Ignite Creation Date:
2025-12-24 @ 7:11 PM
Ignite Modification Date:
2025-12-27 @ 2:49 PM
Study NCT ID:
NCT01981603
Status:
COMPLETED
Last Update Posted:
2018-03-22
First Post:
2013-10-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Transplant Navigator Dissemination
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1926}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-21', 'studyFirstSubmitDate': '2013-10-30', 'studyFirstSubmitQcDate': '2013-11-05', 'lastUpdatePostDateStruct': {'date': '2018-03-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-11-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The proportion of patients who are wait listed or receive a kidney transplant.', 'timeFrame': 'approximately 3 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Navigators', 'Kidney Transplant', 'Hemodialysis'], 'conditions': ['Kidney Transplant', 'Renal Failure Chronic Requiring Hemodialysis']}, 'descriptionModule': {'briefSummary': 'Primary Aim A. To disseminate and determine the impact of streamlined navigation on wait listing and number of transplants. The navigator will provide tailored information and assistance to help dialysis patients complete the tasks required at each step in the transplant process. In the control group, dialysis patients will continue to get usual care from their nephrologists and dialysis facility personnel.\n\nHypothesis: Compared to control patients, intervention patients will be significantly more likely to be wait listed or receive a kidney transplant.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* between the ages of 18-70\n* receiving in center hemodialysis\n\nExclusion Criteria:\n\n* less than 18 years of age\n* older than 70 years of age'}, 'identificationModule': {'nctId': 'NCT01981603', 'briefTitle': 'Transplant Navigator Dissemination', 'organization': {'class': 'OTHER', 'fullName': 'MetroHealth Medical Center'}, 'orgStudyIdInfo': {'id': 'IRB12-00660'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'navigator', 'description': 'Kidney transplant recipients will serve as navigators to educate and assist other patients with the transplant process.', 'interventionNames': ['Other: navigator']}, {'type': 'NO_INTERVENTION', 'label': 'usual care', 'description': 'usual care'}], 'interventions': [{'name': 'navigator', 'type': 'OTHER', 'armGroupLabels': ['navigator']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Fort Wayne', 'state': 'Indiana', 'country': 'United States', 'facility': 'Lutheran Hospital', 'geoPoint': {'lat': 41.1306, 'lon': -85.12886}}, {'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'University of Kentucky', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Jewish Hospital', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '44109', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'MetroHealth Medical Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Ohio State University', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Catherine Sullivan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Center Manager, Research', 'investigatorFullName': 'Catherine Sullivan', 'investigatorAffiliation': 'MetroHealth Medical Center'}}}}