Improving the Informed Consent Process for Youth Undergoing Pediatric Endoscopy and Their Parents
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|ClinicalTrials.gov Identifier: NCT02671734|
Recruitment Status : Completed
First Posted : February 2, 2016
Last Update Posted : February 2, 2016
|Condition or disease||Intervention/treatment||Phase|
|Children||Behavioral: video||Not Applicable|
IC = informed consent
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||77 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Using Media to Improve the Informed Consent Process for Youth Undergoing Pediatric Endoscopy and Their Parents|
|Study Start Date :||June 2014|
|Actual Primary Completion Date :||August 2014|
|Actual Study Completion Date :||August 2014|
No Intervention: control
Subjects in this arm received the standard consent form to read and underwent standard discussions with the procedurist prior to the procedure.
Active Comparator: 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.
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.
- Evaluation of Comprehension of Informed Consent Process via a scored scale [ Time Frame: Day 1 ]Structured Interview
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02671734
|Principal Investigator:||Jeannie Huang, MD, MPH||University of California, San Diego|