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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05972070
• Other study ID #: ROMTherapy_HBCR_1001
• Status: Recruiting
• Start date: June 1, 2023
• Est. completion date: November 30, 2024

Study information

• Verified date: February 2024
• Source: ROM Technologies, INC
• Contact: LaToya T. King
• Phone: 2035184735
• Email: Latoya.King[@]romtech.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: November 30, 2024
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Angina, Stable
• Cardiac Rehabilitation
• Coronary Artery Bypass
• Heart Failure
• Heart Valve Diseases
• Infarction
• Myocardial Infarction
• Percutaneous Transluminal Coronary Angioplasty
• Stable Angina
• Stent
• Valve Disease, Heart

Intervention

Device:
• ROMTech Portable Connect
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.

Locations

Country	Name	City	State
United States	ROMTech	Brookfield	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
ROM Technologies, INC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	12 weeks (End of treatment)
Primary	Sessions completed	Measure the number of sessions completed to determine compliance of patients to utilize home-based cardiac rehab integrated with telemedicine	12 weeks(End of treatment)
Primary	Duke Activity Status Index (DASI)	Estimate of functional capacity	Baseline, 12 weeks (End of Treatment)
Primary	Patient Health Questionnaire(PHQ)	Quality of Life assessment	Baseline, 12 weeks (End of Treatment)
Primary	Short Physical Performance Battery	Lower extremity functional assessment	Baseline, 12 weeks (End of Treatment)
Primary	Short Form-36	Quality of Life assessment	Baseline, 12 weeks (End of Treatment)
Secondary	Laboratory assessment	To determine if there is an improvement in low density lipoprotein, triglycerides,	Baseline, 12 weeks (End of Treatment)