Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2026-03-03 @ 1:36 AM
Study NCT ID:
NCT03099434
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-08
First Post:
2017-03-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Expanding Live Donor Kidney Transplantation Through Advocacy Training and Social Media
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}], 'ancestors': [{'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'FACTORIAL', 'interventionModelDescription': 'Patients will be randomly assigned to one of the 3 arms, where arm 1 is two interventions combined (LDC program + Facebook app), arm 2 is one intervention (Facebook app), and arm 3 is the control group (standard-of-care).'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 775}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2017-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-12-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-04', 'studyFirstSubmitDate': '2017-03-28', 'studyFirstSubmitQcDate': '2017-03-28', 'lastUpdatePostDateStruct': {'date': '2025-12-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2017-04-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Live donor kidney transplantation', 'timeFrame': 'within 1 year of enrollment', 'description': 'Live donor kidney transplantation within one year of enrollment into the study will be the primary outcome and will be collected/identified through electronic medical record system.'}], 'secondaryOutcomes': [{'measure': 'Live Donor Inquiries', 'timeFrame': 'within 1 year of enrollment', 'description': 'Live Donor Inquiries on behalf of candidates will be the secondary outcome and will be collected/identified through electronic medical record system.'}, {'measure': 'knowledge of live donation', 'timeFrame': 'within 6 months of enrollment', 'description': 'knowledge of live donation of transplant candidates will be collected during the survey.'}, {'measure': 'comfort initiating conversations', 'timeFrame': 'within 6 months of enrollment', 'description': 'comfort initiating conversations with others about live donation will be collected during the survey.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Live Donor Transplant, Social Media, Education, Advocacy, Live Donor'], 'conditions': ['Kidney Failure', 'Kidney Diseases']}, 'descriptionModule': {'briefSummary': 'This pilot study will be a clinical trial to test the feasibility and effectiveness of an educational intervention and a mobile health intervention in adults with end stage renal disease (ESRD) who have not yet identified a potential live donor.', 'detailedDescription': 'Transplant candidates are hesitant to discuss their illness and the difficulties associated with dialysis, and are therefore reluctant to pursue live donor kidney transplant (LDKT). The investigators will conduct a prospective 3-arm randomized controlled trial with two novel interventions to increase live donation. Arm 1 includes LDC program and the Facebook app, Arm 2 includes just the Facebook app, and Arm 3 includes standard of care. The investigators primary objective is to demonstrate the the effectiveness of these interventions in increasing live donor transplantation rates for candidates with no prior potential live donor.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Kidney transplant candidates agedā„18 added to the waitlist in the last year with no potential live donors are eligible.\n* If there is an individual willing to donate, but the candidate is unwilling to consider this option or this particular individual, the candidate is eligible for the trial and may still benefit from identification of new donors or increased comfort accepting donation from others.\n* Participants at Johns Hopkins University or University of Alabama must speak English. Participants at Northwestern University must speak English or Spanish.\n\nExclusion Criteria:\n\n* Candidates with live donors currently under evaluation for donation will be excluded.\n* Those with a previous kidney transplant will be excluded'}, 'identificationModule': {'nctId': 'NCT03099434', 'acronym': 'ENGAGE', 'briefTitle': 'Expanding Live Donor Kidney Transplantation Through Advocacy Training and Social Media', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': 'Expanding Live Donor Kidney Transplantation Through Advocacy Training and Social Media', 'orgStudyIdInfo': {'id': 'IRB00125128'}, 'secondaryIdInfos': [{'id': 'R01DK111966', 'link': 'https://reporter.nih.gov/quickSearch/R01DK111966', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Live Donor Champion + Facebook App', 'description': "The LDC program consists of 6 monthly sessions of approx. 1 hour each. Each LDC session is led by a transplant physician or clinical coordinator. LDC sessions incorporate formal didactics, active-participant learning, personal stories, moderated group discussions, role-playing, and other skill-building exercises. LDC sessions are as follows: 1) education about ESRD, KT, and LDKT 2) communication skills building 3) Exploring social networks 4) sharing successful donor and recipient stories 5) encouraging candidate self-efficacy. At session 3, the the Facebook app will be incorporated and given to candidates. The Facebook app provides step-by-step instructions for creating a Facebook post that details each waitlist candidate's struggle with ESRD and their need for a live donor. The post is then uploaded to Facebook so it can be shared with the candidate's Facebook social network.", 'interventionNames': ['Behavioral: Live Donor Champion + Facebook App']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Facebook App', 'description': "The Facebook app provides step-by-step instructions for creating a Facebook post that details each waitlist candidate's struggle with ESRD and their need for a live donor. The post is then uploaded to Facebook so it can be shared with the candidate's Facebook social network. The Facebook App prompts users with specific questions to create a narrative. Links to supplemental resources are auto-populated into the post to provide anyone that views the post with vetted information about the risks, benefits, and process of live donation. Candidates using the Facebook app attend one focus group session held at the transplant center where they are provided with verbal instructions and visual demonstrations of installation and use of the Facebook app.", 'interventionNames': ['Behavioral: Facebook App']}, {'type': 'NO_INTERVENTION', 'label': 'Standard of Care', 'description': 'Standard of Care does not include any of the interventions detailed above, but rather normal routine care as this is the control group.'}], 'interventions': [{'name': 'Facebook App', 'type': 'BEHAVIORAL', 'description': 'This web-based mobile application allows candidates to write a simple and effective story to share with their previously built network on Facebook to help share their story and identify a potential live donor.', 'armGroupLabels': ['Facebook App']}, {'name': 'Live Donor Champion + Facebook App', 'type': 'BEHAVIORAL', 'description': 'A "Live Donor Champion" (LDC) is a friend, family member, or community member who serves as an advocate for the candidate in their pursuit of live donation. The investigators have developed a six-month program that provides education and advocacy training to waitlist candidates and their LDCs.', 'armGroupLabels': ['Live Donor Champion + Facebook App']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60208', 'city': 'Evanston', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University', 'geoPoint': {'lat': 42.04114, 'lon': -87.69006}}, {'zip': '21218', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins University', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Andrew Cameron, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Alabama at Birmingham', 'class': 'OTHER'}, {'name': 'Northwestern University', 'class': 'OTHER'}, {'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}