Ignite Creation Date:
2025-12-25 @ 4:45 AM
Ignite Modification Date:
2025-12-26 @ 3:47 AM
Study NCT ID:
NCT04448418
Status:
COMPLETED
Last Update Posted:
2021-04-29
First Post:
2020-06-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Impact of COVID-19 Outbreak on Trans-population's Health in Italy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 111}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-05-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2020-06-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-28', 'studyFirstSubmitDate': '2020-06-01', 'studyFirstSubmitQcDate': '2020-06-24', 'lastUpdatePostDateStruct': {'date': '2021-04-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of the specific health need of the transpopulation during the COVID-19 pandemic in Italy', 'timeFrame': 'through study completion, an average of 6 months', 'description': 'Evaluation of the specific health care needs of this population'}, {'measure': 'Assessment of risk factors for COVID-19 infection in the traspopulation', 'timeFrame': 'through study completion, an average of 6 months', 'description': 'Evaluation of socioeconomical and working condition of this population'}], 'secondaryOutcomes': [{'measure': 'Evaluation of the satisfaction of this population with telemedicine for hormonal treatment monitoring', 'timeFrame': 'through study completion, an average of 6 months', 'description': 'Use of a web based questionnaire to assess satisfaction with health care with a 0-10 scale (0=no satisfaction to 10=high satisfaction)'}, {'measure': 'Evaluation of the psychological wellbeing of the trans-population during COVID-19 outbreak in Italy', 'timeFrame': 'through study completion, an average of 6 months', 'description': "Use of web based validated questionnaire: Impact of Event Scale-Revised (in Italian) to investigate perception of the COVID-19 event and subjects' mood. The scale is a self-report measure of current subjective distress in response to a specific traumatic event. Minimum score=0, maximum score=60, higher scores correspond to a worse outcome."}, {'measure': 'Evaluation of the psychological and physical wellbeing of the trans-population during COVID-19 outbreak in Italy', 'timeFrame': 'through study completion, an average of 6 months', 'description': 'Use of web based validated questionnaire: Beck Depression Inventory to investigate mood. The 21 symptoms and attitudes contained in the questionnaire reflect the severity of the depression; the final score ranges from 0 to 63, with worse outcome with higher values.'}, {'measure': 'Evaluation of the psychological and physical wellbeing of the trans-population during COVID-19 outbreak in Italy', 'timeFrame': 'through study completion, an average of 6 months', 'description': "Use of web based validated questionnaire: Short Form 2, to assess the impact of health on an individual's everyday life. The SF-12 is made of an eight-scale profile of scores as well as physical and mental health summary measures. Total scores range from 16 to 47 with worse outcomes for lower scores."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Transgender Persons', 'Coronavirus', 'Coronavirus Infection', 'COVID', 'COVID-19']}, 'descriptionModule': {'briefSummary': 'During the COVID-19 outbreak, it was necessary to remodel the healthcare offer for all categories of subjects in order to minimize unnecessary movements of people while maintaining an adequate level of assistance. This is also true for transgender people, who are periodically requested to come into the clinic for hormonal therapy monitoring and continuation. In our center telemedicine programs dedicated to users have been activated for the remote management of hormone therapy.\n\nWe use a web-based survey to assess the impact of COVID-19 outbreak on trans-population health and to assess the specific needs of this population in this particular moment.', 'detailedDescription': 'Use of a dedicated web-based anonymous questionnaire to assess health needs of trans-population during COVID-19 outbreak and to assess specific risk factors for COVID-19 infection.\n\nEvaluation of physical and psychological wellbeing of the trans-population during COIVD-19 outbreak in Italy using anonymous validated questionnaires (SF12, IES-R and BECK DEPRESSION INVENTORY)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'transgender population', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* transgender subjects\n* age \\> 18 years\n\nExclusion Criteria:\n\n\\- none'}, 'identificationModule': {'nctId': 'NCT04448418', 'briefTitle': "The Impact of COVID-19 Outbreak on Trans-population's Health in Italy", 'organization': {'class': 'OTHER', 'fullName': 'Unita Complessa di Ostetricia e Ginecologia'}, 'officialTitle': "Observational Evaluation of the Impact of COVID-19 Outbreak on Transgender Subject's Health and on the Organization of Trans-population Health Care Services", 'orgStudyIdInfo': {'id': 'TRANSCOVID-19'}}, 'armsInterventionsModule': {'interventions': [{'name': 'web based survey', 'type': 'OTHER', 'description': 'Assess specific health care needs for the transpopulation during the COVID-19 outbreack using a newly created questionnaire and some validated questionnaries (Impact of Event Scale-Revised, BECK Depression Inventory and the Self-rated Health SF-12)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '40138', 'city': 'Bologna', 'country': 'Italy', 'facility': '1Gynecology and Physiopathology of Human Reproduction, S. Orsola-Malpighi Hospital, Department of Medical and Surgical Sciences (DIMEC), University of Bologna', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Unita Complessa di Ostetricia e Ginecologia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'maria cristina meriggiola', 'investigatorAffiliation': 'Unita Complessa di Ostetricia e Ginecologia'}}}}