Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2025-12-26 @ 2:33 AM
Study NCT ID:
NCT01127802
Status:
UNKNOWN
Last Update Posted:
2010-05-21
First Post:
2010-05-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Changes of Functional Status, Symptoms Distress and Quality of Life in Patients Undergoing Coronary Artery Bypass Graft (CABG) Surgery
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': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-05', 'completionDateStruct': {'date': '2011-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-05-20', 'studyFirstSubmitDate': '2010-05-20', 'studyFirstSubmitQcDate': '2010-05-20', 'lastUpdatePostDateStruct': {'date': '2010-05-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-05-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-03', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['CABG', 'functional status', 'symptoms distress', 'quality of life', 'the trajectory of functional status', 'the changes of symptoms distress', 'the changes of quality of life'], 'conditions': ['Coronary Artery Bypass Graft Surgery']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to explore the changes of functional status, symptoms distress and quality of life in patients undergoing coronary artery bypass graft (CABG) surgery.', 'detailedDescription': 'This is an observational cohort study. The participants will be inpatients undergoing elective CABG surgery at one tertiary medical center. Functional status (including activity of daily living, cognitive and nutritional status), symptom distress, and quality of life will be measured at multiple points: pre-surgery, day 1 to 7 post-surgery, before discharge, and 2-4 weeks after discharge. Structured questionnaire will be used to collect demographic and medical characteristics. The Barthel Index, hand-held dynamometer, 6-minute walking test, Mini-Nutritional Assessment (MNA), Mini-Mental State Examination (MMSE), Confusion Assessment Method (CAM), Symptoms Distress Scale, and Short-Form-36 Health Survey (SF-36) will be used to collect functional data and compared for changes. The trajectory of functional status, symptoms distress, and quality of life will be further analyzed. The findings will add to the literature by raising the awareness on changes of functional status, symptoms distress, and quality of life for patients undergoing elective CABG so targeted and timely intervention could be developed and planned.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '95 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients undergoing elective CABG surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* receive elective coronary artery bypass surgery\n* able to communicate in Chinese and Taiwanese\n* walk independently or use walker\n* length of stay is over 7 days\n\nExclusion Criteria:\n\n* unable to walk\n* mechanical ventilation\n* neural or muscle disease to influence ambulation(ex: Parkinson Disease)\n* asthma\n* severe psychotic disorder that prevents patient from participating in test'}, 'identificationModule': {'nctId': 'NCT01127802', 'briefTitle': 'Changes of Functional Status, Symptoms Distress and Quality of Life in Patients Undergoing Coronary Artery Bypass Graft (CABG) Surgery', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'Changes of Functional Status, Symptoms Distress and Quality of Life in Patients Undergoing CABG Surgery', 'orgStudyIdInfo': {'id': '201003017R'}}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Chia-Hui Chen, Ph. D.', 'role': 'STUDY_CHAIR', 'affiliation': 'National Taiwan University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Cheryl Chia-Hui Chen', 'oldOrganization': 'Department of Nursing, College of Medicine, National Taiwan University'}}}}