APPROACH-IS II: Assessment of Patterns of Patient Reported Outcomes in Adults With Congenital Heart Disease - International Study II
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- KU Leuven
- 入组人数
- 8,415
- 试验地点
- 53
- 主要终点
- Patient-reported health status
研究概览
简要总结
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.
详细描述
The research aims of this study are:
- 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").
- 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").
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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 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
排除标准
- •Prior heart transplantation
结局指标
主要结局
Patient-reported health status
时间窗: Baseline
This outcome is measured using the Linear Analogue Scale Health Status (LAS HS). Scores range from 0 (worst imaginable health state) to 100 (best imaginable health state).
Patients' perception of providers' autonomy support
时间窗: Baseline
This outcome is measured using the modified Health Care Climate Questionnaire (mHCCQ). Each of the 6 items is scored from 1 to 7. Scores are calculated by averaging the individual item scores. Higher average score represents a higher level of perceived autonomy support.
Patient-reported quality of life
时间窗: Baseline
This outcome is measured using the Linear Analog Scale on Quality of Life (LAS QOL). Scores range from 0 (worst imaginable quality of life) to 100 (best imaginable quality of life).
Cognitive functioning
时间窗: Baseline
This outcome is measured using the Montreal Cognitive Assessment Screener (MoCA). Scores range from 0 to 30. Scores of \<26 indicate cognitive dysfunction.
Patient-reported depressive symptoms
时间窗: Baseline
This outcomes is measured using the Patient Health Questionnaire 8. Scores range from 0 to 24. Scores of ≥10 indicate depression.
Patient-reported anxiety symptoms
时间窗: Baseline
This outcome is measured using the General Anxiety Disorder 7. Scores range from 0 to 21. Scores of 5, 10, and 15 are taken as cut-off points for mild, moderate and severe anxiety.
Frailty phenotype
时间窗: Baseline
This outcome is classified using the Fried method (i.e., non-frail (no positive criterion), pre-frail (1 or 2 criteria positive), or frail (when ≥3 criteria are positive).
次要结局
- Patient-reported empowerment(Baseline)
- Patient-reported social support(Baseline)
- Advance care planning(Baseline)
- Patient-reported stigma(Baseline)
- Patient-reported illness identity(Baseline)
- Patient-reported parental involvement(Baseline)
- Patient-reported social media to connect with peers(Baseline)
- Medical variables by chart review (eg. diagnosis, cardiac surgeries)(Baseline)
- Patient-reported healthcare utilization(Baseline)
- Patient-reported functional status(Baseline)
- Presence and burden of comorbidities(Baseline)
- Patient-reported socio-demographic variables (eg. age, educational level)(Baseline)