Assessment of Patterns of Patient Reported Outcomes in Adults With Congenital Heart Disease - International Study II (APPROACH-IS II)

Catholic University (KU) of Leuven

Status: Completed

Conditions: Congenital Heart Disease

Treatments: Other: This is an observational study, there is no intervention

Study type: Observational

Funder types: Other

Identifiers

NCT04902768

S62537

Details and patient eligibility

About

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.

Full 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").

Enrollment: 8,415 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosed with congenital heart disease, defined as: "a gross structural abnormality of the heart and/or intra-thoracic great vessels that is actually or potentially of functional significance (including mild, moderate, and complex heart defects)"
• Aged 18 years of age or older at the moment of study inclusion
• Diagnosed with congenital heart disease before the age of 10 years
• Follow-up at an ACHD center or included in a national/regional registry
• Physical, cognitive, and language abilities to complete self-report questionnaires

Exclusion criteria

• Prior heart transplantation

Trial design

8,415 participants in 1 patient group

Adults with congenital heart disease

Treatment:

Other: This is an observational study, there is no intervention