Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2025-12-27 @ 11:46 AM
Study NCT ID:
NCT00433134
Status:
COMPLETED
Last Update Posted:
2009-04-24
First Post:
2007-02-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Survey of Adherence to Immunosuppression and Other Medications in Kidney Transplant Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016312', 'term': 'Treatment Refusal'}, {'id': 'D010349', 'term': 'Patient Compliance'}], 'ancestors': [{'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-04', 'completionDateStruct': {'date': '2007-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-04-23', 'studyFirstSubmitDate': '2007-02-07', 'studyFirstSubmitQcDate': '2007-02-08', 'lastUpdatePostDateStruct': {'date': '2009-04-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-02-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-06', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['renal transplant recipient', 'adherence', 'compliance', 'immunosuppression'], 'conditions': ['Kidney Transplantation', 'Treatment Refusal', 'Patient Compliance']}, 'descriptionModule': {'briefSummary': 'Goal:\n\nTo define the causes and issues associated with nonadherence in our population\n\nHypothesis:\n\nThere is a difference in the rates and patterns of adherence to transplant medications versus other medications also taken by transplant patients\n\nMethods:\n\n1. A standardized interviewer-administered confidential survey exploring levels of adherence to transplant medications and other medications as well questionnaires on a variety of cognitive and other factors known to be associated with adherence.\n2. A brief review of demographics and pertinent laboratory information at the same encounter', 'detailedDescription': 'Objectives:\n\n1. To determine the prevalence of nonadherence in our population\n2. To assess possible causes of nonadherence and correlate those causes with demographic information and clinical findings\n3. To assess for differences between adherence with immunosuppressive regime versus adherence with other medications (for hypertension, diabetes, hypercholesterolemia)\n\nMethods:\n\n1. A standardized interviewer-administered confidential survey exploring levels of adherence to transplant medications and other medications as well questionnaires on a variety of cognitive and other factors known to be associated with adherence\n2. A brief review of demographics and pertinent laboratory information at the same encounter'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All renal transplant recipients with a working transplant who are currently attending the transplant clinic and who have been transplanted 6 months to 4.5 years ago are eligible. Patients are recruited at random from the transplant clinic waiting area\n\nExclusion Criteria:\n\n* Less than 6 months post-transplant\n* More than 4.5 years post transplant'}, 'identificationModule': {'nctId': 'NCT00433134', 'briefTitle': 'Survey of Adherence to Immunosuppression and Other Medications in Kidney Transplant Patients', 'organization': {'class': 'OTHER', 'fullName': 'State University of New York - Downstate Medical Center'}, 'officialTitle': 'Survey Investigation of Adherence to Immunosuppression and Other Medications Among Kidney Transplant Recipients at SUNY Downstate', 'orgStudyIdInfo': {'id': '06-093'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Adherence', 'type': 'BEHAVIORAL'}]}, 'contactsLocationsModule': {'locations': [{'zip': '11203', 'city': 'Brooklyn', 'state': 'New York', 'country': 'United States', 'facility': 'SUNY Downstate Medical Center', 'geoPoint': {'lat': 40.6501, 'lon': -73.94958}}], 'overallOfficials': [{'name': 'Mariana Markell, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'State University of New York - Downstate Medical Center'}, {'name': 'Sima Terebelo, MPH, RPA-C', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'State University of New York - Downstate Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'State University of New York - Downstate Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Mariana Markell, MD', 'oldOrganization': 'SUNY Downstate MC'}}}}