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

COVID-19 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04448418
• Other study ID #: TRANSCOVID-19
• Status: Completed
• Start date: May 20, 2020
• Est. completion date: June 20, 2020

Study information

• Verified date: April 2021
• Source: Unita Complessa di Ostetricia e Ginecologia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 111
• Est. completion date: June 20, 2020
• Est. primary completion date: June 20, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• transgender subjects

• age > 18 years

Exclusion Criteria:

• none

Related Conditions & MeSH terms

• Coronavirus
• Coronavirus Infection
• Coronavirus Infections
• COVID
• COVID-19
• Transgender Persons

Intervention

Other:
• web based survey
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)

Locations

Country	Name	City	State
Italy	1Gynecology and Physiopathology of Human Reproduction, S. Orsola-Malpighi Hospital, Department of Medical and Surgical Sciences (DIMEC), University of Bologna	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
Unita Complessa di Ostetricia e Ginecologia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of the specific health need of the transpopulation during the COVID-19 pandemic in Italy	Evaluation of the specific health care needs of this population	through study completion, an average of 6 months
Primary	Assessment of risk factors for COVID-19 infection in the traspopulation	Evaluation of socioeconomical and working condition of this population	through study completion, an average of 6 months
Secondary	Evaluation of the satisfaction of this population with telemedicine for hormonal treatment monitoring	Use of a web based questionnaire to assess satisfaction with health care with a 0-10 scale (0=no satisfaction to 10=high satisfaction)	through study completion, an average of 6 months
Secondary	Evaluation of the psychological wellbeing of the trans-population during COVID-19 outbreak in Italy	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.	through study completion, an average of 6 months
Secondary	Evaluation of the psychological and physical wellbeing of the trans-population during COVID-19 outbreak in Italy	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.	through study completion, an average of 6 months
Secondary	Evaluation of the psychological and physical wellbeing of the trans-population during COVID-19 outbreak in Italy	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.	through study completion, an average of 6 months