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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

Tracking Information
First Submitted Date June 1, 2020
First Posted Date June 25, 2020
Last Update Posted Date August 11, 2020
Actual Study Start Date May 20, 2020
Actual Primary Completion Date June 20, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 24, 2020)
  • 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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: June 24, 2020)
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Impact of COVID-19 Outbreak on Trans-population's Health in Italy
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
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population transgender population
Condition
  • Transgender Persons
  • Coronavirus
  • Coronavirus Infection
  • COVID
  • COVID-19
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)
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: June 24, 2020)
300
Original Estimated Enrollment Same as current
Estimated Study Completion Date November 20, 2020
Actual Primary Completion Date June 20, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • transgender subjects
  • age > 18 years

Exclusion Criteria:

- none

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Italy
Removed Location Countries  
 
Administrative Information
NCT Number NCT04448418
Other Study ID Numbers TRANSCOVID-19
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party maria cristina meriggiola, Unita Complessa di Ostetricia e Ginecologia
Study Sponsor Unita Complessa di Ostetricia e Ginecologia
Collaborators Not Provided
Investigators Not Provided
PRS Account Unita Complessa di Ostetricia e Ginecologia
Verification Date August 2020