Improving Health Outcomes of Migraine Patients Who Present to the Emergency Department
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02945839|
Recruitment Status : Not yet recruiting
First Posted : October 26, 2016
Last Update Posted : January 23, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Migraine||Drug: Preventative Medication (PM) Behavioral: Enhanced Usual Care Behavioral: PMR (progressive muscle relaxation therapy)||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Improving Health Outcomes of Migraine Patients Who Present to the Emergency Department|
|Estimated Study Start Date :||April 2018|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
Active Comparator: 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
Drug: 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.
Other Name: TopiramateBehavioral: 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.Behavioral: PMR (progressive muscle relaxation therapy)
Technique for learning to monitor and control the state of muscular tension
Active Comparator: 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.
Behavioral: 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.
- Migraine Disability Assessment Scale (MIDAS) at 3 Months and Baseline [ Time Frame: 12 Weeks ]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.
- Perceived Stress Scale (PSS) [ Time Frame: 12 Weeks ]PSS scores are obtained by reversing responses (e.g., 0 = 4, 1 = 3, 2 = 2, 3 = 1 & 4 = 0) to the four positively stated items (items 4, 5, 7, & 8) and then summing across all scale items. A short 4 item scale can be made from questions 2, 4, 5 and 10 of the PSS 10 item scale.
- Number of days/week treated with acute medications [ Time Frame: 12 Weeks ]
- Number of drug administrations/week for acute medications [ Time Frame: 12 Weeks ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02945839
|Contact: Liliana Serrano||212 685 4070||Liliana.Serrano2@nyumc.org|
|United States, New York|
|New York University School of Medicine||Not yet recruiting|
|New York, New York, United States, 10016|
|Contact: Liliana Serrano Liliana.Serrano2@nyumc.org|
|Principal Investigator: mia Minen, MD|
|Principal Investigator:||Mia Minen, MD||New York University Medical School|