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

Migraine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02945839
• Other study ID #: 16-00548
• Status: Withdrawn
• Phase: Phase 4
• Start date: December 28, 2016
• Est. completion date: December 2019

Study information

• Verified date: November 2019
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Emergencies
• Migraine
• Migraine Disorders

Intervention

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.

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.
• PMR (progressive muscle relaxation therapy)
Technique for learning to monitor and control the state of muscular tension

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Number of days/week treated with acute medications		12 Weeks
Secondary	Number of drug administrations/week for acute medications		12 Weeks