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

项目概要/摘要 偏头痛影响超过4700万美国人，是全球第二大致残性疾病。医疗保健 偏头痛的使用率很高，在美国每年有超过六百万的门诊就诊。一半以上 这些访问发生在初级保健机构。十分之一的初级保健咨询是头痛， 偏头痛占这些头痛就诊的至少75%。尽管有证据表明身心干预 虽然MBIs对偏头痛有效，但由于供应商有限，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MBIs的机会相当有限 大多数人接受治疗的地方。新的可扩展的，可访问的，以证据为基础的MBIs是 needed.我们的团队在许多环境中进行了多项试点研究，以评估渐进肌肉的输送 在以患者为中心的智能手机应用程序（app）“RELAXaHEAD”中，使用PMR来治疗偏头痛。我们 成功招募（超过300名患者参加了偏头痛RELAXaHEAD试点研究，超过200名患者参加了 其他偏头痛身心研究），进行移动的健康（mHealth）研究的良好记录（8 使用RELAXaHEAD的出版物），以及头痛医学、MBI、临床试验设计和 全体成员的加入使我们能够最好地扩大这项工作。根据NIH的优先顺序， 研究慢性重叠疼痛条件和最近呼吁完全远程MBI研究，我们寻求 进行一项完全有效的远程研究，以评估RELAXaHEAD（RELAX，带日记的应用程序）的疗效 和PMR）与6周内监测的常规护理（MUC，带日记的应用程序）（基于既往PMR）进行比较 研究显示PMR在6周时获益）。我们将比较有临床意义的患者报告 随机分配至RELAX组与MUC组的患者的结局。结果包括偏头痛相关残疾的变化， 偏头痛患者的生活质量和头痛天数。我们将评估短期影响（6周后 的治疗），并在入组后持续获益长达26周。我们也将探讨两者 治疗效果的潜在介导因素（抑郁、焦虑、睡眠改善）和潜在调节因素 (age性别、种族、民族和教育水平）。我们将从初级保健教师小组的做法和招聘 家庭健康中心在一个大型的学术医疗保健系统，包括一个非常广泛的患者， 偏头痛，跨越不同的种族背景和民族，并从城市和郊区 社区.该研究的长期目标是创建一个基于证据的，可扩展的和可访问的MBI 对于偏头痛具有深远的影响，以低成本的方式改善偏头痛相关的残疾， 偏头痛患者的生活质量，并减少头痛天数。

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.