NCT04731493

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 60 (estimated)
• Sponsor: University Hospital, Toulouse · Academic / Other
• Sex: All
• Age: 7 Years – 25 Years
• Healthy volunteers: —

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.

Conditions

• Marfan Syndrome

Interventions

Type	Name	Description
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

Timeline

• Start date: 2020-12-02
• Primary completion: 2024-01-31
• Completion: 2024-01-31
• First posted: 2021-02-01
• Last updated: 2021-02-01

Locations

1 site across 1 country: France