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The Impact of COVID-19 Outbreak on Trans-population's Health in Italy

Observational Evaluation of the Impact of COVID-19 Outbreak on Transgender Subject's Health and on the Organization of Trans-population Health Care Services

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04448418
Enrollment
111
Registered
2020-06-25
Start date
2020-05-20
Completion date
2020-06-20
Last updated
2021-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronavirus, Coronavirus Infection, COVID, COVID-19, Transgender Persons

Brief summary

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. We 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.

Detailed description

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. Evaluation 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)

Interventions

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)

Sponsors

Unita Complessa di Ostetricia e Ginecologia
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes

Inclusion criteria

* transgender subjects * age \> 18 years

Exclusion criteria

\- none

Design outcomes

Primary

MeasureTime frameDescription
Assessment of the specific health need of the transpopulation during the COVID-19 pandemic in Italythrough study completion, an average of 6 monthsEvaluation of the specific health care needs of this population
Assessment of risk factors for COVID-19 infection in the traspopulationthrough study completion, an average of 6 monthsEvaluation of socioeconomical and working condition of this population

Secondary

MeasureTime frameDescription
Evaluation of the satisfaction of this population with telemedicine for hormonal treatment monitoringthrough study completion, an average of 6 monthsUse of a web based questionnaire to assess satisfaction with health care with a 0-10 scale (0=no satisfaction to 10=high satisfaction)
Evaluation of the psychological wellbeing of the trans-population during COVID-19 outbreak in Italythrough study completion, an average of 6 monthsUse 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.
Evaluation of the psychological and physical wellbeing of the trans-population during COVID-19 outbreak in Italythrough study completion, an average of 6 monthsUse 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.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026