Smartphone Delivered In-home Cardiopulmonary Rehabilitation



Status:Recruiting
Conditions:Peripheral Vascular Disease, Peripheral Vascular Disease, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:2/3/2019
Start Date:May 2016
End Date:December 2021
Contact:Abarmard Zafari, MD
Email:azafari@emory.edu
Phone:(404) 327-4019

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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.

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.

Cohort A:

Inclusion Criteria:

Meet eligibility for cardiac rehabilitation program as defined by Centers for Medicare &
Medicaid Services (CMS)

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)

Cohort B:

Inclusion Criteria:

Meet eligibility for pulmonary rehabilitation as defined by the American Thoracic Society
(ATS):

1. Symptomatic impairment attributable to pulmonary disability

2. Failure of standard medical regimen to achieve adequate symptomatic relief

3. Motivated, adherent patient

Exclusion Criteria:

- Lack of motivation

- Non-adherence

- Severe cognitive dysfunction or psychiatric illness

- Unstable comorbidity (unstable angina, decompensated heart failure)

- Severe exercise-induced hypoxemia, not correctable with O2 supplementation

- Inability to exercise due to severe lung or other disease (arthritis, stroke)

- Cigarette smoking
We found this trial at
1
site
303 Parkway Drive Northeast
Atlanta, Georgia 30033
Phone: 404-321-6111
?
mi
from
Atlanta, GA
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