Transgender PersonsNCT04448418
The Impact of COVID-19 Outbreak on Trans-population's Health in Italy
An observational study of Transgender Persons and Coronavirus, run by Unita Complessa di Ostetricia e Ginecologia at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Transgender Persons, Coronavirus, Coronavirus Infection
- What is being tested?
- web based survey
- How many people
- 111 participants
- Where
- 1 siteItaly
- Study dates
- 20 May 2020to 20 Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: transgender population
Who may be able to join
- transgender subjects
- age > 18 years
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
Italy1 site
1Gynecology and Physiopathology of Human Reproduction, S. Orsola-Malpighi Hospital, Department of Medical and Surgical Sciences (DIMEC), University of Bologna
Bologna, 40138
About this study
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
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.
Read the 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)
- Conditions
- Transgender Persons, Coronavirus, Coronavirus Infection, COVID, COVID-19
- Being tested
- web based survey
- Medical subject headings
- Coronavirus Infections, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
web based surveyOther
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)
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: through study completion, an average of 6 months
Secondary outcomes (4)
Evaluation of the satisfaction of this population with telemedicine for hormonal treatment monitoring
Use of a web based questionnaire to assess satisfaction with health care with a 0-10 scale (0=no satisfaction to 10=high satisfaction)
Measured: through study completion, an average of 6 months
Evaluation of the psychological wellbeing of the trans-population during COVID-19 outbreak in Italy
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.
Measured: 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
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.
Measured: 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
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.
Measured: through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2020
- Study start20 May 2020
- Primary completion20 Jun 2020
- Study completion20 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transgender PersonsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unita Complessa di Ostetricia e Ginecologia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, maria cristina meriggiola, Unita Complessa di Ostetricia e Ginecologia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04448418
- Sponsor's protocol ID
- TRANSCOVID-19
- Status last verified
- Apr 2021
- First submitted
- 1 Jun 2020
- Last updated
- 29 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04448418
- Acronym / sponsor ID
- TRANSCOVID-19
- Conditions
- Transgender Persons, Coronavirus, Coronavirus Infection, COVID, COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Unita Complessa di Ostetricia e GinecologiaUniversity, hospital or other
- Study start
- 20 May 2020 (actual)
- Primary completion
- 20 Jun 2020 (actual)
- Study completion
- 20 Jun 2020 (actual)
- First posted
- 25 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- transgender population
Key inclusion criteria (2 listed)
- transgender subjects
- age > 18 years
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| web based surveyAssess 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) | Other | – |
Primary outcome
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
4 secondary outcomes
Evaluation of the satisfaction of this population with telemedicine for hormonal treatment monitoring
Time frame: through study completion, an average of 6 months
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2021.
- Individual participant dataSharing planned: No
Related trials for Transgender Persons
Recruiting
The Trans-Led Care Study
Substance Abuse, Substance Addiction
RecruitingPhase 4
Enhancing PrEP Uptake and Retention Among Latine TGW and GBM in the South Using Long-Acting Injectable PrEP
HIV Prevention, HIV Pre-exposure Prophylaxis
Recruiting
Centering Gender Affirming Resources in Higher Education
Sexual Violence, Drinking Heavy
Active, not recruiting
Integrated Online-to-offline (O2O) Model of Care for HIV Prevention and Treatment Among Transgender Women (CINTAI)
HIV Prevention Program
Recruiting
Adapting and Pilot Testing a Skills-based Smoking Cessation Intervention to Address Developmental and Health-related Stress Among Adults Who Smoke
Smoking Cessation, Depression
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Transgender Persons and Coronavirus, run by Unita Complessa di Ostetricia e Ginecologia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2021.