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NCT05972070Recruiting

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

ROM Technologies, INC

Start Date

6/1/2023

Completion Date

12/31/2025

Summary

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

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.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: 1. Over the age of 18 2. NYHA Functional Class I, II, 3. 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) 4. Candidate for traditional center-based cardiac rehabilitation Exclusion Criteria: 1. Under the age of 18 2. Adults lacking capacity to consent. 3. NYHA Functional Class III, IV 4. Acute coronary syndrome 5. Systolic heart failure (LV EF \<40%) 6. Status post cardiac surgery for structural heart disease or heart transplant 7. Percutaneous coronary angioplasty 8. Adults lacking capacity to consent. 9. Pregnant women

Interventions

DEVICE

ROMTech Portable Connect

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Conditions

Myocardial InfarctionPercutaneous Transluminal Coronary AngioplastyCoronary Artery BypassStable AnginaHeart FailureValve Disease, HeartCardiac RehabilitationStent

Locations

ROMTech

Brookfield, Connecticut 06804

United States