Active not recruitingNAINTERVENTIONAL

Heart Failure Patient Management and Interventions Using Continuous Patient Monitoring Outside Hospitals and Real-world Data

This study aims to improve care for people with chronic heart failure, those with a heart transplant, or those supported by a ventricular assist device (a special heart pump). It uses smart devices to continuously monitor patients outside the hospital. Doctors hope this ongoing information will help them make quicker and more informed decisions about treatment, which could lead to fewer hospital visits, better health, and a higher quality of life. Participants will be split into two groups: one where doctors see the monitoring data to guide care, and another where they don't, to compare the benefits. All will use a mobile app and devices for 18 months.

At a glance

Status

Active not recruiting

Phase

Sponsor

Puerta de Hierro University Hospital

Enrolment target

390

Start

24 Apr 2024

Estimated completion

31 Aug 2026

Chronic Heart Failure Heart Transplant Recipient Left Ventricular Assist Device

What is this study about?

This research study wants to find a better way to look after people who have long-term heart failure, have had a heart transplant, or use a special heart support pump called a ventricular assist device (LVAD). Currently, doctors mainly see how you're doing during your hospital visits. This study tries a new approach by using technology to check your health constantly while you're at home.

The main idea is to build a digital system that collects information about you every day, like your vital signs, how active you are, and even how you're feeling. This system is designed to help your doctors by giving them a clearer and more up-to-date picture of your health. With this information, they might be able to adjust your treatments more quickly if needed, potentially preventing serious problems before they happen.

Ultimately, the study hopes that this new way of monitoring will mean fewer trips to the hospital for these heart conditions. It also aims to make sure patients feel safer, have a better quality of life, and improve their overall well-being. It's about seeing if continuous home monitoring can lead to better care than traditional check-ups alone.

Key takeaways

Uses smart devices for daily home health monitoring.
Aims to reduce hospital visits and improve well-being.
Suitable for specific heart failure, transplant, or LVAD patients.
Requires daily interaction with devices and a mobile app.
Involves 18 months of participation with 4 hospital visits.
Your usual medical care will continue as normal.

Who may be eligible?

To join this study, you generally need to be between 18 and 75 years old and be able to understand and agree to take part. You'll also need to score well on certain short tests that check your memory and mood, ensuring you don't have severe memory problems or significant depression.

If you have heart failure, you must have symptoms that affect your daily life (classed as NYHA Class II or III) and a specific measurement of your heart's pumping ability (LVEF of 40% or less). You also need to have been hospitalised or had an urgent emergency visit for your heart failure in the last year.

If you have a ventricular assist device (LVAD), it must have been fitted between 3 months and 4 years ago. If you've had a heart transplant, it must have been between 1 month and 3 years ago. There are also reasons you might not be able to join, such as if you've recently had a heart attack or are currently very unwell in hospital, receiving certain IV medications for your heart.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 18 and 75 years old?
Can you understand and agree to take part in a study?
Do you have chronic heart failure, a heart transplant (1-3 years ago), or an LVAD (3 months-4 years ago)?
Have you been hospitalised or had an urgent heart failure visit in the last year (if you have heart failure)?
Can you commit to using smart devices daily for 18 months?

Answer every question to see your result.

What does participation involve?

If you join the study, you'll be involved for about 18 months. You'll have four in-person medical visits at the hospital spaced out every four months, in addition to your usual appointments. These study visits will include a doctor's check-up, an ECG (heart tracing), a blood test, and a 6-minute walking test.

You'll be given several smart devices to use at home, including a smartphone with a special app, a blood pressure monitor, an oxygen level monitor, a digital scale, and a smartwatch. You'll need to use these devices daily to send information about your health through the app. The study team will help you set up all the devices. You'll also need to manually enter some information into the app each day, such as your body temperature, symptoms you might have (like tiredness or shortness of breath), and confirm you've taken your medicines. Your usual medical care and appointments for your heart condition will continue as normal and won't be affected by your participation in this study.

Potential risks and benefits

Taking part in this study might offer potential benefits, such as very close monitoring of your health which could lead to quicker adjustments in your treatment and potentially fewer hospital visits. However, it requires a daily commitment to using the devices and entering information into the app, which might feel like a burden to some. While all devices are standard and safe, there's always a small risk of technical issues. You are free to withdraw from the study at any time without giving a reason, and this will not affect your usual medical care.

Locations (6)

Medizinische Hochschule Hannover ('Mhh')
Verified postcode
Hanover, Germany
National and Kapodistrian University of Athens
Verified postcode
Athens, Greece
Onassis Cardiac Surgery Center
Verified postcode
Athens, Greece
Alma Mater Studiorum - Universita Di Bologna
Verified postcode
Bologna, Italy
Hospital Universitario Puerta de Hierro
Verified postcode
Majadahonda, Spain
Hospital Universitario Ramón Y Cajal
Verified postcode
Madrid, Spain

Common questions

What is the main goal of this study?

The main goal is to see if using smart devices to constantly monitor heart patients at home can help doctors make better decisions, leading to fewer hospital stays and a better quality of life.

Will my doctor always see my health data?

You'll be part of one of two groups. In one group, your doctors will see the data to help guide your care. In the other, they won't, so researchers can compare the effectiveness of this new monitoring method.

What devices will I need to use?

You'll use a smartphone, blood pressure monitor, oxygen monitor, scale, and a smartwatch. You'll also have home sensors for temperature and humidity. The study team will help you set them up.

How long will I be in the study?

Your participation in the study will last for 18 months, with four in-person check-ups at the hospital during that time.

Will this study change my regular doctor's appointments?

No, your normal medical appointments and treatments for your heart condition will continue as scheduled and won't be affected by taking part in this study.