Ignite Creation Date:
2025-12-24 @ 5:30 PM
Ignite Modification Date:
2025-12-28 @ 4:59 PM
Study NCT ID:
NCT04902768
Status:
COMPLETED
Last Update Posted:
2024-05-16
First Post:
2021-05-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Patterns of Patient Reported Outcomes in Adults With Congenital Heart Disease - International Study II
Sponsor:
KU Leuven
Organization:
Study Overview
Official Title:
APPROACH-IS II: Assessment of Patterns of Patient Reported Outcomes in Adults With Congenital Heart Disease - International Study II
Status:
COMPLETED
Status Verified Date:
2024-05
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:
APPROACH-IS II
Brief Summary:
This is an international, cross-sectional and descriptive study that aims to investigate differences in patient-reported outcome measures (PROMs) and patient-reported experience measures (PREMs) and that aims to explore the profile and healthcare needs of adults with congenital heart diseases.
Detailed Description:
The research aims of this study are:
1. To further explore differences in a modified selection of patient-reported outcome measures (PROMs) and (as a new addition in APPROACH-IS II) explore differences in patient-reported experience measures (PREMs), by enrolling adults with congenital heart diseases in low, middle, and high income countries and including new potential explanatory variables ("Part 1").
2. To explore the profile and healthcare needs of a subgroup of older adults with congenital heart disease, with a particular focus on investigating the frailty phenotype ("Part 2").
1. To further explore differences in a modified selection of patient-reported outcome measures (PROMs) and (as a new addition in APPROACH-IS II) explore differences in patient-reported experience measures (PREMs), by enrolling adults with congenital heart diseases in low, middle, and high income countries and including new potential explanatory variables ("Part 1").
2. To explore the profile and healthcare needs of a subgroup of older adults with congenital heart disease, with a particular focus on investigating the frailty phenotype ("Part 2").
Study Oversight
Has Oversight DMC:
False
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?: