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Behavioural Intervention

Virtual Cardiac Rehab Program for Heart Disease (mTECH-Rehab Trial)

N/A

Recruiting

Led By Lena Mathews, MD, MHS

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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, and coronary artery angioplasty/stenting.

18 years or older

Must not have

Myocardial infarction or cardiac surgery complications with cardiogenic shock and/or congestive heart failure and/or signs/symptoms of post-procedure ischemia

Untreated high degree atrioventricular block

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks after randomization

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether a multi-component virtual cardiac rehabilitation program can help improve cholesterol levels, cardiovascular health, quality of life and mental health for patients recently diagnosed with atherosclerotic cardiovascular disease.

Who is the study for?

This trial is for adults who've been hospitalized with heart issues like a heart attack or had procedures like bypass grafting or stenting. It's not for those who don't speak English/Spanish, have severe valve disease, physical disabilities preventing exercise, uncontrolled high blood pressure, certain heart complications, severe depression, sensory impairments that hinder using the program, pregnant women or if they're clinically unstable.

What is being tested?

The study tests a virtual cardiac rehab program alongside usual care to see if it betters patients' functional status and overall heart health compared to just standard care. This includes looking at cholesterol levels and mental well-being in people recently diagnosed with cardiovascular diseases.

What are the potential side effects?

Since this is a non-drug intervention focusing on rehabilitation through virtual means there may be minimal side effects directly from the program itself; however indirect effects might include discomfort due to new exercises or stress from technology use.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I was hospitalized for a heart attack or had a procedure to open blocked arteries.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had heart complications after a heart attack or surgery.

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I have an untreated severe heart block.

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I have a history of serious depression.

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My heart surgery did not fix all the blockages.

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I have fallen at least once in the past year.

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I have a history of cardiac arrest or sudden death.

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I have been diagnosed with aortic dissection.

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I am mentally capable of following the study's procedures.

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I have a physical disability that prevents me from exercising safely.

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My heart beats very fast (over 110 beats per minute) when I am resting.

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I have severe heart valve problems causing symptoms.

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I have a heart condition that blocks blood flow and my test shows a specific heart pressure is high.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks after randomization

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks after randomization

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks after randomization for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

The difference in functional status as measured by 6 minute walk test

Secondary study objectives

Cost of Care as assessed by a Markov Model of Cost-effectiveness

Difference in smoking rates as measured by the proportion of current tobacco users

The difference in Health Literacy as measured by The (e) Health Literacy Scale (eHEALS)

+25 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Corrie Hybrid Cardiac Rehabilitation Program (Intervention Group)Experimental Treatment1 Intervention

Receives Corrie Virtual Cardiac Rehabilitation Program along with option to continue traditional, center-based cardiac rehabilitation.

Group II: Facilitated Center-Based Cardiac Rehabilitation Program (Control Group)Active Control1 Intervention

Receives traditional, center-based cardiac rehabilitation. The study team will help facilitate the logistics of receiving center-based cardiac rehabilitation, including proper referrals.

0 / 14Eligibility criteria met