Congenital Heart Disease Clinical Trial
Official title:
Development and Polit Study of an Intervention Program to Enhance the Transition Readiness of Adolescents With Congenital Heart Disease
Verified date | May 2024 |
Source | Children's Hospital of Fudan University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Not yet recruiting |
Enrollment | 48 |
Est. completion date | May 31, 2025 |
Est. primary completion date | March 31, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 12 Years to 21 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | Children's Hospital of Fudan University | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Children's Hospital of Fudan University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 |
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