Designing multimedia patient education materials for adolescent idiopathic scoliosis: A protocol for a feasibility randomized controlled trial of patient education videos

Abstract

Triple-masked three-armed feasibility parallel randomized controlled trial. Multimedia patient education materials are increasingly used in healthcare. While much research focuses on optimising their scientific content, research is equally needed to optimise design and implementation. This study aims to determine the feasibility of a study examining how the implementation of scientific advice on design affects patient outcomes. Participants aged 10–18 with radiographically confirmed adolescent idiopathic scoliosis will be recruited from community settings in Ireland and randomized into usual care or receiving multimedia educational videos with or without evidence-informed design principles. Participants will be masked in the two video intervention arms, as will the therapist sending the educational videos. Outcomes will include the number of participants recruited and randomized, the number analysed post-intervention and at week eight, and the outcomes for baseline, post-intervention, and week 8. Adverse events will also be reported. This feasibility randomized controlled trial will offer insight into the feasibility of implementing advice from the literature in designing a trial of multimedia patient education materials for a population with adolescent idiopathic scoliosis. Trial registration: Clinical Trail: Trial is registered on ClinicalTrials.gov as NCT06090344.