Virtual World-based Cardiac Rehabilitation to Improve Cardiovascular Health and Outcomes Among Cardiac Patients: A Multicenter Randomized Clinical Trial Protocol (Destination Cardiac Rehab Study)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Mayo Clinic
- 入组人数
- 150
- 试验地点
- 3
- 主要终点
- Change in LE8 composite score
研究概览
简要总结
The purpose of this research is to compare health outcomes and participation between a virtual world cardiac rehabilitation (Destination Cardiac Rehab) program and the standard of care Center-based Cardiac Rehabilitation program. Destination Cardiac Rehab, developed with input from patients with heart disease and their caregivers, is a 3-D, interactive program offering an affordable telehealth option for cardiac rehabilitation (cardiac rehab) that can be done from home or any place that you can access the Internet with a computer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
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
- •Indication for CR according to Centers for Medicare & Medicaid Services (CMS) guidelines:
- •Myocardial infarction within the preceding 12 months
- •Coronary artery bypass surgery
- •Current stable angina (chest pain)
- •Heart valve repair or replacement
- •Percutaneous transluminal coronary angioplasty (PTCA) or coronary stenting
- •Heart or heart-lung transplant
- •Stable chronic heart failure
- •Aged ≥18 years
- •Basic Internet navigation skills
- •Active email address
排除标准
- •High risk patients according to the American Association of Cardiovascular and Pulmonary Rehabilitation (AACVPR) risk stratification103 given safety concern of unsupervised exercise:
- •Sudden cardiac arrest survivor
- •Receiving continuous inotropic support
- •Presence of a mechanical circulatory support device
- •Decompensated heart failure
- •Symptomatic valvular heart disease
- •Uncontrolled angina
- •Presence of hemodynamically unstable dysrhythmias (e.g., ventricular tachycardia)
- •Pregnant (due to associated hormonal and weight changes)
- •Non-English-speaking
- •Visual/hearing impairment or mental disability that would preclude independent use of the VW platform
结局指标
主要结局
Change in LE8 composite score
时间窗: Baseline, 3 Months, 6 Months
Life's Essential 8 score is a composite cardiovascular health (CVH) score developed by the American Heart Association (AHA) to quantify and track an individual's heart- and brain-health based on eight key lifestyle behaviors and clinical health factors (healthy diet, physical activity, nicotine exposure, sleep health, body mass index, lipids, glucose and blood pressure). The score ranges from 0 to 100 points, with higher scores indicating better overall cardiovascular health. Interpretation of the composite score usually follows these general categories: 0-49: Low cardiovascular health 50-79: Moderate cardiovascular health 80-100: High (optimal) cardiovascular health
次要结局
- Number of CV-related hospital readmissions(3 Months, 6 Months)
- Number of Deaths(3 Months, 6 Months)
- Number of CV Deaths(3 Months, 6 Months)
研究者
LaPrincess C. Brewer
Principal Investigator
Mayo Clinic