Quality of Life of Transgender People - Implementation and Monitoring of an Online Cohort (e-QoL-Trans) (e-QoL-Trans)

February 27, 2023 updated by: Ramsay Générale de Santé

Quality of Life of Transgender People - Implementation and Monitoring of an Online Cohort

Transgender people have an identity or an expression gender that differs from the sex assigned to them at the birth. Transgender people and their needs remain misunderstood, and more generally by society. THE transgender populations express poor quality of life compared to the general population. However, very few of studies are interested in these people, in their diversity of paths, trajectories and characteristics of life. More of research is needed to study the quality of life, understand the experiences, in their diversity and in the health, social and life trajectories. Researches must be carried out, in particular on how to interrogate by the seeks out transgender people, in order to prevent stigmatization within population studies.

The main objective of this study is to assess the quality of life of people transgender people during their life trajectory and their transition path, based on validated questionnaires scientifically in French, for major themes of the population concerned (quality of life, social support perceived).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Transgender people, whether they have transitioned or not, with or without reassignment surgery.

Description

Inclusion Criteria:

  • Transgender people (having a gender identity or expression that differs from the sex assigned to them at birth);

  • People with any of the following characteristics regarding their trans identity:

    • Consultant in one of the transgender reference centers and services for questions/information on the transition;
    • Integrated or having completed a course of care with or without gender reassignment surgery;
    • Not integrated into a health or care pathway.
  • French-speaking people;
  • Adults;
  • People able to use the tools digital;
  • People with Internet or 4G access (total or limited)

Exclusion Criteria:

  • People who do not identify as transgender;
  • Non-French speaking people;
  • Minors
  • People who do not know how to handle the tools digital data collection;
  • People without Internet access.
  • Non-French speaking people, unable to speak understand the research questions
  • Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by court order or administrative

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Transgender people
Whether they have transitioned or not, with or without reassignment surgery.
Other: Questionnaire quality of life

Quantitative - Validated online self-questionnaires scientifically to assess quality of life and support perceived social. Items created for the study concerning socio-demographic characteristics and satisfaction of health services concerning the accompaniment of the transidentity.

Qualitative - Semi-structured interviews based on a guide maintenance.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life estimated with a validated questionnaire administered over the Internet repeatedly every three months.
Time Frame: 3 months
Quality of life estimated with a validated questionnaire administered over the Internet repeatedly every three months.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ramsay Générale de Santé

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 21, 2023

Primary Completion (Anticipated)

August 21, 2025

Study Completion (Anticipated)

February 21, 2026

Study Registration Dates

First Submitted

February 27, 2023

First Submitted That Met QC Criteria

February 27, 2023

First Posted (Estimate)

March 9, 2023

Study Record Updates

Last Update Posted (Estimate)

March 9, 2023

Last Update Submitted That Met QC Criteria

February 27, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 2021-A03156-35

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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