Ignite Creation Date:
2025-12-24 @ 7:40 PM
Ignite Modification Date:
2026-01-06 @ 6:56 AM
Study NCT ID:
NCT04285203
Status:
COMPLETED
Last Update Posted:
2020-02-26
First Post:
2020-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Living Donation and Kidney Transplantation Information
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 144}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2020-02-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-25', 'studyFirstSubmitDate': '2020-02-10', 'studyFirstSubmitQcDate': '2020-02-25', 'lastUpdatePostDateStruct': {'date': '2020-02-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in knowledge', 'timeFrame': 'Baseline and immediately post exposure', 'description': 'Assessed by knowledge survey pre and post exposure.'}, {'measure': 'Change in attitude about kidney offers', 'timeFrame': 'Baseline and immediately post exposure', 'description': 'Assessed by attitude survey pre and post exposure.'}], 'secondaryOutcomes': [{'measure': 'Change in subjective decisional self-efficacy', 'timeFrame': 'Baseline and immediately post exposure', 'description': 'Assessed by self-efficacy survey pre and post exposure.'}, {'measure': 'Participation and decision making', 'timeFrame': '1 day (During standard of care education at time of clinic visit)', 'description': 'Number of questions and value statements in regards to organ offers.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Kidney Transplantation']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to increase awareness and knowledge regarding the risks and benefits of kidney transplantation and living donation amongst patients seeking kidney transplantation and their family and friends in Buffalo, New York.', 'detailedDescription': 'This prospective randomized parallel controlled trial of kidney transplant candidates receiving and educational intervention and standard of care education versus standard of care education only to improve informed decision making about kidney offers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* be 18 years or older,\n* understand and read English (or have a support person that helps them)\n* have acceptable vision to watch videos\n* be able to give consent\n\nExclusion Criteria:\n\n* incarcerated\n* involved in the former modeling phase of animation development.'}, 'identificationModule': {'nctId': 'NCT04285203', 'acronym': 'KIDNEYTIME', 'briefTitle': 'Living Donation and Kidney Transplantation Information', 'organization': {'class': 'OTHER', 'fullName': 'State University of New York at Buffalo'}, 'officialTitle': 'Living Donation and Kidney Transplantation Information Made Easy (KIDNEYTIME) With Animated Video Education', 'orgStudyIdInfo': {'id': 'STUDY00002771'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Educational Video', 'description': 'Participants were exposed to 2 educational videos in addition to standard of care education.', 'interventionNames': ['Other: Educational Video Intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Standard of Care', 'description': 'Participants received standard of care education.'}], 'interventions': [{'name': 'Educational Video Intervention', 'type': 'OTHER', 'description': 'Educational videos', 'armGroupLabels': ['Educational Video']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14215', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'Erie County Medical Center', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}], 'overallOfficials': [{'name': 'Liise Kayler, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University at Buffalo'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'State University of New York at Buffalo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Liise Kayler', 'investigatorAffiliation': 'State University of New York at Buffalo'}}}}