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

Recruiting

• Conditions: Percutaneous Transluminal Coronary Angioplasty; Stable Angina; Cardiac Rehabilitation; Stent; Myocardial Infarction; Coronary Artery Bypass; Heart Failure; Valve Disease, Heart
• Interventions: Device: ROMTech Portable Connect

• Registration Number: NCT05972070
• Lead Sponsor: ROM Technologies, INC

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.

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 Timeline

• Study Start: 2023-06-01
• Study First Submitted: 2023-07-03
• Study First Submitted QC: 2023-07-24
• Study First Posted: 2023-08-02
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-13
• Last Update Posted: 2024-02-15
• Primary Completion: 2024-10-31
• Study Completion: 2024-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cardiac patients	ROMTech Portable Connect	Adult patients who have undergone surgical or percutaneous coronary revascularization due to atherosclerotic coronary artery disease.

Primary Outcome Measures

Name	Time	Method
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)
Duke Activity Status Index (DASI)	Baseline, 12 weeks (End of Treatment)	Estimate of functional capacity
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
Short Physical Performance Battery	Baseline, 12 weeks (End of Treatment)	Lower extremity functional assessment
Patient Health Questionnaire(PHQ)	Baseline, 12 weeks (End of Treatment)	Quality of Life assessment
Short Form-36	Baseline, 12 weeks (End of Treatment)	Quality of Life assessment

Secondary Outcome Measures

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

Trial Locations

Locations (1)

ROMTech; 🇺🇸 Brookfield, Connecticut, United States