Ignite Creation Date:
2025-12-25 @ 3:04 AM
Ignite Modification Date:
2026-01-01 @ 2:05 AM
Study NCT ID:
NCT01572233
Status:
UNKNOWN
Last Update Posted:
2012-12-27
First Post:
2012-04-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Activity and Education Program on Patients With Chronic Hepatitis C Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006526', 'term': 'Hepatitis C'}, {'id': 'D005221', 'term': 'Fatigue'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018178', 'term': 'Flaviviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-11', 'completionDateStruct': {'date': '2018-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-12-26', 'studyFirstSubmitDate': '2012-04-04', 'studyFirstSubmitQcDate': '2012-04-04', 'lastUpdatePostDateStruct': {'date': '2012-12-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-04-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effects of Activity and Education Program on Patients with Chronic Hepatitis C Infection', 'timeFrame': '4-year project', 'description': 'Phase I of this project, the first and second year, the measurement time will be collected on the baseline (before treatment, T0), the 8 weeks (T1), 16 weeks (T2), and 24 weeks (T3) during treatment.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Fatigue,Physical Activity,Hepatitis C Virus Infection'], 'conditions': ['Hepatitis C Virus Infection, Response to Therapy of']}, 'descriptionModule': {'briefSummary': "This 4-year project will be guided by a biobehavioral model for the study of exercise interventions in two phases with the purposes to :\n\n1. explore the patients' physical activity preferences and develop doable activity lists during treatment period\n2. examine the changes of health-related physical fitness component over interferon treatment\n3. develop the Personalized Physical Activity and Psych-Education (PPAPE) Program and test its effects on decreasing fatigue, physical and psychological distress, and improving their health-related physical fitness and quality of life in patients with chronic hepatitis C receiving Interferon with Ribavirin Combination Therapy\n4. evaluate the outcome of the PPAPE program on increasing adherence to therapy, the sustained virological response (SVR) in 24 weeks after the end of treatment, and the time-consuming for education program during intervention."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with Chronic Hepatitis C Infection Receiving Interferon Therapy\n* Aged above 18\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT01572233', 'briefTitle': 'Effects of Activity and Education Program on Patients With Chronic Hepatitis C Infection', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'Effects of Personalized Physical Activity and Psycho-Education Program on Patients With Chronic Hepatitis C Infection', 'orgStudyIdInfo': {'id': '201103086RC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patient with HCV Infection', 'description': 'Personalized Physical Activity and Psycho-Education (PPAPE) Program will be tested on this group.', 'interventionNames': ['Behavioral: Personalized Physical Activity and Psycho-Education (PPAPE) Program']}, {'type': 'NO_INTERVENTION', 'label': 'usual care', 'description': 'waiting list group with usual care'}], 'interventions': [{'name': 'Personalized Physical Activity and Psycho-Education (PPAPE) Program', 'type': 'BEHAVIORAL', 'description': '1. Effects of Personalized Physical Activity and Psycho-Education Program on Patients with HCV infection\n2. The third and fourth year, will be examine on the 12, 24, 36, and 48 weeks during the interferon treatment.', 'armGroupLabels': ['Patient with HCV Infection']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Shiow-Ching Shun, PhD', 'role': 'CONTACT', 'email': 'scshun@ntu.edu.tw', 'phone': '886-2-23123456', 'phoneExt': '88439'}, {'name': 'Shiow-Ching Shun, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'Siow-ching Shun, PhD', 'role': 'CONTACT', 'email': 'scshun@ntu.edu.tw', 'phone': '886-2-23123456', 'phoneExt': '88439'}], 'overallOfficials': [{'name': 'Shiow-ching Shun, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Taiwan University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Health Research Institutes, Taiwan', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}