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Improving the Informed Consent Process for Youth Undergoing Pediatric Endoscopy and Their Parents

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02671734
Recruitment Status : Completed
First Posted : February 2, 2016
Last Update Posted : February 2, 2016
Sponsor:
Information provided by (Responsible Party):
Jeannie Huang, MD, MPH, Huang, Jeannie, M.D.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Children Behavioral: video Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 77 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Arm Intervention/treatment
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.
Behavioral: 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.




Primary Outcome Measures :
  1. Evaluation of Comprehension of Informed Consent Process via a scored scale [ Time Frame: Day 1 ]
    Structured Interview



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   7 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • For children admitted, age limits listed. Youth-parent pairs were admitted into the study.
  • Had to be undergoing pediatric endoscopy.
  • English speaking

Exclusion Criteria:

  • None.

Information from the National Library of Medicine

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


Sponsors and Collaborators
Huang, Jeannie, M.D.
Investigators
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Principal Investigator: Jeannie Huang, MD, MPH University of California, San Diego
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Responsible Party: Jeannie Huang, MD, MPH, Associate Professor, Huang, Jeannie, M.D.
ClinicalTrials.gov Identifier: NCT02671734    
Other Study ID Numbers: 121426
First Posted: February 2, 2016    Key Record Dates
Last Update Posted: February 2, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Jeannie Huang, MD, MPH, Huang, Jeannie, M.D.:
endoscopy