Improving Drug Adherence Using mHealth and Behavioral Economics in Adolescents with Epilepsy

项目摘要/摘要 不坚持服用抗癫痫药物(AEDs)是一个常见的问题(即58%的患者有一定程度的 对患有癫痫的青少年)，具有潜在的破坏性后果。青少年患有 癫痫是一个特别脆弱的群体，由于他们独立性的增强，父母的减少 监督，组织和记忆缺陷的风险更高，忙碌和不断变化的时间表，动力不足， 更容易受到同龄人的影响。现有的癫痫依从性干预措施并不是为了 应对青少年面临的独特挑战，没有针对青少年的有效干预措施 患有癫痫。毫不奇怪，如果没有有效的干预，坚持在青春期会恶化， 进一步增加了在这一发展阶段出现不良健康结果的风险。同时提醒策略 (例如，自动数字提醒)对于最常见的遗忘和坚持障碍是有效的 繁忙的日程安排很可能不会有效地增加动力。利用社会规范比较 方法(即，对他人行为的反馈与自己的行为有关)提供了一个机会 充分利用同伴影响力的重要性，同时瞄准低动机 以青少年为特征的。最近在青少年中的数据表明，社会规范干预 在没有同伴的情况下，增加价值并改善健康行为，超越标准反馈 比较。与行为干预发展的轨道模型一致，我们的目标是：1) 制定可行的、可获得的和可接受的移动健康社会规范干预措施，以改善AED 青少年癫痫患者的依从性和2)获得未来的初步疗效数据和效果大小 临床试验。我们将通过包括青少年焦点小组在内的迭代进程来解决这些目标 (轨道阶段1a：定义；n=8)、扩展使用测试(轨道阶段1b：改进；n=10)和 最终的移动健康社会规范干预(轨道第二阶段：试点；n=138)。患有癫痫的青少年 在基线期间证明未遵守(根据PI之前的RCT，95%的遵守；58%的样本) 将随机选择1)mHealth社交规范(自动数字提醒、个性化遵守 反馈和社会规范反馈)或2)控制(自动数字提醒和个性化遵守 反馈)。两组都将接受为期五个月的积极干预。主要(即，电子监控 坚持)和二次结局(即癫痫严重程度、HRQOL)将在治疗后和3个月内评估 分别在几个月后。如果成功，这项研究的结果将对儿科 癫痫，有可能通过减少常见障碍来改变治疗不依从的临床实践 行为健康护理。由于需要最少的临床医生时间，我们的mHealth社会规范干预 对癫痫和其他儿科疾病也具有可持续性和广泛传播的潜力。

Project Summary/Abstract Non-adherence to antiepileptic drugs (AEDs) is a common problem (i.e., 58% of patients have some level of non-adherence) for youth with epilepsy, with potentially devastating consequences. Adolescents with epilepsy represent a particularly vulnerable group, given their increased independence, decreased parental supervision, higher risk for deficits in organization and memory, busy and changing schedules, low motivation, and increased susceptibility to peer influence. Existing adherence interventions in epilepsy are not designed to meet the unique challenges faced by adolescents, and there are no efficacious interventions for adolescents with epilepsy. Not surprisingly, without efficacious interventions, adherence worsens during adolescence, further increasing the risk of poor health outcomes during this developmental period. While reminder strategies (e.g., automated digital reminders) are effective for the most common adherence barriers of forgetting and busy schedules, they are likely to be ineffective in increasing motivation. Leveraging social norms comparison methods (i.e., feedback about someone else's behavior related to one's own behavior) offers an opportunity to capitalize on the increased importance of peer influence while simultaneously targeting the low motivation characteristic of adolescents. Recent data in adolescents indicates that social norms interventions have incremental value and improve health behaviors above and beyond standard feedback without peer comparisons. Consistent with the ORBIT model for behavioral intervention development, our aims are to: 1) develop a feasible, accessible, and acceptable mHealth social norms intervention for improving AED adherence in adolescents with epilepsy and 2) obtain preliminary efficacy data and effect sizes for a future clinical trial. We will address these aims through an iterative process, including an adolescent focus group (ORBIT Phase 1a: Define; n=8), extended usage test (ORBIT Phase 1b: Refine; n=10) and a pilot RCT of the final mHealth social norms intervention (ORBIT Phase II: Pilot; n=138). Adolescents with epilepsy who demonstrate non-adherence (< 95% adherence based on PI's previous RCTs; 58% of sample) during baseline will be randomized to either 1) mHealth social norms (automated digital reminders, individualized adherence feedback, and social norms feedback) or 2) control (automated digital reminders and individualized adherence feedback). Both groups will receive active intervention for five months. Primary (i.e., electronically-monitored adherence) and secondary outcomes (i.e., seizure severity, HRQOL) will be assessed post-treatment and 3 months later, respectively. If successful, the results of this study would have a large impact on pediatric epilepsy, with the potential to change clinical practice for treating non-adherence by reducing common barriers to behavioral health care. Because minimal clinician time is required, our mHealth social norms intervention also has potential for sustainability and broad dissemination for epilepsy and other pediatric conditions.