NCT04448418

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
111

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 20, 2020

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

June 1, 2020

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 25, 2020

Completed
Last Updated

April 29, 2021

Status Verified

April 1, 2021

Enrollment Period

1 month

First QC Date

June 1, 2020

Last Update Submit

April 28, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (4)

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

    through study completion, an average of 6 months

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

    through study completion, an average of 6 months

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

    through study completion, an average of 6 months

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

    through study completion, an average of 6 months

Interventions

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)

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

transgender population

You may qualify if:

  • transgender subjects
  • age \> 18 years

You may not qualify if:

  • \- none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Bologna, 40138, Italy

Location

MeSH Terms

Conditions

Coronavirus InfectionsCOVID-19

Condition Hierarchy (Ancestors)

Coronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesInfectionsPneumonia, ViralPneumoniaRespiratory Tract InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 1, 2020

First Posted

June 25, 2020

Study Start

May 20, 2020

Primary Completion

June 20, 2020

Study Completion

June 20, 2020

Last Updated

April 29, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations