MYLIFE: Effect on the Quality of Life of a Therapeutic Education Program in Patients With Marfan Syndrome
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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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 Design
Arms and Interventions
Arm | Intervention/Treatment |
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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. |
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
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Outcome Measures
Primary Outcome Measures
- quality of life of children and young adults with Marfan [Base line]
Answer to the question of PedsQL
- quality of life of children and young adults with Marfan syndrome after therapeutic education program (ETP), [3 months]
Answer to the question of PedsQL
- quality of life of children and young adults with Marfan syndrome after therapeutic education program (ETP), [9 months]
Answer to the question of PedsQL
- quality of life of children and young adults with Marfan syndrome after therapeutic education program (ETP), [12 months]
Answer to the question of PedsQL
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patient aged between 7 and 25 years old with Marfan Syndrome or related according to Ghent criteria
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For minors, no oral opposition from the holders of parental authority and consent of the minor.
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For adults, no oral opposition collected
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Patient affiliated to a social security scheme or equivalent
Exclusion Criteria:
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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)
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Patient who has already participated in a TEP session for his pathology.
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Protected adult: patient under legal guardianship or curator protection
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | UHToulouse | Toulouse | France | 31000 |
Sponsors and Collaborators
- University Hospital, Toulouse
Investigators
- Principal Investigator: Yves DULAC, MD, University Hospital, Toulouse
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RC31/19/0505