Ignite Creation Date:
2025-12-24 @ 7:02 PM
Ignite Modification Date:
2026-04-02 @ 8:19 AM
Study NCT ID:
NCT02090257
Status:
COMPLETED
Last Update Posted:
2017-07-26
First Post:
2014-03-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pediatric Heart Transplantation: Transitioning to Adult Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2019-08-08', 'releaseDate': '2019-07-12'}, {'resetDate': '2021-04-01', 'releaseDate': '2021-03-08'}, {'resetDate': '2025-03-03', 'releaseDate': '2025-02-11'}], 'estimatedResultsFirstSubmitDate': '2019-07-12'}}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 88}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2017-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-25', 'studyFirstSubmitDate': '2014-03-05', 'studyFirstSubmitQcDate': '2014-03-17', 'lastUpdatePostDateStruct': {'date': '2017-07-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-03-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To assess the feasibility of TRANSIT by measuring the transition program adherence for those randomized to the intervention and survey completion for all participants.', 'timeFrame': '6 months', 'description': 'Investigators hypothesize that by the end of the 3 month transition program and 6 months of follow-up, 84% of patients will be retained; 80% will participate in the program (module completion, discussion, and follow-up); and 100% will complete at least 80% of the survey instruments at each data collection point.'}], 'secondaryOutcomes': [{'measure': 'To determine the efficacy of TRANSIT on patient-level outcomes .', 'timeFrame': '6 months', 'description': 'The following patient level outcomes will be measured:\n\n1. At 3 months post intervention and 6 months follow-up, emerging adult heart transplant recipients who participate in TRANSIT will have lower CNI SD (i.e., SD \\<2.5 for tacrolimus and cyclosporine), than patients who receive usual care.\n2. At 3 months post intervention and 6 months follow-up, emerging adult heart transplant recipients who participate in TRANSIT will have a higher percentage of CNI levels within the target range (i.e., \\< 50% of CNI blood levels out of target range for individual patients as reported by their transplant center), better self-reported adherence to the medical regimen, and fewer episodes of treated acute rejection, than patients who receive usual care.\n3. At 3 months post intervention and 6 months follow-up, emerging adult heart transplant recipients who participate in TRANSIT then patients who receive usual care.'}, {'measure': 'To determine the efficacy of TRANSIT on meso-level outcomes.', 'timeFrame': '6 Months', 'description': 'These will be measured based on the use of health care resources: rates of appointments for clinic and CNI blood draws and number of all-cause days re-hospitalized'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Heart transplant recipients who are entering into adult care.'], 'conditions': ['Heart Transplantation']}, 'descriptionModule': {'briefSummary': 'The purpose of this pilot trial, Transitioning to Adult Care (TRANSIT), is to develop and test an intervention (i.e., a standardized, tailored transition program focused on enhancing adherence) to improve outcomes for emerging adults who underwent heart transplantation as children and transfer to adult care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Have received a heart transplant at a children's hospital and are ready to transition, as determined by the pediatric heart transplant cardiologist, to the adult heart transplant center with whom a collaborative relationship has been established;\n* 18 years or older;\n* Able to speak, read at a fifth grade level or above, and write English;\n* Physically able to participate.\n\nExclusion Criteria:\n\n* History of psychiatric hospitalization within the last 3 months, assessed on a case-by-case basis with exclusion only if patients could not potentially benefit from the intervention."}, 'identificationModule': {'nctId': 'NCT02090257', 'acronym': 'TRANSIT', 'briefTitle': 'Pediatric Heart Transplantation: Transitioning to Adult Care', 'organization': {'class': 'OTHER', 'fullName': "Ann & Robert H Lurie Children's Hospital of Chicago"}, 'officialTitle': 'Pediatric Heart Transplantation: Transitioning to Adult Care', 'orgStudyIdInfo': {'id': '1R34HL111492', 'link': 'https://reporter.nih.gov/quickSearch/1R34HL111492', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TRANSIT, behavioral', 'description': 'The intervention group will receive more guidance during their transition from a pediatric center to the adult center', 'interventionNames': ['Behavioral: TRANSIT']}, {'type': 'NO_INTERVENTION', 'label': 'Usual Care Group', 'description': 'The usual care group will receive a standard transfer of care from a pediatric center to an adult center.'}], 'interventions': [{'name': 'TRANSIT', 'type': 'BEHAVIORAL', 'description': 'Educational Modules, staff follow up.', 'armGroupLabels': ['TRANSIT, behavioral']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92354', 'city': 'Loma Linda', 'state': 'California', 'country': 'United States', 'facility': 'Loma Linda University', 'geoPoint': {'lat': 34.04835, 'lon': -117.26115}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'Universtiy of Colorado Denver/Children Colorado', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': "Ann & Robert H. Lurie Children's Hospital of Chicago", 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern Memorial Hospital', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "Children's Hospital of Philadelphia/University of Pennsylvania", 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Elfriede Pahl, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Ann and Robert Lurie Children's Hospital"}, {'name': 'Kathleen Grady, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northwestern University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Ann & Robert H Lurie Children's Hospital of Chicago", 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Attending Physician, Division of Cardiology', 'investigatorFullName': 'Elfriede Pahl, MD', 'investigatorAffiliation': "Ann & Robert H Lurie Children's Hospital of Chicago"}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2019-07-12', 'type': 'RELEASE'}, {'date': '2019-08-08', 'type': 'RESET'}, {'date': '2021-03-08', 'type': 'RELEASE'}, {'date': '2021-04-01', 'type': 'RESET'}, {'date': '2025-02-11', 'type': 'RELEASE'}, {'date': '2025-03-03', 'type': 'RESET'}], 'unpostedResponsibleParty': "Ann & Robert H Lurie Children's Hospital of Chicago"}}}}