Supporting Treatment Adherence Regimens in Pediatric Epilepsy: The STAR Trial

支持小儿癫痫治疗依从性方案：STAR 试验

• 批准号: 8498896
• 负责人: AVANI C MODI
• 金额: $ 62.49万
• 依托单位: CINCINNATI CHILDRENS HOSP MED CTR
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-04-01 至 2018-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8498896
• 关键词: 12 year old; Address; Adherence; Antiepileptic Agents; Behavior Therapy; Child; Childhood; Chronic; Clinic; Clinical Treatment; Comorbidity; Data; Development; Diagnosis; Disease; Dose; Education; Epilepsy; Exhibits; Expenditure; Family; Foundations; Freedom; Goals; Health Care Costs; Healthcare; Interdisciplinary Study; Intervention; Intervention Studies; Knowledge; Lead; Life; Long-Term Effects; Measurement; Modeling; Monitor; Morbidity - disease rate; Newly Diagnosed; Outcome; Parents; Participant; Patients; Pharmacotherapy; Pilot Projects; Population; Problem Solving; Problem behavior; Process; Psychologist; Quality of life; Randomized; Randomized Controlled Trials; Recurrence; Regimen; Reporting; Research; Research Personnel; Seizures; Site; Staging; Statistical Models; Subgroup; Time; arm; base; cost effective; critical period; design; efficacy testing; experience; falls; follow-up; forgetting; high risk; improved; innovation; intervention effect; medication compliance; mortality; nervous system disorder; novel; post intervention; primary outcome; psychosocial; public health relevance; skills; therapy design; treatment adherence

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.

描述（由申请人提供）：对抗癫痫药（AEDS）的不遵守是常见的（即58％的患者具有一定程度的非依从性），并且对于新诊断的癫痫病的幼儿而言，对幼儿的问题不足。鉴于癫痫患者不遵守的后果非常严重，这是令人惊讶的，包括持续癫痫发作，死亡率和高医疗保健支出。尽管需要制定和实施干预措施以提高依从性，但对于患有癫痫病及其家人的幼儿没有家庭干预措施。因此，我们开发了一项家庭定制的依从性干预措施（Star：支持治疗依从性方案），重点是提高癫痫知识和解决问题的技能，围绕着癫痫患者及其家人遵守障碍。来自我们的飞行员依从性干预研究的数据表明，初步效果（效果大小= 0.64）和良好的可行性，家庭报告说这种干预是有益的，并且是积极的经验 为他们的家人。利用这些发现，下一个合乎逻辑的步骤是测试HE恒星干预的功效，以通过随机对照试验来改善200名患有癫痫患者的AED依从性。因此，该研究的目的是检查恒星干预对新发作癫痫病儿童的电子监测药物依从性的短期和长期影响与仅接受教育（EO）干预相比。此外，与EO干预相比，探索性目的是检查恒星干预对癫痫病儿童的癫痫发作自由和QOL的影响。当前的研究使用了一种创新的，顺序的，随机富集设计，该设计可预防200例新发作癫痫患者2 - 12年，这些患者表现出了不遵守。使用我们的试点研究制定的标准，在研究的前六个月内，依从性降至95％以下，将触发参与者随机分为两种8期干预措施之一：Star或eo。如果实现了该项目的目的，则该研究将通过为全国癫痫诊所的常规监测和治疗AED不遵守的常规监测和治疗提供了一种经验证的方法来改变小儿癫痫的实践。这项研究还为确定长期的基础奠定了基础 依从性干预对发病率和死亡率的期限影响。此外，这项研究的创新方法学富集设计应推广到其他儿科状况，并导致基于临床的依从性促进干预措施的发展。