH.S276061. eCollection 2020.'}, {'pmid': '32322183', 'type': 'BACKGROUND', 'citation': "Allen J, Hutchinson AM, Brown R, Livingston PM. Communication and Coordination Processes Supporting Integrated Transitional Care: Australian Healthcare Practitioners' Perspectives. Int J Integr Care. 2020 Apr 16;20(2):1. doi: 10.5334/ijic.4685."}, {'pmid': '32917145', 'type': 'RESULT', 'citation': 'Morkisch N, Upegui-Arango LD, Cardona MI, van den Heuvel D, Rimmele M, Sieber CC, Freiberger E. Components of the transitional care model (TCM) to reduce readmission in geriatric patients: a systematic review. BMC Geriatr. 2020 Sep 11;20(1):345. doi: 10.1186/s12877-020-01747-w.'}, {'pmid': '25485791', 'type': 'RESULT', 'citation': 'Hung D, Leidig RC. Implementing a transitional care program to reduce hospital readmissions among older adults. J Nurs Care Qual. 2015 Apr-Jun;30(2):121-9. doi: 10.1097/NCQ.0000000000000091.'}, {'pmid': '33146267', 'type': 'RESULT', 'citation': 'Costa MFBNAD, Sichieri K, Poveda VB, Baptista CMC, Aguado PC. Transitional care from hospital to home for older people: implementation of best practices. Rev Bras Enferm. 2020 Nov 2;73Suppl 3(Suppl 3):e20200187. doi: 10.1590/0034-7167-2020-0187. eCollection 2020. English, Portuguese.'}, {'pmid': '33901941', 'type': 'RESULT', 'citation': 'Lyu QY, Huang JW, Li YX, Chen QL, Yu XX, Wang JL, Yang QH. Effects of a nurse led web-based transitional care program on the glycemic control and quality of life post hospital discharge in patients with type 2 diabetes: A randomized controlled trial. Int J Nurs Stud. 2021 Jul;119:103929. doi: 10.1016/j.ijnurstu.2021.103929. Epub 2021 Mar 26.'}, {'pmid': '31985129', 'type': 'RESULT', 'citation': "Liu ZC, Gao L, Zhang WH, Wang J, Liu RR, Cao BH. Effects of a 4-week Omaha System transitional care programme on rheumatoid arthritis patients' self-efficacy, health status, and readmission in mainland China: A randomized controlled trial. Int J Nurs Pract. 2020 Aug;26(4):e12817. doi: 10.1111/ijn.12817. Epub 2020 Jan 27."}, {'pmid': '29851443', 'type': 'RESULT', 'citation': 'Kranker K, Barterian LM, Sarwar R, Peterson GG, Gilman B, Blue L, Stewart KA, Hoag SD, Day TJ, Moreno L. Rural hospital transitional care program reduces Medicare spending. Am J Manag Care. 2018 May;24(5):256-260.'}, {'pmid': '31877267', 'type': 'RESULT', 'citation': 'Nall RW, Herndon BB, Mramba LK, Vogel-Anderson K, Hagen MG. An Interprofessional Primary Care-Based Transition of Care Clinic to Reduce Hospital Readmission. Am J Med. 2020 Jun;133(6):e260-e268. doi: 10.1016/j.amjmed.2019.10.040. Epub 2019 Dec 24.'}]}, 'descriptionModule': {'briefSummary': "The aim of this study was to determine the effectiveness of transitional care in patients with total knee arthroplasty on patients' functional status, perceived self-efficacy, and health care use. Based on the sampling inclusion criteria, we assigned the patients who would undergo knee arthroplasty to the control (n=35) and intervention (n=35) groups, via the block randomization method. The intervention group received transitional care, while the control group received usual care. Data were collected on post-intervention functional status, level of self-efficacy, and hospital visits outside of routine control.", 'detailedDescription': "This randomised control study was conducted 70 eligible partients with total knee arthroplasty in a public hospital orthopedic and traumatology service. Participants were randomly assigned to receive either the 6-week 'Transitional Care Model' program or usual care. Assessments of self-efficacy and functional status of patients were conducted at baseline, 2nd and 9th weeks after discharge. Time-dependent changes in patient outcomes were assessed by using Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and Arthritis Self-efficacy Scale (ASES) measurements tools. Assessments of hospital visits outside of routine control were conducted 2nd week, 6th week, 9th week, and 12th weeks after discharge. The functional status of the intervention group patients improved more than the control group according to WOMAC mean scores. Intervention group patients receiving transitional care had higher mean scores at the 2nd-week and 9th-week postoperatively in perceived self-efficacy . Besides, the rate of admission to the hospital in the intervention group was lower compared to the control group, and a significant difference was observed in the 6th-week follow-up."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Having decided to undergo total knee arthroplasty for the first time due to osteoarthritis\n* Volunteering to participate in the research, not having a psychological, physical, and mental disability that may prevent communication, not having any major chronic problems such as end-stage organ failure, kidney, neurological, cancer\n* Being discharged to the home from a hospital\n* Being able to speak Turkish\n* Being available by phone\n* Being aged 50 and over\n\nExclusion Criteria:\n\n* Unwillingness to continue the study\n* Rehospitalization\n* Exposure to a disease or trauma that would affect functional independence during the study'}, 'identificationModule': {'nctId': 'NCT05525793', 'briefTitle': 'Effectiveness of the Transitional Care Model in Total Knee Arthroplasty Patients', 'organization': {'class': 'OTHER', 'fullName': 'Hasan Kalyoncu University'}, 'officialTitle': 'Effectiveness of the Transitional Care Model in Total Knee Arthroplasty Patients: A Randomized Controlled Study', 'orgStudyIdInfo': {'id': 'Hasan Kalyoncu Üniversitesi'}, 'secondaryIdInfos': [{'id': '2021/004', 'type': 'OTHER', 'domain': 'Scientific Research Ethical Board'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Transitional care', 'description': 'This group is the actual intervention group.', 'interventionNames': ['Other: Transitional care model']}, {'type': 'NO_INTERVENTION', 'label': 'Usual care', 'description': 'This group is the routine treatment (control) valid in the clinical practice.'}], 'interventions': [{'name': 'Transitional care model', 'type': 'OTHER', 'description': 'The patients who were assigned to this group with the transitional care model, 6 weeks of counseling and intervention training provided continuity of care and a safe transition, and patients were encouraged about symptom management and a healthy lifestyle.', 'armGroupLabels': ['Transitional care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31060', 'city': 'Antakya', 'state': 'Hatay', 'country': 'Turkey (Türkiye)', 'facility': 'Mustafa Kemal Üniversitesi', 'geoPoint': {'lat': 36.20655, 'lon': 36.15722}}], 'overallOfficials': [{'name': 'Betül Tosun, Assoc. Prof.', 'role': 'STUDY_CHAIR', 'affiliation': 'Hasan Kalyoncu Üniversitesi'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hasan Kalyoncu University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ayla Güllü', 'investigatorAffiliation': 'Hasan Kalyoncu University'}}}}