Clinical trial NCT04448418: The Impact of COVID-19 Outbreak on Trans-population's Health in Italy
Official title: Observational Evaluation of the Impact of COVID-19 Outbreak on Transgender Subject's Health and on the Organization of Trans-population Health Care Services
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Transgender Persons
Coronavirus
Coronavirus Infection
COVID
COVID-19
Lead sponsor: Unita Complessa di Ostetricia e Ginecologia
Sponsor class: OTHER
First posted: 2020-06-25
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: transgender population

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)

Eligibility criteria: Inclusion Criteria:

* transgender subjects
* age \> 18 years

Exclusion Criteria:

- none

Primary outcomes:
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
measure: Assessment of risk factors for COVID-19 infection in the traspopulation
timeFrame: through study completion, an average of 6 months
Secondary outcomes:
measure: Evaluation of the satisfaction of this population with telemedicine for hormonal treatment monitoring
timeFrame: through study completion, an average of 6 months
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
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
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
Other outcomes:
Locations:
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
Study officials:
References: