What is the mechanism of action of this treatment?

Common treatments for cardiac dysfunction include pharmacologic therapies such as beta-blockers, ACE inhibitors, and diuretics, which work by reducing the heart's workload, lowering blood pressure, and decreasing fluid buildup, respectively. Non-pharmacologic treatments include lifestyle modifications and cardiac rehabilitation, which improve cardiovascular health through exercise, diet, and education. These treatments are crucial as they help manage symptoms, prevent disease progression, and improve quality of life. The MyCardiacRecovery (MyCaRe) application supports these treatments by providing structured education, tracking recovery progress, and enhancing communication between patients and healthcare providers, ensuring a comprehensive and coordinated approach to cardiac care.

What side effects are associated with this type of intervention?

Common treatments for cardiac dysfunction include pharmacotherapy, mechanical devices, and lifestyle interventions. Pharmacotherapy often involves medications like beta-blockers, ACE inhibitors, and diuretics, which can cause side effects such as fatigue, dizziness, electrolyte imbalances, and renal dysfunction. Mechanical devices like implantable cardioverter-defibrillators (ICDs) can lead to complications such as infection, lead displacement, and inappropriate shocks. Lifestyle interventions, including structured education and exercise programs, generally have fewer side effects but may cause muscle soreness or fatigue initially. Enhanced communication and recovery tracking, as seen in the MyCardiacRecovery (MyCaRe) application, aim to improve adherence and outcomes with minimal adverse effects.

What prior FDA approvals exist?

The FDA has approved several treatments for cardiac dysfunction that align with the components of the MyCardiacRecovery (MyCaRe) application. These include beta-blockers like metoprolol and carvedilol, which are used to manage heart failure and improve survival. Additionally, angiotensin-converting enzyme (ACE) inhibitors such as enalapril and angiotensin II receptor blockers (ARBs) like losartan are approved for reducing the risk of cardiovascular events. The use of telemedicine and remote monitoring devices, such as the CardioMEMS HF System, has also been approved to track patient recovery and enhance communication between patients and healthcare providers. These treatments collectively support structured education, recovery tracking, and enhanced communication in managing cardiac dysfunction.

What other types of research exist?

Promising alternatives to the MyCardiacRecovery (MyCaRe) application for cardiac dysfunction patients include: 1) Mobile health applications like the 'Heart Failure Health Storylines' app, which offers symptom tracking, medication reminders, and educational resources. 2) Wearable devices such as the Apple Watch or Fitbit, which provide continuous heart rate monitoring, activity tracking, and integration with health apps for comprehensive health management. 3) Telehealth platforms like 'Teladoc' or 'Amwell,' which facilitate remote consultations, continuous monitoring, and personalized care plans. These technologies collectively offer structured education, recovery tracking, and enhanced communication, making them viable alternatives for cardiac care in 2024.

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MyCaRe App for Cardiac Surgery Recovery (MyCaRe Trial)

N/A

Recruiting

Led By Tracey J Colella, PhD

Research Sponsored by University Health Network, Toronto

Eligibility Criteria Checklist

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

Must have

Age > 35 years

Undergoing traditional (sternotomy approach) coronary artery bypass graft (CABG) surgery

Must not have

Sustained in-hospital post-surgical complications of major significance (such as stroke, deep wound infections, pericardial effusion, etc.)

Have cardiac surgery procedures other than CABG

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 8 weeks post operative discharge

Awards & highlights

No Placebo-Only Group

Summary

This trial tests the MyCardiacRecovery (MyCaRe) app, which helps heart surgery patients track their recovery and stay connected with their doctors. The app provides educational materials, monitors healing and activity, and ensures patients get referred to rehab programs. The goal is to improve patient outcomes and satisfaction.

Who is the study for?

The MyCaRe clinical trial is for individuals aged 35 or older who have had a traditional coronary artery bypass graft surgery without complications and stayed in the hospital for 4-8 days. Participants must understand study instructions, use an app/Fitbit, have home wifi, hear phone conversations well, and live in/near Toronto or be willing to mail back devices.

What is being tested?

This pilot RCT tests the MyCaRe Android application designed to aid cardiac recovery post-surgery. It offers educational content, tracks wound healing and activity via photos and Fitbit data, improves patient-provider communication, and streamlines referrals to outpatient care.

What are the potential side effects?

Since this intervention involves using an application rather than medication or invasive procedures, typical medical side effects are not expected. However, participants may experience issues related to technology use such as privacy concerns or stress from learning new tech.

Eligibility Criteria

Inclusion Criteria

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

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I am older than 35 years.

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I am having open-heart surgery to improve blood flow to my heart.

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My hospital stay is expected to last 4 to 8 days.

Exclusion Criteria

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

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I have had major complications after surgery while in the hospital.

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I have had heart surgery that was not a bypass.

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I do not have any mental health conditions that affect my ability to think or communicate.

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I cannot walk by myself at a speed of 2 mph.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 weeks post operative discharge

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~8 weeks post operative discharge

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks post operative discharge for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Enrolment in cardiac rehabilitation

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: MyCaRe Android ApplicationExperimental Treatment1 Intervention

The MyCaRe mobile application (education and symptom monitoring which includes pain, mood scales, wound monitoring) and Fitbit accelerometer (steps walked, distance) will be provided to patients receiving intervention group allocation for the initial 6 to 8 weeks recovery post cardiac surgery. The patients will be provided a temporary loan mobile device loaded with MyCaRe and Fitbit Inspire 2 before leaving hospital. They will be asked to input data (pain, mood, wounds, activity, blood sugar, blood pressure) daily if possible in first 2 weeks and once weekly thereafter until 6 to 8 weeks or until entry to a cardiac rehabilitation program.

Group II: Usual CareActive Control1 Intervention

Patients receiving usual care are typically referred to CR at the time of discharge from the acute care center via paper or electronic systematic referral (completed by a physician or nurse practitioner). Additionally, a conversation with the patient regarding CR by a healthcare provider may occur, however this communication is not always a consistent occurrence. Once referred, patients will await contact from a CR program in their region/area and if actual program enrollment occurs, this usually happens between 8 to 10 weeks post discharge.

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for cardiac dysfunction include pharmacologic therapies such as beta-blockers, ACE inhibitors, and diuretics, which work by reducing the heart's workload, lowering blood pressure, and decreasing fluid buildup, respectively. Non-pharmacologic treatments include lifestyle modifications and cardiac rehabilitation, which improve cardiovascular health through exercise, diet, and education. These treatments are crucial as they help manage symptoms, prevent disease progression, and improve quality of life. The MyCardiacRecovery (MyCaRe) application supports these treatments by providing structured education, tracking recovery progress, and enhancing communication between patients and healthcare providers, ensuring a comprehensive and coordinated approach to cardiac care.