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OpenTrials
Completed

NCT Number: NCT04448418

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

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.

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Key information

Conditions

Transgender Persons COVID COVID-19 Coronaviridae Infections Coronavirus Coronavirus Infection Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Bologna, 40138, Italy

About this study

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)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • transgender subjects
  • age > 18 years

Exclusion criteria

  • none

Treatment and study plan

Web Based Survey

Other

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)

Primary outcomes

  1. Assessment of the specific health need of the transpopulation during the COVID-19 pandemic in Italy

    Time frame: through study completion, an average of 6 months

    Evaluation of the specific health care needs of this population

  2. Assessment of risk factors for COVID-19 infection in the traspopulation

    Time frame: through study completion, an average of 6 months

    Evaluation of socioeconomical and working condition of this population

Secondary outcomes

  1. Evaluation of the satisfaction of this population with telemedicine for hormonal treatment monitoring

    Time frame: 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)

  2. Evaluation of the psychological wellbeing of the trans-population during COVID-19 outbreak in Italy

    Time frame: 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.

  3. Evaluation of the psychological and physical wellbeing of the trans-population during COVID-19 outbreak in Italy

    Time frame: through study completion, an average of 6 months

    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.

  4. Evaluation of the psychological and physical wellbeing of the trans-population during COVID-19 outbreak in Italy

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Unita Complessa di Ostetricia e Ginecologia

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jun 25, 2020
Registry last updated
Apr 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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