Improving Health Outcomes of Migraine Patients Who Present to the Emergency Department
NCT ID: NCT02945839
Last Updated: 2019-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE4
INTERVENTIONAL
2016-12-28
2019-12-31
Brief Summary
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Several aspects of this study are innovative, including: 1. Initiation of preventive medication in a timely manner for migraineurs who present to the ED. 2. Introduction of PM+PMR in the ED at a time that can serve as a teachable moment. 3. Introduction of a smartphone application-based product (a minimal contact based behavioral therapy) in the ED setting to reduce headache disability, frequency, and intensity.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Acute Treatment+ED-initiated preventive medication +PMR
All subjects will be discharged on acute migraine therapy (naproxen, triptan) unless there is a contraindication and will also be started on topiramate (25mg/night) with a plan to increase the dose every week by 25 mg up to 100 mg/night. Subjects will receive medicine along with progressive muscle relaxation therapy
Preventative Medication (PM)
Subjects in the PM group will be given acute migraine medication, preventive medication (topiramate), and the APP with the PMR component. The smartphone app and/or the electronic pill bottles will be used to monitor adherence.
Enhanced Usual Care
General Education Class consisting of basic migraine information of basic migraine information such as evidence-based ways to treat migraines: treat early, limit acute medications \< 2-3 days/week, and call the primary care physician (PCP) if abortive medications are used more frequently.
PMR (progressive muscle relaxation therapy)
Technique for learning to monitor and control the state of muscular tension
Enhanced Usual Care (EUC)
Subjects will be given a general education session consisting of basic migraine information such as evidence-based ways to treat migraines: treat early, limit acute medications \< 2-3 days/week, and call the primary care physician (PCP) if abortive medications are used more frequently. Any migraine treatment decisions on discharge will be left up to the ED attending. The RC will load the APP onto the subjects' smart phones but the PMR component will be blocked on the version of the APP that they receive. All subjects will be asked to track headache frequency, intensity, and acute medication use on the APP.
Enhanced Usual Care
General Education Class consisting of basic migraine information of basic migraine information such as evidence-based ways to treat migraines: treat early, limit acute medications \< 2-3 days/week, and call the primary care physician (PCP) if abortive medications are used more frequently.
Interventions
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Preventative Medication (PM)
Subjects in the PM group will be given acute migraine medication, preventive medication (topiramate), and the APP with the PMR component. The smartphone app and/or the electronic pill bottles will be used to monitor adherence.
Enhanced Usual Care
General Education Class consisting of basic migraine information of basic migraine information such as evidence-based ways to treat migraines: treat early, limit acute medications \< 2-3 days/week, and call the primary care physician (PCP) if abortive medications are used more frequently.
PMR (progressive muscle relaxation therapy)
Technique for learning to monitor and control the state of muscular tension
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Migraine Disability Assessment (MIDAS) score \>5.
Exclusion Criteria
* Cognitive deficit or other physical problem with the potential to interfere with behavioral therapy; Alcohol or other substance abuse as determined by self-report or prior documentation in the medical record;
* Opioid or barbiturate use 10+ days a month;
* PHQ9 score of severe depression;
* Unable or unwilling to follow a treatment program that relies on written and audio recorded materials;
* Not having a smartphone.
18 Years
64 Years
ALL
No
Sponsors
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NYU Langone Health
OTHER
Responsible Party
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Principal Investigators
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Mia Minen, MD
Role: PRINCIPAL_INVESTIGATOR
New York University Medical School
Locations
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New York University School of Medicine
New York, New York, United States
Countries
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Other Identifiers
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16-00548
Identifier Type: -
Identifier Source: org_study_id
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