Prospective ED Headache Cohort Study

NCT ID: NCT00313703

Last Updated: 2018-05-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 477 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2004-03-31
• Study Completion Date: 2005-11-30

Brief Summary

The purpose of this study is to determine how often headaches recur and to learn how to predict continued suffering from headache after emergency department discharge.

Detailed Description

The majority of the 5 million people who arrive at Emergency Departments (ED) with a headache every year are suffering from an acute exacerbation of a chronic, recurrent headache disorder. The role of the ED in treating these patients has been ill-defined. Often emergency physicians will treat the acute exacerbation and will not attend to the natural history of the disease. However, about two thirds of primary headache patients will suffer a recurrent headache in the 24 hours after discharge from the ED. And, many patients will continue to suffer recurrent headaches for months after their ED discharge.

The purpose of this study is to learn how often headaches recur and to try to find a way to predict who will have a recurrent headache after ED discharge.

After standard ED treatment for headache, participants in the study will be asked to answer questions about prior headaches and medical history, and some census-like questions about race/ethnicity, salary, and education via a 20-minute interview with a research associate. The researchers will follow-up with 10-minute telephone calls to each participant's home in 24 hours and in 3 months with additional questions. Total length of time for study participation is approximately 40 minutes.

Conditions

Headache

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Emergency Department patients who present primarily for headache.
• Need to consent to and be available for follow-up

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Neurological Disorders and Stroke (NINDS)

NIH

Sponsor Role: collaborator

Montefiore Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Benjamin W. Friedman, MD

Prof. Emergency Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Benjamin Friedman, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Department of Emergency Medicine, Montefiore Medical Center

Locations

Montefiore Medical Center, 111 East 210th Street

The Bronx, New York, United States

Countries

United States

Other Identifiers

04-03-077E

Identifier Type: -

Identifier Source: org_study_id