Clinical trial NCT06418373: Development and Polit Study of Get Ready With my Heart Program
Official title: Development and Polit Study of an Intervention Program to Enhance the Transition Readiness of Adolescents With Congenital Heart Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Transition to Adult Care
Congenital Heart Disease
Keywords: Transition to adult care
CHD
Adolescent
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
First posted: 2024-05-17
Enrollment: 30
Sex: ALL
Minimum age (years): 12
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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:

1. Is the Get Ready with my Heart Program clinically feasible？
2. Does the Get Ready with my Heart Program improve participants' Transition Readiness?

Participants will:

1. The intervention group will receive interventions according to the Get Ready with my Heart Program, while the control group will receive standard interventions.
2. Outcome measures will be collected before the implementation of the program, and at 3 months and 6 months after the implementation.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Age between 12 and 21 years;
2. Diagnosed with congenital structural heart disease for at least 6 months;
3. Regularly receiving outpatient follow-up at Fudan University Children's Hospital;
4. Cognitive abilities corresponding to age, with adequate reading and comprehension skills;
5. Informed consent provided.

Exclusion Criteria:

1. Patients with physical conditions that limit participation (e.g., severe heart failure);
2. Presence of other congenital malformations (e.g., various syndromes caused by chromosomal abnormalities);
3. Patients with psychiatric disorders such as schizophrenia, intellectual disabilities, visual impairments, or other conditions that preclude participation in the study.

Primary outcomes:
measure: Self-Management and Transition to Adulthood with Rx = Treatment (STAR(x)) Questionnaire
timeFrame: before，3 and 6 months after intervention
Secondary outcomes:
measure: Health-related quality of life for adolescent CHD patients
timeFrame: before and 6 months after intervention
measure: Transition skill levels for adolescent CHD patients-- General Self-Efficacy
timeFrame: before and 6 months after intervention
measure: Transition skill levels for adolescent CHD patients--Knowledge
timeFrame: before and 6 months after intervention
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Children's Hospital of Fudan University
Study officials:
References: