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

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

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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.

项目摘要/摘要偏头痛影响超过4700万美国人，是全球第二大最禁用的状况。卫生保健偏头痛的利用率很高，在美国，每年有超过600万个门诊就诊。超过一半这些访问发生在初级保健环境中。十分之一的初级保健咨询是针对标题的，并且偏头痛至少占这些标题访问的75％。尽管有证据表明心身干预（MBI）对于偏头痛有效，由于提供者的可用性有限以及患者报告的障碍，例如时间和费用。获得MBI的初级保健非常有限大多数人接受治疗的设置。新的可扩展，可访问和循证的MBI是需要。我们的团队在许多情况下进行了多次试点研究，以评估渐进肌肉的交付在以患者为中心的智能手机应用程序（APP）中，偏头痛的放松（PMR）“ slayahead”。我们的成功招募（超过300名偏头痛雷sheahead试验研究，超过200名患者其他偏头痛研究），证明了进行移动健康（MHealth）研究的记录（8 出版物使用selyahead）和标头医学，MBI，临床试验设计的专业知识和依从性统一将我们定位为最佳，以扩大这项工作。响应NIH的优先级关于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，我们试图进行完全动力的，完全远程的研究，以评估selyahead的效率（放松，应用日记与监测的常规护理（MUC，带有日记的应用程序）相比）在6周期间（基于先前的PMR 研究显示PMR在6周时的好处）。我们将比较具有临床意义的患者报告随机放松与MUC的患者的结果。结果包括偏头痛相关的残疾的变化，偏头痛特定的生活质量和标题日。我们将评估两个短期效应（6周后）治疗）和入学后长达26周的福利持续存在。我们还将探索这两个潜在的治疗效果介质（抑郁，焦虑，睡眠的改善）和潜在的主持人（年龄，性别，种族，种族和教育水平）。我们将从初级保健教师团体实践中招募大型学术医疗系统中的家庭卫生中心，包括非常广泛的患者偏头痛，跨越潜水的种族背景和种族，以及城市和郊区社区。该研究的长期目标是创建一个基于证据，可扩展且可访问的MBI 对于偏头痛，以低成本的方式具有深远的影响，以改善与偏头痛相关的残疾，改善患有偏头痛的人的生活质量，并减少标题日。