Assessment of Patterns of Patient-reported Outcomes in Adults With Congenital Heart Disease - International Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 4,000
- 试验地点
- 24
- 主要终点
- Patient-reported health status (EuroQol-5D)
研究概览
简要总结
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).
研究设计
- 研究类型
- Observational
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Prior heart transplantation
- •Isolated pulmonary hypertension
- •Syndromes affecting cognitive abilities
结局指标
主要结局
Patient-reported health status (EuroQol-5D)
时间窗: Baseline
Patient-reported psychosocial functioning (Hospital Anxiety and Depression Scale)
时间窗: Baseline
Patient-reported behavioral outcomes (Health Behavior Scale - Congenital Heart Disease)
时间窗: Baseline
Patient-reported quality of life (Linear Analog Scale Quality of Life;Satisfaction with Life Scale)
时间窗: Baseline
次要结局
- 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)
研究者
Philip Moons
prof. dr. Philip Moons
Universitaire Ziekenhuizen KU Leuven