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

RELAXaHEAD：初级保健中远程偏头痛管理的行为方法

基本信息

批准号：
10709496
负责人：
Mia Minen
金额：
$ 81.58万
依托单位：
NEW YORK UNIVERSITY SCHOOL OF MEDICINE
依托单位国家：
美国
项目类别：
财政年份：
2022
资助国家：
美国
起止时间：
2022-09-23 至 2027-08-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10709496
关键词：
Accident and Emergency department Adherence Affect Aftercare Age American Anxiety Appointment Behavior Therapy Behavioral Biofeedback Blinded COVID-19 pandemic Cellular Phone Chronic Clinical Clinical Trials Design Cognitive Therapy Consultations Country Data Educational Status Electronics Enrollment Ethnic Origin Evidence based intervention Evidence based treatment Exercise Faculty Family health status Goals Grant Group Practice Headache Healthcare Systems Hospitals Intervention Intervention Studies Learning Measures Mediator Medicine Mental Depression Mentored Patient-Oriented Research Career Development Award Migraine Mind-Body Intervention Monitor Muscle relaxation phase National Center for Complementary and Integrative Health Neurology Outcome Outcome Study Pain Participant Patient Outcomes Assessments Patient-Focused Outcomes Patients Persons Pharmacological Treatment Phase Pilot Projects Positioning Attribute Primary Care Provider Publications Qualifying Quality of life Race Randomized Randomized, Controlled Trials Relaxation Reporting Research Research Priority Schedule Self Management Sleep Specialist Subgroup Testing Time Training United States National Institutes of Health Urban Community Visit Work acceptability and feasibility arm behavioral economics clinically significant cost diaries disability disability-adjusted life years effective intervention efficacy evaluation electronic medical record system evidence base experience health care service utilization improved mHealth mind/body motivational enhancement therapy patient oriented patient subsets phase III trial primary care practice primary care setting primary care visit primary endpoint primary outcome prospective racial diversity recruit remote delivery response secondary outcome sex smartphone application social stigma suburban communities telephone based treatment as usual treatment effect

项目摘要

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.

项目概要/摘要偏头痛影响超过 4700 万美国人，是全球第二大致残疾病。偏头痛的使用率很高，美国每年门诊就诊人数超过 600 万人次，超过一半。其中十分之一的初级保健咨询是针对头痛的。尽管有证据表明身心干预措施，偏头痛至少占这些头痛就诊的 75%。 (MBI) 对偏头痛有效，但由于提供者的可用性有限，这些治疗方法的利用率极低以及患者报告的障碍，例如在初级保健中获得 MBI 的机会相当有限。大多数人接受治疗的新的、可扩展的、可访问的、基于证据的 MBI。我们的团队在许多环境中进行了多项试点研究，以评估渐进式肌肉的交付。在以患者为中心的智能手机应用程序（应用程序）“RELAXaHEAD”中针对偏头痛进行放松（PMR）。成功招募（超过 300 名患者参加偏头痛 RELAXaHEAD 试点研究，超过 200 名患者参加其他偏头痛身心研究），进行移动健康（mHealth）研究的良好记录（8 使用 RELAXaHEAD 的出版物），以及头痛医学、MBI、临床试验设计和集体坚持让我们以最佳方式扩展这项工作，以响应 NIH 的优先事项。针对慢性重叠疼痛状况的研究以及最近对完全远程 MBI 研究的呼吁，我们寻求进行一项功能齐全、完全远程的研究，以评估 RELAXaHEAD（RELAX，带有日记功能的应用程序）的功效和 PMR）与 6 周内监测的常规护理（MUC、带有日记的应用程序）相比（基于之前的 PMR）研究显示 PMR 在 6 周时有益处），我们将比较具有临床意义的患者报告。随机分配至 RELAX 组与 MUC 组的患者的结果包括偏头痛相关残疾的变化、我们将评估偏头痛的短期影响（6 周后）。治疗）以及入组后长达 26 周的持续获益。我们还将探讨这两个方面。治疗效果的潜在调节因素（抑郁、焦虑、睡眠的改善）和潜在的调节因素（年龄、性别、种族、民族和教育水平）我们将从初级保健教职人员团体实践中招募。大型学术医疗保健系统中的家庭健康中心，涵盖范围广泛的患者偏头痛，跨越不同的种族背景和民族，来自城市和郊区该研究的长期目标是创建一个基于证据的、可扩展的、可访问的 MBI。对于具有深远影响的偏头痛，以低成本的方式改善偏头痛相关的残疾，改善偏头痛患者的生活质量，并减少头痛天数。