Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2025-12-26 @ 3:10 AM
Study NCT ID:
NCT05087420
Status:
COMPLETED
Last Update Posted:
2022-05-04
First Post:
2021-09-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Migraine in Poland - a Web-based Cross-sectional Survey
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008881', 'term': 'Migraine Disorders'}, {'id': 'D006261', 'term': 'Headache'}, {'id': 'D000096825', 'term': 'Rhinosinusitis'}, {'id': 'D000086382', 'term': 'COVID-19'}], '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'}, {'id': 'D012220', 'term': 'Rhinitis'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D012852', 'term': 'Sinusitis'}, {'id': 'D010254', 'term': 'Paranasal Sinus Diseases'}, {'id': 'D009668', 'term': 'Nose Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2800}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2022-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-03', 'studyFirstSubmitDate': '2021-09-19', 'studyFirstSubmitQcDate': '2021-10-09', 'lastUpdatePostDateStruct': {'date': '2022-05-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Headache phenotype', 'timeFrame': 'in the preceding year', 'description': 'Classification of reported headache according to International Classification of Headache Disorders'}, {'measure': 'Migraine burden', 'timeFrame': 'in the preceding year', 'description': 'Consequences of the disease measured by the Migraine Disability Assessment Test'}], 'secondaryOutcomes': [{'measure': 'Monthly headache days', 'timeFrame': 'in the preceding month', 'description': 'Number of days per month'}, {'measure': 'Monthly headache days', 'timeFrame': 'in the preceding year', 'description': 'Number of days per year'}, {'measure': 'Time from last headache professional consultation', 'timeFrame': 'in the preceding 10 years', 'description': 'Number of months'}, {'measure': 'Migraine diagnosed by headache professional', 'timeFrame': 'in the preceding 10 years', 'description': 'yes/no'}, {'measure': 'Age at diagnosis', 'timeFrame': 'from the onset of headache (time frame up to 99 years)', 'description': 'years'}, {'measure': 'Comoribidities', 'timeFrame': 'in the preceding year', 'description': 'Disease according to International Classsification of Disease 10'}, {'measure': 'Type of previous headache professional consultation', 'timeFrame': 'in the preceding 10 years', 'description': 'Name of headache profession/speciality'}, {'measure': 'Number of consultations in the last year', 'timeFrame': 'in the last 12 months', 'description': 'Number 0-100'}, {'measure': 'Number of consultations in the last year because of headaches', 'timeFrame': 'in the last 12 months', 'description': 'Number 0-100'}, {'measure': 'Number of days spent in hospital in the last year because of headaches', 'timeFrame': 'in the last 12 months', 'description': 'Number 0-100'}, {'measure': 'Acute treatment used', 'timeFrame': 'in the preceding 10 years', 'description': 'Name of abortive medication'}, {'measure': 'Preventive treatment used', 'timeFrame': 'in the preceding 10 years', 'description': 'Name of abortive medication'}, {'measure': 'Acute treatment frequency', 'timeFrame': 'in the last 3 months', 'description': 'Number of days per month'}, {'measure': 'Preventive treatment frequency', 'timeFrame': 'in the last 12 months', 'description': 'Number of months form the last dose'}, {'measure': 'Preventive treatment effectiveness', 'timeFrame': 'in the last 12 months', 'description': 'Likert scale'}, {'measure': 'Employment', 'timeFrame': 'in the last 12 months', 'description': 'Type of employment'}, {'measure': 'Time spent at work', 'timeFrame': 'in the last 12 months', 'description': 'Number of hours per week'}, {'measure': 'Work absence due to headache', 'timeFrame': 'in the last month', 'description': 'Number of days per month'}, {'measure': 'Presenteeism', 'timeFrame': 'in the last month', 'description': 'Number of days per month'}, {'measure': 'PHQ-9 Patient Health Questionnaire', 'timeFrame': 'in the last 2 weeks', 'description': 'Number'}, {'measure': 'Sinus headache', 'timeFrame': 'in the last 3 months', 'description': 'Number of days'}, {'measure': 'Sinonasal symptoms accompanying headache', 'timeFrame': 'in the last 12 months', 'description': 'Type of symptoms'}, {'measure': 'Sinonasal symptoms not associated with headache', 'timeFrame': 'in the last 12 months', 'description': 'Type of symptom'}, {'measure': 'COVID-19 association with headache', 'timeFrame': 'in the last 2 years', 'description': 'Likert scale'}, {'measure': 'COVID-19 vaccine association with headache', 'timeFrame': 'in the last year', 'description': 'Likert scale'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['migraine', 'headache', 'rhinosinusitis', 'COVID-19'], 'conditions': ['Migraine']}, 'referencesModule': {'references': [{'pmid': '38652923', 'type': 'DERIVED', 'citation': 'Straburzynski M, Waliszewska-Prosol M, Nowaczewska M, Czapinska-Ciepiela EK, Gryglas-Dworak A, Budrewicz S. Prevalence of cranial autonomic symptoms in frequent episodic tension-type headache: A post hoc analysis of the cross-sectional Migraine in Poland study. Dent Med Probl. 2024 Jul-Aug;61(4):489-493. doi: 10.17219/dmp/175611.'}]}, 'descriptionModule': {'briefSummary': 'A survey of Polish respondents will aim to define migraine characteristics in Polish subjects. To achieve this, a structured questionnaire based mainly on American Migraine Prevalence and Prevention Study has been prepared to serve as a tool for data extraction. The obtained data should allow for defining disease parameters, burden and received treatments. Additionally questions regarding patients rhinological symptoms and COVID-19-related history were included.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participant will be recruited from miscellaneous sources including: specialist headache practices, primary care clinics, patients associations. An invitation would be also extended via social and traditional media and employers.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* consent to participate in the study\n\nExclusion Criteria:\n\n* responses missing in questionnaire'}, 'identificationModule': {'nctId': 'NCT05087420', 'acronym': 'MIGinPOL2021', 'briefTitle': 'Migraine in Poland - a Web-based Cross-sectional Survey', 'organization': {'class': 'OTHER', 'fullName': 'Swiat Zdrowia'}, 'officialTitle': 'Migraine in Poland - a Web-based Cross-sectional Survey', 'orgStudyIdInfo': {'id': 'MIGinPOL2021'}}, 'contactsLocationsModule': {'locations': [{'zip': '12-120', 'city': 'Dźwierzuty', 'state': 'Warmian-Masurian Voivodeship', 'country': 'Poland', 'facility': 'Marcin Straburzyński', 'geoPoint': {'lat': 53.70494, 'lon': 20.96037}}, {'city': 'Wroclaw', 'country': 'Poland', 'facility': 'Department of Neurology, Wrocław Medical University', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}], 'overallOfficials': [{'name': 'Marta Waliszewska-Prosół, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Departament of Neurolog, Wrocław Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Swiat Zdrowia', 'class': 'OTHER'}, 'collaborators': [{'name': 'Wroclaw Medical University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'General practitioner', 'investigatorFullName': 'Marcin Straburzynski', 'investigatorAffiliation': 'Swiat Zdrowia'}}}}