Evaluation of the Variation in Quality of Life During Medical Transition According Different Modalities of Supported Care for Transgender People.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 400
- 试验地点
- 13
- 主要终点
- Quality of life scores
研究概览
简要总结
Transgender people can benefit from psychological, psychiatric, endocrinological support, sexual reassignment surgery, sexology support and dermatological care. The value of transitional care courses is scientifically recognized. Currently, the modalities of decision and realization of the care paths are heterogeneous on the territory, little standardized, and are the subject of debates between representatives of users and medical teams.
The french national report of IGAS from 2011 warns of the need to argue and legitimize care practices through more numerous, more exhaustive scientific studies, presenting a better level of evidence
Since 2011, no prospective study has been carried out on the national and international level, making it possible to assess the relevance of the planned care modalities. This research project, conducted over five consecutive years at the first contact of a transgender people with a care device, aims to correlate a variation in the quality of life of people with the characteristics of the care methods provided. This is a first proposal to assess care practices for transgender people. The results of this study would first allow us to infer the care modalities most suited to the needs of people. Secondly, secondary hypotheses could support new experimental protocols.
详细描述
This research is a prospective multicenter cohort study with a 3-year and 5-year follow-up of transgender people in medical transition.
Main aim:
Evaluate the evolution of the quality of life during five years in transgender people who benefit from transition support cares.
Secondary objectives:
Secondary objective n°1 :
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •With a diagnosis of Gender Dysphoria according to DSM5 diagnostic criteria
- •Wishing to benefit from supportive care for their transition trajectory and addressing a care system represented by the collaborating centers participating in the study,
- •Willing to comply with all study procedures and duration,
- •Understanding and able to speak French.
排除标准
- •Minor or adult under curatorship, under judicial protection, persons deprived of their liberty
- •Refusal to participate after clear and fair information from the study
- •Person with sexual reassignment surgery or with cross hormon therapy since two years.
结局指标
主要结局
Quality of life scores
时间窗: 3 years
Scores on the WHOQOL BREF (World Health Organisation Quality Of Life) scale
次要结局
- Social factors (age, gender, profession, knowledge of care system)(Baseline and 6 months, 12 months, 18 months, 24 months, 30 months, 3 years and 5 years)
- Satisfaction of the shared medical decision(6 months, 12 months, 18 months, 24 months, 30 months, 3 years and 5 years)
- General psychopathology(6 months, 12 months, 18 months, 24 months, 30 months, 3 years and 5 years)
- Anxiety and depression(6 months, 12 months, 18 months, 24 months, 30 months, 3 years and 5 years)
- Satisfaction of body image(6 months, 12 months, 18 months, 24 months, 30 months, 3 years and 5 years)
- Quality of life scores(6 months, 12 months, 18 months, 24 months, 30 months, 5 years)