Integration of Telemedicine and Home-Based Cardiac Rehabilitation: Feasibility, Efficacy, and Adherence
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Myocardial Infarction
- Sponsor
- ROM Technologies, INC
- Enrollment
- 500
- Locations
- 1
- Primary Endpoint
- Session attended
- Status
- Recruiting
- Last Updated
- 9 months ago
Overview
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.
Investigators
Eligibility Criteria
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
Exclusion Criteria
- •Under the age of 18
- •Adults lacking capacity to consent.
- •NYHA Functional Class III, IV
- •Acute coronary syndrome
- •Systolic heart failure (LV EF \<40%)
- •Status post cardiac surgery for structural heart disease or heart transplant
- •Percutaneous coronary angioplasty
- •Adults lacking capacity to consent.
- •Pregnant women
Outcomes
Primary Outcomes
Session attended
Time Frame: 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)
Time Frame: Baseline, 12 weeks (End of Treatment)
Estimate of functional capacity
Sessions completed
Time Frame: 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
Time Frame: Baseline, 12 weeks (End of Treatment)
Lower extremity functional assessment
Patient Health Questionnaire(PHQ)
Time Frame: Baseline, 12 weeks (End of Treatment)
Quality of Life assessment
Short Form-36
Time Frame: Baseline, 12 weeks (End of Treatment)
Quality of Life assessment
Secondary Outcomes
- Laboratory assessment(Baseline, 12 weeks (End of Treatment))