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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-12-02

Study Completion Date

2024-01-31

Brief Summary

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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.

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Detailed Description

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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

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Marfan Syndrome

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Therapeutic Education Program

Intervention Type OTHER

* 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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

7 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No