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NCT02671734 Clinical Trial

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

Children Clinical Trial

Official title:
Using Media to Improve the Informed Consent Process for Youth Undergoing Pediatric Endoscopy and Their Parents

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02671734
Other study ID # 121426
Secondary ID
Status Completed
Phase N/A
First received January 25, 2016
Last updated January 29, 2016
Start date June 2014
Est. completion date August 2014

Study information
Verified date January 2016
Source Huang, Jeannie, M.D.
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 77
Est. completion date August 2014
Est. primary completion date August 2014
Accepts healthy volunteers No
Gender Both
Age group 7 Years to 17 Years
Eligibility 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:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Huang, Jeannie, M.D.

Outcome
Type Measure Description Time frame Safety issue
Primary Evaluation of Comprehension of Informed Consent Process via a scored scale Structured Interview Day 1 No
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