Smartphone Delivered In-home Cardiopulmonary Rehabilitation

Coronary Artery Disease Clinical Trial

Official title:

Smartphone Delivered In-home Cardiopulmonary Rehabilitation

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02791685
• Other study ID #: IRB00085938
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 2016
• Est. completion date: December 2026

Study information

• Verified date: May 2023
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: December 2026
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Coronary Artery Disease

Intervention

Behavioral:
• MULTIFIT Cardiac Rehabilitation
MULTIFIT is a cardiac rehabilitation program delivered by the Movn smartphone application that will provide risk factor modification, prescribed exercises, education and counseling. The application will track activity using a built-in accelerometer or through connected devices such as a Fitbit for daily physical activity and management. Weight and blood pressure (BP) will be tracked by manual input or through wireless scales and BP monitors. The program will last for 12 weeks.
• Movn Pulmonary Rehabilitation
Movn pulmonary rehabilitation is a program delivered by the Movn smartphone application that includes targeted educational content and prescribed exercises with mild resistance training in addition to walking and other cardiovascular exercises. The application will track activity using a built-in accelerometer or through connected devices such as a Fitbit for daily physical activity and management. Weight and blood pressure (BP) will be tracked by manual input or through wireless scales and BP monitors. The program will last for 12 weeks.
• Standard of Care Cardiac Rehabilitation
Standard cardiac rehabilitation involves a facility's standard rehabilitation practices. Participants will be seen at baseline and during a 12 and 24 week follow-up visit.

Locations

Country	Name	City	State
United States	Atlanta VA Medical Center	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	Atlanta VA Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Functional Capacity assessed by the Six Minute Walk Test (6MWT)	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.	Week 12, Week 24
Secondary	Change in Measure of Exercise Intensity (MET)	An exercise test will be used to collect MET.	Baseline, Week 12
Secondary	Change in Weight	Weight will be measured in kilograms.	Baseline, Week 12
Secondary	Change in Body Mass Index (BMI)	Body Mass Index (BMI) is a person's weight in kilograms divided by the square of height in meters. A high BMI can be an indicator of high body fatness.	Baseline, Week 12
Secondary	Change in Blood Pressure	Blood pressure is measured using a blood pressure cuff to the upper extremity. The top number, which is also the higher of the two numbers, measures the pressure in the arteries when the heart beats (systolic).The bottom number, which is also the lower of the two numbers, measures the pressure in the arteries between heartbeats (diastolic). Readings are measured as follows: Normal = systolic less than 120 and diastolic less than 80 Prehypertension = systolic 120 - 139 or diastolic 80 - 89 High Blood Pressure (Hypertension) Stage 1 = systolic 140 - 159 or diastolic 90 - 99 High Blood Pressure(Hypertension) Stage 2 = systolic 160 or higher or diastolic 100 or higher Hypertensive Crisis (Emergency care needed) systolic = higher than 180 or diastolic higher than 110	Baseline, Week 12
Secondary	Change in A1c Level	The A1C test is a blood test that provides information about a person's average levels of blood glucose, also called blood sugar, over the past 3 months.; Levels are measured as follows: Normal = below 5.7 percent Diabetes = 6.5 percent or above Prediabetes = 5.7 to 6.4 percent	Baseline, Week 12
Secondary	Change in Low-density Lipoprotein (LDL) Level	LDL cholesterol is considered "bad" cholesterol because it contributes to plaque, a thick, hard deposit that can clog arteries and make them less flexible.; Levels are measured as follows: < 100 mg/ dL = Optimal 100-129 mg/dL = Near optimal/above optimal 130-159 mg/dL = Borderline high 160-189 mg/dL = High >190 mg/dL = Very high	Baseline, Week 12
Secondary	Change in Duke Activity Status Index (DASI) Score	The Duke Activity Status Index (DASI) is a 12-item questionnaire that utilizes self-reported physical work capacity to estimate peak metabolic equivalents. The DASI is scored by adding all activities performed together. A higher score indicates the ability to perform more physical activities.	Baseline, Week 12
Secondary	Change in Patient Health Questionnaire (PHQ-9) Score	The PHQ-9 is an instrument for screening, diagnosing, monitoring, and measuring the severity of depression.; Score ranges from 5-9 indicate minimal depressive symptoms. Scores 10-14 may indicate minor depression, dysthymia, and mild major depression. Scores 15-19 indicate moderately severe, major depression. Scores greater than or equal to 20 indicate severe major depression.	Baseline, Week 12