Patient-Reported Outcomes in Adults With Congenital Heart Disease (APPROACH-IS)

Philip Moons

Status: Completed

Conditions: Heart Defects, Congenital

Study type: Observational

Funder types: Other

Identifiers

NCT02150603

ML9231

Details and patient eligibility

About

The purpose of this study is to examine the differences in perceived health, psychosocial functioning, behavioral outcomes and quality of life of adults with congenital heart disease who are living in different areas of the world, and how these differences can be understood (e.g., differences in sense of coherence or illness perceptions).

Enrollment: 4,000 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 or intra-thoracic great vessels that is actually or potentially of functional significance (including mild, moderate, and severe heart defects)
• 18 years of age or older
• Diagnosed under the age of ten, i.e. before adolescence
• Continuing follow-up at an adult congenital heart disease center or included in a national/regional registry
• Physical, cognitive, and language abilities to complete self-report questionnaires

Exclusion criteria

• Prior heart transplantation
• Isolated pulmonary hypertension
• Syndromes affecting cognitive abilities

Trial design

4,000 participants in 1 patient group

Adults with congenital heart disease