Evaluation of the Variation in Quality of Life During Medical Transition for Transgender People.

Официальное название

Evaluation of the Variation in Quality of Life During Medical Transition According Different Modalities of Supported Care for Transgender People.

Обзор

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.

Подробное описание

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 :

Identify the different factors that influence the evolution of quality of life evaluated over three years in transgender people who benefit from transition support cares.

Secondary objective n°2 :

Evaluate the evolution of the satisfaction of the shared medical decision for transgender people in medical transition.

Secondary objective n°3 :

Evaluate the evolution of the satisfaction of body image for transgender people in medical transition.

Secondary objective n°4 :

Evaluate the evolution of psychiatric comorbidities for transgender people in medical transition.

Secondary objective n°5 :

Evaluate the benefits and limits in long term (five years) on the quality of life, the satisfaction of the shared medical decision, the satisfaction of body image and the evolution of psychiatric comorbidities.

Первичные конечные точки

• Quality of life scores [Срок оценки: 3 years]

Вторичные конечные точки (6)

• Social factors (age, gender, profession, knowledge of care system) [Срок оценки: Baseline and 6 months, 12 months, 18 months, 24 months, 30 months, 3 years and 5 years]
• Satisfaction of the shared medical decision [Срок оценки: 6 months, 12 months, 18 months, 24 months, 30 months, 3 years and 5 years]
• Satisfaction of body image [Срок оценки: 6 months, 12 months, 18 months, 24 months, 30 months, 3 years and 5 years]
• General psychopathology [Срок оценки: 6 months, 12 months, 18 months, 24 months, 30 months, 3 years and 5 years]
• Anxiety and depression [Срок оценки: 6 months, 12 months, 18 months, 24 months, 30 months, 3 years and 5 years]
• Quality of life scores [Срок оценки: 6 months, 12 months, 18 months, 24 months, 30 months, 5 years]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Франция · 13 центров

• Centre Hospitalier de Béziers — Béziers
• CHU de Bordeaux — Bordeaux
• CHU de Brest — Brest
• CHU de Caen — Caen
• CHU de Lille — Lille
• Maison de Santé Lille Moulins — Lille
• Maison de Santé Lille Sud — Lille
• CHU de Lyon — Lyon
• … и ещё 5 центров

Идентификаторы

NCT: NCT05273112 · 2020_09 · 2021-A00154-37 · PREPS-19-0078

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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