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Trial record 40 of 54 for:    COPD OR COPD OR chronic obstructive pulmonary disease OR chronic bronchitis OR emphysema | Recruiting, Not yet recruiting, Available Studies | NIH, U.S. Fed

Smartphone Delivered In-home Cardiopulmonary Rehabilitation

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ClinicalTrials.gov Identifier: NCT02791685
Recruitment Status : Recruiting
First Posted : June 7, 2016
Last Update Posted : February 1, 2019
Sponsor:
Collaborator:
Atlanta VA Medical Center
Information provided by (Responsible Party):
Amit J. Shah, MD, MSc, Emory University

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.

Condition or disease Intervention/treatment
Cardiovascular Disease Coronary Artery Disease Behavioral: MULTIFIT Cardiac Rehabilitation Behavioral: Movn Pulmonary Rehabilitation Behavioral: Standard of Care Cardiac Rehabilitation

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.

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Smartphone Delivered In-home Cardiopulmonary Rehabilitation
Study Start Date : May 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.

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.

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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Change in Measure of Exercise Intensity (MET) [ Time Frame: Baseline, Week 12 ]
    An exercise test will be used to collect MET.

  2. Change in Weight [ Time Frame: Baseline, Week 12 ]
    Weight will be measured in kilograms.

  3. 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.

  4. 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


  5. 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


  6. 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


  7. 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.

  8. Change in Rate your Plate Assessment Score [ Time Frame: Baseline, Week 12 ]

    The Rate your Plate Assessment measures eating behaviors and food choices over the past six months.

    Scoring is as follows:

    35-42 Excellent = keep eating those healthy foods. 16-34 Good = overall you are on the right path. 1-15 Fair = a visit with our nutritionists is recommended. 0 or less Poor = highly recommend you visit with a nutritionists to give you some specific guidelines to improve your diet and decrease your risk for chronic disease.


  9. 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.


  10. Change in the Number of Cumulative Exercise Minutes Per Week [ Time Frame: Baseline, Week 12 ]
    Participants will be asked to provide the number of cumulative exercise minutes per week via the Lifestyle Questionnaire. Change is defined as the difference in the number of minutes exercised per week from baseline to week 12.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Veterans from Atlanta, Cincinnati, Gainesville, Ann Arbor, Palo Alto, and San Francisco
Criteria

Cohort A:

Inclusion Criteria:

Meet eligibility for cardiac rehabilitation program as defined by Centers for Medicare & Medicaid Services (CMS)

  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)

Cohort B:

Inclusion Criteria:

Meet eligibility for pulmonary rehabilitation as defined by the American Thoracic Society (ATS):

  1. Symptomatic impairment attributable to pulmonary disability
  2. Failure of standard medical regimen to achieve adequate symptomatic relief
  3. Motivated, adherent patient

Exclusion Criteria:

  • Lack of motivation
  • Non-adherence
  • Severe cognitive dysfunction or psychiatric illness
  • Unstable comorbidity (unstable angina, decompensated heart failure)
  • Severe exercise-induced hypoxemia, not correctable with O2 supplementation
  • Inability to exercise due to severe lung or other disease (arthritis, stroke)
  • Cigarette smoking

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02791685


Contacts
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Contact: Abarmard Zafari, MD (404) 327-4019 azafari@emory.edu

Locations
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United States, Georgia
Atlanta VA Medical Center Recruiting
Atlanta, Georgia, United States, 30033
Contact: Amit Shah, MD    404-321-6111 ext 205523    ajshah3@emory.edu   
Sponsors and Collaborators
Emory University
Atlanta VA Medical Center
Investigators
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Principal Investigator: Abarmard Zafari, MD Emory University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Amit J. Shah, MD, MSc, Assistant Professor, Emory University
ClinicalTrials.gov Identifier: NCT02791685     History of Changes
Other Study ID Numbers: IRB00085938
First Posted: June 7, 2016    Key Record Dates
Last Update Posted: February 1, 2019
Last Verified: January 2019
Keywords provided by Amit J. Shah, MD, MSc, Emory University:
Cardiac Rehabilitation
Additional relevant MeSH terms:
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Coronary Artery Disease
Cardiovascular Diseases
Coronary Disease
Myocardial Ischemia
Heart Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases