What side effects are associated with this type of intervention?

Common treatments for heart failure, such as ACE inhibitors, beta-blockers, diuretics, and digitalis, can have various side effects. ACE inhibitors may cause cough, elevated blood potassium levels, and kidney dysfunction. Beta-blockers can lead to fatigue, cold extremities, and bradycardia. Diuretics often result in electrolyte imbalances, dehydration, and kidney issues. Digitalis can cause nausea, vomiting, and arrhythmias. Telemonitoring and positive behavior change interventions, like those studied in the Medly trial, generally have fewer direct side effects but may include issues related to technology use, such as data privacy concerns and the need for patient adherence to monitoring protocols.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of heart failure, including beta-blockers like metoprolol and carvedilol, which help manage heart rate and blood pressure. Additionally, angiotensin-converting enzyme (ACE) inhibitors and angiotensin II receptor blockers (ARBs) such as enalapril and losartan are commonly used to reduce the workload on the heart. More recently, digital health interventions like telemonitoring systems have been explored to improve self-care management and clinical outcomes in heart failure patients. These systems, such as the Medly telemonitoring program, aim to promote positive behavior change and individualized outpatient care, potentially reducing hospital readmissions and improving quality of life.

What other types of research exist?

Promising novel alternatives to Medly for heart failure patients in 2024 include: 1) Advanced telemonitoring systems with AI-driven predictive analytics to anticipate decompensation events, 2) Wearable devices integrated with telehealth platforms for continuous monitoring and real-time feedback, 3) Implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy (CRT) devices with remote monitoring capabilities, 4) Regenerative therapies focusing on cardiac tissue repair and regeneration, and 5) Comprehensive digital health platforms that combine telemonitoring with personalized behavior change programs and virtual coaching.

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Digital Health Intervention

Telemonitoring for Heart Failure (Medly-AID Trial)

Q: What is the mechanism of action of this treatment?

Common treatments for heart failure include medications such as ACE inhibitors, beta-blockers, diuretics, and aldosterone antagonists. ACE inhibitors and beta-blockers work by reducing the workload on the heart and improving its efficiency, while diuretics help to remove excess fluid from the body, reducing symptoms like swelling and shortness of breath. Aldosterone antagonists help to prevent fluid retention and reduce the risk of hospitalization. Telemonitoring and positive behavior change, as studied in the Medly trial, enhance these treatments by enabling continuous monitoring of vital signs and promoting adherence to medication and lifestyle changes. This approach helps in early detection of worsening symptoms, timely intervention, and overall better management of heart failure, leading to improved quality of life and reduced hospital readmissions.

N/A

Waitlist Available

Led By Emily Seto, 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

Adults (18 years or older)

Hospitalization for decompensated HF > 48 hours

Must not have

Terminal diagnosis of any health condition with a life expectancy < 1 year

Patients who will require inpatient rehabilitation after discharge

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 month, 3 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will test a new smartphone app, Medly, for patients recently diagnosed with heart failure. The app is designed to help manage self-care and improve quality of life. The trial will measure if the app leads to a reduction in 30-day readmissions rates, without increasing the average length of stay or visits to the emergency department.

Who is the study for?

This trial is for adults over 18 who've been hospitalized for heart failure longer than 48 hours. They must speak and read English (or have a caregiver who can translate) to use the Medly app, which monitors their condition after discharge. People with dementia, psychiatric illnesses, terminal conditions, or those in long-term care or other trials cannot join.

What is being tested?

The study tests if using the Medly telemonitoring system improves self-care and quality of life for heart failure patients post-discharge. It also checks if Medly reduces hospital readmissions within 30 days without increasing emergency visits or hospital stay lengths.

What are the potential side effects?

Since this trial involves monitoring through an app rather than medication, traditional side effects are not expected. However, there may be indirect effects related to stress from technology use or data privacy concerns.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

Select...

I was hospitalized for heart failure symptoms for more than 48 hours.

Exclusion Criteria

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

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My doctor expects I have less than a year to live due to my condition.

Select...

I will need inpatient rehab after I leave the hospital.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 month, 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 month, 3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 month, 3 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change BNP/NT-pro BNP levels

Change in NYHA class

Change in quality of life

+2 more

Secondary study objectives

30-day HF readmission rate

Hospital length of stay

Number of visits to the emergency department

Other study objectives

Safety Endpoint: Change in creatinine levels

Safety Endpoint: Change in potassium levels

Safety Endpoint: Change in sodium levels

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: Telemonitoring (Medly)Experimental Treatment1 Intervention

Medly is a smartphone application allows heart failure (HF) patients to measure and record their daily weight, blood pressure (BP), heart rate, and self-reported symptoms. This monitoring information is then transmitted wirelessly to a data server where an algorithm is used to generate an alert to a healthcare provider as necessary. The patient also receives an automated self-care message based on their measurements and reported symptoms.

Group II: ControlActive Control1 Intervention

Standard of care: Control groups will receive standard medical care when discharged from hospital, including discharge instructions, home medications as well as follow-up in a heart failure clinic or with a primary care doctor.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Medly

2016

N/A

~100

0 / 4Eligibility 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 heart failure include medications such as ACE inhibitors, beta-blockers, diuretics, and aldosterone antagonists. ACE inhibitors and beta-blockers work by reducing the workload on the heart and improving its efficiency, while diuretics help to remove excess fluid from the body, reducing symptoms like swelling and shortness of breath. Aldosterone antagonists help to prevent fluid retention and reduce the risk of hospitalization. Telemonitoring and positive behavior change, as studied in the Medly trial, enhance these treatments by enabling continuous monitoring of vital signs and promoting adherence to medication and lifestyle changes. This approach helps in early detection of worsening symptoms, timely intervention, and overall better management of heart failure, leading to improved quality of life and reduced hospital readmissions.