Effect of HeartMate Application-Based Remote Patient Monitoring on Cardiovascular Risk Factor Management: An Exploratory Randomized Controlled Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 主要终点
- Change from Baseline in 6-Minute Walk Test (6MWT) Distance at 6 Weeks
研究概览
简要总结
This exploratory pilot randomized controlled trial evaluates whether a HeartMate application-based remote patient monitoring (RPM) and digital cardiac rehabilitation program improves cardiovascular, functional, and psychological outcomes in patients with cardiac disease. A total of 200 participants with cardiovascluar disease requiring rehabilitation are randomly assigned in a 1:1 ratio to an intervention group or a control group. The intervention group uses the HeartMate app-based remote cardiac rehabilitation program for 6 weeks, including a daily heart check using smartphone remote photoplethysmography (rPPG), aerobic and resistance exercise, breathing training, and a cognitive-behavioral 'mind' program, with weekly remote coaching. The control group receives usual outpatient care and lifestyle education materials, with the app installed only for rPPG measurement so that digital-biomarker measurement is identical across groups. Clinical assessments (6-minute walk distance, grip strength, blood pressure, blood lipids and metabolic markers), questionnaires (SF-12, PHQ-9, GAD-7, KOSS-24), and digital biomarkers (rPPG-derived heart rate, heart rate variability, respiration, activity) are collected at baseline and at 6 weeks. The primary outcome is the between-group difference in the change in 6-minute walk distance from baseline to 6 weeks. Because this is an exploratory pilot, the results are intended to estimate the effect size and variance for a future definitive randomized controlled trial, and to assess the validity of digital biomarkers as well as the safety, feasibility, and adherence of the program.
详细描述
Study design: This is a single-center, prospective, open-label, randomized controlled exploratory pilot trial with two parallel groups and 1:1 allocation. A total of 200 participants (100 per group) are planned, with approximately 170 evaluable participants expected after an anticipated 10-20% dropout.
Background and rationale: Traditional hospital-based cardiac rehabilitation has low participation because of travel, time, and cost barriers. Smartphone-based remote patient monitoring and digital cardiac rehabilitation may lower these barriers and enable continuous monitoring of cardiovascular risk factors. Smartphone-derived digital biomarkers, including remote photoplethysmography (rPPG) and heart rate variability (HRV), may provide non-invasive markers correlated with conventional cardiovascular risk indicators.
Randomization: After completion of baseline assessment, participants are randomly allocated 1:1 to the intervention or control group using a random number table with block randomization (block size of 4). The allocation sequence is generated by a person independent of the study, and allocation is concealed using sequentially numbered, password-protected locked files. Investigators performing screening and enrollment do not have access to the allocation sequence.
Intervention group: Participants use the HeartMate app-based remote cardiac rehabilitation program for 6 weeks. The program provides a daily heart check using rPPG, aerobic and resistance exercise, breathing training, and a cognitive-behavioral mind program. Trained staff provide message-based counseling and exercise and lifestyle guidance at least weekly; the Severance research team reviews monitoring logs at least weekly and handles all medical decisions and adverse events.
Control group: Participants receive usual outpatient follow-up and lifestyle education materials. The HeartMate app is installed for rPPG-based measurement only, with no exercise or mind program, so that digital-biomarker measurement is identical across groups and to minimize confounding from app installation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 19 years or older
- •Patients with cardiac disease judged to require cardiac rehabilitation (e.g., heart failure, valvular heart disease, coronary artery disease, peripheral arterial disease)
- •Able to be followed for at least 6 weeks during the study period
- •Able to consent to blood testing and PPG measurement at baseline and endpoint
- •Able to use a smartphone application
排除标准
- •Judged unable to undergo PPG measurement
- •Atrial fibrillation
- •Condition or disease making participation in cardiac rehabilitation difficult
- •Psychiatric illness, cognitive impairment, or expected poor adherence that may affect study participation
结局指标
主要结局
Change from Baseline in 6-Minute Walk Test (6MWT) Distance at 6 Weeks
时间窗: Baseline and 6 weeks (change from baseline to Week 6)
The distance walked (in meters) during the 6-minute walk test, measured at baseline and at 6 weeks. The change (Week 6 minus baseline) is compared between the intervention and control groups. As an exploratory pilot outcome, the primary purpose is to estimate the effect size and standard deviation for a future randomized controlled trial rather than to confirm efficacy.
次要结局
- Number of Participants With At Least One Adverse Event (AE)(From randomization through 6 weeks)
- Number of Participants With At Least One Serious Adverse Event (SAE)(From randomization through 6 weeks)
- Proportion of Participants Achieving Target Application Usage (>= 80%)(Over the 6-week intervention period)