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

Completed

• Conditions: Transgender Persons; Coronavirus; COVID-19; Coronavirus Infection; COVID

• Registration Number: NCT04448418
• Lead Sponsor: Unita Complessa di Ostetricia e Ginecologia

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)

Study Timeline

• Study Start: 2020-05-20
• Study First Submitted: 2020-06-01
• Primary Completion: 2020-06-20
• Study Completion: 2020-06-20
• Study First Submitted QC: 2020-06-24
• Study First Posted: 2020-06-25
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-28
• Last Update Posted: 2021-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 111

Inclusion Criteria

• transgender subjects
• age > 18 years

Exclusion Criteria

• none

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assessment of the specific health need of the transpopulation during the COVID-19 pandemic in Italy	through study completion, an average of 6 months	Evaluation of the specific health care needs of this population
Assessment of risk factors for COVID-19 infection in the traspopulation	through study completion, an average of 6 months	Evaluation of socioeconomical and working condition of this population

Secondary Outcome Measures

Name	Time	Method
Evaluation of the satisfaction of this population with telemedicine for hormonal treatment monitoring	through study completion, an average of 6 months	Use 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 Italy	through study completion, an average of 6 months	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.
Evaluation of the psychological and physical wellbeing of the trans-population during COVID-19 outbreak in Italy	through study completion, an average of 6 months	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.

Trial Locations

Locations (1)

1Gynecology and Physiopathology of Human Reproduction, S. Orsola-Malpighi Hospital, Department of Medical and Surgical Sciences (DIMEC), University of Bologna; 🇮🇹 Bologna, Italy