Marfan Syndrome: the Impact on the Quality of Life, Phenotypic Manifestations on Self-image and Self-management Skills, as an Index of Adaptation to the Disease in Pediatric Patients
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Psychological counseling
研究概览
简要总结
The goal of this observational study is to learn about the impact of Marfan syndrome (MFS) in paediatric affected subjects. the main questions it aims to answer are:
- The assessment of quality of life in MFS Italian patients;
- The impact of phenotypic manifestations on self-image and self-management skills;
- Stratify patients according to the need of psychological support. Participants will take part in the study by completing four self-report questionnaires.
详细描述
In literature, adolescents with MFS experience difficulty in connecting with peers, and are convinced that they would have been more physically attractive without the disease. Additionally, due to physical activity restrictions and orthopedic limitations, these patients reported having difficulty adjusting and participating in educational events.
Data from present study will be able to support clinicians in identifying patients who need psychological support (through parental counseling interviews) aimed at increasing compliance with treatments and adaptation to the disease.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent;
- •MFS diagnosis according to Revised Ghent criteria (2010);
排除标准
- •Known cognitive deficits
结局指标
主要结局
Psychological counseling
时间窗: 12 months
Questionnaire to assess psychological support is KINDL-R (Quality of life);
次要结局
未报告次要终点
研究者
Alessandro Pini
Principal Investigator
IRCCS Policlinico S. Donato