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 对于新诊断出癫痫症的幼儿来说，不遵守规定）可能会造成毁灭性的后果。 不遵守 AED 会使癫痫发作风险增加 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率和成本。依从性的主要障碍之一 正在遗忘，这可能特别适合 mHealth（医疗保健移动技术）干预。 尽管迫切需要制定和实施干预措施来提高依从性，但很少有家庭 对患有癫痫的幼儿及其家庭进行基于干预的干预措施，但 PI 的试点和 现有R01试用版。尽管前景广阔，但这种干预措施需要六次面对面的会议，这可以 对于由于时间、经济或交通原因而无法常规获得三级专业护理的家庭来说是不可能的 限制。因此，服务不足的儿童癫痫人群的医疗和社会心理需求未得到满足 由于获得这种最先进的护理的机会有限，这种情况持续存在并变得更加复杂。我们的总体目标是测试 使用基于个人的强化护理模式可以轻松实现移动医疗依从性干预 需要。这种强化的护理模式将节省患者、家属和提供者的时间、成本和资源。这 该多中心 R01 的目的是进行两阶段、序贯、多重分配、随机试验 (SMART) 评估移动医疗干预策略对于提高护理人员对 AED 依从性的有效性 患有癫痫的幼儿。两个月的基准期之后将是两个阶段。在第一阶段（3个月 长），不依从的护理人员（< 95%）将被随机分配到移动医疗教育模块并自动化 数字提醒（控制）或移动健康教育模块、自动数字提醒和个性化 基于实时依从性监测（治疗）的依从性反馈，以解决主要障碍 忘记。在第二阶段（长达两个月）开始时，护理人员随机接受不接受治疗的治疗 在第 1 阶段结束时达到 > 95%（响应）的依从性将被重新随机分配到继续 个性化依从性反馈或通过两个 mHealth 增强的个性化依从性反馈 与治疗师一起解决问题的模块（从 PI 现有的 RCT 翻译而来）。因此，有三个 SMART 中嵌入的干预策略：#1 控制，#2 治疗，#3 增强解决问题 如果三个月后无反应，则进行治疗。主要结果是电子监控的依从性和 次要结局包括癫痫发作严重程度/频率、生活质量和医疗保健利用率。如果目标是 该项目一旦实现，这项研究将对小儿癫痫产生重大影响，有可能 改变治疗不依从性的临床实践。 SMART 设计将使我们能够识别出哪些患者 最有可能对干预措施做出反应，并花费更多时间和资源加强护理 必要时进行干预（即通过网络与治疗师一起解决问题）。