Ignite Creation Date:
2025-12-25 @ 2:20 AM
Ignite Modification Date:
2026-01-08 @ 9:01 PM
Study NCT ID:
NCT02671734
Status:
COMPLETED
Last Update Posted:
2016-02-02
First Post:
2016-01-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improving the Informed Consent Process for Youth Undergoing Pediatric Endoscopy and Their Parents
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 77}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-29', 'studyFirstSubmitDate': '2016-01-25', 'studyFirstSubmitQcDate': '2016-01-29', 'lastUpdatePostDateStruct': {'date': '2016-02-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-02-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of Comprehension of Informed Consent Process via a scored scale', 'timeFrame': 'Day 1', 'description': 'Structured Interview'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['endoscopy'], 'conditions': ['Children']}, 'descriptionModule': {'briefSummary': 'The investigators employed a randomized control study design to evaluate the efficacy of a video intervention augmenting informed consent discussions in improving parental and youth informed consent comprehension.', 'detailedDescription': 'IC = informed consent\n\nThe investigators employed a randomized control study design to evaluate the efficacy of a video intervention augmenting IC discussions in improving parental and youth IC comprehension. Sample size was selected to detect a 30% improvement in comprehension scores in the intervention v. control group. The local Institutional Review Board approved the study. Informed consent and assent were obtained prior to all study procedures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '7 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* For children admitted, age limits listed. Youth-parent pairs were admitted into the study.\n* Had to be undergoing pediatric endoscopy.\n* English speaking\n\nExclusion Criteria:\n\n* None.'}, 'identificationModule': {'nctId': 'NCT02671734', 'briefTitle': 'Improving the Informed Consent Process for Youth Undergoing Pediatric Endoscopy and Their Parents', 'organization': {'class': 'INDIV', 'fullName': 'Huang, Jeannie, M.D.'}, 'officialTitle': 'Using Media to Improve the Informed Consent Process for Youth Undergoing Pediatric Endoscopy and Their Parents', 'orgStudyIdInfo': {'id': '121426'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'control', 'description': 'Subjects in this arm received the standard consent form to read and underwent standard discussions with the procedurist prior to the procedure.'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'intervention', 'description': 'Subjects in this arm viewed a video detailing key elements of informed consent. Subjects in this arm also received the standard consent form to read and underwent standard discussions with the procedurist prior to the procedure.', 'interventionNames': ['Behavioral: video']}], 'interventions': [{'name': 'video', 'type': 'BEHAVIORAL', 'description': 'Short (2 minute 43 second), animated videos were designed addressing nature of the procedure, risks, benefits, and alternatives for upper and lower endoscopy respectively using PowToon (www.powtoon.com). Sixth grade language was used throughout the video. Videos were shown to youth and their parents on an iPad.', 'armGroupLabels': ['intervention']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Jeannie Huang, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Diego'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Huang, Jeannie, M.D.', 'class': 'INDIV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Jeannie Huang, MD, MPH', 'investigatorAffiliation': 'Huang, Jeannie, M.D.'}}}}