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: 9794766
• 负责人: AVANI C MODI
• 金额: $ 19.17万
• 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 2021-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9794766
• 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; childhood epilepsy; 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.

项目总结/摘要 不依从抗癫痫药物（AED）是一个常见的问题（即，58%的患者有一定程度的 不遵守）的青年癫痫，具有潜在的破坏性后果。青少年 癫痫是一个特别脆弱群体，因为他们的独立性增加，父母的照顾减少， 监督，组织和记忆缺陷的风险更高，忙碌和改变时间表，低动力， 以及对同伴影响的敏感性增加。癫痫的现有依从性干预措施的设计目的不是 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措施，青少年时期的依从性就会下降， 这进一步增加了在这一发育时期健康状况不佳的风险。虽然提醒战略 (e.g.,自动化数字提醒）对于最常见的遗忘的坚持障碍是有效的， 忙碌的日程安排，他们很可能是无效的增加动力。利用社会规范比较 方法（即，关于别人的行为与自己的行为有关的反馈）提供了一个机会， 利用同伴影响力的重要性，同时针对低动机 青少年的特点。最近的青少年数据表明，社会规范干预措施 增加价值和改善健康行为，超越标准反馈，无需同行 比较。与行为干预发展的ORBIT模型一致，我们的目标是：1） 制定可行、可获得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应量 临床试验我们将通过一个反复的过程，包括一个青少年焦点小组， （ORBIT阶段1a：定义; n=8），扩展使用试验（ORBIT阶段1b：细化; n=10）和 最终的移动健康社会规范干预（ORBIT第二阶段：试点; n=138）。患有癫痫的青少年， 在基线期间证明不依从（基于PI先前的RCT，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，个性化依从性 反馈和社会规范反馈）或2）控制（自动化数字提醒和个性化遵守 反馈）。这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，癫痫发作严重程度，HRQOL）将在治疗后进行评估， 几个月后，分别。如果成功，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mHealth社会规范干预 还具有可持续性和广泛传播癫痫和其他儿科疾病的潜力。

项目成果

Predictors of objective treatment adherence in adolescents with epilepsy: The important role of motivation.

青少年癫痫患者客观治疗依从性的预测因素：动机的重要作用。

• DOI: 10.1016/j.yebeh.2023.109192
• 发表时间: 2023
• 期刊: Epilepsy & behavior : E&B
• 作者: Lang,AmyC;Stevens,Jack;Mara,ConstanceA;Patel,AnupD;Schmidt,Matthew;Tenney,JeffreyR;Modi,AvaniC
• 通讯作者: Modi,AvaniC

The development of a social norms adherence intervention for adolescents with epilepsy.

• DOI: 10.1016/j.yebeh.2020.107628
• 发表时间: 2021-01
• 期刊: Epilepsy & behavior : E&B
• 作者: Modi AC;Patel AD;Gutierrez-Colina AM;Wetter SE;Heckaman LM;Debs A;Mara CA;Wentzel E;Schmidt M;Stevens J
• 通讯作者: Stevens J

Pilot randomized controlled clinical trial of an adherence social norms intervention for adolescents with epilepsy.

针对癫痫青少年遵守社会规范干预的随机对照临床试验。

• DOI: 10.1016/j.yebeh.2022.109082
• 发表时间: 2023
• 期刊: Epilepsy & behavior : E&B
• 作者: Modi,AvaniC;Patel,AnupD;Mara,ConstanceA;Schmidt,Matthew;Tenney,JeffreyR;Stevens,Jack
• 通讯作者: Stevens,Jack