Fostering medication adherence in children with epilepsy using mHealth technology

项目概要/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）的幼儿与新诊断的癫痫，具有潜在的破坏性后果。 AED非依从性与癫痫发作风险增加3倍、生活质量差、不准确的 临床决策，以及更高的卫生保健利用率和成本。坚持的主要障碍之一 这可能特别适合于mHealth（医疗保健中的移动的技术）干预。 尽管迫切需要制定和实施干预措施以提高依从性，但很少有家庭- 为癫痫患儿及其家庭提供基于基础的干预措施，除了PI的试点和 现有R 01试验。虽然很有希望，但这种干预需要六次面对面的会议，这可能是 对于由于时间、经济或交通原因而无法获得三级专科护理的家庭来说， 约束因此，未得到满足的医疗和心理社会需求的儿童癫痫人口是 由于获得这种最先进护理的机会有限，这种情况长期存在并加剧。我们的总体目标是测试一个 移动健康依从性干预，使用基于个人的逐步护理模式， 需求这种加强的护理模式将节省患者，家庭和提供者的时间，成本和资源。的 本多中心R 01的目的是进行一项两阶段、序贯、多重分配、随机化试验（SMART） 评估移动健康干预策略在改善护理人员AED依从性方面的有效性， 小儿癫痫两个月的基线期之后将分两个阶段。第1阶段（3个月 长期），非依从性护理人员（< 95%）将被随机分配到移动健康教育模块， 数字提醒（控制）或mHealth教育模块，自动数字提醒，个性化 基于实时依从性监测（治疗）的依从性反馈，以解决 遗忘在第二阶段（两个月）开始时，照顾者随机接受治疗， 在第1阶段结束时达到依从性> 95%（缓解）的受试者将重新随机分配至 个性化的坚持反馈或个性化的坚持反馈增强了两个mHealth 问题解决模块（翻译自PI现有RCT）与治疗师。因此存在三 SMART中嵌入的干预策略：#1控制，#2治疗，#3问题解决增强 如果在三个月内无反应，则进行治疗。主要结局是电子监测的依从性， 次要结果包括癫痫发作的严重程度/频率、生活质量和医疗保健利用。如果目标是 该项目的实现，这项研究将对儿童癫痫产生很大的影响，有可能 改变治疗不依从的临床实践。SMART设计将使我们能够识别 最有可能对干预措施做出反应，并加强时间和资源密集型的护理 干预（即，通过网络与治疗师一起解决问题）。

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 young children with newly diagnosed epilepsy, with potentially devastating consequences. AED non-adherence is associated with a 3-fold increased risk of seizures, poor quality of life, inaccurate clinical decision-making, and higher health care utilization and costs. One of the primary barriers to adherence is forgetting, which may be particularly amenable to mHealth (mobile technology in healthcare) interventions. Despite the critical need to develop and implement interventions to improve adherence, there are few family- based interventions for young children with epilepsy and their families, with the exception of the PI's pilot and existing R01 trial. Although highly promising, this intervention requires six in-person sessions, which can be impossible for families who lack routine access to tertiary specialty care due to time, financial, or transportation constraints. Thus, unmet medical and psychosocial needs of the underserved pediatric epilepsy population are perpetuated and compounded by limited access to this state of the art care. Our overall goal is to test a mHealth adherence intervention that is easily accessible using a stepped up care model based on individual needs. This stepped up care model will conserve patient, family, and provider time, costs and resources. The aim of this multi-site R01 is to conduct a two-stage, sequential, multiple assignment, randomized trial (SMART) to evaluate the effectiveness of mHealth intervention strategies for improving AED adherence in caregivers of young children with epilepsy. A two-month baseline period will be followed by two stages. In Stage 1 (3-months long), non-adherent caregivers (< 95%) will be randomized to a mHealth education module and automated digital reminders (control) or the mHealth education module, automated digital reminders, and individualized adherence feedback based on real-time adherence monitoring (treatment) to address the primary barrier of forgetting. At the beginning of Stage 2 (two months long), caregivers randomized to treatment who do not achieve adherence > 95% (response) by the end of Stage 1 will be re-randomized to either continued individualized adherence feedback or individualized adherence feedback augmented with two mHealth problem-solving modules (translated from the PIs existing RCTs) with a therapist. Thus, there are three intervention strategies embedded in this SMART: #1 control, #2 treatment, and #3 problem-solving augmented treatment if nonresponsive at three months. The primary outcome is electronically-monitored adherence and secondary outcomes include seizure severity/frequency, quality of life, and healthcare utilization. If the aims of the project are achieved, this study would have a large impact on pediatric epilepsy, with the potential to change clinical practice for treating non-adherence. The SMART design would allow us to identify patients who are most likely to respond to interventions and step up care with more time- and resource-intensive interventions (i.e., problem-solving with a therapist via the web), when necessary.