Cohort Study on Factors Associated with the Evolution of Quality of Life Among Transgender Individuals in the French Population
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,500
- 试验地点
- 1
- 主要终点
- Change in quality of life (WHOQOL-BREF) between 0 and 12 months.
研究概览
简要总结
This research focuses on identifying medical, social, and healthcare journey determinants associated with the evolution of quality of life in the transgender population at 12 months. To address the research question, it is planned to include 1,500 transgender individuals, among those attending healthcare professionals or associations in the French territory who have agreed to take on the role of investigators (professionals in healthcare or designated individuals within an association).
详细描述
Information Note:
- What is the purpose of this research? This research focuses on identifying medical, social, and healthcare journey determinants associated with the evolution of quality of life in the transgender population at 12 months. To address the research question, it is planned to include 1,500 transgender individuals, among those attending healthcare professionals or associations in the French territory who have agreed to take on the role of investigators (professionals in healthcare or designated individuals within an association).
- What does the research involve? In the proposed research, the investigators will assess quality of life through a standardized questionnaire. The investigators will analyse this quality of life in relation to various collected data concerning participants social context, medical data, mental health, transition journey, isolation and violence, as well as participants use of psychoactive substances.
In the framework of this research, an initial questionnaire will be administered at time T0, during participants appointment (either via video call or in person) with a health mediator. A second questionnaire will be administered 6 months later during a second appointment (via video call or in person) with a health mediator. Finally, a third and final questionnaire will be administered 12 months after T0 during a final appointment (via video call or in person) with a health mediator. The aim of these various questionnaires is to assess the evolution of quality of life over a period of 12 months. Each questionnaire will take a maximum of 40 minutes to complete. 3. What is the research timeline? The expected duration of the research is 2 years, and the participation will be for 12 months. If person agree to participate in this research, the course of the research will be as follows: A health mediator will schedule a video (or if impossible, in-person) interview with participant. Health mediators are professionals whose role is dedicated to reducing social health inequalities. They create interfaces between various stakeholders in the healthcare system and individuals facing challenges in their healthcare and prevention journeys due to various vulnerabilities. The goal is to assist these individuals in engaging with and successfully navigating these pathways, while considering their living environment. The first questionnaire will then be completed: some sections will be filled out by participants, while other questions will be asked directly by the health mediator. The health mediator will contact participants subsequently to arrange the 6-month and 12-month interviews, which will proceed in the same manner.
The maximum time between the presentation of the information note and the contact by the health mediator is 1 month. 4. What are the benefits of participation? By participating in this research, participants will contribute to a better understanding of the factors associated with the evolution of quality of life in transgender individuals. Moreover, participation in the 3 questionnaires (0, 6 months, 12 months) will entitle participant to receive a gift card worth €20 as a token of appreciation for participation.
If there is a need to travel to complete the questionnaires in person, the travel expenses will be covered by the sponsor. 5. How will the collected data be processed for the research? As part of the research in which participants are invited to participate, processing of personal data will be carried out by CNGE Conseil, the research sponsor and data controller, to analyse the results.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Person identifying themselves as trans
- •Person of legal age (≥ 18 years)
- •Person living in France
- •Person who has not expressed any opposition after receiving full information about the protocol
- •Person who understands and speaks French, or who is an allophone speaking English, Spanish or Portuguese
排除标准
- •People who do not understand or speak French, English, Spanish or Portuguese.
- •Person under guardianship or curatorship, under legal protection or under safeguard of justice
- •Anyone who has expressed their opposition after receiving full information about the protocol.
结局指标
主要结局
Change in quality of life (WHOQOL-BREF) between 0 and 12 months.
时间窗: From enrollment to the last questionnaire at 12 months
Differences in the WHOQOL-BREF between 0 and 12 months. The WHOQOL-BREF (World Health Organization Quality Of Life tool) consists of four dimensions: physical health, psychological health, social relationships and environment, with scores ranging from 0 to 100. A higher score denotes a higher quality of life.
次要结局
- Quality of life (WHOQOL-BREF) at baseline and 6 months(Baseline and 6 months)
- Change in quality of life (WHOQOL-BREF) between 0 and 6 months.(From baseline to 6 months)
- Mental health at baseline(Baseline)
- Sexual health at baseline(Baseline)
- Addictions at baseline(Baseline)
- Screenings at baseline(Baseline)
- Iatrogeny at baseline(Baseline)
- Comorbidities at baseline(Baseline)
- Violence experienced at baseline(Baseline)
- Transition modalities(At baseline, 6 months and 12 months)
- Healthcare pathway(At baseline, 6 months and 12 months)
- Self-medication(At baseline, 6 months and 12 months)
