Cincinnati Children's Hospital Medical Center, 3333 Burnet Ave., Cincinnati, OH 45229, United States of America; College of Medicine, University of Cincinnati, Cincinnati, OH 45267, United States of America.
Contemp Clin Trials. 2020 Mar;90:105959. doi: 10.1016/j.cct.2020.105959. Epub 2020 Feb 14.
This article describes the methodology, recruitment, design, and baseline participant characteristics of the Supporting Treatment Adherence Regimens (STAR) trial. STAR is a randomized controlled clinical trial of an education and problem-solving adherence intervention for young children (2-12 years old) with newly diagnosed epilepsy and their families. Using an enrichment design, only participants who demonstrated non-adherence to anti-epileptic drugs within the baseline period were randomized to treatment or control arms. Randomized participants received 8 intervention sessions over a 4-month period and completed three follow-up visits (3, 6, and 12 months following intervention). Two-hundred participants were recruited for the study. The primary outcome was electronically monitored adherence, while secondary and exploratory outcomes included seizure freedom and health-related quality of life. Novel aspects of the trial design (e.g., enrichment, sequential randomization, daily adherence data use), as well as recruitment and retention challenges are discussed.
本文介绍了支持治疗依从性方案（STAR）试验的方法学、招募、设计和基线参与者特征。STAR 是一项针对新诊断为癫痫的幼儿（2-12 岁）及其家庭的教育和解决问题依从性干预的随机对照临床试验。该试验采用富集设计，仅在基线期内表现出抗癫痫药物不依从的参与者才被随机分配到治疗组或对照组。随机分组的参与者在 4 个月的时间内接受了 8 次干预，完成了 3 次随访（干预后 3、6 和 12 个月）。该研究招募了 200 名参与者。主要结局是电子监测的依从性，次要和探索性结局包括无癫痫发作和健康相关生活质量。本文讨论了试验设计的新颖方面（例如，富集、序贯随机化、每日依从性数据使用）以及招募和保留方面的挑战。
