Clinical trial NCT02791685: Smartphone Delivered In-home Cardiopulmonary Rehabilitation
Official title: Smartphone Delivered In-home Cardiopulmonary Rehabilitation
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cardiovascular Disease
Coronary Artery Disease
Keywords: Cardiac Rehabilitation
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Atlanta VA Medical Center
First posted: 2016-06-07
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change in Functional Capacity assessed by the Six Minute Walk Test (6MWT)
timeFrame: Week 12, Week 24
Secondary outcomes:
measure: Change in Measure of Exercise Intensity (MET)
timeFrame: Baseline, Week 12
measure: Change in Weight
timeFrame: Baseline, Week 12
measure: Change in Body Mass Index (BMI)
timeFrame: Baseline, Week 12
measure: Change in Blood Pressure
timeFrame: Baseline, Week 12
measure: Change in A1c Level
timeFrame: Baseline, Week 12
measure: Change in Low-density Lipoprotein (LDL) Level
timeFrame: Baseline, Week 12
measure: Change in Duke Activity Status Index (DASI) Score
timeFrame: Baseline, Week 12
measure: Change in Patient Health Questionnaire (PHQ-9) Score
timeFrame: Baseline, Week 12
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Atlanta VA Medical Center
state: Georgia
Study officials:
affiliation: Emory University
name: Amit J Shah, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Harzand A, Witbrodt B, Davis-Watts ML, Alrohaibani A, Goese D, Wenger NK, Shah AJ, Zafari AM. Feasibility of a Smartphone-enabled Cardiac Rehabilitation Program in Male Veterans With Previous Clinical Evidence of Coronary Heart Disease. Am J Cardiol. 2018 Nov 1;122(9):1471-1476. doi: 10.1016/j.amjcard.2018.07.028. Epub 2018 Aug 4.