Improving Health Outcomes of Migraine Patients Who Present to the Emergency Department

Study Overview
=================
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.

Detailed Description
-----------------
Investigators will conduct a randomized trial to evaluate the impact of a comprehensive migraine treatment program on the quality of life for migraineurs with frequent and disabling headaches who present to the ED. The intervention (PM+PMR) will combine acute treatment, migraine preventive medication-topiramate, and the APP with PMR. Data from patients in the intervention group will be compared with data from an enhanced usual care (EUC) group to examine the efficacy of the combined treatment effects.

Official Title
-----------------
Improving Health Outcomes of Migraine Patients Who Present to the Emergency Department

Conditions
-----------------
Migraine

Intervention / Treatment
-----------------
* Drug: Preventative Medication (PM)
* Behavioral: Enhanced Usual Care
* Behavioral: PMR (progressive muscle relaxation therapy)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Acute Treatment+ED-initiated preventive medication +PMR<br>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)<br>* 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.<br>* Other names: Topiramate;Behavioral: Enhanced Usual Care<br>* 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.<br>Behavioral: PMR (progressive muscle relaxation therapy)<br>* Technique for learning to monitor and control the state of muscular tension<br>|
| Active Comparator: Enhanced Usual Care (EUC)<br>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<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perceived Stress Scale (PSS) | 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. | 12 Weeks | 
| Number of days/week treated with acute medications |  | 12 Weeks | 
| Number of drug administrations/week for acute medications |  | 12 Weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Migraine, emergency department