Transition to Adult CareNCT06418373
Development and Polit Study of Get Ready With my Heart Program
A study testing Get Ready with My Heart Program and Conventional intervention in people with Transition to Adult Care and Congenital Heart Disease, run by Children's Hospital of Fudan University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 21 years
- Conditions the study is for
- Transition to Adult Care, Congenital Heart Disease
- What is being tested?
- Get Ready with My Heart Program and Conventional intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 26 Jun 2024to 28 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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:
- Is the Get Ready with my Heart Program clinically feasible？
- Does the Get Ready with my Heart Program improve participants' Transition Readiness?
Participants will:
- The intervention group will receive interventions according to the Get Ready with my Heart Program, while the control group will receive standard interventions.
- Outcome measures will be collected before the implementation of the program, and at 3 months and 6 months after the implementation.
Read the 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.
- Conditions
- Transition to Adult Care, Congenital Heart Disease
- Being tested
- Get Ready with My Heart Program, Conventional intervention
- Keywords
- Transition to adult care, CHD, Adolescent
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Get Ready with My Heart ProgramBehavioural
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.
Conventional interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Conventional intervention |
| Intervention group | Experimental | Patients and their caregivers implement the "Get Ready with My Heart Program" Receives: Behavioral: Get Ready with My Heart Program; Behavioral: Conventional intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: before，3 and 6 months after intervention
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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%.
Measured: before and 6 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2024
- Study start26 Jun 2024
- Primary completion28 Feb 2025
- Study completion28 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transition to Adult CareStudies of the same condition, open and under way.
- More trials run by Children's Hospital of Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06418373
- Sponsor's protocol ID
- CHFudanU0505
- Status last verified
- Apr 2025
- First submitted
- 6 May 2024
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Polit Study of an Intervention Program to Enhance the Transition Readiness of Adolescents With Congenital Heart Disease
- ClinicalTrials.gov ID
- NCT06418373
- Acronym / sponsor ID
- CHFudanU0505
- Conditions
- Transition to Adult Care, Congenital Heart Disease
- Keywords
- Transition to adult care, CHD, Adolescent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 26 Jun 2024 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 17 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Is the Get Ready with my Heart Program clinically feasible？
- Does the Get Ready with my Heart Program improve participants' Transition Readiness?
Participants will:
- The intervention group will receive interventions according to the Get Ready with my Heart Program, while the control group will receive standard interventions.
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional intervention group | Active comparator | Behavioral: Conventional interventionBased on the current congenital heart disease care standards at Fudan University Children's Hospital, health education and medical management for adolescent CHD |
| Intervention group | Experimental | Behavioral: Get Ready with My Heart Program, Behavioral: Conventional interventionPatients and their caregivers implement the "Get Ready with My Heart Program" |
Who may qualify
- Ages
- 12 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Get Ready with My Heart ProgramIn 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. | Behavioural | Intervention group |
| Conventional interventionAdolescent 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. | Behavioural | Conventional intervention group, Intervention group |
Primary outcome
Self-Management and Transition to Adulthood with Rx = Treatment (STAR(x)) Questionnaire
Time frame: before，3 and 6 months after intervention
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.
3 secondary outcomes
Health-related quality of life for adolescent CHD patients
Time frame: before and 6 months after intervention
Transition skill levels for adolescent CHD patients-- General Self-Efficacy
Time frame: before and 6 months after intervention
Transition skill levels for adolescent CHD patients--Knowledge
Time frame: before and 6 months after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Get Ready with My Heart Program and Conventional intervention in people with Transition to Adult Care and Congenital Heart Disease, run by Children's Hospital of Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-Management and Transition to Adulthood with Rx = Treatment (STAR(x)) Questionnaire (time frame: before，3 and 6 months after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2025.