Smartphone Delivered In-home Cardiopulmonary Rehabilitation

Emory University

Status: Completed

Conditions: Coronary Artery Disease; Cardiovascular Disease

Treatments: Behavioral: MULTIFIT Cardiac Rehabilitation; Behavioral: Standard of Care Cardiac Rehabilitation; Behavioral: Movn Pulmonary Rehabilitation

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT02791685

2025P008772 (Other Identifier)

IRB00085938

Details and patient eligibility

About

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.

Full description

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:

1. Determine whether a home-based cardiac or pulmonary rehabilitation program delivered through smartphones is feasible and improves functional status.
2. Determine if education and lifestyle counseling lead to increased adherence with prescribed follow-up, pharmacotherapy, quality of life, self-efficacy and lifestyle changes.
3. Determine if a home-based cardiac or pulmonary rehabilitation program reduces health system utilization, including ED visits and readmission rates.

Enrollment: 258 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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.

1. Following acute myocardial infarction (within the preceding 12 months)
2. Coronary artery bypass grafting (CABG)
3. Current stable angina pectoris
4. Heart valve repair or replacement
5. Percutaneous transluminal coronary angioplasty (PTCA) or coronary stenting
6. Heart or heart-lung transplant
7. Other diagnosis by specific physician referral

Exclusion criteria

• 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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

258 participants in 3 patient groups

Cardiac Rehabilitation - Movn Program

Experimental group

Description:

Participants with coronary artery disease (CAD) and chronic obstructive pulmonary disease (COPD) who are eligible for cardiac rehabilitation will undergo an in-home program.

Treatment:

Behavioral: MULTIFIT Cardiac Rehabilitation

Pulmonary Rehabilitation - Movn Program

Experimental group

Description:

Participants with stable chronic obstructive pulmonary disease (COPD) or hospitalized with an acute exacerbation of COPD will undergo an in-home pulmonary rehabilitation program.

Treatment:

Behavioral: Movn Pulmonary Rehabilitation

Traditional Cardiac Rehabilitation

Active Comparator group

Description:

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.

Treatment:

Behavioral: Standard of Care Cardiac Rehabilitation