Ignite Creation Date:
2025-12-24 @ 3:51 PM
Ignite Modification Date:
2025-12-26 @ 4:16 AM
Study NCT ID:
NCT03447392
Status:
COMPLETED
Last Update Posted:
2018-02-27
First Post:
2018-02-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Discharge Education of Integrated Traditional and Western Medicine Reduces Re-hospitalization in Patients With Chronic Heart Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 134}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2018-01-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-02-26', 'studyFirstSubmitDate': '2018-02-16', 'studyFirstSubmitQcDate': '2018-02-26', 'lastUpdatePostDateStruct': {'date': '2018-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-01-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'total number of days hospitalized', 'timeFrame': '84 days', 'description': 'total number of days hospitalized in the 84-day follow-up period.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Patient Education', 'Chinese Medicine'], 'conditions': ['Heart Failure']}, 'descriptionModule': {'briefSummary': 'Although interventions combining patient education and postdischarge management have demonstrated benefits in patients with chronic heart failure, the benefit attributable to patient education alone is not known. The investigators hypothesized that a patient discharge education program would improve clinical outcomes in patients with chronic heart failure.', 'detailedDescription': 'Although interventions combining patient education and postdischarge management have demonstrated benefits in patients with chronic heart failure, the benefit attributable to patient education of Integrated Traditional and Western Medicine is not known. The investigators hypothesized that a patient discharge education of Integrated Traditional and Western Medicine program would improve clinical outcomes in patients with chronic heart failure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Candidates for this study were admitted to the hospital with a diagnosis of heart failure and documented left ventricular systolic dysfunction (ejection fraction\\<0.40).\n\nExclusion Criteria:\n\n* CKD4 and CKD5'}, 'identificationModule': {'nctId': 'NCT03447392', 'briefTitle': 'Discharge Education of Integrated Traditional and Western Medicine Reduces Re-hospitalization in Patients With Chronic Heart Failure', 'organization': {'class': 'OTHER', 'fullName': 'Guangzhou University of Traditional Chinese Medicine'}, 'officialTitle': 'Discharge Education of Integrated Traditional and Western Medicine Reduces Re-hospitalization in Patients With Chronic Heart Failure', 'orgStudyIdInfo': {'id': 'Jguo'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'patient education and Chinese medicine', 'description': '1-hour, one-on-one teaching session with a educator to the standard discharge education of Integrated Traditional and Western Medicine', 'interventionNames': ['Behavioral: Discharge Education of Chinese Medicine']}, {'type': 'NO_INTERVENTION', 'label': 'patient education', 'description': 'no discharge education'}], 'interventions': [{'name': 'Discharge Education of Chinese Medicine', 'type': 'BEHAVIORAL', 'description': 'Discharge Education of Integrated Traditional and Western Medicine', 'armGroupLabels': ['patient education and Chinese medicine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510405', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Guangdong Provincial Hospital of Traditional Chinese Medicine', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'overallOfficials': [{'name': 'Xu ZOU', 'role': 'STUDY_CHAIR', 'affiliation': 'The Second Clinical College, Guangzhou University of Chinese Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Guangzhou University of Traditional Chinese Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}