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

Primary Purpose

Migraine

Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Preventative Medication (PM)
Enhanced Usual Care
PMR (progressive muscle relaxation therapy)
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine focused on measuring Migraine, emergency department

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • New York University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Acute Treatment+ED-initiated preventive medication +PMR

Enhanced Usual Care (EUC)

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Number of days/week treated with acute medications
Number of drug administrations/week for acute medications

Full Information

First Posted
October 17, 2016
Last Updated
November 26, 2019
Sponsor
NYU Langone Health
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1. Study Identification

Unique Protocol Identification Number
NCT02945839
Brief Title
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

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Withdrawn
Why Stopped
Significant changes have been made to the protocol.
Study Start Date
December 28, 2016 (Actual)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine
Keywords
Migraine, emergency department

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acute Treatment+ED-initiated preventive medication +PMR
Arm Type
Active Comparator
Arm Description
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
Arm Title
Enhanced Usual Care (EUC)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Preventative Medication (PM)
Other Intervention Name(s)
Topiramate
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Enhanced Usual Care
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
PMR (progressive muscle relaxation therapy)
Intervention Description
Technique for learning to monitor and control the state of muscular tension
Primary Outcome Measure Information:
Title
Migraine Disability Assessment Scale (MIDAS) at 3 Months and Baseline
Description
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.
Time Frame
12 Weeks
Secondary Outcome Measure Information:
Title
Perceived Stress Scale (PSS)
Description
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.
Time Frame
12 Weeks
Title
Number of days/week treated with acute medications
Time Frame
12 Weeks
Title
Number of drug administrations/week for acute medications
Time Frame
12 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mia Minen, MD
Organizational Affiliation
New York University Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States

12. IPD Sharing Statement

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

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