Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2026-04-14 @ 5:59 AM
Study NCT ID:
NCT00843960
Status:
UNKNOWN
Last Update Posted:
2009-10-07
First Post:
2009-02-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Medication Adherence Enhancement in Heart Transplant Recipients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055118', 'term': 'Medication Adherence'}, {'id': 'D012059', 'term': 'Rejection, Psychology'}], 'ancestors': [{'id': 'D010349', 'term': 'Patient Compliance'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D012919', 'term': 'Social Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010166', 'term': 'Palliative Care'}], 'ancestors': [{'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-10', 'completionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-10-06', 'studyFirstSubmitDate': '2009-02-12', 'studyFirstSubmitQcDate': '2009-02-12', 'lastUpdatePostDateStruct': {'date': '2009-10-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-02-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occurrence of adverse events (composite endpoint)', 'timeFrame': 'at month 60'}], 'secondaryOutcomes': [{'measure': 'Adherence behavior measurement variables from MEMS system', 'timeFrame': 'first 3 month'}, {'measure': 'Immunosuppression level', 'timeFrame': 'Month 3, 12 and 60'}, {'measure': 'All individual components of the composite endpoint occurence of adverse events', 'timeFrame': 'at month 60'}, {'measure': 'Immunosuppression level', 'timeFrame': 'month 12'}, {'measure': 'Immunosuppression level', 'timeFrame': 'at month 60'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Medication Adherence', 'Self Management', 'Rejection']}, 'referencesModule': {'references': [{'pmid': '36094829', 'type': 'DERIVED', 'citation': "Mellon L, Doyle F, Hickey A, Ward KD, de Freitas DG, McCormick PA, O'Connell O, Conlon P. Interventions for increasing immunosuppressant medication adherence in solid organ transplant recipients. Cochrane Database Syst Rev. 2022 Sep 12;9(9):CD012854. doi: 10.1002/14651858.CD012854.pub2."}]}, 'descriptionModule': {'briefSummary': "Medication-related non-adherence increases the risk of rejections and associated graft loss after solid organ transplantation. A randomized controlled intervention will use adherence enhancing strategies out of a larger sample of 300 heart transplant recipients. Non-Adherence will be assessed by patients' self-report and based on immunosuppression level. All non-adherent patients will be randomly designed to either intervention or control group. Multi-module interventions include patient education, electronic medication event monitoring, and a combined behavior and symptom management. Longitudinal follow-up is envisioned after initial intervention."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* all eligible patients with follow-up at our outpatient clinic\n* written informed consent\n* sufficient German language skills to read and answer a battery of questionnaires\n* \\> 18 years\n* minimum 6 mts post HTX\n\nExclusion Criteria:\n\n* illiteracy'}, 'identificationModule': {'nctId': 'NCT00843960', 'briefTitle': 'Medication Adherence Enhancement in Heart Transplant Recipients', 'organization': {'class': 'OTHER', 'fullName': 'Hannover Medical School'}, 'officialTitle': 'Medication Adherence Enhancement in Heart Transplant Recipients: a Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'IFB-P46-377'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'intervention group', 'interventionNames': ['Behavioral: behavioral adaptation and symptom management']}, {'type': 'NO_INTERVENTION', 'label': '2', 'description': 'control group'}], 'interventions': [{'name': 'behavioral adaptation and symptom management', 'type': 'BEHAVIORAL', 'description': 'behavioral adaptation and symptom management', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30625', 'city': 'Hanover', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Christiane Kugler, PhD', 'role': 'CONTACT', 'email': 'kugler.christiane@mh-hannover.de', 'phone': '++49.511.532.', 'phoneExt': '6586'}, {'name': 'Christoph Bara, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Clinic for Cardiac, Thoracic, Transplantation and Vascular Surgery', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}], 'centralContacts': [{'name': 'Christiane Kugler, PhD', 'role': 'CONTACT', 'email': 'kugler.christiane@mh-hannover.de', 'phone': '++49.511.532', 'phoneExt': '6586'}], 'overallOfficials': [{'name': 'Christiane Kugler, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinic for Cardiac, Thoracic, Transplantation and Vascular Surgery'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hannover Medical School', 'class': 'OTHER'}, 'collaborators': [{'name': 'German Federal Ministry of Education and Research', 'class': 'OTHER_GOV'}], 'responsibleParty': {'oldNameTitle': 'Dr. rer. biol. hum. Christiane Kugler', 'oldOrganization': 'Hannover Medical School'}}}}