Health-Related Quality of Life in Patients With Hypertrophic Cardiomyopathy in Japan
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 149
- 试验地点
- 1
- 主要终点
- Participant height
研究概览
简要总结
This cross-sectional, non-interventional study will assess health-related quality of life in in patients with hypertrophic cardiomyopathy in Japan. The study consists of two phases. Phase I is a qualitative study using semi-structured in-depth interviews in participants with hypertrophic cardiomyopathy. Phase II is a quantitative study using questionnaires in participants with hypertrophic cardiomyopathy and a control group of participants who do not have hypertrophic cardiomyopathy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Participant height
时间窗: Baseline
Participant employment status
时间窗: Baseline
History of non-drug therapy in participants with diagnosed hypertrophic cardiomyopathy
时间窗: Baseline
Percutaneous transluminal septal myocardial ablation, pacing therapy, other surgical therapies
Participant weight
时间窗: Baseline
Participant smoking status
时间窗: Baseline
Family members co-residing with participant
时间窗: Baseline
Family history of hypertrophic cardiomyopathy (HCM) in participants with diagnosed HCM
时间窗: Baseline
New York Heart Association functional classification (self-reported) in participants with diagnosed hypertrophic cardiomyopathy
时间窗: Baseline
Participant drinking status
时间窗: Baseline
Participant comorbidities
时间窗: Baseline
Participant current medications for hypertrophic cardiomyopathy in participants with diagnosed with HCM
时间窗: Baseline
Patient-reported health-related quality of life assessed by using the European Quality of Life 5 Dimension 5 Level (EQ-5D-5L) questionnaire
时间窗: Baseline
EQ-5D-5L consists of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each with five levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The total score ranges from -0.025 to 1, and higher scores reflect better health status.
Participant age
时间窗: Baseline
Participant sex
时间窗: Baseline
Participant mental disorders under current medical treatment
时间窗: Baseline
Period from first diagnosis of hypertrophic cardiomyopathy (HCM) in participants with diagnosed HCM
时间窗: Baseline
Time from first diagnosis of mental disorders
时间窗: Baseline
Participant need for support/caregivers in participants with diagnosed hypertrophic cardiomyopathy
时间窗: Baseline
Patient-reported health-related quality of life assessed by using the Hospital Anxiety Depression Scale (HADS)
时间窗: Baseline
HADS is an anxiety and depression assessment scale consisting of seven items (rated 0, 1, 2, or 3) related to anxiety (subscale A) and seven other items related to depression (subscale D). The total score ranges from 0 to 14, and higher scores reflect a worse health status.
Patient-reported health-related quality of life assessed by using the Kansas City Cardiomyopathy Questionnaire (KCCQ)
时间窗: Baseline
The KCCQ is a 23-item questionnaire developed to assess HRQoL in patients with congestive heart failure. The KCCQ consists of five domains: physical limitation, symptoms (frequency, severity, and recent change over time), QoL, social interference, and self-efficacy. The total score ranges from 0 to 100, and higher scores reflect better health status.
次要结局
未报告次要终点