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

利用移动医疗和行为经济学提高癫痫青少年的药物依从性

• 批准号: 9664255
• 负责人: AVANI C MODI
• 金额: $ 25.66万
• 依托单位: CINCINNATI CHILDRENS HOSP MED CTR
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-09-27 至 2020-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9664255
• 关键词: Address; Adherence; Adolescence; Adolescent; Adolescent Development; Affect; Aftercare; Age; Antiepileptic Agents; Behavior; Behavior Therapy; Behavioral Model; Cessation of life; Characteristics; Child; Childhood; Chronic; Clinical Trials; Control Groups; Data; Development; Epilepsy; Evaluation; Family; Feedback; Feeling hopeless; Focus Groups; Foundations; Friends; Future; Health; Health behavior; Healthcare; Intervention; Memory; Methods; Modeling; Monitor; Motivation; Neurologic; Outcome; Participant; Patient Outcomes Assessments; Patients; Pattern; Pharmacotherapy; Phase; Population; Populations at Risk; Predisposition; Problem Solving; Process; Randomized; Randomized Controlled Clinical Trials; Rewards; Risk; Sampling; Schedule; Seizures; Self Management; Severities; Site; Supervision; Technology; Testing; Time; United States; Vulnerable Populations; Youth; age group; barrier to care; base; behavior change; behavioral economics; behavioral health; clinical practice; digital; evidence base; follow-up; forgetting; health management; health related quality of life; high risk; high-risk adolescents; improved; innovation; mHealth; medication compliance; motivated behavior; non-drug; patient oriented; peer; peer influence; secondary outcome; social norm; therapy design; therapy development; treatment group

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.

项目概要/摘要 不遵守抗癫痫药物 (AED) 是一个常见问题（即 58% 的患者有一定程度的 对于患有癫痫的青少年来说，这可能会带来毁灭性的后果。青少年有 癫痫患者是一个特别脆弱的群体，因为他们的独立性增强，父母的照顾减少 监督、组织和记忆力缺陷的风险较高、日程安排繁忙且不断变化、动力不足、 以及对同伴影响的敏感性增加。现有的癫痫依从性干预措施并非旨在 应对青少年面临的独特挑战，目前尚无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措施，青春期的依从性会恶化， 进一步增加了这一发育时期健康状况不佳的风险。同时提醒策略 （例如，自动数字提醒）对于最常见的遗忘和遵守障碍非常有效 由于日程繁忙，它们可能无法有效地提高动力。利用社会规范比较 方法（即对他人与自己行为相关的行为的反馈）提供了一个机会 利用同伴影响力日益增加的重要性，同时针对低积极性 青少年的特征。青少年的最新数据表明，社会规范干预措施已 增加价值并改善健康行为，超越标准反馈，无需同行 比较。与行为干预开发的 ORBIT 模型一致，我们的目标是：1) 制定可行、可及且可接受的移动医疗社会规范干预措施以改善 AED 癫痫青少年的依从性；2) 获得未来的初步疗效数据和效果大小 临床试验。我们将通过迭代过程来实现这些目标，包括青少年焦点小组 （ORBIT 阶段 1a：定义；n=8）、扩展使用测试（ORBIT 阶段 1b：细化；n=10）和试点 RCT 最终的移动医疗社会规范干预（ORBIT 第二阶段：试点；n=138）。患有癫痫病的青少年 在基线期间表现出不依从性（根据 PI 之前的随机对照试验，依从性< 95%；样本的 58%） 将被随机分配到 1) mHealth 社会规范（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 依从性）和次要结果（即癫痫严重程度、HRQOL）将在治疗后进行评估，3 分别是几个月后。如果成功的话，这项研究的结果将对儿科产生重大影响 癫痫，有可能通过减少常见障碍来改变治疗不依从性的临床实践 行为健康护理。由于需要最少的临床医生时间，我们的移动医疗社会规范干预 对于癫痫和其他儿科疾病也具有可持续性和广泛传播的潜力。