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

Sponsor
Ramsay Générale de Santé (Other)
Overall Status
Recruiting
CT.gov ID
NCT05761678
Collaborator
(none)
500
1
36
13.9

Study Details

Study Description

Brief Summary

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).

Condition or Disease Intervention/Treatment Phase
  • Other: Questionnaire quality of life

Study Design

Study Type:
Observational
Anticipated Enrollment :
500 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Quality of Life of Transgender People - Implementation and Monitoring of an Online Cohort
Actual Study Start Date :
Feb 21, 2023
Anticipated Primary Completion Date :
Aug 21, 2025
Anticipated Study Completion Date :
Feb 21, 2026

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Quality of life estimated with a validated questionnaire administered over the Internet repeatedly every three months. [3 months]

    Quality of life estimated with a validated questionnaire administered over the Internet repeatedly every three months.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hôpital privé Jean Mermoz Lyon France 69008

Sponsors and Collaborators

  • Ramsay Générale de Santé

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ramsay Générale de Santé
ClinicalTrials.gov Identifier:
NCT05761678
Other Study ID Numbers:
  • 2021-A03156-35
First Posted:
Mar 9, 2023
Last Update Posted:
Mar 9, 2023
Last Verified:
Feb 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Mar 9, 2023