Trial of Comprehensive Migraine Intervention

NCT ID: NCT01071317

Last Updated: 2018-08-31

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2012-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Migraine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Comprehensive care

Reinforcement of diagnosis, education, medications, and referral

Group Type EXPERIMENTAL

Naproxen

Intervention Type DRUG

Naproxen 500mg PO bid prn headache

Sumatriptan

Intervention Type DRUG

100mg po q day prn headache

Migraine education

Intervention Type BEHAVIORAL

Educational program available through NIH/ national library of medicine/ X-plain

Reenforcement of diagnosis

Intervention Type BEHAVIORAL

Patient advised has migraine headache and how the headache meets migraine criteria

Typical care

Usual care

Group Type ACTIVE_COMPARATOR

Typical care

Intervention Type OTHER

Care to be determined by attending physician

Interventions

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Naproxen

Naproxen 500mg PO bid prn headache

Intervention Type DRUG

Sumatriptan

100mg po q day prn headache

Intervention Type DRUG

Migraine education

Educational program available through NIH/ national library of medicine/ X-plain

Intervention Type BEHAVIORAL

Reenforcement of diagnosis

Patient advised has migraine headache and how the headache meets migraine criteria

Intervention Type BEHAVIORAL

Typical care

Care to be determined by attending physician

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

21 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Montefiore Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Benjamin W. Friedman, MD

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Montefiore Medical Center

The Bronx, New York, United States

Site Status

Countries

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United States

Other Identifiers

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09-08-248

Identifier Type: -

Identifier Source: org_study_id

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