Trial of Comprehensive Migraine Intervention

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Benjamin Friedman, Montefiore Medical Center
ClinicalTrials.gov Identifier:
NCT01071317
First received: February 17, 2010
Last updated: April 26, 2012
Last verified: April 2012
  Purpose

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. We intend to enroll 21 patients in each arm of this study for a total of 42 patients. Using headache surveys, we will determine if the protocol improves migraine-related pain and functional disability one month after the ER visit.


Condition Intervention Phase
Migraine
Drug: Naproxen
Drug: Sumatriptan
Behavioral: Migraine education
Behavioral: Reenforcement of diagnosis
Other: Typical care
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: An RCT of a Comprehensive Migraine Intervention at the Time of Discharge From the ED After Treatment for Acute Migraine

Resource links provided by NLM:


Further study details as provided by Montefiore Medical Center:

Primary Outcome Measures:
  • Headache Impact Test 6 (HIT6) scale [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Satisfaction with care [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Migraine Disability Assessment Scale (MIDAS) [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Comfort with disease management [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Healthcare use [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: February 2010
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Comprehensive care
Reinforcement of diagnosis, education, medications, and referral
Drug: Naproxen
Naproxen 500mg PO bid prn headache
Drug: Sumatriptan
100mg po q day prn headache
Behavioral: Migraine education
Educational program available through HIH/ national library of medicine/ X-plain
Behavioral: Reenforcement of diagnosis
Patient told he/s he has migraine headache and how the headache meets migraine criteria
Active Comparator: Typical care
Usual care
Other: Typical care
Care to be determined by attending physician

  Eligibility

Ages Eligible for Study:   21 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01071317

Locations
United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467
Sponsors and Collaborators
Montefiore Medical Center
  More Information

No publications provided

Responsible Party: Benjamin Friedman, Associate professor, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT01071317     History of Changes
Other Study ID Numbers: ED Migraine Intervention
Study First Received: February 17, 2010
Last Updated: April 26, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on September 16, 2014