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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorROM Technologies, INC

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Under the age of 18

Adults lacking capacity to consent.

NYHA Functional Class III, IV

Acute coronary syndrome

Trial population

Adult patients who have undergone surgical or percutaneous coronary revascularization due to atherosclerotic coronary artery disease.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • ROMTech Portable Connect

    Device

    The ROMTech PortableConnect Rehab System is a continuous rehabilitative exercise therapy device that uses assisted movement to measure, evaluate, exercise, re-educate and strengthen muscles, and to increase joint range of motion.

Treatment groups

500 Participants
are divided into 1 treatment group
Group A: Cardiac patients1 intervention

Trial outcomes

Primary outcomes

1

Session attended

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)

Time frame
12 weeks (End of treatment)
2

Sessions completed

Measure the number of sessions completed to determine compliance of patients to utilize home-based cardiac rehab integrated with telemedicine

Time frame
12 weeks(End of treatment)
3

Duke Activity Status Index (DASI)

Estimate of functional capacity

Time frame
Baseline, 12 weeks (End of Treatment)
4

Patient Health Questionnaire(PHQ)

Quality of Life assessment

Time frame
Baseline, 12 weeks (End of Treatment)

Secondary outcomes

1

Laboratory assessment

To determine if there is an improvement in low density lipoprotein, triglycerides,

Time frame
Baseline, 12 weeks (End of Treatment)

Other outcomes

Sponsors and contacts

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