Ignite Creation Date:
2025-12-25 @ 12:55 AM
Ignite Modification Date:
2025-12-29 @ 3:49 PM
Study NCT ID:
NCT05987267
Status:
UNKNOWN
Last Update Posted:
2023-08-14
First Post:
2023-07-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nurse-led Multidisciplinary Precision Care for Patients With Chronic Heart Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 96}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-11-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-08-03', 'studyFirstSubmitDate': '2023-07-26', 'studyFirstSubmitQcDate': '2023-08-03', 'lastUpdatePostDateStruct': {'date': '2023-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'left ventricular ejection fraction', 'timeFrame': 'baseline, pre-intervention, 1 month after intervention, 3 months after intervention'}, {'measure': '6-minute walking distance', 'timeFrame': 'baseline, pre-intervention, 1 month after intervention, 3 months after intervention'}], 'secondaryOutcomes': [{'measure': 'the European Organization for Research and Treatment of Cancer (EORTC) quality-of-life (QoL) questionnaires (QLQ) QLQ-C30 (version 3.0) score Quality of Life', 'timeFrame': 'baseline, pre-intervention, 1 month after intervention, 3 months after intervention'}, {'measure': 'Symptom Check List-90', 'timeFrame': 'baseline, pre-intervention, 1 month after intervention, 3 months after intervention'}, {'measure': 'Performance Status Score', 'timeFrame': 'baseline, pre-intervention, 1 month after intervention, 3 months after intervention'}, {'measure': 'Numbers of patients with cardiovascular complications', 'timeFrame': 'baseline, pre-intervention, 1 month after intervention, 3 months after intervention'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ["Nurse's Role", 'Multidisciplinary Communication', 'Chronic Heart Failure']}, 'descriptionModule': {'briefSummary': 'This study aimed to evaluate the feasibility and effectiveness of a nurse-led multidisciplinary precision care in early cardiac rehabilitation of patients with chronic heart failure, and further to promote the application of nurse-led multidisciplinary precision care.', 'detailedDescription': 'Enrolled patients were randomly divided as 1:1 ratio to experimental group and control group, while experimental group received nurse-led multidisciplinary precision care and the control group received standard care according to guidelines. The primary and secondary outcomes were evaluated and analyzed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged from 18 to 80 years;\n* Conscious, with normal cognitive function and being communicable;\n* NYHA heart function class II-IV;\n* Patients met the diagnostic criteria of the clinical guidelines for the diagnosis and treatment of heart failure and were diagnosed with chronic heart failure;\n* Informed consent was obtained.\n\nExclusion Criteria:\n\n* Patients with congenital heart disease, cardiac shock, or persistent hypotension;\n* Patients with severe liver and kidney dysfunction, moderate to severe anemia or coagulation disorders, and other serious systemic complications;\n* Patients with a history of mental illness, a state of severe anxiety or depression, cognitive or communication impairments, and inability to communicate and respond to investigations;\n* Patients have been involved in other research that would interfere with this study;\n* Patients who declined cardiac rehabilitation and signed informed consent.'}, 'identificationModule': {'nctId': 'NCT05987267', 'briefTitle': 'Nurse-led Multidisciplinary Precision Care for Patients With Chronic Heart Failure', 'organization': {'class': 'OTHER', 'fullName': "Zhongshan People's Hospital, Guangdong, China"}, 'officialTitle': 'Nurse-led Multidisciplinary Precision Care for Patients With Chronic Heart Failure', 'orgStudyIdInfo': {'id': 'K2019-017'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'multidisciplinary precision care group', 'description': 'Give the intervention of nurse-led multidisciplinary precision care', 'interventionNames': ['Other: multidisciplinary precision care']}, {'type': 'NO_INTERVENTION', 'label': 'control group', 'description': 'standard care according to guidelines'}], 'interventions': [{'name': 'multidisciplinary precision care', 'type': 'OTHER', 'description': 'The experimental group received precision nursing based on a multidisciplinary collaborative team in addition to standard treatment and care', 'armGroupLabels': ['multidisciplinary precision care group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '528400', 'city': 'Zhongshan', 'state': 'Guangdong', 'country': 'China', 'facility': "Zhongshan City People's Hospital", 'geoPoint': {'lat': 22.52306, 'lon': 113.37912}}], 'overallOfficials': [{'name': 'Xiuxian Zhu', 'role': 'STUDY_CHAIR', 'affiliation': "Zhongshan People's Hospital, Guangdong, China"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Zhongshan People's Hospital, Guangdong, China", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Xiuxian Zhu', 'investigatorAffiliation': "Zhongshan People's Hospital, Guangdong, China"}}}}