Supporting Treatment Adherence Regimens in Pediatric Epilepsy: The STAR Trial

描述（由申请人提供）：不依从抗癫痫药物（AED）是常见的（即，58%的患者有一定程度的不依从性）和以前未被认识到的新诊断癫痫患儿的问题。这是令人惊讶的，因为癫痫患者不依从的后果非常严重，包括持续癫痫发作，死亡率和高医疗费用。尽管迫切需要制定和实施干预措施以提高依从性，但没有针对癫痫幼儿及其家庭的基于家庭的干预措施。因此，我们开发了一种家庭定制的依从性干预措施（星星：支持治疗依从性方案），重点是增加癫痫知识和解决癫痫儿童及其家庭依从性障碍的问题技能。我们的依从性干预试点研究的数据显示了良好的初步效果（效应量= 0.64）和出色的可行性，家庭报告说，干预是有益的，是一个积极的经验 为了他们的家庭利用这些发现，下一个合乎逻辑的步骤是通过随机对照试验测试星星干预对200名癫痫儿童提高AED依从性的有效性。因此，本研究的目的是检查星星干预对新发癫痫儿童电子监测药物依从性的短期和长期影响，与仅教育（EO）干预相比。此外，探索性目的是检查与EO干预相比，星星干预对癫痫儿童无癫痫发作和生活质量的影响。目前的研究使用了一种创新的、序贯的、随机化的富集设计，该设计针对200例新发癫痫患者，年龄在2 - 12岁之间，表现出不依从性。使用我们的试点研究建立的标准，在研究的前六个月内依从性低于95%将触发参与者随机分配到两个8阶段干预之一：星星或EO。如果该项目的目标得以实现，这项研究将通过提供一种行之有效的方法来改变儿科癫痫的实践，在全国癫痫诊所对AED不依从性进行常规监测和治疗。这项研究也为确定长期 依从性干预对发病率和死亡率长期影响。此外，这项研究的创新方法丰富的设计应推广到其他儿科条件，并导致成本效益，临床为基础的依从性促进干预措施的发展。

DESCRIPTION (provided by applicant): Non-adherence to antiepileptic drugs (AEDs) is a common (i.e., 58% of patients have some level of non- adherence) and previously under-recognized problem for young children with newly diagnosed epilepsy. This is surprising given the consequences of non-adherence in patients with epilepsy are extremely serious, including continued seizures, mortality, and high healthcare expenditures. Despite the critical need to develop and implement interventions to improve adherence, there are no family-based interventions for young children with epilepsy and their families. As such, we developed a family-tailored adherence intervention (STAR: Supporting Treatment Adherence Regimens) focused on increasing epilepsy knowledge and problem-solving skills around barriers to adherence for children with epilepsy and their families. Data from our pilot adherence intervention studies demonstrated good preliminary effects (effect size= 0.64) and excellent feasibility, with families reporting that the intervention was beneficial and a positive experience for their family. Capitalizing on these findings, the next logical step is to test the efficacy of he STAR intervention to improve AED adherence in 200 children with epilepsy via a randomized controlled trial. Thus, the aims of the study are to examine the short-term and long-term effects of the STAR intervention on electronically-monitored medication adherence in children with new-onset epilepsy compared to an education only (EO) intervention. In addition, exploratory aims are to examine the effect of the STAR intervention on seizure freedom and QOL in children with epilepsy compared to the EO intervention. The current study uses an innovative, sequential, randomization enrichment design that preventatively targets 200 patients with new-onset epilepsy, between 2-12 years, who demonstrate non-adherence. Using criteria established from our pilot studies, adherence falling below 95% within the first six months of the study will trigger participant randomization into one of two 8-session interventions: STAR or EO. If the aims of the project are achieved, this study will change the practice of pediatric epilepsy by providing a proven approach to the routine monitoring and treatment of AED non-adherence in epilepsy clinics across the nation. This study also lays the foundation for determining the long term impact of adherence intervention on morbidity and mortality. In addition, this study's innovative methodological enrichment design should be generalizable to other pediatric conditions and lead to the development of cost effective, clinic-based adherence promotion interventions.