HeadacheNCT00313703
Prospective ED Headache Cohort Study
An observational study of Headache, run by Montefiore Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Headache
- How many people
- 477 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2004to Nov 2005
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Convenience sample of ED patients
Who may be able to join
- Emergency Department patients who present primarily for headache.
- Need to consent to and be available for follow-up
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Montefiore Medical Center, 111 East 210th Street
The Bronx, New York, 10467
About this study
Official title: Predicting Poor Pain and Functional Outcomes After Discharge From the Emergency Department With a Primary Headache
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.
Read the 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
- Keywords
- headache, emergency department, migraine, recurrent headache
- Medical subject headings
- Headache, Emergencies, Migraine Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Report Moderate or Severe Pain Within 24 Hours of Emergency Department(ED) Discharge
Moderate/ Severe pain after discharge from the Emergency Department (ED). Moderate and severe are study subject's description of pain
Measured: 24 hours after Emergency Department (ED) discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2006 (estimated)
- Study startMar 2004
- Primary completionAug 2005
- Study completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 477 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Responsible party
- Principal investigator, Benjamin W. Friedman, MD, Montefiore Medical Center
- Investigators
- Benjamin Friedman, MD, MS, Principal investigator, Department of Emergency Medicine, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00313703
- Sponsor's protocol ID
- 04-03-077E
- Status last verified
- Apr 2018
- First submitted
- 10 Apr 2006
- Last updated
- 15 May 2018
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting Poor Pain and Functional Outcomes After Discharge From the Emergency Department With a Primary Headache
- ClinicalTrials.gov ID
- NCT00313703
- Acronym / sponsor ID
- 04-03-077E
- Conditions
- Headache
- Keywords
- headache, emergency department, migraine, recurrent headache
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 477 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- Mar 2004 (actual)
- Primary completion
- Aug 2005 (actual)
- Study completion
- Nov 2005 (actual)
- First posted
- 12 Apr 2006 (estimated)
- Results
- Posted 9 May 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Convenience sample of ED patients
Key inclusion criteria (2 listed)
- Emergency Department patients who present primarily for headache.
- Need to consent to and be available for follow-up
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benjamin Friedman, MD, MS principal investigator
Department of Emergency Medicine, Montefiore Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Headache, run by Montefiore Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 May 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2018.