Smartphone Delivered In-home Cardiopulmonary Rehabilitation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 258
- 试验地点
- 1
- 主要终点
- Change in Functional Capacity assessed by the Six Minute Walk Test (6MWT)
研究概览
简要总结
The goal of this study is to determine if a remote cardiac or pulmonary rehabilitation program delivered via a smartphone application and regular telephone calls will lead to improved delivery of cardiac rehabilitation compared to usual care. This includes increased adherence for eligible veterans, increased program completion, improved patient outcomes as measured by functional capacity, improved patient compliance in monitoring symptoms, improved self-efficacy and knowledge in managing disease and, a decreased rate of hospitalization and re-admissions.
详细描述
This project aims to determine if a smartphone-delivered cardiac rehabilitation (CR) program could show similar clinical outcomes to in-person programs at a low cost in a large population of patients. Investigators will also assess the feasibility of tailoring a virtual CR program to a small sample of COPD participants who also stand to benefit in the absence of an established pulmonary rehabilitation (PR) program.
This is a non-randomized clinical trial of participants at the Atlanta Veterans Affairs Medical Center with an applicable diagnosis for cardiac or pulmonary rehabilitation versus usual care during the study period. We will evaluate the outcomes related to smartphone-enabled home base cardiopulmonary rehabilitation in those who choose the intervention and those who opt into home-based CR, traditional CR, or those who decline. Data from the past 5 years will also be evaluated to obtain a baseline event rate.
Investigators seek to address the following:
- Determine whether a home-based cardiac or pulmonary rehabilitation program delivered through smartphones is feasible and improves functional status.
- Determine if education and lifestyle counseling lead to increased adherence with prescribed follow-up, pharmacotherapy, quality of life, self-efficacy and lifestyle changes.
- Determine if a home-based cardiac or pulmonary rehabilitation program reduces health system utilization, including ED visits and readmission rates.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Meet eligibility for cardiac rehabilitation program as defined by Centers for Medicare & Medicaid Services (CMS); they may also have stable CAD and be referred for cardiac rehab by their provider.
- •Following acute myocardial infarction (within the preceding 12 months)
- •Coronary artery bypass grafting (CABG)
- •Current stable angina pectoris
- •Heart valve repair or replacement
- •Percutaneous transluminal coronary angioplasty (PTCA) or coronary stenting
- •Heart or heart-lung transplant
- •Other diagnosis by specific physician referral
排除标准
- •Unstable angina
- •Resting systolic blood pressure >200 mm Hg or resting diastolic blood pressure >110 mm Hg
- •Significant drop (>=20 mm Hg) in resting systolic blood pressure from the patient's average level that cannot be explained by medications
- •Moderate to severe aortic stenosis
- •Acute systemic illness or fever
- •Uncontrolled atrial or ventricular arrhythmias
- •Symptomatic congestive heart failure (stage C)
- •Third-degree heart block without pacemaker
- •Active pericarditis or myocarditis
- •Recent venous thromboembolism (VTE, as determined by physician)
- •Current Thrombophlebitis
- •Uncontrolled diabetes (A1c > 7.0 or as determined by physician)
- •Orthopedic problems that would prohibit exercise
- •Other by specific physician instruction
- •Peripheral vascular disease (PVD; symptomatic or that would prohibit exercise)
研究组 & 干预措施
Cardiac Rehabilitation - Movn Program
Participants with coronary artery disease (CAD) and chronic obstructive pulmonary disease (COPD) who are eligible for cardiac rehabilitation will undergo an in-home program.
干预措施: MULTIFIT Cardiac Rehabilitation (Behavioral)
Pulmonary Rehabilitation - Movn Program
Participants with stable chronic obstructive pulmonary disease (COPD) or hospitalized with an acute exacerbation of COPD will undergo an in-home pulmonary rehabilitation program.
干预措施: Movn Pulmonary Rehabilitation (Behavioral)
Traditional Cardiac Rehabilitation
Participants enrolled in a facility's traditional cardiac rehabilitation program will be seen at baseline and during a 12 and 24 week follow-up visit.
干预措施: Standard of Care Cardiac Rehabilitation (Behavioral)
结局指标
主要结局
Change in Functional Capacity assessed by the Six Minute Walk Test (6MWT)
时间窗: Week 12, Week 24
The six-minute walk test (6MWT) measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes. The individual is allowed to self-pace and rest as needed as they traverse back and forth along a marked walkway.
次要结局
- Change in Measure of Exercise Intensity (MET)(Baseline, Week 12)
- Change in Weight(Baseline, Week 12)
- Change in Body Mass Index (BMI)(Baseline, Week 12)
- Change in Blood Pressure(Baseline, Week 12)
- Change in Low-density Lipoprotein (LDL) Level(Baseline, Week 12)
- Change in Patient Health Questionnaire (PHQ-9) Score(Baseline, Week 12)
- Change in A1c Level(Baseline, Week 12)
- Change in Duke Activity Status Index (DASI) Score(Baseline, Week 12)
研究者
Amit J. Shah
Assistant Professor
Emory University