Destination Cardiac Rehab: A Multicenter Feasibility Clinical Trial of an Enhanced Virtual World-based Cardiac Rehabilitation Intervention to Improve Cardiovascular Health and Outcomes Among Cardiac Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 8
- 试验地点
- 3
- 主要终点
- Change in Cardiovascular health score
研究概览
简要总结
A single-group, multi-center, non-randomized clinical trial will be conducted to assess the feasibility of implementing an enhanced virtual world-based cardiac rehabilitation (VWCR) program within a muti-site clinical trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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 (diagnosed within the preceding 12 months) to include one or more of the following:
- •Myocardial infarction
- •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
- •Receiving care at one of the participating CR centers
- •Age ≥18 years
- •Basic Internet navigation skills
- •Active email address
- •Access to Internet at home or public access (church, library, etc) for 3 virtual visits per week
排除标准
- •High risk patients according to the AACVPR risk stratification44 given safety concern of unsupervised exercise
- •Patients receiving continuous inotropic support
- •Recent receipt of a mechanical support device
- •Presence of hemodynamically unstable dysrhythmias (e.g., ventricular tachycardia)
- •Decompensated heart failure
- •Symptomatic valvular heart disease
- •Uncontrolled angina
- •Pregnancy (due to associated hormonal and weight changes) per patient report
- •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) given safety concern of unsupervised exercise
- •Visual/hearing impairment or mental disability that would preclude independent use of the VW platform
- •Non-English-speaking patients due to logistical challenges with real time translation over a virtual platform
- •Currently participating in a cardiac rehab program
研究组 & 干预措施
Virtual World-Based Cardiac Rehab
干预措施: Virtual World-based Cardiac Rehabilitation (VWCR) program (Behavioral)
结局指标
主要结局
Change in Cardiovascular health score
时间窗: Baseline, 2 Months, 5 Months
Cardiovascular health score will be determined by the American Heart Association's (AHA) Life's Essential 8 (LS8). The scale is 0-100 pts (low to high), with LE8 categories as low (0-49), moderate (50-79) and high (80-100). A higher score indicates higher cardiovascular health.
Percent of Virtual world-based cardiac rehabilitation attended
时间窗: Baseline, 6 Months
Virtual world-based cardiac rehabilitation attended will be determined by the number of sessions prescribed vs the number of sessions attended (reported as a percent).
次要结局
- Number of cardiovascular hospital readmissions(Baseline, 6 Months)
- All-cause mortality(6 Months)
研究者
LaPrincess C. Brewer
Principal Investigator
Mayo Clinic