Fostering medication adherence in children with epilepsy using mHealth technology

利用移动医疗技术促进癫痫儿童的药物依从性

• 批准号: 9753370
• 负责人: AVANI C MODI
• 金额: $ 70.18万
• 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: 2018-08-01 至 2023-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9753370
• 关键词: Address; Adherence; Admission activity; Affect; Age; Antiepileptic Agents; Caregivers; Caring; Cessation of life; Characteristics; Child; Childhood; Chronic; Comorbidity; Data; Development; Education; Effectiveness; Emergency department visit; Epilepsy; Family; Family Characteristics; Feedback; Fostering; Frequencies; Goals; Health Care Costs; Healthcare; Improve Access; Individual; Inpatients; Internet; Intervention; Learning Module; Medical; Mental Health; Modeling; Monitor; Neurologic; Newly Diagnosed; Participant; Patients; Pattern; Pediatrics; Persons; Population; Problem Solving; Provider; Quality of life; Randomized; Randomized Controlled Clinical Trials; Research; Resources; Risk; Seizures; Self Management; Severities; Site; Technology; Testing; Text; Time; Translating; Transportation; Underserved Population; United States; Vulnerable Populations; Work; Youth; adaptive intervention; base; childhood epilepsy; clinical decision-making; clinical practice; compare effectiveness; cost; digital; evidence base; follow-up; forgetting; health care service utilization; improved; innovation; mHealth; medical specialties; medication compliance; mobile computing; monitoring device; mortality; non-drug; patient-clinician communication; physical conditioning; post intervention; primary outcome; prospective; psychosocial; randomized trial; response; secondary outcome; skills; tool; treatment adherence; treatment group; trial design

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.

项目摘要/摘要 对抗癫痫药（AED）不遵守是一个常见问题（即58％的患者有一定程度的水平 对于有新诊断的癫痫病的幼儿而言，不遵守），可能会带来毁灭性的后果。 AED不遵守性与癫痫发作的风险增加3倍，生活质量差，不准确 临床决策以及更高的医疗保健利用和成本。依从性的主要障碍之一 正在忘记，这可能特别适合MHealth（医疗保健中的移动技术）干预措施。 尽管需要制定和实施干预措施以提高依从性，但很少有家庭 - 除了PI的飞行员，对患有癫痫病及其家人的幼儿进行了干预措施 现有的R01试验。尽管非常有前途，但这种干预需要六个面对面的会议，这可能是 对于由于时间，财务或运输而缺乏常规访问三级专业护理的家庭来说，不可能是不可能的 约束。因此，服务不足的小儿癫痫群的未满足的医疗和社会心理需求是 由于有限的访问这种状态护理而使其永久化和复杂。我们的总体目标是测试 MHealth依从性干预措施，使用基于个人的加速护理模型可以轻松访问 需要。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。这 该多站点R01的目的是进行两阶段的，顺序的，多个分配，随机试验（SMART） 评估MHealth干预策略的有效性，以改善AED依从性 患有癫痫病的幼儿。两个月的基线期将是两个阶段。在第1阶段（3个月 长），非依从者的看护人（<95％）将被随机分为MHealth教育模块并自动化 数字提醒（控制）或MHealth教育模块，自动数字提醒和个性化 基于实时依从性监测（处理）的依从性反馈以解决的主要障碍 忘记。在第2阶段（两个月）的开始时，护理人员随机进行治疗 在第1阶段结束时达到依从性> 95％（响应）将被重新传递到任一续 两个MHealth增强的个性化依从性反馈或个性化的依从性反馈 解决问题的模块（从PIS现有RCT翻译）与治疗师。因此，有三个 嵌入在此智能中的干预策略：＃1控制，＃2治疗和＃3解决问题的问题 治疗如果三个月不反应。主要结果是以电子方式依从性和 次要结果包括癫痫发作的严重性/频率，生活质量和医疗保健利用。如果目的 实现了该项目，这项研究将对儿科癫痫有很大影响，并有可能 改变治疗不遵守的临床实践。智能设计将使我们能够确定患者 最有可能对干预措施做出反应，并加强时间和资源密集型 必要时（即通过Web解决治疗师解决问题）。