Improving Health Outcomes of Migraine Patients Who Present to the Emergency Department
Study Details
Study Description
Brief Summary
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Active Comparator: Progressive Muscle Relaxation (PMR) Therapy 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)
Technique for learning to monitor and control the state of muscular tension. The relaxation therapy should take about 20 minutes a day.
|
| Active Comparator: Active Comparator: Monitored Usual Care (MUC) 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)
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.
|
Outcome Measures
Primary Outcome Measures
- Number of enrolled participants out of recruited participants [Baseline (Visit 0)]
Reported as participants who enrolled in the study / total recruited for the study (proportion).
- Number of days PMR was practiced per week [Baseline (Visit 0)]
This number will be determined with backend analytics in the RELAXaHEAD app
- Minutes per day spent doing PMR [Baseline (Visit 0)]
This number will be determined with backend analytics in the RELAXaHEAD app
- Score on Satisfaction Questionnaire [Baseline (Visit 0)]
A Likert scale questionnaire will be used to report RELAXaHEAD usability, content, and functionality. 0 means not satisfied, 5 means very satisfied. The higher the score, the higher the satisfaction.
- Score on "Willingness to Repeat" Questionnaire [Baseline (Visit 0)]
Willingness to repeat a similar treatment intervention in the future will be reported as Definitely No/Probably No/Unsure/Probably Yes/ Definitely
- Number of participants who leave the study [up to 12 weeks]
Attrition rate will be reported.
- Migraine Quality of Life (MSQv2) [Baseline (Visit 0)]
A validated migraine-specific quality of life questionnaire. The item responses range from one to six (1 = "None of the time;" 2 = "A little bit of time;" 3 = "Some of the time;" 4 = "A good bit of the time;" 5 = "Most of the time;" 6 = "All of the time"). All items are reverse-coded, and standardized to a 0-100 scale. Thus, higher scale scores indicate better migraine-related quality of life.
- Migraine Quality of Life (MSQv2) [Visit 12 weeks]
A validated migraine-specific quality of life questionnaire. The item responses range from one to six (1 = "None of the time;" 2 = "A little bit of time;" 3 = "Some of the time;" 4 = "A good bit of the time;" 5 = "Most of the time;" 6 = "All of the time"). All items are reverse-coded, and standardized to a 0-100 scale. Thus, higher scale scores indicate better migraine-related quality of life.
- Migraine Disability Assessment Scale (MIDAS) [Baseline (Visit 0)]
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. The total MIDAS score can be used to define four grades of migraine-related disability with grade I for "little or no disability" (0-5); grade II for "mild disability" (6-10); grade III for "moderate disability" (11-20); and grade IV for "severe disability" (≥ 21).
- Migraine Disability Assessment Scale (MIDAS) [Visit 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. The total MIDAS score can be used to define four grades of migraine-related disability with grade I for "little or no disability" (0-5); grade II for "mild disability" (6-10); grade III for "moderate disability" (11-20); and grade IV for "severe disability" (≥ 21).
Eligibility Criteria
Criteria
Inclusion Criteria:
- Meets migraine criteria and has 4+ headache days a month
Exclusion Criteria:
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Patients who have had Cognitive Behavioral Therapy, Biofeedback or other Relaxation Therapy in the past year
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Cognitive deficit or other physical problem with the potential to interfere with behavioral therapy
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Alcohol or other substance abuse as determined by self-report or prior documentation in the medical record
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Unable or unwilling to follow a treatment program that relies on written and audio recorded materials
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Not having a smartphone
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | NYU Langone | New York | New York | United States | 10003 |
Sponsors and Collaborators
- NYU Langone Health
Investigators
- Principal Investigator: Mia Minen, MD, NYU Langone
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 16-00548 - 2