A Study to Assess Health-Related Quality of Life in Patients With Hypertrophic Cardiomyopathy in Japan
- Conditions
- Hypertrophic Cardiomyopathy
- Registration Number
- NCT06181617
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 149
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Participant smoking status Baseline Participant height Baseline Participant employment status Baseline History of non-drug therapy in participants with diagnosed hypertrophic cardiomyopathy Baseline Percutaneous transluminal septal myocardial ablation, pacing therapy, other surgical therapies
Participant weight Baseline Family members co-residing with participant Baseline Family history of hypertrophic cardiomyopathy (HCM) in participants with diagnosed HCM Baseline New York Heart Association functional classification (self-reported) in participants with diagnosed hypertrophic cardiomyopathy Baseline Participant drinking status Baseline Participant comorbidities Baseline Participant current medications for hypertrophic cardiomyopathy in participants with diagnosed with HCM Baseline Patient-reported health-related quality of life assessed by using the European Quality of Life 5 Dimension 5 Level (EQ-5D-5L) questionnaire 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 Baseline Participant sex Baseline Participant mental disorders under current medical treatment Baseline Period from first diagnosis of hypertrophic cardiomyopathy (HCM) in participants with diagnosed HCM Baseline Time from first diagnosis of mental disorders Baseline Participant need for support/caregivers in participants with diagnosed hypertrophic cardiomyopathy Baseline Patient-reported health-related quality of life assessed by using the Hospital Anxiety Depression Scale (HADS) 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) 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Local Institution - 0001
🇯🇵Minato-ku, Tokyo, Japan
Local Institution - 0001🇯🇵Minato-ku, Tokyo, Japan