Smartphone Delivered In-home Cardiopulmonary Rehabilitation

NCT ID: NCT02791685

Last Updated: 2024-06-25

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2026-12-31

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.

Conditions

Cardiovascular Disease; Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

MULTIFIT Cardiac Rehabilitation

Intervention Type: BEHAVIORAL

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.

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.

Group Type: EXPERIMENTAL

Movn Pulmonary Rehabilitation

Intervention Type: BEHAVIORAL

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.

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.

Group Type: ACTIVE_COMPARATOR

Standard of Care Cardiac Rehabilitation

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Atlanta VA Medical Center

FED

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Amit J. Shah

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amit J Shah, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Atlanta VA Medical Center

Atlanta, Georgia, United States

Countries

United States

References

Harzand A, Alrohaibani A, Idris MY, Spence H, Parrish CG, Rout PK, Nazar R, Davis-Watts ML, Wright PP, Vakili AA, Abdelhamid S, Vathsangam H, Adesanya A, Park LG, Whooley MA, Wenger NK, Zafari AM, Shah AJ. Effects of a patient-centered digital health intervention in patients referred to cardiac rehabilitation: the Smart HEART clinical trial. BMC Cardiovasc Disord. 2023 Sep 12;23(1):453. doi: 10.1186/s12872-023-03471-w.

Reference Type: DERIVED

PMID: 37700245 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 30217377 (View on PubMed)

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

IRB00085938

Identifier Type: -

Identifier Source: org_study_id