RELAXaHEAD: A Behavioral Approach to Remote Migraine Management in Primary Care

项目摘要/摘要 偏头痛影响着超过4700万美国人，是全球第二大致残疾病。医疗保健 偏头痛的使用率很高，在美国每年有超过600万人次的门诊就诊。过半 其中一些就诊发生在初级保健环境中。十分之一的初级保健会诊是为了头痛，以及 在这些头痛的就诊中，偏头痛至少占75%。尽管有证据表明心理-身体干预 (MBIS)对偏头痛有效，但由于供应商的可获得性有限，这些治疗方法的利用率极低 以及患者报告的障碍，如时间和费用。在初级保健中，获得mbi的机会相当有限。 大多数人接受治疗的环境。新的可扩展、可访问和基于证据的MBI是 需要的。我们的团队在许多环境中进行了多项试点研究，以评估渐进性肌肉的交付 在以患者为中心的智能手机应用程序(APP)“RELAXaHEAD”中为偏头痛提供放松(PMR)功能。我们的 成功招募(300多名偏头痛患者参加RELAXaHEAD试验性研究，200多名患者参加 其他偏头痛心身研究)，进行移动健康(MHealth)研究的可靠记录(8 使用RELAXaHEAD的出版物)，以及头痛药物、MBIS、临床试验设计和 坚持集体立场使我们能够最大限度地扩大这项工作。为了回应NIH的优先顺序 关于慢性重叠疼痛状况的研究，以及最近呼吁进行完全远程MBI研究，我们寻求 进行一项全能、完全远程的研究，以评估RELAXaHEAD(RELAX，带日记的应用程序)的疗效 和PMR)与6周内受监控的常规护理(MUC、APP和日记)进行比较(基于之前的PMR 显示PMR在6周内有效的研究)。我们将比较临床上有意义的患者报告 患者随机分为RELAY组和MUC组的结果。结果包括偏头痛相关残疾的变化， 偏头痛特有的生活质量和头痛天数。我们将评估这两种短期效果(6周后 治疗)和在登记后最多持续26周的福利。我们还将探索这两个方面 治疗效果的潜在调节因素(抑郁、焦虑、睡眠的改善)和潜在调节因素 (年龄、性别、种族、民族和教育水平)。我们将从初级保健教师小组招募实践和 在大型学术医疗保健系统中的家庭健康中心包括非常广泛的 偏头痛，跨越不同的种族背景和民族，来自城市和郊区 社区。这项研究的长期目标是创建一种基于证据、可扩展和可访问的MBI 对于偏头痛影响深远的低成本改善偏头痛相关残疾，改善 提高偏头痛患者的生活质量，减少头痛天数。

PROJECT SUMMARY/ABSTRACT Migraine affects over 47 million Americans and is the second most disabling condition globally. Healthcare utilization rates for migraine are high, with over six million ambulatory visits annually in the US. More than half of these visits occur in primary care settings. One in ten primary care consultations is for headache, and migraine accounts for at least 75% of these headache visits. Despite evidence that mind-body interventions (MBIs) are effective for migraine, these treatments are vastly under-utilized due to limited provider availability as well as patient-reported barriers, such as time and expense. Access to MBIs is quite limited in primary care settings where most people receive treatment. New scalable, accessible, and evidence-based MBIs are needed. Our team conducted multiple pilot studies in many settings to evaluate delivery of progressive muscle relaxation (PMR) for migraine in a patient-centered smartphone application (app) “RELAXaHEAD”. Our successful recruitment (over 300 patients to migraine RELAXaHEAD pilot studies and over 200 patients to other migraine mind-body studies), proven track record of conducting mobile health (mHealth) studies (8 publications using RELAXaHEAD), and expertise in headache medicine, MBIs, clinical trial design, and adherence collectively position us optimally to expand on this work. In response to the NIH prioritization of research on chronic overlapping pain conditions and the recent call for fully remote MBI studies, we seek to conduct a fully powered, entirely remote study to assess the efficacy of RELAXaHEAD (RELAX, app with diary and PMR) compared to monitored usual care (MUC, app with diary) over a 6-week period (based on prior PMR studies which showed benefit of PMR at 6 weeks). We will compare clinically meaningful patient-reported outcomes in patients randomized to RELAX vs. MUC. Outcomes include change in migraine-related disability, migraine-specific quality of life, and headache days. We will assess both the short-term effects (after 6 weeks of treatment) and the persistence of benefits for up to 26 weeks following enrollment. We will also explore both potential mediators of treatment effect (improvement in depression, anxiety, sleep) and potential moderators (age, sex, race, ethnicity, and education level). We will recruit from primary care faculty group practices and family health centers in a large academic healthcare system to include a very wide range of patients with migraine, spanning diverse racial backgrounds and ethnicities, and from both urban and suburban communities. The long-term goal of the research is to create an evidence-based, scalable, and accessible MBI for migraine with far-reaching impact in a low-cost manner to improve migraine-related disability, improve quality of life in people with migraine, and reduce headache days.