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:
- 金额:$ 81.58万
- 依托单位:
- 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:
- 关键词:Accident and Emergency departmentAdherenceAffectAftercareAgeAmericanAnxietyAppointmentBehavior TherapyBehavioralBiofeedbackBlindedCOVID-19 pandemicCellular PhoneChronicClinicalClinical Trials DesignCognitive TherapyConsultationsCountryDataEducational StatusElectronicsEnrollmentEthnic OriginEvidence based interventionEvidence based treatmentExerciseFacultyFamily health statusGoalsGrantGroup PracticeHeadacheHealthcare SystemsHospitalsInterventionIntervention StudiesLearningMeasuresMediatorMedicineMental DepressionMentored Patient-Oriented Research Career Development AwardMigraineMind-Body InterventionMonitorMuscle relaxation phaseNational Center for Complementary and Integrative HealthNeurologyOutcomeOutcome StudyPainParticipantPatient Outcomes AssessmentsPatient-Focused OutcomesPatientsPersonsPharmacological TreatmentPhasePilot ProjectsPositioning AttributePrimary CareProviderPublicationsQualifyingQuality of lifeRaceRandomizedRandomized, Controlled TrialsRelaxationReportingResearchResearch PriorityScheduleSelf ManagementSleepSpecialistSubgroupTestingTimeTrainingUnited States National Institutes of HealthUrban CommunityVisitWorkacceptability and feasibilityarmbehavioral economicsclinically significantcostdiariesdisabilitydisability-adjusted life yearseffective interventionefficacy evaluationelectronic medical record systemevidence baseexperiencehealth care service utilizationimprovedmHealthmind/bodymotivational enhancement therapypatient orientedpatient subsetsphase III trialprimary care practiceprimary care settingprimary care visitprimary endpointprimary outcomeprospectiveracial diversityrecruitremote deliveryresponsesecondary outcomesexsmartphone applicationsocial stigmasuburban communitiestelephone basedtreatment as usualtreatment 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.
项目总结/文摘
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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Mia Minen的其他文献
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{{ truncateString('Mia Minen', 18)}}的其他基金
Progressive Muscle Relaxation for Chronic Pain in an Acute Care Setting
渐进式肌肉放松治疗急性护理环境中的慢性疼痛
- 批准号:
10648574 - 财政年份:2018
- 资助金额:
$ 81.58万 - 项目类别:
Progressive Muscle Relaxation for Chronic Pain in an Acute Care Setting
渐进式肌肉放松治疗急性护理环境中的慢性疼痛
- 批准号:
10327639 - 财政年份:2018
- 资助金额:
$ 81.58万 - 项目类别:
Progressive Muscle Relaxation for Chronic Pain in an Acute Care Setting
渐进式肌肉放松治疗急性护理环境中的慢性疼痛
- 批准号:
10066309 - 财政年份:2018
- 资助金额:
$ 81.58万 - 项目类别:
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