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Behavioural Intervention
Virtual Cardiac Rehab Program for Heart Disease (mTECH-Rehab Trial)
N/A
Waitlist Available
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 belowSelect...
I was hospitalized for a heart attack or had a procedure to open blocked arteries.
Select...
I am 18 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had heart complications after a heart attack or surgery.
Select...
I have an untreated severe heart block.
Select...
I have a history of serious depression.
Select...
My heart surgery did not fix all the blockages.
Select...
I have fallen at least once in the past year.
Select...
I have a history of cardiac arrest or sudden death.
Select...
I have been diagnosed with aortic dissection.
Select...
I am mentally capable of following the study's procedures.
Select...
I have a physical disability that prevents me from exercising safely.
Select...
My heart beats very fast (over 110 beats per minute) when I am resting.
Select...
I have severe heart valve problems causing symptoms.
Select...
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
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 moreAwards & 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.
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Who is running the clinical trial?
Johns Hopkins UniversityLead Sponsor
2,339 Previous Clinical Trials
14,881,414 Total Patients Enrolled
27 Trials studying Coronary Artery Disease
56,279 Patients Enrolled for Coronary Artery Disease
Apple Inc.Industry Sponsor
23 Previous Clinical Trials
1,791,439 Total Patients Enrolled
1 Trials studying Coronary Artery Disease
200 Patients Enrolled for Coronary Artery Disease
American Heart AssociationOTHER
346 Previous Clinical Trials
4,970,928 Total Patients Enrolled
12 Trials studying Coronary Artery Disease
1,639 Patients Enrolled for Coronary Artery Disease
Lena Mathews, MD, MHSPrincipal InvestigatorJohns Hopkins University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had heart complications after a heart attack or surgery.I have an untreated severe heart block.You have a heart device called a defibrillator.You have trouble seeing or hearing, which makes it difficult for you to use the treatment.I was hospitalized for a heart attack or had a procedure to open blocked arteries.I have a history of serious depression.My heart surgery did not fix all the blockages.I have fallen at least once in the past year.I have a history of cardiac arrest or sudden death.Your heart's pumping ability is less than 40%.I have been diagnosed with aortic dissection.I am mentally capable of following the study's procedures.I have a physical disability that prevents me from exercising safely.You have very high blood pressure when you are resting.My heart beats very fast (over 110 beats per minute) when I am resting.I have severe heart valve problems causing symptoms.I have a heart condition that blocks blood flow and my test shows a specific heart pressure is high.I am 18 years old or older.If initially too unwell, I can be reassessed for the trial later.
Research Study Groups:
This trial has the following groups:- Group 1: Corrie Hybrid Cardiac Rehabilitation Program (Intervention Group)
- Group 2: Facilitated Center-Based Cardiac Rehabilitation Program (Control Group)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.