Clinical trial NCT05972070: Integration of Telemedicine and Home-Based Cardiac Rehabilitation: Feasibility, Efficacy, and Adherence
Official title: Integration of Telemedicine and Home-Based Cardiac Rehabilitation: Feasibility, Efficacy, and Adherence
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Myocardial Infarction
Percutaneous Transluminal Coronary Angioplasty
Coronary Artery Bypass
Stable Angina
Heart Failure
Valve Disease, Heart
Cardiac Rehabilitation
Stent
Keywords: Cardiac rehabilitation
Home based cardiac rehabilitation
Telemedicine and Home-Based Cardiac Rehabilitation
Lead sponsor: ROM Technologies, INC
Sponsor class: INDUSTRY
First posted: 2023-08-02
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients who have undergone surgical or percutaneous coronary revascularization due to atherosclerotic coronary artery disease.

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.

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

Primary outcomes:
measure: Session attended
timeFrame: 12 weeks (End of treatment)
measure: Sessions completed
timeFrame: 12 weeks(End of treatment)
measure: Duke Activity Status Index (DASI)
timeFrame: Baseline, 12 weeks (End of Treatment)
measure: Patient Health Questionnaire(PHQ)
timeFrame: Baseline, 12 weeks (End of Treatment)
measure: Short Physical Performance Battery
timeFrame: Baseline, 12 weeks (End of Treatment)
measure: Short Form-36
timeFrame: Baseline, 12 weeks (End of Treatment)
Secondary outcomes:
measure: Laboratory assessment
timeFrame: Baseline, 12 weeks (End of Treatment)
Other outcomes:
Locations:
city: Brookfield
country: United States
facility: ROMTech
state: Connecticut
Study officials:
References: