Ignite Creation Date:
2025-12-24 @ 7:35 PM
Ignite Modification Date:
2025-12-25 @ 5:16 PM
Study NCT ID:
NCT00313703
Status:
COMPLETED
Last Update Posted:
2018-05-15
First Post:
2006-04-10
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Prospective ED Headache Cohort Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006261', 'term': 'Headache'}, {'id': 'D004630', 'term': 'Emergencies'}, {'id': 'D008881', 'term': 'Migraine Disorders'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D051270', 'term': 'Headache Disorders, Primary'}, {'id': 'D020773', 'term': 'Headache Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'befriedm@montefiore.org', 'phone': '718-920-6626', 'title': 'Benjamin Friedman', 'organization': 'Montefiore Medical Center'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'description': 'No adverse event information was gathered.', 'eventGroups': [{'id': 'EG000', 'title': 'Migraine', 'description': 'met International Headache Society migraine criteria', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Tension-type Headache', 'description': 'met International Headache Society tension-type headache criteria', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Unclassifiable', 'description': 'Had recurrent headache disorder but did not meet any International Headache Society criteria', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Other', 'description': 'Met other International Headache Society criteria', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Who Report Moderate or Severe Pain Within 24 Hours of Emergency Department(ED) Discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '75', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Migraine', 'description': 'met International Headache Society migraine criteria'}, {'id': 'OG001', 'title': 'Tension-type Headache', 'description': 'met International Headache Society tension-type headache criteria'}, {'id': 'OG002', 'title': 'Unclassifiable', 'description': 'Had recurrent headache disorder but did not meet any International Headache Society criteria'}, {'id': 'OG003', 'title': 'Other', 'description': 'Met other International Headache Society criteria'}], 'classes': [{'categories': [{'measurements': [{'value': '53', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 hours after Emergency Department (ED) discharge', 'description': "Moderate/ Severe pain after discharge from the Emergency Department (ED). Moderate and severe are study subject's description of pain", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'A small number of patients in each group were lost-to-follow-up and could not be included in this analysis.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants Who Reported Headache Disability Scores (MIDAS) More Than Minimal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Migraine', 'description': 'met International Headache Society migraine criteria'}, {'id': 'OG001', 'title': 'Tension-type Headache', 'description': 'met International Headache Society tension-type headache criteria'}, {'id': 'OG002', 'title': 'Unclassifiable', 'description': 'Had recurrent headache disorder but did not meet any International Headache Society criteria'}, {'id': 'OG003', 'title': 'Other', 'description': 'Met other International Headache Society criteria'}], 'classes': [{'categories': [{'measurements': [{'value': '65', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 months', 'description': 'Headache disability scores. On the MIDAS scale, a score \\> five signifies more than minimal headache related disability. MIDAS stands for MIgraine Disability Assessment Scale. More information on it can be found at http://www.migraines.org/disability/pdfs/midas.pdf. Scores of 0 are desirable. Scores greater than 20 signify a severe, functionally disabling migraine disorder.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'A small number of patients in each group were lost-to-follow-up and could not be included in this analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Migraine', 'description': 'met International Headache Society migraine criteria'}, {'id': 'FG001', 'title': 'Tension-type Headache', 'description': 'met International Headache Society tension-type headache criteria'}, {'id': 'FG002', 'title': 'Unclassifiable', 'description': 'Had recurrent headache disorder but did not meet any International Headache Society criteria'}, {'id': 'FG003', 'title': 'Other', 'description': 'Met other International Headache Society criteria'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '186'}, {'groupId': 'FG001', 'numSubjects': '34'}, {'groupId': 'FG002', 'numSubjects': '77'}, {'groupId': 'FG003', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Some subjects lost to follow-up', 'groupId': 'FG000', 'numSubjects': '175'}, {'comment': 'Some subjects lost-to follow-up', 'groupId': 'FG001', 'numSubjects': '32'}, {'comment': 'Some subjects lost-to-follow-up', 'groupId': 'FG002', 'numSubjects': '72'}, {'comment': 'Outcomes not reported due to heterogeneity of this group', 'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '12'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '12'}]}]}], 'recruitmentDetails': 'We enrolled adult patients who presented to one urban emergency department (ED) with a chief complaint of headache.Patients were assigned a headache diagnosis based on criteria established by the International Headache Society (These are available at http://217.174.249.183/upload/CT\\_Clas/ICHD-IIR1final.pdf)', 'preAssignmentDetails': '477 patients underwent a detailed interview in the ED. 309 of these patients were determined to have a primary headache disorder (a benign recurrent headache disease) and were entered into the post-ED follow-up portion of this cohort study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '309', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Migraine', 'description': 'met International Headache Society migraine criteria'}, {'id': 'BG001', 'title': 'Tension-type Headache', 'description': 'met International Headache Society tension-type headache criteria'}, {'id': 'BG002', 'title': 'Unclassifiable', 'description': 'Had recurrent headache disorder but did not meet any International Headache Society criteria'}, {'id': 'BG003', 'title': 'Other', 'description': 'Met other International Headache Society criteria'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '38', 'spread': '12', 'groupId': 'BG000'}, {'value': '40', 'spread': '12', 'groupId': 'BG001'}, {'value': '42', 'spread': '12', 'groupId': 'BG002'}, {'value': '40', 'spread': '11', 'groupId': 'BG003'}, {'value': '39', 'spread': '12', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '169', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '256', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '53', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 477}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2005-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-16', 'studyFirstSubmitDate': '2006-04-10', 'resultsFirstSubmitDate': '2010-10-06', 'studyFirstSubmitQcDate': '2006-04-10', 'lastUpdatePostDateStruct': {'date': '2018-05-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2011-04-15', 'studyFirstPostDateStruct': {'date': '2006-04-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-05-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of Participants Who Reported Headache Disability Scores (MIDAS) More Than Minimal', 'timeFrame': '3 months', 'description': 'Headache disability scores. On the MIDAS scale, a score \\> five signifies more than minimal headache related disability. MIDAS stands for MIgraine Disability Assessment Scale. More information on it can be found at http://www.migraines.org/disability/pdfs/midas.pdf. Scores of 0 are desirable. Scores greater than 20 signify a severe, functionally disabling migraine disorder.'}], 'primaryOutcomes': [{'measure': 'Number of Participants Who Report Moderate or Severe Pain Within 24 Hours of Emergency Department(ED) Discharge', 'timeFrame': '24 hours after Emergency Department (ED) discharge', 'description': "Moderate/ Severe pain after discharge from the Emergency Department (ED). Moderate and severe are study subject's description of pain"}]}, 'conditionsModule': {'keywords': ['headache', 'emergency department', 'migraine', 'recurrent headache'], 'conditions': ['Headache']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nThe 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.\n\nAfter 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Convenience sample of ED patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Emergency Department patients who present primarily for headache.\n* Need to consent to and be available for follow-up'}, 'identificationModule': {'nctId': 'NCT00313703', 'briefTitle': 'Prospective ED Headache Cohort Study', 'organization': {'class': 'OTHER', 'fullName': 'Montefiore Medical Center'}, 'officialTitle': 'Predicting Poor Pain and Functional Outcomes After Discharge From the Emergency Department With a Primary Headache', 'orgStudyIdInfo': {'id': '04-03-077E'}}, 'contactsLocationsModule': {'locations': [{'zip': '10467', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Montefiore Medical Center, 111 East 210th Street', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}], 'overallOfficials': [{'name': 'Benjamin Friedman, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Emergency Medicine, Montefiore Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Montefiore Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Neurological Disorders and Stroke (NINDS)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Emergency Medicine', 'investigatorFullName': 'Benjamin W. Friedman, MD', 'investigatorAffiliation': 'Montefiore Medical Center'}}}}