{"doi":"10.2196/44252","title":"Comprehension by Caregivers and Adolescents of Clinical Trial Information Delivered via Multimedia Video Versus Conventional Practice: Nonrandomized Controlled Trial","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.","journal":"JMIR Pediatrics and Parenting","year":2023,"id":376540,"datarank":0.20794415416798362,"base_score":1.3862943611198906,"endowment":1.3862943611198906,"self_citation_contribution":0.20794415416798362,"citation_network_contribution":0.0,"self_endowment_contribution":0.20794415416798362,"citer_contribution":0.0,"corpus_percentile":null,"corpus_rank":null,"citation_count":3,"citer_count":3,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.9571,"is_data_producer":true,"deposit_databanks":{"ClinicalTrials.gov":["NCT02061280","NCT01437995"]},"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2023-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":1139758,"name":"Holly Antal","orcid":"0009-0004-2664-7379","position":1,"is_corresponding":false},{"id":805140,"name":"H. Timothy Bunnell","orcid":"0000-0002-3099-7572","position":2,"is_corresponding":false},{"id":1098713,"name":"Jiaxian He","orcid":"0000-0003-2727-6448","position":3,"is_corresponding":false},{"id":451250,"name":"Robert J. Henderson","orcid":"0000-0001-6805-269X","position":4,"is_corresponding":false},{"id":451251,"name":"Janet T. Holbrook","orcid":"0000-0002-0899-2345","position":5,"is_corresponding":false},{"id":390027,"name":"Suzanne M. McCahan","orcid":"0000-0003-4459-0949","position":6,"is_corresponding":false},{"id":1139759,"name":"Christopher Pennington","orcid":"0000-0002-1844-9901","position":7,"is_corresponding":false},{"id":451253,"name":"Linda Rogers","orcid":"0000-0001-8714-2738","position":8,"is_corresponding":false},{"id":448226,"name":"David Shade","orcid":null,"position":9,"is_corresponding":false},{"id":258295,"name":"Elizabeth A. Sugar","orcid":"0000-0002-0148-1091","position":10,"is_corresponding":false},{"id":1139760,"name":"Alexandra Taylor","orcid":"0009-0006-0745-7670","position":11,"is_corresponding":false},{"id":350029,"name":"Robert A. Wise","orcid":"0000-0002-8353-2349","position":12,"is_corresponding":false},{"id":1139761,"name":"Tim Wysocki","orcid":"0000-0003-4099-4639","position":13,"is_corresponding":false},{"id":316902,"name":"Kathryn Blake","orcid":"0000-0001-9959-8572","position":0,"is_corresponding":true}],"reference_count":42,"raw_metadata":null,"created_at":"2026-07-19T01:16:32.368674Z","pmid":"37347518","pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}