Development and Polit Study of an Intervention Program to Enhance the Transition Readiness of Adolescents With Congenital Heart Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Self-Management and Transition to Adulthood with Rx = Treatment (STAR(x)) Questionnaire
研究概览
简要总结
The goal of this clinical trial is to learn if the Get Ready with my Heart Program developed based on SMART theory is applicable for AYAs with CHD to enhance their Transition Readiness. The main questions it aims to answer are:
- Is the Get Ready with my Heart Program clinically feasible？
- Does the Get Ready with my Heart Program improve participants' Transition Readiness?
Participants will:
- The intervention group will receive interventions according to the Get Ready with my Heart Program, while the control group will receive standard interventions.
- Outcome measures will be collected before the implementation of the program, and at 3 months and 6 months after the implementation.
详细描述
China currently has the highest number of congenital heart disease (CHD) patients in the world, placing a heavy disease burden on the country. As the number of adolescent CHD patients continues to grow, the strain on pediatric healthcare systems increases significantly, which in turn imposes a serious disease burden on families and society.
Over the past thirty years, the overall health of children and adolescents in China has greatly improved, but they are now facing new health issues and societal challenges. For example, unhealthy lifestyle behaviors are prevalent, and mental health issues are on the rise. Additionally, as treatment levels have improved, the focus of congenital heart disease care has shifted from simply improving survival rates to enhancing management throughout the entire lifecycle and overall prognosis. Effective transitional care management not only helps improve patients' self-management abilities and adherence to treatment but also reduces the socio-economic burden and enhances patients' quality of life. However, studies show that only a minority of adolescent CHD patients successfully complete this transition, highlighting the urgent need to strengthen transitional care management.
The purpose of this clinical pilot trial is to verify the feasibility and effectiveness of a management program designed to improve the transition readiness of adolescents with congenital heart disease based on the SMART model.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 12 and 21 years;
- •Diagnosed with congenital structural heart disease for at least 6 months;
- •Regularly receiving outpatient follow-up at Fudan University Children's Hospital;
- •Cognitive abilities corresponding to age, with adequate reading and comprehension skills;
- •Informed consent provided.
排除标准
- •Patients with physical conditions that limit participation (e.g., severe heart failure);
- •Presence of other congenital malformations (e.g., various syndromes caused by chromosomal abnormalities);
- •Patients with psychiatric disorders such as schizophrenia, intellectual disabilities, visual impairments, or other conditions that preclude participation in the study.
结局指标
主要结局
Self-Management and Transition to Adulthood with Rx = Treatment (STAR(x)) Questionnaire
时间窗: before，3 and 6 months after intervention
Evaluate the transition readiness levels of adolescent CHD patients using the Chinese version of Self-Management and Transition to Adulthood with Rx = Treatment (STAR(x)) . The questionnaire includes a total of 13 items across three categories: self-management (5 items), disease knowledge (3 items), and patient-doctor communication (5 items). It uses a 5-point Likert scale ranging from "never" to "always" or "very difficult" to "very easy," with scores assigned from 1 to 5 respectively. The maximum score and minimal score for the questionnaire is 65 points and 13 points, , with higher scores indicating higher levels of self-management and transition readiness. The questionnaire is available in both parent-reported and self-reported versions, to be filled out by the adolescent CHD patients and their primary caregivers, with consistent assessment content and scoring methods.
次要结局
- Health-related quality of life for adolescent CHD patients(before and 6 months after intervention)
- Transition skill levels for adolescent CHD patients-- General Self-Efficacy(before and 6 months after intervention)
- Transition skill levels for adolescent CHD patients--Knowledge(before and 6 months after intervention)