Prospective ED Headache Cohort Study

Completed

• Conditions: Headache

• Registration Number: NCT00313703
• Lead Sponsor: Montefiore Medical Center

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.

Study Timeline

• Study Start: 2004-03
• Primary Completion: 2005-08
• Study Completion: 2005-11
• Study First Submitted: 2006-04-10
• Study First Submitted QC: 2006-04-10
• Study First Posted: 2006-04-12
• Results First Submitted: 2010-10-06
• Results First Submitted QC: 2011-04-15
• Results First Posted: 2011-05-09
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-16
• Last Update Posted: 2018-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 477

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Report Moderate or Severe Pain Within 24 Hours of Emergency Department(ED) Discharge	24 hours after Emergency Department (ED) discharge	Moderate/ Severe pain after discharge from the Emergency Department (ED). Moderate and severe are study subject's description of pain

Trial Locations

Locations (1)

Montefiore Medical Center, 111 East 210th Street; 🇺🇸 Bronx, New York, United States