Effect on the Quality of Life of a Therapeutic Education Program in Patients With Marfan Syndrome: an Observational, Prospective and Multicenter Study
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- quality of life of children and young adults with Marfan
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 7 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
quality of life of children and young adults with Marfan
时间窗: Base line
Answer to the question of PedsQL
quality of life of children and young adults with Marfan syndrome after therapeutic education program (ETP),
时间窗: 12 months
Answer to the question of PedsQL
次要结局
未报告次要终点