Development and Polit Study of Get Ready With my Heart Program

NCT06418373 | Completed DMC

• 1 other identifier: CHFudanU0505
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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. 1.Is the Get Ready with my Heart Program clinically feasible？
2. 2.Does the Get Ready with my Heart Program improve participants' Transition Readiness?
3. 3.The intervention group will receive interventions according to the Get Ready with my Heart Program, while the control group will receive standard interventions.
4. 4.Outcome measures will be collected before the implementation of the program, and at 3 months and 6 months after the implementation.

Conditions

Transition to Adult Care; Congenital Heart Disease

Keywords

Transition to adult care; CHD; Adolescent

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (2)

Conventional intervention group

ACTIVE COMPARATOR

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

Intervention group

EXPERIMENTAL

Patients and their caregivers implement the "Get Ready with My Heart Program"

Behavioral: Get Ready with My Heart Program; Behavioral: Conventional intervention

Interventions

Get Ready with My Heart Program BEHAVIORAL

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.

Intervention group

Conventional intervention BEHAVIORAL

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.

Conventional intervention group; Intervention group

Eligibility Criteria

• Age: 12 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's Hospital of Fudan University: lead

Study Sites (1)

Children's Hospital of Fudan University

Shanghai, 201102, China

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2024
• First Posted: May 17, 2024
• Study Start: June 26, 2024
• Primary Completion: February 28, 2025
• Study Completion: February 28, 2025
• Last Updated: April 9, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)