Study Stopped
Significant changes have been made to the protocol.
Improving Health Outcomes of Migraine Patients Who Present to the Emergency Department
1 other identifier
interventional
N/A
1 country
1
Brief Summary
Collectively, evidence shows that a combination of medication and behavioral therapy is most effective for migraine care. The ED is a critical point of contact with the health care system for many migraine patients; in current practice, it is a missed opportunity to initiate and establish a comprehensive migraine management paradigm. Behavioral headache treatments (e.g., progressive muscle relaxation (PMR), biofeedback, cognitive-behavioral therapy (CBT)) are effective migraine treatment options that are essentially free of side effects. PMR has also been successful as a technique that patients can do independently. Studies have shown that combination pharmacological-behavioral therapy is most effective for migraine treatment. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Dec 2016
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 17, 2016
CompletedFirst Posted
Study publicly available on registry
October 26, 2016
CompletedStudy Start
First participant enrolled
December 28, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedNovember 29, 2019
November 1, 2019
2.9 years
October 17, 2016
November 26, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Migraine Disability Assessment Scale (MIDAS) at 3 Months and Baseline
A decrease of 3 points in the MIDAS score corresponds to a one day reduction in headache related disability per month, a clinically meaningful difference.
12 Weeks
Secondary Outcomes (3)
Perceived Stress Scale (PSS)
12 Weeks
Number of days/week treated with acute medications
12 Weeks
Number of drug administrations/week for acute medications
12 Weeks
Study Arms (2)
Acute Treatment+ED-initiated preventive medication +PMR
ACTIVE COMPARATORAll 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
Enhanced Usual Care (EUC)
ACTIVE COMPARATORSubjects 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.
Interventions
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.
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.
Technique for learning to monitor and control the state of muscular tension
Eligibility Criteria
You may qualify if:
- Meets migraine criteria based on Information in Study Manual or based on Headache expert opinion -4+ migraines a month
- Migraine Disability Assessment (MIDAS) score \>5.
You may not qualify if:
- Patients who have had Cognitive Behavioral Therapy, Biofeedback or other Relaxation Therapy in the past year;
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
New York University School of Medicine
New York, New York, 10016, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mia Minen, MD
New York University Medical School
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 17, 2016
First Posted
October 26, 2016
Study Start
December 28, 2016
Primary Completion
December 1, 2019
Study Completion
December 1, 2019
Last Updated
November 29, 2019
Record last verified: 2019-11