Health-Related Quality of Life in Patients With Hypertrophic Cardiomyopathy in Japan
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hypertrophic Cardiomyopathy
- Sponsor
- Bristol-Myers Squibb
- Enrollment
- 149
- Locations
- 1
- Primary Endpoint
- Participant height
- Status
- Completed
- Last Updated
- 9 months ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Participant height
Time Frame: Baseline
Participant employment status
Time Frame: Baseline
History of non-drug therapy in participants with diagnosed hypertrophic cardiomyopathy
Time Frame: Baseline
Percutaneous transluminal septal myocardial ablation, pacing therapy, other surgical therapies
Participant weight
Time Frame: Baseline
Participant smoking status
Time Frame: Baseline
Family members co-residing with participant
Time Frame: Baseline
Family history of hypertrophic cardiomyopathy (HCM) in participants with diagnosed HCM
Time Frame: Baseline
New York Heart Association functional classification (self-reported) in participants with diagnosed hypertrophic cardiomyopathy
Time Frame: Baseline
Participant drinking status
Time Frame: Baseline
Participant comorbidities
Time Frame: Baseline
Participant current medications for hypertrophic cardiomyopathy in participants with diagnosed with HCM
Time Frame: Baseline
Patient-reported health-related quality of life assessed by using the European Quality of Life 5 Dimension 5 Level (EQ-5D-5L) questionnaire
Time Frame: 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
Time Frame: Baseline
Participant sex
Time Frame: Baseline
Participant mental disorders under current medical treatment
Time Frame: Baseline
Period from first diagnosis of hypertrophic cardiomyopathy (HCM) in participants with diagnosed HCM
Time Frame: Baseline
Time from first diagnosis of mental disorders
Time Frame: Baseline
Participant need for support/caregivers in participants with diagnosed hypertrophic cardiomyopathy
Time Frame: Baseline
Patient-reported health-related quality of life assessed by using the Hospital Anxiety Depression Scale (HADS)
Time Frame: 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)
Time Frame: 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.