Assessment of Patterns of Patient-reported Outcomes in Adults With Congenital Heart Disease - International Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Heart Defects, Congenital
- Sponsor
- Philip Moons
- Enrollment
- 4000
- Locations
- 24
- Primary Endpoint
- Patient-reported health status (EuroQol-5D)
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
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).
Investigators
Philip Moons
prof. dr. Philip Moons
Universitaire Ziekenhuizen KU Leuven
Eligibility Criteria
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
Outcomes
Primary Outcomes
Patient-reported health status (EuroQol-5D)
Time Frame: Baseline
Patient-reported psychosocial functioning (Hospital Anxiety and Depression Scale)
Time Frame: Baseline
Patient-reported behavioral outcomes (Health Behavior Scale - Congenital Heart Disease)
Time Frame: Baseline
Patient-reported quality of life (Linear Analog Scale Quality of Life;Satisfaction with Life Scale)
Time Frame: Baseline
Secondary Outcomes
- Patient-reported sense of coherence (Sense of Coherence scale 13 items)(Baseline)
- Patient-reported illness perceptions (Brief Illness Perception Questionnaire)(Baseline)
- Patient-reported socio-demographic variables (e.g. age, educational level)(Baseline)
- Medical variables by chart review (e.g. cardiac surgeries, frequency of follow-up)(Baseline)