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

History of Changes

Tracking Information
First Received Date ^ICMJE	February 17, 2010
Last Updated Date	April 26, 2012
Start Date ^ICMJE	February 2010
Primary Completion Date	January 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: February 18, 2010)	Headache Impact Test 6 (HIT6) scale [ Time Frame: 1 month ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01071317 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: February 18, 2010)	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 ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Trial of Comprehensive Migraine Intervention
Official Title ^ICMJE	An RCT of a Comprehensive Migraine Intervention at the Time of Discharge From the ED After Treatment for Acute Migraine
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. 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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Prevention
Condition ^ICMJE	Migraine
Intervention ^ICMJE	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
Study Arm (s)	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
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	50
Completion Date	January 2012
Primary Completion Date	January 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	21 Years to 70 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01071317
Other Study ID Numbers ^ICMJE	ED Migraine Intervention
Has Data Monitoring Committee	No
Responsible Party	Benjamin Friedman, Montefiore Medical Center
Study Sponsor ^ICMJE	Montefiore Medical Center
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Montefiore Medical Center
Verification Date	April 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top