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Trial of Comprehensive Migraine Intervention

Primary Purpose

Migraine

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Naproxen
Sumatriptan
Migraine education
Reenforcement of diagnosis
Typical care
Sponsored by
Montefiore Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Migraine

Eligibility Criteria

21 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Migraine,
  • Baseline migraine related disability of mild or worse,
  • No current or past triptan use,
  • Not satisfied with current headache care.

Exclusion Criteria:

  • Allergy or contraindication to study medications,
  • Daily or near daily analgesic medication use.

Sites / Locations

  • Montefiore Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Comprehensive care

Typical care

Arm Description

Reinforcement of diagnosis, education, medications, and referral

Usual care

Outcomes

Primary Outcome Measures

Migraine Functional Impairment as Measured by Score on the Headache Impact Test 6 (HIT6) Scale
This is a standardized instrument commonly used in migraine research. Participants answer 6 Likert questions about the impact of migraine on their daily life. A score of 36, the lowest possible score, indicates minimal functional impairment. A score of 78, the highest possible score, indicates substantial functional impairment

Secondary Outcome Measures

Number of Participants Who Report Satisfaction With Treatment, as Measured by a Three Item Likert Scale
Participants could report that they were completely satisfied, mostly satisfied or unsatisfied. Reported here are the number who were unsatisfied.
Number of Participants Who Report They Are Comfortable With Disease Management, as Measured by a Three-item Likert Scale
Participants were asked to describe themselves as very comfortable, somewhat comfortable, or uncomfortable. Reported here are those who were very comfortable
Number of Participants Who Returned to the Emergency Department for Management of Headache
We report the number of patient who returned to the emergency department for management of headache

Full Information

First Posted
February 17, 2010
Last Updated
August 1, 2018
Sponsor
Montefiore Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01071317
Brief Title
Trial of Comprehensive Migraine Intervention
Official Title
A Random Controlled Trial a Comprehensive Migraine Intervention at the Time of Discharge From the Emergency Department After Treatment for Acute Migraine
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Montefiore Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Despite the fact that more than 10% of Americans suffer from migraine, this headache disorder is often not diagnosed and not appropriately treated. The goal of this proposal is to determine whether a migraine protocol designed for use in an emergency room can be used to deliver the headache care that many migraine patients never receive. This is a randomized trial. Consecutive inadequately treated migraine patients will be randomized to TYPICAL care or to COMPREHENSIVE care. Those patients in the comprehensive care arm will receive the following intervention: 1) reinforcement of diagnosis, 2) an adaptable online educational intervention, reading material, and headache diaries, 3) two migraine specific medications and 4) expedited referral to a headache specialist, if needed. Patients in the typical care arm will receive whatever intervention the emergency physician feels is most appropriate. Headache surveys will be used toll if the protocol improves migraine-related pain and functional disability one month after the ER visit.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Comprehensive care
Arm Type
Experimental
Arm Description
Reinforcement of diagnosis, education, medications, and referral
Arm Title
Typical care
Arm Type
Active Comparator
Arm Description
Usual care
Intervention Type
Drug
Intervention Name(s)
Naproxen
Intervention Description
Naproxen 500mg PO bid prn headache
Intervention Type
Drug
Intervention Name(s)
Sumatriptan
Intervention Description
100mg po q day prn headache
Intervention Type
Behavioral
Intervention Name(s)
Migraine education
Intervention Description
Educational program available through NIH/ national library of medicine/ X-plain
Intervention Type
Behavioral
Intervention Name(s)
Reenforcement of diagnosis
Intervention Description
Patient advised has migraine headache and how the headache meets migraine criteria
Intervention Type
Other
Intervention Name(s)
Typical care
Intervention Description
Care to be determined by attending physician
Primary Outcome Measure Information:
Title
Migraine Functional Impairment as Measured by Score on the Headache Impact Test 6 (HIT6) Scale
Description
This is a standardized instrument commonly used in migraine research. Participants answer 6 Likert questions about the impact of migraine on their daily life. A score of 36, the lowest possible score, indicates minimal functional impairment. A score of 78, the highest possible score, indicates substantial functional impairment
Time Frame
1 month after study enrollment
Secondary Outcome Measure Information:
Title
Number of Participants Who Report Satisfaction With Treatment, as Measured by a Three Item Likert Scale
Description
Participants could report that they were completely satisfied, mostly satisfied or unsatisfied. Reported here are the number who were unsatisfied.
Time Frame
1 month after study enrollment
Title
Number of Participants Who Report They Are Comfortable With Disease Management, as Measured by a Three-item Likert Scale
Description
Participants were asked to describe themselves as very comfortable, somewhat comfortable, or uncomfortable. Reported here are those who were very comfortable
Time Frame
1 month after study enrollment
Title
Number of Participants Who Returned to the Emergency Department for Management of Headache
Description
We report the number of patient who returned to the emergency department for management of headache
Time Frame
1 month after study enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Migraine, Baseline migraine related disability of mild or worse, No current or past triptan use, Not satisfied with current headache care. Exclusion Criteria: Allergy or contraindication to study medications, Daily or near daily analgesic medication use.
Facility Information:
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States

12. IPD Sharing Statement

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Trial of Comprehensive Migraine Intervention

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