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

Marfan Syndrome Clinical Trial

— MYLIFE  

Official title:

Effect on the Quality of Life of a Therapeutic Education Program in Patients With Marfan Syndrome: an Observational, Prospective and Multicenter Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04731493
• Other study ID #: RC31/19/0505
• Status: Active, not recruiting
• Start date: December 2, 2020
• Est. completion date: January 31, 2024

Study information

• Verified date: January 2021
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: January 31, 2024
• Est. primary completion date: January 31, 2024
• Gender: All
• Age group: 7 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Marfan Syndrome
• Syndrome

Intervention

Other:
• Therapeutic Education Program
needs assessment educational group workshop specialized workshops by age group: child / adolescent / transition / adult / entourage / separated parents and in parallel socio-administrative workshop individual summary (accompanied or not by his entourage / family) satisfaction questionnaire

Locations

Country	Name	City	State
France	UHToulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	quality of life of children and young adults with Marfan	Answer to the question of PedsQL	Base line
Primary	quality of life of children and young adults with Marfan syndrome after therapeutic education program (ETP),	Answer to the question of PedsQL	3 months
Primary	quality of life of children and young adults with Marfan syndrome after therapeutic education program (ETP),	Answer to the question of PedsQL	9 months
Primary	quality of life of children and young adults with Marfan syndrome after therapeutic education program (ETP),	Answer to the question of PedsQL	12 months