Integration of Telemedicine and Home-Based Cardiac Rehabilitation: Feasibility, Efficacy, and Adherence

Study Overview
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Brief Summary
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The aim of this study is to evaluate feasibility, efficacy, and adherence of home-based cardiac rehabilitation with the integration of telemedicine. Several components will be assessed such as quality-of-life, nutritional counseling, maximum metabolic activity (MET's), diabetic management, tobacco cessation, lipid, blood pressure, and psychosocial management. These tasks will be accomplished through concurrent conversations between patients and their therapist's utilizing telemedicine with observed exercise training.

Detailed Description
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The focus of this study is to determine the feasibility, efficacy, and adherence of home-based cardiac rehabilitation with the integration of telemedicine. The study consists of an initial review, rehabilitation sessions, nutrition consultation, and risk stratification. Once the patient is cleared for the rehabilitation program, they will be assigned a cardiac rehab specialist and begin the 36 rehabilitation sessions. The sessions include pre-session questions, surveys, pre-, during, and post vitals, exercise protocol, and off-the-device exercises.

Official Title
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Integration of Telemedicine and Home-Based Cardiac Rehabilitation: Feasibility, Efficacy, and Adherence

Conditions
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Myocardial Infarction, Percutaneous Transluminal Coronary Angioplasty, Coronary Artery Bypass, Stable Angina, Heart Failure, Valve Disease, Heart, Cardiac Rehabilitation, Stent

Intervention / Treatment
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* Device: ROMTech Portable Connect


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Over the age of 18 NYHA Functional Class I, II, Recent (within 60 days) status post coronary artery revascularization for atherosclerotic coronary artery disease (coronary artery bypass grafting or percutaneous coronary revascularization with stent implantation) Candidate for traditional center-based cardiac rehabilitation Exclusion Criteria: Under the age of 18 Adults lacking capacity to consent. NYHA Functional Class III, IV Acute coronary syndrome Systolic heart failure (LV EF <40%) Status post cardiac surgery for structural heart disease or heart transplant Percutaneous coronary angioplasty Adults lacking capacity to consent. Pregnant women

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cardiac patients<br>Adult patients who have undergone surgical or percutaneous coronary revascularization due to atherosclerotic coronary artery disease. | Device: ROMTech Portable Connect<br>* The ROMTech PortableConnect Rehab System is a continuous rehabilitative exercise therapy device that uses assisted movement to measure, evaluate, exercise, re-educate and strengthen muscles, and to increase joint range of motion.<br>* Other names: ROMTech PortableConnect Rehab System;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Session attended | Measure the number of sessions attended to determine the ease of patients to utilize home-based cardiac rehab integrated with telemedicine (non-inferiority to historical controls) | 12 weeks (End of treatment) | 
| Sessions completed | Measure the number of sessions completed to determine compliance of patients to utilize home-based cardiac rehab integrated with telemedicine | 12 weeks(End of treatment) | 
| Duke Activity Status Index (DASI) | Estimate of functional capacity | Baseline, 12 weeks (End of Treatment) | 
| Patient Health Questionnaire(PHQ) | Quality of Life assessment | Baseline, 12 weeks (End of Treatment) | 
| Short Physical Performance Battery | Lower extremity functional assessment | Baseline, 12 weeks (End of Treatment) | 
| Short Form-36 | Quality of Life assessment | Baseline, 12 weeks (End of Treatment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Laboratory assessment | To determine if there is an improvement in low density lipoprotein, triglycerides, | Baseline, 12 weeks (End of Treatment) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiac rehabilitation, Home based cardiac rehabilitation, Telemedicine and Home-Based Cardiac Rehabilitation