Ignite Creation Date:
2025-12-26 @ 10:58 AM
Ignite Modification Date:
2026-03-06 @ 8:51 AM
Study NCT ID:
NCT00870506
Status:
COMPLETED
Last Update Posted:
2025-08-05
First Post:
2009-03-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Community Trial to Enhance Organ Donation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015438', 'term': 'Health Behavior'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014743', 'term': 'Videotape Recording'}], 'ancestors': [{'id': 'D013637', 'term': 'Tape Recording'}, {'id': 'D001296', 'term': 'Audiovisual Aids'}, {'id': 'D018961', 'term': 'Educational Technology'}, {'id': 'D013672', 'term': 'Technology'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}, {'id': 'D013690', 'term': 'Television'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 973}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-31', 'studyFirstSubmitDate': '2009-03-26', 'studyFirstSubmitQcDate': '2009-03-26', 'lastUpdatePostDateStruct': {'date': '2025-08-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-03-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of signed donor cards', 'timeFrame': 'One day'}], 'secondaryOutcomes': [{'measure': 'Proportion of participants willing to donate organs while living', 'timeFrame': 'One Day'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Randomized Controlled Trial', 'Healthcare Disparities'], 'conditions': ['Tissue and Organ Procurement', 'Health Behavior']}, 'referencesModule': {'references': [{'pmid': '22473435', 'type': 'DERIVED', 'citation': 'Thornton JD, Alejandro-Rodriguez M, Leon JB, Albert JM, Baldeon EL, De Jesus LM, Gallardo A, Hossain S, Perez EA, Martin JY, Lasalvia S, Wong KA, Allen MD, Robinson M, Heald C, Bowen G, Sehgal AR. Effect of an iPod video intervention on consent to donate organs: a randomized trial. Ann Intern Med. 2012 Apr 3;156(7):483-90. doi: 10.7326/0003-4819-156-7-201204030-00004.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the effect of a 5-minute video intervention regarding organ donation and transplantation on increasing the number of organ donor cards signed in Northeastern Ohio Bureau of Motor Vehicles (OBMV) branches and on willingness to donate organs while living. The investigators hypothesize that persons in the intervention group will sign more donor cards and be more willing to donate organs while living than persons in the control group.', 'detailedDescription': "We propose a community-based randomized controlled trial involving 450 intervention and 450 control patrons visiting Ohio Bureau of Motor Vehicle branches (OBMV) to obtain a driver's license. Interventions patrons will watch a 5-minute video prior to entering the OBMV. Study personnel will interview intervention and control patrons after they leave the OBMV to determine whether they signed an organ donor card. We will also determine the effect of the video intervention on willingness to donate organs while living."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '15 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* English speaking\n* Applying for driver's license, driver's permit or state id\n\nExclusion Criteria:\n\n* Non-English speaking\n* Persons who have already signed donor card"}, 'identificationModule': {'nctId': 'NCT00870506', 'briefTitle': 'Community Trial to Enhance Organ Donation', 'organization': {'class': 'OTHER', 'fullName': 'Case Western Reserve University'}, 'officialTitle': 'Community-based Intervention to Enhance Signing of Organ Donor Cards', 'orgStudyIdInfo': {'id': 'P60MD002265DT1'}, 'secondaryIdInfos': [{'id': '1P60MD002265-01', 'link': 'https://reporter.nih.gov/quickSearch/1P60MD002265-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': '2', 'description': 'No intervention (control)'}, {'type': 'EXPERIMENTAL', 'label': '1', 'description': '5-minute video on donation and transplantation', 'interventionNames': ['Behavioral: video']}], 'interventions': [{'name': 'video', 'type': 'BEHAVIORAL', 'description': '5-minute video compared (intervention) to no video and no other intervention (control)', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44109', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio Bureau of Motor Vehicles', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': 'John D Thornton, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Case Western Reserve University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Case Western Reserve University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Robert Wood Johnson Foundation', 'class': 'OTHER'}, {'name': 'National Institute on Minority Health and Health Disparities (NIMHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}