Clinical trial NCT02945839: Improving Health Outcomes of Migraine Patients Who Present to the Emergency Department
Official title: Improving Health Outcomes of Migraine Patients Who Present to the Emergency Department
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Migraine
Keywords: Migraine
emergency department
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2016-10-26
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Migraine Disability Assessment Scale (MIDAS) at 3 Months and Baseline
timeFrame: 12 Weeks
Secondary outcomes:
measure: Perceived Stress Scale (PSS)
timeFrame: 12 Weeks
measure: Number of days/week treated with acute medications
timeFrame: 12 Weeks
measure: Number of drug administrations/week for acute medications
timeFrame: 12 Weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: New York University Medical School
name: Mia Minen, MD
role: PRINCIPAL_INVESTIGATOR
References: