RecruitingRecruiting
Integration of Telemedicine and Home-Based Cardiac Rehabilitation: Feasibility, Efficacy, and Adherence
NCT05972070 · ROM Technologies, INC
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
About this study
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
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
Enrollment target: 500 participants
Age groups: adult, older_adult
Timeline
Starts: 2023-06-01
Estimated completion: 2025-12-31
Last updated: 2025-07-24
Interventions
Device: ROMTech Portable Connect
Primary outcomes
- • Session attended (12 weeks (End of treatment))
- • Sessions completed (12 weeks(End of treatment))
- • Duke Activity Status Index (DASI) (Baseline, 12 weeks (End of Treatment))
Sponsor
ROM Technologies, INC · industry
Contacts & investigators
ContactLaToya T. King · contact · Latoya.King@romtech.com · 2035184735
All locations (1)
ROMTechRecruiting
Brookfield, Connecticut, United States