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

Sponsor

ROM Technologies, INC (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05972070

Collaborator

(none)

500

Enrollment

Location

Anticipated Duration (Months)

83.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Myocardial Infarction Percutaneous Transluminal Coronary Angioplasty Coronary Artery Bypass Stable Angina Heart Failure Valve Disease, Heart Cardiac Rehabilitation Stent	Device: ROMTech Portable Connect

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

500 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jun 1, 2023

Anticipated Primary Completion Date :

Oct 31, 2023

Anticipated Study Completion Date :

Nov 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Cardiac patients Adult patients who have undergone surgical or percutaneous coronary revascularization due to atherosclerotic coronary artery disease.	Device: ROMTech Portable Connect 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. Other Names: ROMTech PC ROMTech PortableConnect Rehab System

Arm

Intervention/Treatment

Cardiac patients

Adult patients who have undergone surgical or percutaneous coronary revascularization due to atherosclerotic coronary artery disease.

Device: ROMTech Portable Connect

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.

Other Names:

ROMTech PC

ROMTech PortableConnect Rehab System

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Laboratory assessment [Baseline, 12 weeks (End of Treatment)]
To determine if there is an improvement in low density lipoprotein, triglycerides,

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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