Ignite Creation Date:
2025-12-25 @ 5:06 AM
Ignite Modification Date:
2026-03-02 @ 6:08 PM
Study NCT ID:
NCT03526627
Status:
UNKNOWN
Last Update Posted:
2020-06-22
First Post:
2018-03-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Advanced Care Management in Patients With Advanced Heart Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 227}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-01-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-06-18', 'studyFirstSubmitDate': '2018-03-06', 'studyFirstSubmitQcDate': '2018-05-03', 'lastUpdatePostDateStruct': {'date': '2020-06-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'advanced care management', 'timeFrame': '3 months for each interval and 4 times on each patient (total 9 months on this study)', 'description': 'we use a modified questionnaire "assessment the medical needs and preference on terminal patients and their families (Tang, et al., 2004) by literature review and named "The prognosis and message status on patients with advanced Heart failure. the questionnaire include 3 parts: medical preference in their advanced status, communication between physician and patients and physician and their families ( the definition of families in this study is the major medical decision for the patients), and the knowledge of disease prognosis. The questionnaire include 17 items with continue and category variables. Before study we use expert validity from 5 experts who works in group at least 10 years. Each items is scored on a five-point Likert scale range from 0(not at all) to 4 (very appropriate to this study). The overall score was calculated as the average of all items and finally we got 3.67-points.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['advanced care management, advanced heart failure'], 'conditions': ['Advanced Heart Failure']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to explore the trajectory of advanced management care in patients with heart failure over a period of 9 months, then comparing the medical treatment accepted by patients after 2 years later and compliance with the preferences of patients and their families.', 'detailedDescription': 'this study is to observe the trajectory of the advanced care management on patients with advanced heart failure and follow the difference between the actual medical treatment accepted by patients on 2years later and the preference of the patient and their families.\n\nthe advance care management in this study is mean the patients who know about the preference of medical treatment, communication, and prognosis of illness. we also measure the sense of coherence, self-efficacy and their quality of life to compare their relationship of the advanced care management.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patient with advanced heart disease and received medical treatment now.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosed with AHA stage D, or NYHA class function 4, or LVEF\\<=30%.\n* has one or more than one symptoms such as dyspnea, lower legs edema, weakness.\n* ever admission to the hospital (include emergency room or the general room)\n\nExclusion Criteria:\n\n* with other end-stage diseases such cancer, dementia, COPD, ESRD...etc.\n* had other physical, cognitive, or psychological condition which may influence their answer.'}, 'identificationModule': {'nctId': 'NCT03526627', 'briefTitle': 'Advanced Care Management in Patients With Advanced Heart Failure', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'Advanced Care Management in Patients With Advanced Heart Failure', 'orgStudyIdInfo': {'id': '201711101RIND'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'patient with advanced heart failure', 'description': 'we included the patients with advanced heart failure who had the poor cardiac function(LVEF\\<=30%) and was admitted to the general ward or emergency room within one year.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '100', 'city': 'Taipei', 'state': 'Zhongzheng', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Kai-di Kao', 'role': 'CONTACT', 'email': 'keddy0717@gmail.com', 'phone': '886-928846909'}, {'name': 'Shiu-yu Chiu', 'role': 'CONTACT', 'email': 'shiuyu@ntunhs.edu.tw', 'phone': '886-2-2822-7101', 'phoneExt': '3316'}], 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'Kai-di Kao', 'role': 'CONTACT', 'email': 'keddy0717@gmail.com', 'phone': '+886928846909'}, {'name': 'Shiu-yu Chiu, PhD', 'role': 'CONTACT', 'email': 'shiuyu@ntunhs.edu.tw', 'phone': '886-2-2822-7101', 'phoneExt': '3316'}], 'overallOfficials': [{'name': 'Kai-di Kao', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Taiwan University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}