Randomized Controlled Trial of Migraine Manager: A Digital Therapeutic Self-Management Tool for Adolescents with Migraine

项目摘要 不良的疾病自我管理是儿童偏头痛作为综合治疗的一个重要问题。 偏头痛包括药物和生物行为干预以及持续参与 健康的习惯（即，充足的水分，健康均衡的饮食，经常锻炼， 睡眠），并且需要患者每天努力以确保最佳结果。每年不遵守的成本 美国医疗保健超过3000亿美元，慢性病的自我管理对降低发病率至关重要 和医疗费用。我们已经确定了许多因素，干扰青少年的能力， 有效地自我管理，包括治疗负担，遗忘，灾难化，对 治疗效果和缺乏父母支持/监测。虽然这些障碍是可以接受的行为 在干预/CBT中，许多青少年缺乏自我管理技能，无法自己克服这些问题， 基于诊所的自我管理努力已被证明是不够的。通过我们的干预研究， 证明了多成分自我管理干预和CBT治疗偏头痛的有效性。 然而，偏头痛人群中接受这种治疗的比例受到限制 由于有限的访问（例如，缺乏训练有素的临床医生，患者家庭和治疗之间的距离 设施）。在我们最近的R21（NS 094476）的资助下，并与关键利益相关者（即， 患者、父母和临床医生），我们通过迭代开发 第一个偏头痛专用数字治疗自我管理工具，偏头痛管理器，可供所有人使用 关键用户，以满足患者的自我管理需求。患者接受算法衍生的个体化 干预，以满足他们的需求，临床医生可以访问有关他们的症状和自我的病人数据， 可以在诊所访视之前或之间获得的管理干预数据。拟建项目 旨在进行一项随机对照临床试验，以测试偏头痛管理器门户网站对 160名青少年头痛频率、健康相关生活质量和偏头痛相关残疾 与注意力控制组相比，偏头痛。我们还将测试治疗效果的可持续性 通过检查3个月、6个月、9个月和12个月随访时的临床终点，以及 观察到的治疗效果的机制。这项研究将对公共卫生产生重大影响， 为大部分患者提供更多的循证资源， 因此，减少家庭获得保健服务机会有限的家庭在保健方面的差距。 考虑到偏头痛自我管理不良对健康和经济的影响，这项研究是及时和重要的， 因为它有可能对这一人群的健康结果产生积极影响，并作为自我- 儿科人群的管理干预。

Project Summary Poor disease self-management is a significant issue in pediatric migraine as comprehensive treatment for migraine includes pharmacological and biobehavioral interventions as well as consistent engagement in healthy habits (i.e., adequate hydration, eating a healthy and balanced diet, regular exercise, and sufficient sleep), and requires daily patient effort to ensure optimal outcomes. With the annual cost of nonadherence in US health care exceeding $300 billion, self-management of chronic conditions is critical to reducing morbidity and health care expenses. We have identified numerous factors that interfere with adolescents’ ability to effectively self-manage including treatment burden, forgetting, catastrophizing, negative beliefs about treatment efficacy, and lack of parental support/monitoring. Although these barriers are amenable to behavioral intervention/CBT, many adolescents lack the self-management skills to overcome them on their own, and clinic-based self-management efforts have proven inadequate. Through our intervention research, we have demonstrated the efficacy of multicomponent self-management intervention and CBT for migraine treatment. However, the proportion of the migraine population that could receive this type of treatment has been restricted due to limited access (e.g., lack of available trained clinicians, distance between patient homes and treatment facility). With funding from our recent R21 (NS094476) and in collaboration with key stakeholders (i.e., patients, parents, and clinicians), we have addressed these accessibility issues by iteratively developing the first migraine-specific digital therapeutic self-management tool, Migraine Manager, which can be used by all key users to address patient self-management needs. Patients receive algorithmically-derived individualized intervention to meet their needs, and clinicians have access to patient data regarding their symptoms and self- management intervention data that can be obtained prior to or in-between clinic visits. The proposed project aims to conduct a randomized controlled clinical trial to test the effect of the Migraine Manager portal on headache frequency, health-related quality of life, and migraine-related disability in 160 adolescents with migraine compared to an attention control group. We will also test the sustainability of treatment effects through examination of clinical endpoints at 3-, 6-, 9-, and 12-month follow-up, as well as potential mechanisms of observed treatment effects. This study will have a significant impact on public health by providing greater access to an evidence-based resource to a large proportion of patients who otherwise would not receive treatment, thereby reducing health care disparities for families that have limited access to services. Given the health and economic impact of poor self-management in migraine, this study is timely and important, as it has the potential to positively impact health outcomes in this population and serve as a model for self- management intervention across pediatric populations.