Ignite Creation Date:
2025-12-24 @ 7:38 PM
Ignite Modification Date:
2025-12-29 @ 10:38 AM
Study NCT ID:
NCT01706003
Status:
COMPLETED
Last Update Posted:
2019-10-25
First Post:
2012-10-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Utility of Telemedicine in the Management of Migraine
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008881', 'term': 'Migraine Disorders'}, {'id': 'D006261', 'term': 'Headache'}], 'ancestors': [{'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'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Deborah.Friedman@utsouthwestern.edu', 'phone': '2146483517', 'title': 'Deborah I. Friedman, MD, MPH, Professor of Neurology and Neurotherapeutics and Ophthalmology', 'organization': 'UT Southwestern Medical Center'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '1 year', 'eventGroups': [{'id': 'EG000', 'title': 'In-Office Group', 'description': "People who suffer from Migraine Headaches who own a computer and have internet access and will be treated in the clinician's office for migraine headaches", 'otherNumAtRisk': 23, 'deathsNumAtRisk': 23, 'otherNumAffected': 0, 'seriousNumAtRisk': 23, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Telemedicine Group', 'description': 'People who suffer from Migraine Headaches who own a computer and have internet access and will be treated via telemedicine for migraine headaches', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 0, 'seriousNumAtRisk': 22, 'deathsNumAffected': 0, 'seriousNumAffected': 3}], 'seriousEvents': [{'term': 'Hospital admission', 'notes': 'Hospitalized for headache treatment as part of routine clinical care', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 5, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Assess the Utility of Telemedicine for Follow-up Care in a Headache Medicine Practice', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'In-Office Group', 'description': "People who suffer from Migraine Headaches who own a computer and have internet access and will be treated in the clinician's office for migraine headaches"}, {'id': 'OG001', 'title': 'Telemedicine Group', 'description': 'People who suffer from Migraine Headaches who own a computer and have internet access and will be treated via telemedicine for migraine headaches'}], 'classes': [{'categories': [{'measurements': [{'value': '87', 'groupId': 'OG000'}, {'value': '92.7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'One Year', 'description': 'Percentage of completed scheduled study visits for each group.', 'unitOfMeasure': 'percentage of scheduled appointments', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'In-Office Group', 'description': "People who suffer from Migraine Headaches who own a computer and have internet access and will be treated in the clinician's office for migraine headaches"}, {'id': 'FG001', 'title': 'Telemedicine Group', 'description': 'People who suffer from Migraine Headaches who own a computer and have internet access and will be treated via telemedicine for migraine headaches'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Not scheduled', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'In-Office Group', 'description': "People who suffer from Migraine Headaches who own a computer and have internet access and will be treated in the clinician's office for migraine headaches"}, {'id': 'BG001', 'title': 'Telemedicine Group', 'description': 'People who suffer from Migraine Headaches who own a computer and have internet access and will be treated via telemedicine for migraine headaches'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Migraine Disability Assessment Score (MIDAS)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '40.5', 'groupId': 'BG000', 'lowerLimit': '3', 'upperLimit': '161'}, {'value': '65', 'groupId': 'BG001', 'lowerLimit': '11', 'upperLimit': '192'}, {'value': '47.9', 'groupId': 'BG002', 'lowerLimit': '3', 'upperLimit': '192'}]}]}], 'paramType': 'MEAN', 'description': 'The Migraine Disability Assessment Score (MIDAS) has a scale range of 0-270. Lower values represents a better outcome, higher values represents a worse outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'FULL_RANGE'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2012-02-28', 'size': 388749, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-06-11T13:07', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2018-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-29', 'studyFirstSubmitDate': '2012-10-10', 'resultsFirstSubmitDate': '2019-06-11', 'studyFirstSubmitQcDate': '2012-10-10', 'lastUpdatePostDateStruct': {'date': '2019-10-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-09-29', 'studyFirstPostDateStruct': {'date': '2012-10-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-10-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assess the Utility of Telemedicine for Follow-up Care in a Headache Medicine Practice', 'timeFrame': 'One Year', 'description': 'Percentage of completed scheduled study visits for each group.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Migraine', 'Headaches', 'Telemedicine'], 'conditions': ['Migraine Headaches']}, 'referencesModule': {'references': [{'pmid': '31450969', 'type': 'DERIVED', 'citation': 'Friedman DI, Rajan B, Seidmann A. A randomized trial of telemedicine for migraine management. Cephalalgia. 2019 Oct;39(12):1577-1585. doi: 10.1177/0333102419868250. Epub 2019 Aug 26.'}]}, 'descriptionModule': {'briefSummary': 'Patients will be randomly assigned to receive their follow-up care via telemedicine or in-office visits.', 'detailedDescription': "After obtaining informed consent, patients will be randomly assigned to receive their follow-up care via telemedicine or in-office visits. All subjects will complete a MIDAS questionnaire and allodynia questionnaire at their initial visit. Follow-up visits will be scheduled at 4-6 weeks, 3, 6, 9 and 12 months. In-person follow-up visits will be conducted in the standard fashion of the current physician's practice, with the initial intake conducted by an ophthalmic technician or resident, followed by the physician visit. Telemedicine visits will be conducted by the physician and recorded. Similar information will be gathered in both groups including: current medications, interim medical and headache history (including visits to the ED or hospitalizations for headache), description of headache, response to treatment (including adverse reactions), allergies, blood pressure and weight. Subjects randomized to telemedicine will be asked to have their blood pressure and weight measured within 5 days of their telemedicine session at a location convenient to them. We will record the length of each visit. Subjects in the in-person group, will be queried about travel time, and the total amount of time for the visit, and any activities missed to attend the visit. We will also ask about other costs associated with attending the office visit, such as child care.\n\nAt the one-year follow-up visit, subjects will complete the MIDAS, allodynia questionnaire, Modified Group Health Association of America's Consumer Satisfaction scale, and have the opportunity to express their views on the aspect of care received in a semi-structured interview. The follow-up questionnaires may be completed on line (telemedicine group, optional for in-person group) or on paper (in-person group). Headache diaries will be provided on line or may be done on paper, a smartphone, or a computer program of the subject's choosing.\n\nAll subjects will be able to access the physician by telephone, using MyChart, or with additional non-study visits as needed.\n\nSubjects will be responsible for the cost of the medications, treatments prescribed, and laboratory monitoring needed for their condition.\n\nSupport staff will be available to help set up the video system for subjects assigned to the telemedicine group who are in need of assistance."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients must be diagnosed with Migraine Headaches', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:• Ages 18 - 89 years\n\n* Diagnosis of migraine with or without aura, menstrual migraine, hemiplegic migraine\n* Able to provide informed consent\n* Able, in the opinion of the investigator, to reliably perform all aspects of the study\n* Ownership of or access to a computer and high speed internet\n\nCriteria for Exclusion of Subjects:\n\n* Age less than 18 years\n* Headache type is not migraine\n* No ownership or access to a computer or high speed internet\n* Unfamiliar with basic computer operations or uncomfortable using a computer\n* Unwilling to participate\n* Unable to read English (because of assessment tools)\n* History of another medical, psychiatric, social or behavioral problem that, in the opinion of the investigator, makes it unlikely that they will be able to complete the study activities. Questions regarding mood and anxiety are asked of all patients as part of their initial evaluation for headache.'}, 'identificationModule': {'nctId': 'NCT01706003', 'briefTitle': 'The Utility of Telemedicine in the Management of Migraine', 'organization': {'class': 'OTHER', 'fullName': 'University of Texas Southwestern Medical Center'}, 'officialTitle': 'The Utility of Telemedicine in the Management of Migraine: A Pilot Study :MK0974-071-00', 'orgStudyIdInfo': {'id': 'MK0974-071-00'}, 'secondaryIdInfos': [{'id': 'MERCK', 'type': 'OTHER', 'domain': 'MISP'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Telemedicine Group', 'description': 'People who suffer from Migraine Headaches who own a computer and have internet access and will be treated via telemedicine for migraine headaches'}, {'label': 'In-Office Group', 'description': "People who suffer from Migraine Headaches who own a computer and have internet access and will be treated in the clinician's office for migraine headaches"}]}, 'contactsLocationsModule': {'locations': [{'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Universit of Texas Southwestern', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'Deborah Friedman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Texas Southwestern Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Texas Southwestern Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Primary Investigator, MD, Neurology and Neurotheraputics', 'investigatorFullName': 'Deborah Friedman', 'investigatorAffiliation': 'University of Texas Southwestern Medical Center'}}}}