Migraine
Conditions
Brief 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.
Interventions
DRUGNaproxen
Naproxen 500mg PO bid prn headache
DRUGSumatriptan
100mg po q day prn headache
BEHAVIORALMigraine education
Educational program available through NIH/ national library of medicine/ X-plain
BEHAVIORALReenforcement of diagnosis
Patient advised has migraine headache and how the headache meets migraine criteria
OTHERTypical care
Care to be determined by attending physician
Sponsors
Montefiore Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Migraine Functional Impairment as Measured by Score on the Headache Impact Test 6 (HIT6) Scale | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Report Satisfaction With Treatment, as Measured by a Three Item Likert Scale | 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. |
| Number of Participants Who Report They Are Comfortable With Disease Management, as Measured by a Three-item Likert Scale | 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 |
| Number of Participants Who Returned to the Emergency Department for Management of Headache | 1 month after study enrollment | We report the number of patient who returned to the emergency department for management of headache |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Comprehensive Care Reinforcement of diagnosis, education, medications, and referral
Naproxen: Naproxen 500mg PO bid prn headache
Sumatriptan: 100mg po q day prn headache
Migraine education: Educational program available through NIH/ national library of medicine/ X-plain
Reenforcement of diagnosis: Patient told he/s he has migraine headache and how the headache meets migraine criteria | 25 |
| Typical Care Usual care
Typical care: Care to be determined by attending physician | 25 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 2 |
Baseline characteristics
| Characteristic | Comprehensive Care | Typical Care | Total |
|---|---|---|---|
| Age, Continuous | 33 years STANDARD_DEVIATION 9 | 35 years STANDARD_DEVIATION 9 | 34 years STANDARD_DEVIATION 9 |
| Pre-existing migraine-related functional impairment as measured by the MIDAS scale | 10 units on a scale | 13 units on a scale | 12 units on a scale |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment United States | 25 participants | 25 participants | 50 participants |
| Sex: Female, Male Female | 23 Participants | 20 Participants | 43 Participants |
| Sex: Female, Male Male | 2 Participants | 5 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 25 | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 |
Outcome results
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
Time frame: 1 month after study enrollment
Population: 2 patients in each group were lost-to-followup
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Comprehensive Care | Migraine Functional Impairment as Measured by Score on the Headache Impact Test 6 (HIT6) Scale | 59 units on a scale |
| Typical Care | Migraine Functional Impairment as Measured by Score on the Headache Impact Test 6 (HIT6) Scale | 56 units on a scale |
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.
Time frame: 1 month after study enrollment
Population: 2 patients in each group were lost to followup. One patient in the Typical Care group did not answer the question
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Comprehensive Care | Number of Participants Who Report Satisfaction With Treatment, as Measured by a Three Item Likert Scale | 4 Participants |
| Typical Care | Number of Participants Who Report Satisfaction With Treatment, as Measured by a Three Item Likert Scale | 4 Participants |
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
Time frame: 1 month after study enrollment
Population: Two patients in each arm were lost-to-follow-up. One patient in Typical Care did not answer this question.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Comprehensive Care | Number of Participants Who Report They Are Comfortable With Disease Management, as Measured by a Three-item Likert Scale | 10 Participants |
| Typical Care | Number of Participants Who Report They Are Comfortable With Disease Management, as Measured by a Three-item Likert Scale | 6 Participants |
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
Time frame: 1 month after study enrollment
Population: Two patients in each arm were lost to followup.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Comprehensive Care | Number of Participants Who Returned to the Emergency Department for Management of Headache | 1 Participants |
| Typical Care | Number of Participants Who Returned to the Emergency Department for Management of Headache | 3 Participants |