Smartphone Delivered In-home Cardiopulmonary Rehabilitation

May 31, 2023 updated by: Amit J. Shah, Emory University
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30033
        • Atlanta VA Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
Experimental: 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.
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.
Active Comparator: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Functional Capacity assessed by the Six Minute Walk Test (6MWT)
Time Frame: Week 12, Week 24
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Measure of Exercise Intensity (MET)
Time Frame: Baseline, Week 12
An exercise test will be used to collect MET.
Baseline, Week 12
Change in Weight
Time Frame: Baseline, Week 12
Weight will be measured in kilograms.
Baseline, Week 12
Change in Body Mass Index (BMI)
Time Frame: Baseline, Week 12
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
Change in Blood Pressure
Time Frame: Baseline, Week 12

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
Change in A1c Level
Time Frame: Baseline, Week 12

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
Change in Low-density Lipoprotein (LDL) Level
Time Frame: Baseline, Week 12

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
Change in Duke Activity Status Index (DASI) Score
Time Frame: Baseline, Week 12
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
Change in Patient Health Questionnaire (PHQ-9) Score
Time Frame: Baseline, Week 12

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Emory University

Collaborators

Atlanta VA Medical Center

Investigators

  • Principal Investigator: Amit J Shah, MD, Emory University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Estimated)

September 1, 2025

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

June 2, 2016

First Submitted That Met QC Criteria

June 2, 2016

First Posted (Estimated)

June 7, 2016

Study Record Updates

Last Update Posted (Estimated)

June 2, 2023

Last Update Submitted That Met QC Criteria

May 31, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00085938

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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