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Prospective ED Headache Cohort Study

This study has been completed.
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by:
Montefiore Medical Center
ClinicalTrials.gov Identifier:
NCT00313703
First received: April 10, 2006
Last updated: April 15, 2011
Last verified: April 2011
  Purpose
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.

Condition
Headache

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Predicting Poor Pain and Functional Outcomes After Discharge From the Emergency Department With a Primary Headache

Resource links provided by NLM:


Further study details as provided by Montefiore Medical Center:

Primary Outcome Measures:
  • Number of Participants Who Report Moderate or Severe Pain Within 24 Hours of Emergency Department(ED) Discharge [ Time Frame: 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


Enrollment: 477
Study Start Date: March 2005
Study Completion Date: May 2008
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.

  Eligibility

Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Convenience sample of ED patients
Criteria

Inclusion Criteria:

  • Emergency Department patients who present primarily for headache.
  • Need to consent to and be available for follow-up
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00313703

Locations
United States, New York
Montefiore Medical Center, 111 East 210th Street
Bronx, New York, United States, 10467
Sponsors and Collaborators
Montefiore Medical Center
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
Principal Investigator: Benjamin Friedman, MD, MS Department of Emergency Medicine, Montefiore Medical Center
  More Information

Responsible Party: Benjamin Friedman, MD, MS, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT00313703     History of Changes
Other Study ID Numbers: 04-03-077E
Study First Received: April 10, 2006
Results First Received: October 6, 2010
Last Updated: April 15, 2011

Keywords provided by Montefiore Medical Center:
headache
emergency department
migraine
recurrent headache

Additional relevant MeSH terms:
Headache
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on July 18, 2017