Patient-Reported Outcomes in Adults With Congenital Heart Disease

Philip Moons4,000 enrolled

Overview

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).

Study Type

OBSERVATIONAL

Enrollment

4,000

Conditions

Heart Defects, Congenital

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (24)

Stanford Hospital & Clinics

Stanford, California, United States

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)

Time frame: Baseline

Patient-reported illness perceptions (Brief Illness Perception Questionnaire)

Time frame: Baseline

Patient-reported socio-demographic variables (e.g. age, educational level)

Time frame: Baseline

Medical variables by chart review (e.g. cardiac surgeries, frequency of follow-up)

Time frame: Baseline

Data from ClinicalTrials.gov

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