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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
Sponsor:
Information provided by (Responsible Party):
maria cristina meriggiola, 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.


Condition or disease Intervention/treatment
Transgender Persons Coronavirus Coronavirus Infection COVID COVID-19 Other: web based survey

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)

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
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

Resource links provided by the National Library of Medicine



Intervention Details:
  • 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)


Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
transgender population
Criteria

Inclusion Criteria:

  • transgender subjects
  • age > 18 years

Exclusion Criteria:

- none


Information from the National Library of Medicine

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


Locations
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Italy
1Gynecology and Physiopathology of Human Reproduction, S. Orsola-Malpighi Hospital, Department of Medical and Surgical Sciences (DIMEC), University of Bologna
Bologna, Italy, 40138
Sponsors and Collaborators
Unita Complessa di Ostetricia e Ginecologia
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Responsible Party: maria cristina meriggiola, Professor, Unita Complessa di Ostetricia e Ginecologia
ClinicalTrials.gov Identifier: NCT04448418    
Other Study ID Numbers: TRANSCOVID-19
First Posted: June 25, 2020    Key Record Dates
Last Update Posted: August 11, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Coronavirus Infections
Severe Acute Respiratory Syndrome
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases