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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorUniversity Hospital, Lille

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

transgender people in medical transition

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Quality of life scores

Scores on the WHOQOL BREF (World Health Organisation Quality Of Life) scale

Time frame
3 years

Secondary outcomes

1

Social factors (age, gender, profession, knowledge of care system)

Answers given by the patient during interview

Time frame
Baseline and 6 months, 12 months, 18 months, 24 months, 30 months, 3 years and 5 years
2

Satisfaction of the shared medical decision

Scores on the CDIS (Clinical Decision-making Involvement and Satisfaction) clinical decision making involvement and satisfaction score 15 questions scored 1-5 (totally disagree, strongly disagree, neither agree nor disagree, strongly agree, totally agree)

Time frame
6 months, 12 months, 18 months, 24 months, 30 months, 3 years and 5 years
3

Satisfaction of body image

Score on the BIS (Body Image Scale), total score ranges from 0 to 30, A higher score means a higher level of body image disturbance

Time frame
6 months, 12 months, 18 months, 24 months, 30 months, 3 years and 5 years
4

General psychopathology

French version of Mini International Neuropsychiatric Interview (DSM)

Time frame
6 months, 12 months, 18 months, 24 months, 30 months, 3 years and 5 years

Other outcomes

Sponsors and contacts

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