NCT02671734

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
77

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2014

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

January 25, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 2, 2016

Completed
Last Updated

February 2, 2016

Status Verified

January 1, 2016

Enrollment Period

2 months

First QC Date

January 25, 2016

Last Update Submit

January 29, 2016

Conditions

Children

Keywords

endoscopy

Outcome Measures

Primary Outcomes (1)

  • Evaluation of Comprehension of Informed Consent Process via a scored scale

    Structured Interview

    Day 1

Study Arms (2)

control

NO INTERVENTION

Subjects in this arm received the standard consent form to read and underwent standard discussions with the procedurist prior to the procedure.

intervention

ACTIVE COMPARATOR

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

Interventions

videoBEHAVIORAL

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.

intervention

Eligibility Criteria

Age7 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • None.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Videotape Recording

Intervention Hierarchy (Ancestors)

Tape RecordingAudiovisual AidsEducational TechnologyTechnologyTechnology, Industry, and AgricultureTelevision

Study Officials

  • Jeannie Huang, MD, MPH

    University of California, San Diego

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
INDIV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 25, 2016

First Posted

February 2, 2016

Study Start

June 1, 2014

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

February 2, 2016

Record last verified: 2016-01

Data Sharing

IPD Sharing
Will not share