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Smartphone Delivered In-home Cardiopulmonary Rehabilitation

Primary Purpose

Cardiovascular Disease, Coronary Artery Disease

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MULTIFIT Cardiac Rehabilitation
Movn Pulmonary Rehabilitation
Standard of Care Cardiac Rehabilitation
Sponsored by
Emory University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiovascular Disease focused on measuring Cardiac Rehabilitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Atlanta VA Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Cardiac Rehabilitation - Movn Program

Pulmonary Rehabilitation - Movn Program

Traditional Cardiac Rehabilitation

Arm Description

Participants with coronary artery disease (CAD) and chronic obstructive pulmonary disease (COPD) who are eligible for cardiac rehabilitation will undergo an in-home 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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in Measure of Exercise Intensity (MET)
An exercise test will be used to collect MET.
Change in Weight
Weight will be measured in kilograms.
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.
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
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
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
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.
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.

Full Information

First Posted
June 2, 2016
Last Updated
May 31, 2023
Sponsor
Emory University
Collaborators
Atlanta VA Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02791685
Brief Title
Smartphone Delivered In-home Cardiopulmonary Rehabilitation
Official Title
Smartphone Delivered In-home Cardiopulmonary Rehabilitation
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 2016 (undefined)
Primary Completion Date
September 2025 (Anticipated)
Study Completion Date
December 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
Collaborators
Atlanta VA Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: Determine whether a home-based cardiac or pulmonary rehabilitation program delivered through smartphones is feasible and improves functional status. Determine if education and lifestyle counseling lead to increased adherence with prescribed follow-up, pharmacotherapy, quality of life, self-efficacy and lifestyle changes. Determine if a home-based cardiac or pulmonary rehabilitation program reduces health system utilization, including ED visits and readmission rates.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Disease, Coronary Artery Disease
Keywords
Cardiac Rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cardiac Rehabilitation - Movn Program
Arm Type
Experimental
Arm Description
Participants with coronary artery disease (CAD) and chronic obstructive pulmonary disease (COPD) who are eligible for cardiac rehabilitation will undergo an in-home program.
Arm Title
Pulmonary Rehabilitation - Movn Program
Arm Type
Experimental
Arm Description
Participants with stable chronic obstructive pulmonary disease (COPD) or hospitalized with an acute exacerbation of COPD will undergo an in-home pulmonary rehabilitation program.
Arm Title
Traditional Cardiac Rehabilitation
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
MULTIFIT Cardiac Rehabilitation
Intervention Description
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
Intervention Name(s)
Movn Pulmonary Rehabilitation
Intervention Description
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
Intervention Name(s)
Standard of Care Cardiac Rehabilitation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Functional Capacity assessed by the Six Minute Walk Test (6MWT)
Description
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.
Time Frame
Week 12, Week 24
Secondary Outcome Measure Information:
Title
Change in Measure of Exercise Intensity (MET)
Description
An exercise test will be used to collect MET.
Time Frame
Baseline, Week 12
Title
Change in Weight
Description
Weight will be measured in kilograms.
Time Frame
Baseline, Week 12
Title
Change in Body Mass Index (BMI)
Description
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.
Time Frame
Baseline, Week 12
Title
Change in Blood Pressure
Description
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
Time Frame
Baseline, Week 12
Title
Change in A1c Level
Description
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
Time Frame
Baseline, Week 12
Title
Change in Low-density Lipoprotein (LDL) Level
Description
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
Time Frame
Baseline, Week 12
Title
Change in Duke Activity Status Index (DASI) Score
Description
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.
Time Frame
Baseline, Week 12
Title
Change in Patient Health Questionnaire (PHQ-9) Score
Description
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.
Time Frame
Baseline, Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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. Following acute myocardial infarction (within the preceding 12 months) Coronary artery bypass grafting (CABG) Current stable angina pectoris Heart valve repair or replacement Percutaneous transluminal coronary angioplasty (PTCA) or coronary stenting Heart or heart-lung transplant 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amit J Shah, MD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Atlanta VA Medical Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30217377
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.
Results Reference
derived

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Smartphone Delivered In-home Cardiopulmonary Rehabilitation

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