Phase 4
N=50
Trial of Comprehensive Migraine Intervention
Migraine
Bottom Line
View on ClinicalTrials.gov: NCT01071317 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Jul 2018
Primary outcome: Primary: Migraine Functional Impairment as Measured by Score on the Headache Impact Test 6 (HIT6) Scale — 59; 56 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Naproxen (Drug); Sumatriptan (Drug); Migraine education (Behavioral); Reenforcement of diagnosis (Behavioral); Typical care (Other)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Montefiore Medical Center
- Primary completion
- Jan 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Migraine Functional Impairment as Measured by Score on the Headache Impact Test 6 (HIT6) Scale |
59; 56 | — |
| SECONDARY Number of Participants Who Report Satisfaction With Treatment, as Measured by a Three Item Likert Scale |
4; 4 | — |
| SECONDARY Number of Participants Who Report They Are Comfortable With Disease Management, as Measured by a Three-item Likert Scale |
10; 6 | — |
| SECONDARY Number of Participants Who Returned to the Emergency Department for Management of Headache |
1; 3 | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01071317). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.