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

Study Overview
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Brief Summary
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This is a pilot feasibility acceptability study to examine the impact of smartphone-based progressive muscle relaxation (PMR) on migraine quality of life, frequency, intensity, and disability. Feasibility is measured by: a) Proportion of patients who enrolled in the study/were recruited for the study, b) Number of days PMR practiced/week as determined with the backend analytics in the RELAXaHEAD app, c) Minutes/day spent doing PMR, d) Reasons for non-adherence. Acceptability is measured by: a) Satisfaction using Likert scale questions on RELAXaHEAD usability, content, and functionality b) Willingness to repeat a similar treatment intervention in the future (Definitely No/Probably No/Unsure/Probably Yes/ Definitely Yes) c) Attrition. In addition, whether use of electronically based PMR introduced in the ED improves migraine quality of life (MSQv2) at 3 months post ED-discharge (or post enrollment date if recruited post ED discharge) compared to those who are not introduced to PMR will be assessed. All participants (N=85) will complete a migraine quality of life assessment and track their headache frequency and intensity using our smartphone application (app).

Detailed Description
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While explaining the study, potential participants will be assured that they will receive all of the medication for their acute headache that they would otherwise receive. Once consented, participants will be randomized to PMR therapy or monitored usual care (MUC). Participants will be told that either group is being tested as an enhancement to the care they typically get in the ED for headache. (At the end, they will be informed which group they were in.) The study team will collect participants' health histories (biologic variables) and baseline data in REDCap, download the app onto subjects' smartphones, and conduct the sessions.

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

Conditions
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Migraine

Intervention / Treatment
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* Behavioral: PMR (Progressive muscle relaxation therapy)
* Behavioral: Monitored Usual Care (MUC)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Meets migraine criteria and has 4+ headache days a month 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 Unable or unwilling to follow a treatment program that relies on written and audio recorded materials Not having a smartphone

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active Comparator: Progressive Muscle Relaxation (PMR) Therapy<br>After the PMR APP is loaded onto the subject's smartphone, the subject will perform PMR in the ED and discuss the optimal time and place to practice PMR at home. All subjects will be asked to keep records of headache occurrence, side effects, compliance, and medication changes on the APP. | Behavioral: PMR (Progressive muscle relaxation therapy)<br>* Technique for learning to monitor and control the state of muscular tension. The relaxation therapy should take about 20 minutes a day.<br>|
| Active Comparator: Active Comparator: Monitored Usual Care (MUC)<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 the MUC subjects receive. All subjects will be asked to keep records of headache occurrence, side effects, compliance, and medication changes on the APP. | Behavioral: Monitored Usual Care (MUC)<br>* General Education Session 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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Migraine-Specific Quality of Life Questionnaire-Version 2 (MSQv2) Scores | 14-item self-assessment of how migraines affect a patient's life. Items ranked on 6-point Likert scale, where: 1 = None of the time; 2 = A little bit of the time; 3 = Some of the time; 4 = A good bit of time; 5 = Most of the time; and 6 = All of the time. Raw dimension scores are computed as a sum of item responses and rescaled on a 0-100 scale; higher scores indicate better quality of life. | Baseline, Month 3 Post-Discharge | 
| Change in Migraine Disability Assessment Scale (MIDAS) Score | 5-item self-administered questionnaire designed to quantify headache-related disability over a 3-month period. For each item, participants indicate the number of days over the past three months that migraine limited their ability to participant in specific activities. The score is the sum responses. Scores are classified as follows: 0 to 5 = Little or no disability (MIDAS Grade I) 6 to 10 = Mild disability (MIDAS Grade II) 11 to 20 = Moderate disability (MIDAS Grade III) 21 and over = Severe disability (MIDAS Grade IV) | Baseline, Month 3 Post-Discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfaction Questionnaire Score | 9-item questionnaire assessing RELAXaHEAD usability, content, and functionality. Items are ranked on a 5-point Likert scale ranging from 0 (Strongly Disagree) to 4 (Strongly Agree). Total scores range from 0 to 36; higher scores indicate greater satisfaction with the app. | 48-Hours Post-Discharge | 
| Number of Participants who Experience 50% Decrease in Frequency and/or Intensity of Headaches (HAs) | Measured by electronic HA diary data. HA Frequency reported as number of HAs over the past 30 days, with days starting and ending at midnight. HA Intensity ranked on a 4-point Likert scale: 0 (no HA), 1 (mild HA), 2 (moderate HA), 3 (severe HA). | Up to Month 3 Post-Discharge | 
| Number of Days of Acute Medication Use Per Week | Medications included: NSAIDs, acetaminophen, caffeine, aspirin, triptans, barbiturates, opioids, antipsychotics. | Up to Month 3 Post-Discharge | 
| Change in Perceived Stress Scale (PSS) Scores | 10-item self-assessment measuring perception of stress. Items ranked on 5-point Likert scale, where: 0 = Never; 1 = Almost never; 2 = Sometimes; 3 = Fairly often; and 4 = Very often. Scores on the PSS range from 0-40; higher scores indicate higher perceived stress. | Baseline, Month 3 Post-Discharge | 
| Change in Patient Health Questionnaire-2 (PHQ-2) Scores | 2-item questionnaire assessing the frequency of anxiety symptoms over the past two weeks. Items ranked on 4-point Likert scale: 0 (Not at all), 1 (Several days), 2 (More than half the days), 3 (Nearly every day). Scores range from 0-6. Scores greater than 3 indicate major depressive disorder is likely. | Baseline, Month 3 Post-Discharge | 
| Change in General Anxiety Disorder-7 (GAD-7) Scores | 7-item questionnaire assessing the frequency of depressed mood and anhedonia over the past two weeks. Items ranked on 4-point Likert scale: 0 (Not at all), 1 (Several days), 2 (More than half the days), 3 (Nearly every day). Scores range from 0-21; where: 0-4: minimal anxiety; 5-9: mild anxiety; 10-14: moderate anxiety; and 15-21: severe anxiety. | Baseline, Month 3 Post-Discharge | 
| Length of Stay in Emergency Department (ED) |  | Up to Discharge (Average: 2-3 Days) | 
| Number of Participants who Re-Visit ED within 72-Hours Post-Discharge |  | Up to 72 Hours Post-Discharge | 
| Number of Healthcare Visits for Migraine Post-ED Discharge |  | Up to Month 3 Post-Discharge | 
| Number of Participants who Experience Adverse Events |  | Up to Month 3 Post-Discharge | 
| Percentage of Participants who Performed PMR at least 5 Days Per Week |  | Up to Month 3 Post-Discharge | 
| Time Spent Performing PMR |  | Up to Month 3 Post-Discharge | 
| Percentage of Participants with 70% Topiramate Adherence Rate |  | Up to Month 3 Post-Discharge |