Transition From Adolescents to Adulthood for Patients With Congenital Patients With Congenital Heart Diseases: Impact of a Therapeutic Education Program on Quality of Life
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- PedsQL 4.0 score
研究概览
简要总结
The Investigators aim to measure the impact of a transition program in congenital cardiology in terms of health-related quality of life.
详细描述
The number of adults with congenital heart diseases (CHD) is increasing. However, many young adults are lost to follow-up even in experienced tertiary care centers. American and European guidelines recommend to improve the management of young adults with CHD. Structured therapeutic education programs are therefore needed to optimize the transfer to adult healthcare. Our tertiary care CHD center recently implemented a transition program and simultaneously investigators decided to measure its impact. Indeed investigators need data from randomized trials in this filed. After previous controlled quality of life studies among children and adults with CHD, investigators chose to use the health-related quality of life (HR-QoL) as primary endpoint in this randomized study to focus on patient related outcomes.
The investigators assume that patients who participate in this program will improve their quality of life compared to controls. If investigators demonstrate the benefit of this program, it will have important consequences for patients with CHD and eventually for patients with other chronic medical conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient from 13 years to 25 years inclusive.
- •Carrying of Congenital Heart Disease as defined in the International Classification.
- •Possible follow-up for one year on one of the three hospital center.
- •Informed consent of the patient for adults and, parents or legal guardians for minors.
- •Affiliation to a social security system.
排除标准
- •Non-francophone,
- •Severe intellectual impairment.
研究组 & 干预措施
Therapeutic education
Structured therapeutic education programs
干预措施: Therapeutic education (Other)
Control group
standard outpatient follow-up
干预措施: Standard follow-up (Other)
结局指标
主要结局
PedsQL 4.0 score
时间窗: Follow up of patients over 12 months
Evolution of the quality of life assessed by PedsQL 4.0 self-reported scores from month 0 to month 12.
次要结局
- Disease severity(Follow up of patients over 12 months)
- Anxiety and depression(Follow up of patients over 12 months)
- Ricci and Gagnon score(Follow up of patients over 12 months)
- Leuven Knowledge score(Follow up of patients over 12 months)
- Physiological parameters(Follow up of patients over 12 months)