Improving the Informed Consent Process for Youth Undergoing Pediatric Endoscopy and Their Parents
NCT ID: NCT02671734
Last Updated: 2016-02-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
77 participants
INTERVENTIONAL
2014-06-30
2014-08-31
Brief Summary
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Detailed Description
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The 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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control
Subjects in this arm received the standard consent form to read and underwent standard discussions with the procedurist prior to the procedure.
No interventions assigned to this group
intervention
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.
video
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.
Interventions
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video
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.
Eligibility Criteria
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Inclusion Criteria
* Had to be undergoing pediatric endoscopy.
* English speaking
Exclusion Criteria
7 Years
17 Years
ALL
No
Sponsors
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Huang, Jeannie, M.D.
INDIV
Responsible Party
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Jeannie Huang, MD, MPH
Associate Professor
Principal Investigators
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Jeannie Huang, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
University of California, San Diego
Other Identifiers
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121426
Identifier Type: -
Identifier Source: org_study_id
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