The Impact of COVID-19 Outbreak on Trans-population's Health in Italy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04448418|
Recruitment Status : Active, not recruiting
First Posted : June 25, 2020
Last Update Posted : August 11, 2020
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.
|Condition or disease||Intervention/treatment|
|Transgender Persons Coronavirus Coronavirus Infection COVID COVID-19||Other: web based survey|
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 Type :||Observational|
|Estimated Enrollment :||300 participants|
|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|
|Actual Study Start Date :||May 20, 2020|
|Actual Primary Completion Date :||June 20, 2020|
|Estimated Study Completion Date :||November 20, 2020|
- 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)
- 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
- 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
- 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)
- 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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04448418
|1Gynecology and Physiopathology of Human Reproduction, S. Orsola-Malpighi Hospital, Department of Medical and Surgical Sciences (DIMEC), University of Bologna|
|Bologna, Italy, 40138|