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

February 17, 2010
April 26, 2012
February 2010
January 2012   (final data collection date for primary outcome measure)
Headache Impact Test 6 (HIT6) scale [ Time Frame: 1 month ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01071317 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Trial of Comprehensive Migraine Intervention
An RCT of a Comprehensive Migraine Intervention at the Time of Discharge From the ED After Treatment for Acute Migraine

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Migraine
  • 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
  • Other: Typical care
    Care to be determined by attending physician
  • Experimental: Comprehensive care
    Reinforcement of diagnosis, education, medications, and referral
    Interventions:
    • Drug: Naproxen
    • Drug: Sumatriptan
    • Behavioral: Migraine education
    • Behavioral: Reenforcement of diagnosis
  • Active Comparator: Typical care
    Usual care
    Intervention: Other: Typical care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
January 2012
January 2012   (final data collection date for primary outcome measure)

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.
Both
21 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01071317
ED Migraine Intervention
No
Benjamin Friedman, Montefiore Medical Center
Montefiore Medical Center
Not Provided
Not Provided
Montefiore Medical Center
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP