Trial of Comprehensive Migraine Intervention

Migraine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01071317
• Other study ID #: 09-08-248
• Status: Completed
• Phase: Phase 4
• Start date: February 2010
• Est. completion date: January 2012

Study information

• Verified date: August 2018
• Source: Montefiore Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Drug:
• Naproxen
Naproxen 500mg PO bid prn headache
• Sumatriptan
100mg po q day prn headache

Behavioral:
• Migraine education
Educational program available through NIH/ national library of medicine/ X-plain
• Reenforcement of diagnosis
Patient advised has migraine headache and how the headache meets migraine criteria

Other:
• Typical care
Care to be determined by attending physician

Locations

Country	Name	City	State
United States	Montefiore Medical Center	Bronx	New York

Sponsors (1)

Lead Sponsor	Collaborator
Montefiore Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	1 month after study enrollment
Secondary	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.	1 month after study enrollment
Secondary	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	1 month after study enrollment
Secondary	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	1 month after study enrollment