From the Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, Center for Health Technology Research, Cincinnati, OH.
the Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH.
J Pediatr Gastroenterol Nutr. 2023 Jan 1;76(1):38-42. doi: 10.1097/MPG.0000000000003623. Epub 2022 Sep 20.
The objective of this study was to design, code, and test the feasibility, acceptability, and preliminary efficacy of a digital therapeutic self-management tool for pediatric inflammatory bowel disease (IBD). The Self-Management Assistance for Recommended Treatment (SMART) portal development involved an iterative co-design process with a series of focus group/interview sessions with key stakeholders. Subsequently, a pilot, single-arm, open-label trial was conducted with 22 patients; medication adherence was the primary outcome. Usage data for the SMART portal were good, with patients demonstrating better engagement than parents. Results from the trial demonstrated improvement in medication adherence ( M = 24%-31%; t = 7.94, P < 0.05) and self-management barriers as well as trends in health-related quality of life and symptoms. The SMART portal is a feasible digital therapeutic self-management tool for pediatric IBD that demonstrated preliminary efficacy in this pilot trial. Large, controlled trials are needed to definitively determine the clinical efficacy of this tool.
本研究旨在设计、编写并测试一款用于儿童炎症性肠病（IBD）的数字治疗自我管理工具的可行性、可接受性和初步疗效。自我管理辅助推荐治疗（SMART）门户的开发涉及与主要利益相关者进行一系列焦点小组/访谈的迭代共同设计过程。随后，对 22 名患者进行了一项先导性、单臂、开放标签试验，主要结局为药物依从性。SMART 门户的使用数据良好，患者的参与度优于家长。试验结果表明，药物依从性有所改善（M = 24%-31%；t = 7.94，P < 0.05），自我管理障碍以及健康相关生活质量和症状也有改善趋势。SMART 门户是一种用于儿童 IBD 的可行的数字治疗自我管理工具，在这项先导试验中显示出初步疗效。需要进行大型对照试验来明确确定该工具的临床疗效。
