Impact of a Corrie Cardiac Rehabilitation Program

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

259 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-03

Study Completion Date

2024-10-14

Brief Summary

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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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Corrie Hybrid Cardiac Rehabilitation Program (Intervention Group)

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

Group Type EXPERIMENTAL

Corrie Hybrid Cardiac Rehabilitation Program

Intervention Type COMBINATION_PRODUCT

The Corrie Hybrid Cardiac Rehabilitation Program is a multi-component intervention. It consists of the Corrie smartphone app for cardiovascular health optimization which is paired with wristband device (Apple Watch or Fitbit), Bluetooth-enabled Omron blood pressure monitor and exercise resistance bands. The program also includes individualized treatment plan development, setting health goals and communication with trained Corrie Health Coach. Furthermore, the intervention includes motivational text messages sent to participants throughout the study to aid with risk factor modification.

Facilitated Center-Based Cardiac Rehabilitation Program (Control Group)

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Corrie Hybrid Cardiac Rehabilitation Program

The Corrie Hybrid Cardiac Rehabilitation Program is a multi-component intervention. It consists of the Corrie smartphone app for cardiovascular health optimization which is paired with wristband device (Apple Watch or Fitbit), Bluetooth-enabled Omron blood pressure monitor and exercise resistance bands. The program also includes individualized treatment plan development, setting health goals and communication with trained Corrie Health Coach. Furthermore, the intervention includes motivational text messages sent to participants throughout the study to aid with risk factor modification.

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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
* Untreated high degree atrioventricular block
* Atrial fibrillation with uncontrolled ventricular rate (Heart rate \>110 at rest) at baseline assessment
* History of cardiac arrest or sudden death
* Myocardial infarction or cardiac surgery complications with cardiogenic shock and/or congestive heart failure and/or signs/symptoms of post-procedure ischemia
* Left ventricular ejection fraction \<40%
* History of Clinically significant depression
* Visual or hearing impairment which precludes the use of the intervention
* Presence of cardiac defibrillator
* Incomplete revascularization procedure
* History of one or more episodes of falls in the last year
* Pregnancy

* If patients are deemed clinically unstable and unable to participate at the time of initial screening, the research team member may return at a later date to determine whether this status has changed.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No