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Completed

NCT Number: NCT01071317

Trial of Comprehensive Migraine Intervention

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.

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Key information

Conditions

Migraine Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases

Age range

21 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Naproxen

Drug

Naproxen 500mg PO bid prn headache

Sumatriptan

Drug

100mg po q day prn headache

Migraine education

Behavioral

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

Reenforcement of diagnosis

Behavioral

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

Typical care

Other

Care to be determined by attending physician

Primary outcomes

  1. Migraine Functional Impairment as Measured by Score on the Headache Impact Test 6 (HIT6) Scale

    Time frame: 1 month after study enrollment

    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 outcomes

  1. Number of Participants Who Report Satisfaction With Treatment, as Measured by a Three Item Likert Scale

    Time frame: 1 month after study enrollment

    Participants could report that they were completely satisfied, mostly satisfied or unsatisfied. Reported here are the number who were unsatisfied.

  2. Number of Participants Who Report They Are Comfortable With Disease Management, as Measured by a Three-item Likert Scale

    Time frame: 1 month after study enrollment

    Participants were asked to describe themselves as very comfortable, somewhat comfortable, or uncomfortable. Reported here are those who were very comfortable

  3. Number of Participants Who Returned to the Emergency Department for Management of Headache

    Time frame: 1 month after study enrollment

    We report the number of patient who returned to the emergency department for management of headache

Sponsors and collaborators

Lead sponsor

Montefiore Medical Center

Other

Registry information

Official study title

A Random Controlled Trial a Comprehensive Migraine Intervention at the Time of Discharge From the Emergency Department After Treatment for Acute Migraine

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Feb 19, 2010
Registry last updated
Aug 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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