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Development and Polit Study of Get Ready With my Heart Program

NCT06418373 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-04-09

No results posted yet for this study

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.

Conditions

  • Transition to Adult Care
  • Congenital Heart Disease

Interventions

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.

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.

Sponsors & Collaborators

  • Children's Hospital of Fudan University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-26
Primary Completion
2025-02-28
Completion
2025-02-28

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06418373 on ClinicalTrials.gov