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

This study is not yet open for participant recruitment.
Verified August 2017 by New York University School of Medicine
Sponsor:
ClinicalTrials.gov Identifier:
NCT02945839
First Posted: October 26, 2016
Last Update Posted: August 11, 2017
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.
Information provided by (Responsible Party):
New York University School of Medicine
  Purpose

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 Intervention Phase
Migraine Drug: Preventative Medication (PM) Behavioral: Enhanced Usual Care Behavioral: PMR (progressive muscle relaxation therapy) Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Improving Health Outcomes of Migraine Patients Who Present to the Emergency Department

Resource links provided by NLM:


Further study details as provided by New York University School of Medicine:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 90
Anticipated Study Start Date: December 2017
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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: Topiramate
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.
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.

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02945839


Contacts
Contact: Liliana Serrano 212 685 4070 Liliana.Serrano2@nyumc.org

Locations
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         
Sponsors and Collaborators
New York University School of Medicine
Investigators
Principal Investigator: Mia Minen, MD New York University Medical School
  More Information

Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT02945839     History of Changes
Other Study ID Numbers: 16-00548
First Submitted: October 17, 2016
First Posted: October 26, 2016
Last Update Posted: August 11, 2017
Last Verified: August 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by New York University School of Medicine:
Migraine
emergency department

Additional relevant MeSH terms:
Emergencies
Migraine Disorders
Disease Attributes
Pathologic Processes
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Topiramate
Anticonvulsants
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Anti-Obesity Agents