Actively Recruiting
Integration of Telemedicine and Home-Based Cardiac Rehabilitation: Feasibility, Efficacy, and Adherence
Led by ROM Technologies, INC · Updated on 2025-07-24
500
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the feasibility, effectiveness, and patient adherence of a home-based cardiac rehabilitation program that incorporates telemedicine. It focuses on patients who have undergone coronary revascularization due to atherosclerotic coronary artery disease. The study assesses multiple aspects including quality of life, nutritional counseling, exercise capacity measured by metabolic equivalents (METs), diabetes management, tobacco cessation, lipid and blood pressure control, and psychosocial support. Participants will start with an initial review and risk assessment before beginning 36 rehabilitation sessions led by a cardiac rehab specialist. These sessions include pre-session questions, surveys, vital sign measurements before, during, and after exercise, guided exercise protocols, and additional exercises performed off the device. The ROMTech PortableConnect Rehab System, a device that assists movement and monitors muscle activity and joint motion, is used as part of the exercise therapy. Throughout the study, participants will be monitored using various assessments such as the Duke Activity Status Index, Patient Health Questionnaire, Short Physical Performance Battery, and Short Form-36 at baseline and after 12 weeks. Laboratory tests are also conducted at these timepoints. The study tracks session attendance and completion to evaluate adherence. The total duration of participation is 12 weeks, concluding with an end-of-treatment evaluation of physical and psychosocial outcomes.
CONDITIONS
Brief Title
Integration of Telemedicine and Home-Based Cardiac Rehabilitation: Feasibility, Efficacy, and Adherence
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Over the age of 18
- NYHA Functional Class I or II
- Recent (within 60 days) 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
You will not qualify if you...
- Under the age of 18
- Adults lacking capacity to consent
- NYHA Functional Class III or IV
- Acute coronary syndrome
- Systolic heart failure with left ventricular ejection fraction less than 40%
- History of cardiac surgery for structural heart disease or heart transplant
- Percutaneous coronary angioplasty
- Pregnant women
- Adults lacking capacity to consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 60 days prior to starting rehabilitation
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person or remote)
Duration - Approximately 12 weeks
Participants use the ROMTech Portable Connect device as part of home-based cardiac rehabilitation with telemedicine integration, including pre-session questions, surveys, vital signs monitoring, exercise protocols, and off-the-device exercises.
36 rehabilitation sessions
Trial Site Locations
Total: 1 location
1
ROMTech
Brookfield, Connecticut, United States, 06804
Actively Recruiting
Research Team
L
LaToya T. King
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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