@Article{info:doi/10.2196/44252,
author="Blake, Kathryn V
and Antal, Holly
and Bunnell, H Timothy
and He, Jiaxian
and Henderson, Robert
and Holbrook, Janet T
and McCahan, Suzanne M
and Pennington, Chris
and Rogers, Linda
and Shade, David
and Sugar, Elizabeth A
and Taylor, Alexandra
and Wise, Robert A
and Wysocki, Tim",
title="Comprehension by Caregivers and Adolescents of Clinical Trial Information Delivered via Multimedia Video Versus Conventional Practice: Nonrandomized Controlled Trial",
journal="JMIR Pediatr Parent",
year="2023",
month="Jun",
day="22",
volume="6",
pages="e44252",
keywords="adolescent; clinical trial; comprehension; informed consent; internet; multimedia",
abstract="Background: Research participants often misunderstand the required elements of informed consent information, whether provided in written or oral format. Informed consent instruments with embedded evidence-based learning theory principles administered in multimedia electronic formats may improve comprehension and retention. Objective: This study aims to determine whether study information comprehension and retention using an interactive multimedia video consent process was noninferior to comprehension and retention after an in-person face-to-face interaction with a conventional written consent document for caregivers and adolescents enrolled in a clinical trial. Methods: Participants were caregivers and children aged 12 to 17 years who were enrolled in a clinical trial of asthma treatment. Consent information was presented as a multimedia web-based video consent interaction or as a conventional written consent document with in-person interaction between the prospective participants and the study staff. The trial used a parallel nonrandomized noninferiority design that compared the 2 consent methods. Caregivers and adolescents completed a 17-item open-ended comprehension questionnaire (score range 17-51) at enrollment and at the end of the study 20 weeks later. Comprehension and retention were compared between the consent formats. Noninferiority was established if the 95{\%} CI upper bound of the difference in scores (conventional format minus web-based) was less than the noninferiority margin of 2.4; superiority was established if the upper bound of the CI was <0. Results: In total, 54 caregiver and adolescent dyads completed the interactive multimedia web-based video consent, and 25 dyads completed the conventional consent. Overall, 33{\%} (26/79) of all adolescents were Black, 57{\%} (45/79) were male, and 61{\%} (48/79) had a household income of <US {\$}60,000 per year. For caregivers, the interactive multimedia web-based format was noninferior to the conventional format at enrollment (difference between the conventional and web-based formats: mean −0.30, 95{\%} CI −2.52 to 1.92) and was superior at the end of the study 20 weeks later (mean −2.20, 95{\%} CI −3.9 to −0.5). There was a loss of comprehension over 20 weeks (mean −1.65, 95{\%} CI −3.1 to −0.19) with the conventional format but not with the multimedia web-based format (mean 0.14, 95{\%} CI −0.84 to 1.12). For adolescents, the noninferiority of the multimedia web-based format was not established. Conclusions: Caregivers who are considering enrolling their adolescent in an asthma clinical trial have similar comprehension of study information when delivered through an interactive multimedia web-based platform, which incorporates evidence-based learning theory principles, compared with having a conventional in-person, face-to-face discussion. The retention of study information over time was better with the multimedia format for caregivers. Trial Registration: ClinicalTrials.gov NCT02061280; https://clinicaltrials.gov/ct2/show/NCT02061280 and NCT01437995; https://clinicaltrials.gov/ct2/show/NCT01437995 ",
issn="2561-6722",
doi="10.2196/44252",
url="https://pediatrics.jmir.org/2023/1/e44252",
url="https://doi.org/10.2196/44252",
url="http://www.ncbi.nlm.nih.gov/pubmed/37347518"
}