Blake, Kathryn V;
Antal, Holly;
Bunnell, H Timothy;
He, Jiaxian;
Henderson, Robert;
Holbrook, Janet T;
McCahan, Suzanne M;
Pennington, Chris;
Rogers, Linda;
Shade, David;
Sugar, Elizabeth A;
Taylor, Alexandra;
Wise, Robert A;
Wysocki, Tim
Comprehension by Caregivers and Adolescents of Clinical Trial Information Delivered via Multimedia Video Versus Conventional Practice: Nonrandomized Controlled Trial
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Media type:
E-Article
Title:
Comprehension by Caregivers and Adolescents of Clinical Trial Information Delivered via Multimedia Video Versus Conventional Practice: Nonrandomized Controlled Trial
Contributor:
Blake, Kathryn V;
Antal, Holly;
Bunnell, H Timothy;
He, Jiaxian;
Henderson, Robert;
Holbrook, Janet T;
McCahan, Suzanne M;
Pennington, Chris;
Rogers, Linda;
Shade, David;
Sugar, Elizabeth A;
Taylor, Alexandra;
Wise, Robert A;
Wysocki, Tim
Description:
<jats:sec>
<jats:title>Background</jats:title>
<jats:p>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.</jats:p>
</jats:sec>
<jats:sec>
<jats:title>Objective</jats:title>
<jats:p>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.</jats:p>
</jats:sec>
<jats:sec>
<jats:title>Methods</jats:title>
<jats:p>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.</jats:p>
</jats:sec>
<jats:sec>
<jats:title>Results</jats:title>
<jats:p>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.</jats:p>
</jats:sec>
<jats:sec>
<jats:title>Conclusions</jats:title>
<jats:p>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.</jats:p>
</jats:sec>
<jats:sec>
<jats:title>Trial Registration</jats:title>
<jats:p>ClinicalTrials.gov NCT02061280; https://clinicaltrials.gov/ct2/show/NCT02061280 and NCT01437995; https://clinicaltrials.gov/ct2/show/NCT01437995</jats:p>
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