Development and Polit Study of Get Ready With my Heart Program

Development and Polit Study of an Intervention Program to Enhance the Transition Readiness of Adolescents With Congenital Heart Disease

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.

Study Overview

• Status: Completed
• Conditions: Congenital Heart Disease; Transition to Adult Care
• Intervention / Treatment: Behavioral: Conventional intervention; Behavioral: Get Ready with My Heart Program

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai, China, 201102
    • Children's Hospital of Fudan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Conventional intervention group; Based on the current congenital heart disease care standards at Fudan University Children's Hospital, health education and medical management for adolescent CHD	Behavioral: Conventional intervention; Adolescent CHD patients and their caregivers receive comprehensive health education and medical management. Upon admission, a detailed assessment of each patient's medical history and physical examination is conducted. A treatment and perioperative care plan is then tailored, including medication management with anticoagulants and antiarrhythmics, and surgery-related health guidance. Regular cardiac monitoring and follow-up assessments ensure treatment effectiveness and health status updates. Post-discharge, patients receive lifestyle management advice through remote consultations, focusing on diet and physical activity. Additionally, training on recognizing and managing emergencies is provided, equipping patients and caregivers to handle potential crises effectively. This holistic approach aims to improve both immediate and long-term health outcomes for adolescent CHD patients.
Experimental: Intervention group; Patients and their caregivers implement the "Get Ready with My Heart Program"	Behavioral: Conventional intervention; Adolescent CHD patients and their caregivers receive comprehensive health education and medical management. Upon admission, a detailed assessment of each patient's medical history and physical examination is conducted. A treatment and perioperative care plan is then tailored, including medication management with anticoagulants and antiarrhythmics, and surgery-related health guidance. Regular cardiac monitoring and follow-up assessments ensure treatment effectiveness and health status updates. Post-discharge, patients receive lifestyle management advice through remote consultations, focusing on diet and physical activity. Additionally, training on recognizing and managing emergencies is provided, equipping patients and caregivers to handle potential crises effectively. This holistic approach aims to improve both immediate and long-term health outcomes for adolescent CHD patients.; Behavioral: Get Ready with My Heart Program; In the intervention group, adolescent CHD patients undergo a comprehensive assessment by cardiology and cardiothoracic experts to determine their suitability for transitional care management. Based on the "Get Ready with My Heart Program," a personalized transition plan is developed, offering courses and resources that enhance self-management skills such as medication management, symptom monitoring, and health record maintenance. Throughout the transition period, regular support and follow-ups are provided to ensure that both patients and their families are adequately supported. The program includes regular assessments of transition readiness and quality of life changes to understand the intervention's impact and make necessary adjustments. Additionally, feedback is actively collected from patients and their families to continuously improve and refine the program.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-Management and Transition to Adulthood with Rx = Treatment (STAR(x)) Questionnaire	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.	before，3 and 6 months after intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health-related quality of life for adolescent CHD patients	Evaluated using the Chinese version of the Pediatric Quality of Life Inventory Cardiac Module (PedsQLTM 3.0 Cardiac Module)，The PedsQL 3.0 Cardiac Module consists of 22 items across five dimensions: heart problems and symptoms (5 items), perceived physical appearance (3 items), treatment anxiety (4 items), cognitive psychological issues (5 items), and communication issues (3 items). Additionally, a medication treatment issue section (5 items) is included for children who are currently undergoing medication treatment. It uses a 5-point Likert scale ranging from 0 (Never) to 4 (Almost always). Higher scores indicate a better quality of life.	before and 6 months after intervention
Transition skill levels for adolescent CHD patients-- General Self-Efficacy	Assessed using the General Self-Efficacy Scale (GSES) to evaluate patients' general self-efficacy and CHD disease knowledge. The Chinese version of the General Self-Efficacy Scale consists of 10 items, using a 4-point Likert scale ranging from 1 to 4. The scores of the 10 items are summed and then divided by 10 to calculate the overall scale score. A higher score indicates a higher sense of general self-efficacy.	before and 6 months after intervention
Transition skill levels for adolescent CHD patients--Knowledge	Assessed using the Chinese version of the Leuven Knowledge Questionnaire for Congenital Heart Disease (LKQCHD) to evaluate patients' general CHD disease knowledge.The Chinese version of the LKQCHD consists of 27 items that assess the knowledge of children with congenital heart disease and their caregivers across four dimensions: (1) disease and treatment; (2) complications and prevention; (3) physical activity; (4) sexuality and genetics. The accuracy rate is calculated as the number of items correctly identified as "correct" divided by the total number of items, multiplied by 100%.	before and 6 months after intervention

Collaborators and Investigators

• Sponsor: Children's Hospital of Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): June 26, 2024
• Primary Completion (Actual): February 28, 2025
• Study Completion (Actual): February 28, 2025

Study Registration Dates

• First Submitted: May 6, 2024
• First Submitted That Met QC Criteria: May 13, 2024
• First Posted (Actual): May 17, 2024

Study Record Updates

• Last Update Posted (Actual): April 9, 2025
• Last Update Submitted That Met QC Criteria: April 7, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Adolescent; CHD; Transition to adult care
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Heart Diseases; Heart Defects, Congenital
• Other Study ID Numbers: CHFudanU0505

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No