Impact of a Mobile Technology Enabled Corrie Cardiac Rehabilitation Program on Functional Status and Cardiovascular Outcomes (mTECH-Rehab): A Randomized Controlled Trial

Johns Hopkins University1 site in 1 country259 target enrollmentApril 3, 2023

ConditionsCoronary Artery Disease Myocardial Infarction Myocardial Ischemia Coronary Artery Occlusion Coronary Artery Stenosis Stent Bypass Graft Occlusion Valve Heart Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Coronary Artery Disease
Sponsor: Johns Hopkins University
Enrollment: 259
Locations: 1
Primary Endpoint: 6-minute Walking Distance (Meters)
Status: Completed
Last Updated: 4 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

In this randomized clinical trial, the researchers are investigating whether a multi-component virtual/hybrid cardiac rehabilitation program will improve functional status, cholesterol level, overall cardiovascular health, individual risk factors, quality of life and mental health for patients who have recently been diagnosed with myocardial infarction, received a coronary stent, underwent heart surgery or catheter-based valve replacement, as compared to traditional, center-based cardiac rehabilitation.

Registry

clinicaltrials.gov

Start Date

April 3, 2023

End Date

October 14, 2024

Last Updated

4 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Johns Hopkins University

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•18 years or older
•Individuals admitted to the hospital for the following conditions or interventions during the index admission: Acute myocardial infarction (STEMI or NSTEMI type 1), Coronary artery bypass grafting (CABG), and Coronary artery angioplasty/stenting (PCI), Heart valve surgery, catheter-based aortic valve replacement (TAVR).
•Exclusion Criteria
•Non-English speaking
•Symptomatic severe aortic stenosis or other severe valvular disease
•Physical disability that would preclude safe and adequate exercise performance
•Hypertrophic obstructive cardiomyopathy with peak resting left ventricular outflow gradient of \>25 mmHg
•Known aortic dissection
•Severe resting arterial hypertension (Systolic blood pressure \>200 mmHg or diastolic BP \>110mmHg) at baseline assessment
•Mental impairment leading to inability to cooperate with study procedures

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

6-minute Walking Distance (Meters)

Time Frame: 12 weeks after randomization

Mean difference in 6 minute walk distance, between Intervention and Control groups, as measured at final study visit occurring at 12 weeks after randomization.

Secondary Outcomes

Composite Cardiovascular Health Metric for Secondary Prevention(12 weeks after randomization)
Blood Pressure (mmHg)(12 weeks after randomization)
Low Density Lipoprotein - Cholesterol (LDL-C)(12 weeks after randomization)
Glycosylated Hemoglobin (HbA1c)(12 weeks after randomization)
Body Mass Index (kg/m^2)(12 weeks after randomization)
Quality of Life as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health-10(12 weeks after randomization)
Blood Pressure Control(12 weeks after randomization)
Cholesterol (LDL-C) Control(12 weeks after randomization)
Diabetes Control(12 weeks after randomization)
Weight (BMI) Categories(12 weeks after randomization)
Physical Activity Categories(12 weeks after randomization)
Diet Categories(12 weeks after randomization)
Tobacco Use(12 weeks after randomization)
Cardiac Rehabilitation Engagement(12 weeks after randomization)