RecruitingOBSERVATIONAL

WeRoaM: Wearable Remote Monitoring in Heart Failure

This research is exploring a new way to monitor children with heart failure from their own homes using special wearable clothing. Currently, children with heart problems usually need to visit the hospital often, which can be hard for some families. This study aims to test if a 'smart' shirt, which tracks things like heart rate and breathing, can safely monitor children and help predict if they might become unwell. If successful, this technology could mean children get more care at home, reducing hospital visits and making healthcare fairer for everyone. The study will look at whether the system works well and is easy for families to use, and if it can accurately spot signs of trouble early on.

At a glance

Status

Recruiting

Sponsor

University of Alberta

Enrolment target

100

Start

24 Feb 2025

Estimated completion

31 Dec 2028

Heart Failure

What is this study about?

This study, called "WeRoaM," is looking into new ways to help children with heart failure by monitoring them remotely – essentially, from home. Currently, most children with heart failure need to go to the hospital regularly for check-ups. This can be difficult for families, especially if they live far away, have limited income, or juggle other responsibilities. This new approach uses special wearable technology to keep an eye on a child’s health without them needing to leave their house.

We already know that this type of remote monitoring can be very helpful for adults with heart failure, helping them stay out of the hospital and improving their quality of life. However, this hasn't been properly tested for children yet. Children come in all shapes and sizes, and their bodies work differently, so we need to make sure the technology is suitable and accurate for them. This study will involve using a 'smart' shirt that can measure important things like heart rate, breathing, and activity, along with other home checks like blood pressure and weight.

The main goal is to find out if this home monitoring system is practical and acceptable for children and their families. We also want to see if the information collected can help doctors predict if a child’s heart condition might get worse early on. If this new system works well, it could mean fewer hospital visits for children, less disruption for families, and better, more equal access to care for all young patients with heart failure.

Key takeaways

Exploring home monitoring for children with heart failure.
Using a 'smart' shirt to track vital signs.
Aims to reduce hospital visits and improve access to care.
Focused on children aged 8-18 with heart failure or at risk.
Hopes to make healthcare more convenient and equitable.
Will assess how well the system works and is liked by families.

Who may be eligible?

To be part of this study, children need to be between 8 and 18 years old and be seen regularly as outpatients (meaning they visit the hospital but don't stay overnight). They should have a certain chest size so that the special monitoring shirt fits correctly. The child must have heart failure or be at risk of developing it. This can be due to various reasons, such as having a heart problem from birth, certain muscle disorders, or conditions that affect the heart’s pumping ability.

There are also some reasons why a child might not be able to join. For example, if they've had surgery very recently (within the last three months) or if they use a special device to help their heart pump blood. Children who can't use technology easily, either themselves or their caregiver, or those who don't speak English, won't be able to take part. Also, if a child has a pacemaker or an implanted heart defibrillator, they won't be able to join. Lastly, the study device needs to fit properly, so children with chest sizes that are too big or too small for the available shirts won't be included.

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.

Is your child between 8 and 18 years old?
Does your child attend outpatient heart clinics?
Does your child have heart failure or are they at risk?
Can your child's chest fit the monitoring shirt (at least 69.85 cm around)?
Can you or your child comfortably use technology?
Has your child NOT had surgery in the last 3 months?

Answer every question to see your result.

What does participation involve?

If your child takes part in this study, they will need to wear a special 'smart' textile shirt that remotely monitors their heart rate, heart rhythm, breathing rate, and activity. This shirt works with a monitoring platform. You'll also be asked to help with additional home monitoring, which includes checking blood pressure, oxygen levels, and weight regularly. The full duration of participation isn't specified in detail, but it will involve using these devices and sharing the collected health information. There are no specific visits, medication changes, or follow-up plans mentioned beyond the home monitoring itself. The study aims to look at how well this system works over time.

Potential risks and benefits

Participating in this study might offer your child the potential benefit of closer home monitoring of their heart condition, which could lead to earlier detection of any changes. This could potentially reduce their need for frequent hospital visits. However, there's always a chance that the wearable device might be uncomfortable or that using the technology could be a bit challenging at first. The study is designed to be as safe as possible and we don't expect any serious risks from wearing the monitoring items. Remember, taking part in any study is entirely voluntary, and you have the right to withdraw your child at any time, for any reason, without it affecting their ongoing standard medical care.

Locations (4)

Stollery Children's Hospital
Verified postcode
Edmonton, Canada· Recruiting
BC Children's Hospital
Verified postcode
Vancouver, Canada· Not yet recruiting
The Hospital for Sick Children
Verified postcode
Toronto, Canada· Not yet recruiting
CHU Sainte-Justine
Verified postcode
Montreal, Canada· Not yet recruiting

Common questions

What is 'remote physiologic monitoring'?

It's a way for doctors to keep an eye on your child's health from home, using special devices that measure things like heart rate and breathing.

What is 'heart failure' in children?

Heart failure means the heart isn't pumping blood as well as it should. It can be caused by different things in children.

Will my child have to visit the hospital more often for this study?

No, the main idea of this study is to see if monitoring can be done from home, potentially reducing the need for hospital visits.

What kind of device will my child wear?

Your child will wear a 'smart' shirt made from special fabric that can track their heart rate, breathing, and activity.

What if we don't speak English?

Unfortunately, participation is currently limited to English-speaking families.

How to find out more

Jennifer L Conway, MD, MSc

jennifer.conway2@ahs.ca 780-407-4848 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.