Effect on the Quality of Life of a Therapeutic Education Program in Patients With Marfan Syndrome (MYLIFE)

Toulouse University Hospital

Status: Unknown

Conditions: Marfan Syndrome

Treatments: Other: Therapeutic Education Program

Study type: Observational

Funder types: Other

Identifiers

NCT04731493

RC31/19/0505

Details and patient eligibility

About

This is a before-after, observational, prospective, multicenter cohort study. The study will consist of 2 phases: an initial observational phase of a minimum of 3 months before the Therapeutic Education Program (TEP) intervention, then a phase of evolution analysis of at least 3 months.

Full description

During the first observational phase, the quality of life assessment will be carried out 3 months apart without intervention. The data obtained during this first phase will make it possible to characterize the functional impact in patients, to verify the reproducibility of our evaluations, and to evaluate the spontaneous evolution of the parameters over a period of 3 months.

During the second phase of evolution analysis, the quality of life will be assessed at 3 month intervals (M9, M12) after the therapeutic Education Program (M6). The comparison between the evolution during the two phases, before and after the TEP will allow us to assess the benefits of the TEP.

Enrollment: 60 estimated patients

Sex: All

Ages: 7 to 25 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient aged between 7 and 25 years old with Marfan Syndrome or related according to Ghent criteria
• For minors, no oral opposition from the holders of parental authority and consent of the minor.
• For adults, no oral opposition collected
• Patient affiliated to a social security scheme or equivalent

Exclusion criteria

• Inability of the patient to understand the content of the TEP sessions or the questionnaire about quality of life (non-French speaking, severe intellectual disability)
• Patient who has already participated in a TEP session for his pathology.
• Protected adult: patient under legal guardianship or curator protection

Trial design

60 participants in 1 patient group

therapeutic Education Program

Description:

individual and group sessions will be set up with educational workshops specialized by age group (child / adolescent / transition / adult / entourage / parents), socio-administrative workshops, etc. The objectives will be adapted to each age group and to each patient individually.

Treatment:

Other: Therapeutic Education Program