Supporting Treatment Adherence Regimens in Pediatric Epilepsy: The STAR Trial

描述(由申请人提供)：对于新诊断的癫痫儿童，不坚持抗癫痫药物(AEDs)是一种常见的(即58%的患者有某种程度的不坚持)和以前未被认识到的问题。这是令人惊讶的，因为癫痫患者不坚持治疗的后果是极其严重的，包括持续癫痫发作、死亡率和高昂的医疗费用。尽管迫切需要制定和实施干预措施以提高遵从性，但目前还没有针对患有癫痫的幼儿及其家人的家庭干预措施。因此，我们开发了家庭定制的依从性干预(STAR：支持治疗依从性方案)，重点是为癫痫儿童及其家人增加癫痫知识和解决问题的技能，帮助他们克服依从性障碍。我们的试点坚持干预研究的数据显示了良好的初步效果(效果大小=0.64)和极好的可行性，家庭报告干预是有益的和积极的体验 为了他们的家人。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STAR干预措施的有效性，以改善200名癫痫儿童的AED依从性。因此，这项研究的目的是与单纯教育干预(EO)相比，检验STAR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。此外，探索性目的是检验STAR干预对癫痫儿童癫痫发作自由和生活质量的影响，并与EO干预进行比较。目前的研究使用了一种创新的、顺序的、随机的浓缩设计，该设计预防性地针对200名新发癫痫患者，他们的年龄在2-12岁之间，他们表现出不坚持。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%将触发参与者随机进入两种为期8个疗程的干预：STAR或EO。如果该项目的目标得以实现，这项研究将通过为全国癫痫诊所对AED不依从性的常规监测和治疗提供一种经过验证的方法，从而改变儿童癫痫的实践。这项研究也为确定长期 坚持干预对发病率和死亡率的长期影响。此外，这项研究的创新方法丰富设计应该可以推广到其他儿科疾病，并导致成本效益高的、基于临床的依从性促进干预措施的开发。

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.