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

• Conditions: Marfan Syndrome
• Interventions: Other: Therapeutic Education Program

• Registration Number: NCT04731493
• Lead Sponsor: University Hospital, Toulouse

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2020-12-02
• Study First Submitted: 2020-12-03
• Status Verified: 2021-01
• Study First Submitted QC: 2021-01-28
• Last Update Submitted: 2021-01-28
• Study First Posted: 2021-02-01
• Last Update Posted: 2021-02-01
• Primary Completion: 2024-01-31
• Study Completion: 2024-01-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
therapeutic Education Program	Therapeutic Education Program	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.

Primary Outcome Measures

Name	Time	Method
quality of life of children and young adults with Marfan syndrome after therapeutic education program (ETP),	12 months	Answer to the question of PedsQL
quality of life of children and young adults with Marfan	Base line	Answer to the question of PedsQL

Trial Locations

Locations (1)

UHToulouse; 🇫🇷 Toulouse, France