Ignite Creation Date:
2024-05-19 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06418373
Status:
RECRUITING
Last Update Posted:
2024-06-28
First Post:
2024-05-06
Brief Title:
Development and Polit Study of Get Ready With my Heart Program
Sponsor:
Childrens Hospital of Fudan University
Organization:
Childrens Hospital of Fudan University
Study Overview
Official Title:
Development and Polit Study of an Intervention Program to Enhance the Transition Readiness of Adolescents With Congenital Heart Disease
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None