Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2026-01-07 @ 7:43 PM
Study NCT ID:
NCT03706794
Status:
COMPLETED
Last Update Posted:
2025-04-06
First Post:
2018-10-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Decision Support for Patient Migraine Management
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008881', 'term': 'Migraine Disorders'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Elizabeth.Seng@einsteinmed.edu', 'phone': '646-592-4368', 'title': 'Dr. Elizabeth Seng', 'organization': 'Albert Einstein College of Medicine'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': "Participants were contacted bi-weekly by the research coordinator and monthly by the research assistant throughout the study to assess for adverse events. The PI also monitored each participant's recorded headache diaries monthly to assess for adverse events. Adverse events were monitored/collected over a period of 3 months during the interventional phase of the study.", 'description': 'Adverse Events were assessed in accordance with HHS/NIH/NCI Common Terminology Criteria for Adverse Events (Version 4.0)', 'eventGroups': [{'id': 'EG000', 'title': 'Clinical Decision Support Tool', 'description': 'Tailored education provided via a smartphone application\n\nClinical Decision Support Tool: Tailored education provided via a smartphone application.', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 0, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Headache Education', 'description': 'Non-tailored education provided via a smartphone application.\n\nHeadache Education: Non-tailored education provided via a smartphone application.', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 1, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'COVID-19 Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Adherence to Acute Migraine Management Strategies: Treat Early', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Clinical Decision Support Tool', 'description': 'Tailored education provided via a smartphone application\n\nClinical Decision Support Tool: Tailored education provided via a smartphone application.'}, {'id': 'OG001', 'title': 'Headache Education', 'description': 'Non-tailored education provided via a smartphone application.\n\nHeadache Education: Non-tailored education provided via a smartphone application.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Month 6 of the Treatment', 'description': 'Participants record headache activity in an electronic daily headache diary and if experiencing a headache were asked about the type of headache and the level of pain experienced when they took the Migraine Specific Medication (MSM). A headache episode is coded as "Treat Early" if a participant took the MSM when the pain was mild (as opposed to moderate or severe). The number of participants who were "Treated early" during Month 6 is reported by study arm/group.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Adherence to Acute Migraine Management Strategies: Overuse', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Clinical Decision Support Tool', 'description': 'Tailored education provided via a smartphone application\n\nClinical Decision Support Tool: Tailored education provided via a smartphone application.'}, {'id': 'OG001', 'title': 'Headache Education', 'description': 'Non-tailored education provided via a smartphone application.\n\nHeadache Education: Non-tailored education provided via a smartphone application.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Month 6 of the Treatment', 'description': 'Overuse is considered taking Migraine Specific Medication (MSM) more than 10 times in a month or a Nonsteroidal Anti-Inflammatory drug (NSAID) (non-combination) 15 or more times per month. The number of participants who met the definition of overuse during Month 6 is summarized and reported by study arm/group.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Adherence to Preventive Behavioral Strategies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Clinical Decision Support Tool', 'description': 'Tailored education provided via a smartphone application\n\nClinical Decision Support Tool: Tailored education provided via a smartphone application.'}, {'id': 'OG001', 'title': 'Headache Education', 'description': 'Non-tailored education provided via a smartphone application.\n\nHeadache Education: Non-tailored education provided via a smartphone application.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.1', 'spread': '8.5', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 6 of the Treatment', 'description': 'Adherence to Preventive Behavioral Strategies is determined by the mean number of documented adherent days/month for a single preventive behavioral strategy, either stress management, sleep management, or consistent eating. The behavioral strategy was selected by the investigator and determined as the strategy with which the participant had the poorest adherence during the baseline run in period. Preventive Behavioral Strategies were evaluated daily in the electronic headache diary. Adherence to one of the aforementioned Preventive Behavioral Strategies during Month 6 is reported.', 'unitOfMeasure': 'days/month', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Adherence to Preventive Medication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Clinical Decision Support Tool', 'description': 'Tailored education provided via a smartphone application\n\nClinical Decision Support Tool: Tailored education provided via a smartphone application.'}, {'id': 'OG001', 'title': 'Headache Education', 'description': 'Non-tailored education provided via a smartphone application.\n\nHeadache Education: Non-tailored education provided via a smartphone application.'}], 'classes': [{'categories': [{'measurements': [{'value': '15.0', 'spread': '7.5', 'groupId': 'OG000'}, {'value': '12.3', 'spread': '13.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 6 of the Treatment', 'description': 'If a participant was taking a preventive medication, adherence to preventive medication was assessed as the number of days/month participants took their preventive medication as recorded in the electronic daily headache diary. Taking preventive medication = Adherent, Not taking preventive medication = Not-adherent. The mean number of "Adherent" days/month in Month 6 are reported.', 'unitOfMeasure': 'days/month', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "4 participants in the 'Clinical Decision Support Tool (CDST)' arm and 3 participants in the 'Headache Education' arm had been taking a preventive medication and were able to be assessed for this Outcome Measure."}, {'type': 'SECONDARY', 'title': 'Headache Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Clinical Decision Support Tool', 'description': 'Tailored education provided via a smartphone application\n\nClinical Decision Support Tool: Tailored education provided via a smartphone application.'}, {'id': 'OG001', 'title': 'Headache Education', 'description': 'Non-tailored education provided via a smartphone application.\n\nHeadache Education: Non-tailored education provided via a smartphone application.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.4', 'groupId': 'OG000', 'lowerLimit': '1.9', 'upperLimit': '3.8'}, {'value': '4.4', 'groupId': 'OG001', 'lowerLimit': '2.1', 'upperLimit': '5.3'}]}]}], 'analyses': [{'pValue': '.829', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mann-Whitney U', 'ciNumSides': 'TWO_SIDED', 'paramValue': '43.0', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Month 6 of the Treatment', 'description': 'Participants recorded headaches in their electronic daily headache diary. The median number of headache days/month during Month 6 was summarized and reported.', 'unitOfMeasure': 'days/month', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Headache Pain Intensity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Clinical Decision Support Tool', 'description': 'Tailored education provided via a smartphone application\n\nClinical Decision Support Tool: Tailored education provided via a smartphone application.'}, {'id': 'OG001', 'title': 'Headache Education', 'description': 'Non-tailored education provided via a smartphone application.\n\nHeadache Education: Non-tailored education provided via a smartphone application.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.0', 'groupId': 'OG000', 'lowerLimit': '4.3', 'upperLimit': '9.3'}, {'value': '6.0', 'groupId': 'OG001', 'lowerLimit': '4.0', 'upperLimit': '7.0'}]}]}], 'analyses': [{'pValue': '.633', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mann-Whitney U', 'ciNumSides': 'TWO_SIDED', 'paramValue': '45.5', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Month 6 of the Treatment', 'description': 'Headache pain intensity was recorded in an electronic daily headache diary. If a headache was confirmed, the average one-month headache pain intensity was assessed on a 0-10 scale, where 0 indicated no pain and 10 indicated the worst pain imaginable. The median headache pain intensity during Month 6 was summarized and reported.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Migraine-Related Disability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Clinical Decision Support Tool', 'description': 'Tailored education provided via a smartphone application\n\nClinical Decision Support Tool: Tailored education provided via a smartphone application.'}, {'id': 'OG001', 'title': 'Headache Education', 'description': 'Non-tailored education provided via a smartphone application.\n\nHeadache Education: Non-tailored education provided via a smartphone application.'}], 'classes': [{'categories': [{'measurements': [{'value': '18.0', 'groupId': 'OG000', 'lowerLimit': '7.5', 'upperLimit': '26.3'}, {'value': '12.5', 'groupId': 'OG001', 'lowerLimit': '8.3', 'upperLimit': '27.5'}]}]}], 'analyses': [{'pValue': '.633', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mann-Whitney U', 'ciNumSides': 'TWO_SIDED', 'paramValue': '45.5', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Month 6 of the Treatment', 'description': 'Migraine Disability Assessment (MIDAS) is a 5-item questionnaire used to measure migraine-related functional impairment. The survey queries as to the number of lost days of housework, job-work, and non-work activities over the prior 90-day period. Each item is an open entry allowing for input of the number of days lost over the prior 90 days. Total score ranges from 0 - 270, with higher scores indicate higher degrees of impairment/disability. Scores of 21 and above are considered "severe" levels of migraine-related disability. Group median MIDAS scores collected at Month 6 were summarized and reported.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Migraine-Specific Quality of Life', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Clinical Decision Support Tool', 'description': 'Tailored education provided via a smartphone application\n\nClinical Decision Support Tool: Tailored education provided via a smartphone application.'}, {'id': 'OG001', 'title': 'Headache Education', 'description': 'Non-tailored education provided via a smartphone application.\n\nHeadache Education: Non-tailored education provided via a smartphone application.'}], 'classes': [{'categories': [{'measurements': [{'value': '26.4', 'groupId': 'OG000', 'lowerLimit': '14.0', 'upperLimit': '58.9'}, {'value': '21.6', 'groupId': 'OG001', 'lowerLimit': '8.9', 'upperLimit': '53.8'}]}]}], 'analyses': [{'pValue': '.633', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mann-Whitney U', 'ciNumSides': 'TWO_SIDED', 'paramValue': '46.0', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Month 6 of the Treatment', 'description': 'The Migraine-Specific Quality of Life (MSQL) questionnaire (v2.1), a 14-item survey, was used to measure migraine-related quality of life. Responses on the MSQL assessed the effect on migraines on daily activity over the prior 4 weeks and were scored from 1 ("None of the Time") to 6 ("All of the Time"), for an overall total scoring range of 14-84. Higher scores indicated lower migraine-related quality of life. Group median MSQL scores at Month 6 were summarized and reported.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pain Interference', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Clinical Decision Support Tool', 'description': 'Tailored education provided via a smartphone application\n\nClinical Decision Support Tool: Tailored education provided via a smartphone application.'}, {'id': 'OG001', 'title': 'Headache Education', 'description': 'Non-tailored education provided via a smartphone application.\n\nHeadache Education: Non-tailored education provided via a smartphone application.'}], 'classes': [{'categories': [{'measurements': [{'value': '52.8', 'groupId': 'OG000', 'lowerLimit': '42.5', 'upperLimit': '61.6'}, {'value': '55.8', 'groupId': 'OG001', 'lowerLimit': '47.6', 'upperLimit': '56.0'}]}]}], 'analyses': [{'pValue': '.315', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mann-Whitney U', 'ciNumSides': 'TWO_SIDED', 'paramValue': '52.0', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Month 6 of the Treatment', 'description': 'Pain Interference was evaluated using v1.0 of the PROMIS (Patient-Reported Outcomes Measurement Information System) Pain Interference (PI) Short Form (PROMIS-PI). PROMIS-PI is an 8-item survey which evaluates the self-reported consequences of pain on aspects of daily life activities and enjoyment of life over the past 7 days. Possible response options ranged from 1 ("Not at all") to 5 ("Very Much"). Raw scores were converted to T-scores using population norms with a mean of 50 and a standard deviation of 15 such that a Pain Interference score of 65 would be one SD worse than average, such that a person has more problems with pain hindering activities, and a pain interference score of 35 is one SD better than the average.', 'unitOfMeasure': 'T-score', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Clinical Decision Support Tool', 'description': 'Tailored education provided via a smartphone application\n\nClinical Decision Support Tool: Tailored education provided via a smartphone application.'}, {'id': 'FG001', 'title': 'Headache Education', 'description': 'Non-tailored education provided via a smartphone application.\n\nHeadache Education: Non-tailored education provided via a smartphone application.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Clinical Decision Support Tool', 'description': 'Tailored education provided via a smartphone application\n\nClinical Decision Support Tool: Tailored education provided via a smartphone application.'}, {'id': 'BG001', 'title': 'Headache Education', 'description': 'Non-tailored education provided via a smartphone application.\n\nHeadache Education: Non-tailored education provided via a smartphone application.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'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': '8', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '18', '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': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '29.1', 'spread': '6.3', 'groupId': 'BG000'}, {'value': '36.1', 'spread': '9.8', 'groupId': 'BG001'}, {'value': '33.0', 'spread': '9.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Headache Days', 'classes': [{'categories': [{'measurements': [{'value': '5.8', 'spread': '2.9', 'groupId': 'BG000'}, {'value': '4.3', 'spread': '1.9', 'groupId': 'BG001'}, {'value': '5.0', 'spread': '2.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Mean number of headache days per month was recorded at baseline and summarized by study arm.', 'unitOfMeasure': 'days/month', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-06-30', 'size': 855070, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-03-20T11:36', 'hasProtocol': True}, {'date': '2021-07-29', 'size': 156226, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-03-20T11:17', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Participants will be informed that they will receive one of two educational interventions. The "care provider" is a smartphone application; the only person aware of the condition is the research assistant assigning participants to the smartphone application conditions. The investigator, research coordinator, and all other personnel including outcomes assessors will be unaware of condition.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2022-03-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-04', 'studyFirstSubmitDate': '2018-10-04', 'resultsFirstSubmitDate': '2025-01-27', 'studyFirstSubmitQcDate': '2018-10-11', 'lastUpdatePostDateStruct': {'date': '2025-04-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-04-04', 'studyFirstPostDateStruct': {'date': '2018-10-16', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-04-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adherence to Acute Migraine Management Strategies: Treat Early', 'timeFrame': 'Month 6 of the Treatment', 'description': 'Participants record headache activity in an electronic daily headache diary and if experiencing a headache were asked about the type of headache and the level of pain experienced when they took the Migraine Specific Medication (MSM). A headache episode is coded as "Treat Early" if a participant took the MSM when the pain was mild (as opposed to moderate or severe). The number of participants who were "Treated early" during Month 6 is reported by study arm/group.'}, {'measure': 'Adherence to Acute Migraine Management Strategies: Overuse', 'timeFrame': 'Month 6 of the Treatment', 'description': 'Overuse is considered taking Migraine Specific Medication (MSM) more than 10 times in a month or a Nonsteroidal Anti-Inflammatory drug (NSAID) (non-combination) 15 or more times per month. The number of participants who met the definition of overuse during Month 6 is summarized and reported by study arm/group.'}, {'measure': 'Adherence to Preventive Behavioral Strategies', 'timeFrame': 'Month 6 of the Treatment', 'description': 'Adherence to Preventive Behavioral Strategies is determined by the mean number of documented adherent days/month for a single preventive behavioral strategy, either stress management, sleep management, or consistent eating. The behavioral strategy was selected by the investigator and determined as the strategy with which the participant had the poorest adherence during the baseline run in period. Preventive Behavioral Strategies were evaluated daily in the electronic headache diary. Adherence to one of the aforementioned Preventive Behavioral Strategies during Month 6 is reported.'}, {'measure': 'Adherence to Preventive Medication', 'timeFrame': 'Month 6 of the Treatment', 'description': 'If a participant was taking a preventive medication, adherence to preventive medication was assessed as the number of days/month participants took their preventive medication as recorded in the electronic daily headache diary. Taking preventive medication = Adherent, Not taking preventive medication = Not-adherent. The mean number of "Adherent" days/month in Month 6 are reported.'}], 'secondaryOutcomes': [{'measure': 'Headache Days', 'timeFrame': 'Month 6 of the Treatment', 'description': 'Participants recorded headaches in their electronic daily headache diary. The median number of headache days/month during Month 6 was summarized and reported.'}, {'measure': 'Headache Pain Intensity', 'timeFrame': 'Month 6 of the Treatment', 'description': 'Headache pain intensity was recorded in an electronic daily headache diary. If a headache was confirmed, the average one-month headache pain intensity was assessed on a 0-10 scale, where 0 indicated no pain and 10 indicated the worst pain imaginable. The median headache pain intensity during Month 6 was summarized and reported.'}, {'measure': 'Migraine-Related Disability', 'timeFrame': 'Month 6 of the Treatment', 'description': 'Migraine Disability Assessment (MIDAS) is a 5-item questionnaire used to measure migraine-related functional impairment. The survey queries as to the number of lost days of housework, job-work, and non-work activities over the prior 90-day period. Each item is an open entry allowing for input of the number of days lost over the prior 90 days. Total score ranges from 0 - 270, with higher scores indicate higher degrees of impairment/disability. Scores of 21 and above are considered "severe" levels of migraine-related disability. Group median MIDAS scores collected at Month 6 were summarized and reported.'}, {'measure': 'Migraine-Specific Quality of Life', 'timeFrame': 'Month 6 of the Treatment', 'description': 'The Migraine-Specific Quality of Life (MSQL) questionnaire (v2.1), a 14-item survey, was used to measure migraine-related quality of life. Responses on the MSQL assessed the effect on migraines on daily activity over the prior 4 weeks and were scored from 1 ("None of the Time") to 6 ("All of the Time"), for an overall total scoring range of 14-84. Higher scores indicated lower migraine-related quality of life. Group median MSQL scores at Month 6 were summarized and reported.'}, {'measure': 'Pain Interference', 'timeFrame': 'Month 6 of the Treatment', 'description': 'Pain Interference was evaluated using v1.0 of the PROMIS (Patient-Reported Outcomes Measurement Information System) Pain Interference (PI) Short Form (PROMIS-PI). PROMIS-PI is an 8-item survey which evaluates the self-reported consequences of pain on aspects of daily life activities and enjoyment of life over the past 7 days. Possible response options ranged from 1 ("Not at all") to 5 ("Very Much"). Raw scores were converted to T-scores using population norms with a mean of 50 and a standard deviation of 15 such that a Pain Interference score of 65 would be one SD worse than average, such that a person has more problems with pain hindering activities, and a pain interference score of 35 is one SD better than the average.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Migraine']}, 'descriptionModule': {'briefSummary': 'Little is known about who adheres to migraine management strategies, and circumstances that enhance adherence. This knowledge is required to develop patient-level interventions to improve adherence to migraine management strategies. The proposed project will pilot the first patient level intervention designed to improve adherence to preventive and acute migraine management strategies. The study will identify people most at risk for non-adherence to migraine management strategies. Participants will be randomly assigned to receive a tailored clinical decision support tool or education intervention.', 'detailedDescription': 'Participants with a diagnosis with migraine who currently meet criteria for episodic migraine (migraine with headaches that occur on fewer than 15 days per month) will be recruited from local providers. After an initial screening, eligible participants will complete 30 days of monitoring 3 times daily on an electronic headache diary (a smartphone app) to confirm study eligibility. Participants whose eligibility is confirmed will complete an additional 2 months (60 days) of monitoring headache activity and adherence to acute and preventive (medication and behavioral) strategies recommended for people with migraine. Participants who show suboptimal adherence during the first 3 months of monitoring (\\<50% of eligible days) will be eligible to continue to the intervention component of the study. Participants who choose to continue in the study will be randomized to receive a tailored clinical decision support tool or education intervention, both delivered through the smartphone app. Participants will continue to self-monitor, with the intervention components active, for 3 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have an International Classification of Headache Disorders - 3 beta diagnosis of migraine\n* Self-report and diary-confirmed 6 to 14 headache days per month\n* Are currently prescribed a triptan for acute migraine management\n* Are stable on current preventive and acute treatment regimen for migraine\n* Are between the ages of 18 and 65\n* Reads and understands English\n* Has capacity to consent\n* Completes 80% of diary recordings in the first 30 days of monitoring\n\nExclusion Criteria:\n\n* Probable or confirmed medication overuse headache\n* A plan to change, or changing preventive or acute migraine medication during study participation\n* Are pregnant or are planning to become pregnant during study involvement (as triptans are Category C medications)\n* Psychiatric illness or cognitive difficulties that would interfere with participation in the study\n* Participated in the pilot development of the intervention evaluated by this research protocol.'}, 'identificationModule': {'nctId': 'NCT03706794', 'acronym': 'CDST', 'briefTitle': 'Clinical Decision Support for Patient Migraine Management', 'organization': {'class': 'OTHER', 'fullName': 'Albert Einstein College of Medicine'}, 'officialTitle': 'Clinical Decision Support for Patient Migraine Management', 'orgStudyIdInfo': {'id': '2015-5743'}, 'secondaryIdInfos': [{'id': '1K23NS096107-01', 'link': 'https://reporter.nih.gov/quickSearch/1K23NS096107-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Clinical Decision Support Tool', 'description': 'Tailored education provided via a smartphone application', 'interventionNames': ['Behavioral: Clinical Decision Support Tool']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Headache Education', 'description': 'Non-tailored education provided via a smartphone application.', 'interventionNames': ['Behavioral: Headache Education']}], 'interventions': [{'name': 'Clinical Decision Support Tool', 'type': 'BEHAVIORAL', 'description': 'Tailored education provided via a smartphone application.', 'armGroupLabels': ['Clinical Decision Support Tool']}, {'name': 'Headache Education', 'type': 'BEHAVIORAL', 'description': 'Non-tailored education provided via a smartphone application.', 'armGroupLabels': ['Headache Education']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10461', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Albert Einstein College of Medicine', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}], 'overallOfficials': [{'name': 'Elizabeth Seng, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Albert Einstein College of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Albert Einstein College of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Neurological Disorders and Stroke (NINDS)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Assistant Professor of Neurology', 'investigatorFullName': 'Elizabeth Seng', 'investigatorAffiliation': 'Albert Einstein College of Medicine'}}}}