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: 8634808
• 负责人: AVANI C MODI
• 金额: $ 54.9万
• 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/8634808
• 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）：对于新诊断为癫痫的幼儿来说，不坚持使用抗癫痫药物 (AED) 是一个常见问题（即 58% 的患者有一定程度的不坚持），而且之前并未得到充分认识。这是令人惊讶的，因为癫痫患者不依从治疗的后果极其严重，包括持续癫痫发作、死亡和高额医疗支出。尽管迫切需要制定和实施干预措施来提高依从性，但目前还没有针对癫痫幼儿及其家人的基于家庭的干预措施。因此，我们开发了一种针对家庭的依从性干预措施（STAR：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人依从性障碍的问题解决技能。我们的试点依从性干预研究的数据显示出良好的初步效果（效果大小 = 0.64）和出色的可行性，家庭报告干预措施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 干预措施对提高 200 名癫痫儿童的 AED 依从性的有效性。因此，本研究的目的是考察与纯教育 (EO) 干预相比，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，探索性目的是检查与 EO 干预相比，STAR 干预对癫痫儿童无癫痫发作和生活质量的影响。目前的研究采用创新、序贯、随机富集设计，预防性地针对 200 名 2 至 12 岁之间、表现出不依从性的新发癫痫患者。使用我们的试点研究建立的标准，如果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个为期 8 个疗程的干预措施之一：STAR 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常规监测和治疗全国各地癫痫诊所不遵守 AED 的情况，从而改变小儿癫痫的治疗实践。本研究也为确定长期 依从性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，并导致开发具有成本效益的、基于临床的依从性促进干预措施。