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）：抗癫痫药物（aed）的不依从性是一种常见的（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的幼儿问题。考虑到癫痫患者不遵医嘱的后果极其严重，包括持续发作、死亡率和高昂的医疗支出，这一结果令人惊讶。尽管迫切需要制定和实施干预措施以改善依从性，但目前还没有针对癫痫幼儿及其家庭的以家庭为基础的干预措施。因此，我们开发了一种适合家庭的依从性干预措施（STAR：支持治疗依从性方案），重点是提高癫痫知识和解决癫痫患儿及其家庭依从性障碍的问题能力。我们的试点依从性干预研究的数据显示了良好的初步效果（效应值= 0.64）和极好的可行性，家庭报告说干预是有益的，是一种积极的体验