RecruitingNAINTERVENTIONAL

Digital Health Promotion for Children With Congenital Heart Disease and Their Guardians

This research project is exploring how a digital health programme can support children aged 8-13 who were born with heart problems, also known as congenital heart disease. Often, these children don't get enough physical activity. This study will develop and test a 12-week online programme, including a special fitness watch (Garmin Vivofit Jr. 2), to help children become more active. We will continuously track their activity levels to see if the programme makes a difference. Beyond physical activity, we'll also look at how it affects their overall quality of life, eating habits, and understanding of health. We also want to see if the programme improves the quality of life and health knowledge of their parents or guardians. The goal is to find new ways to help these children and their families lead healthier lives.

At a glance

Status

Recruiting

Phase

Sponsor

Deutsches Herzzentrum Muenchen

Enrolment target

Start

01 Oct 2024

Estimated completion

01 Feb 2026

Congenital Heart Disease Pediatric ALL

What is this study about?

This research is looking into how digital tools can help children who were born with heart conditions (called congenital heart disease) to be more active and healthier. Around 1 in 100 babies are born with a heart condition, and sometimes these children find it harder to get enough exercise compared to other children their age. Getting enough physical activity is really important for everyone's health, particularly for children with heart conditions.

At the moment, there aren't many digital tools specifically designed to encourage physical activity in children with congenital heart disease. So, this study plans to create and test a special 12-week online programme. This programme will be for children aged 8 to 13 and their parents or guardians. As part of the programme, children will wear a fitness tracker similar to a smartwatch, called a Garmin Vivofit Jr. 2. This device will help continuously monitor how active they are throughout the day.

The main goal of the study is to see if this digital programme helps children get more moderate to vigorous physical activity (like brisk walking or playing active games) and increases their daily steps. We'll also be checking to see if it improves their overall quality of life, eating habits, and how much they understand about staying healthy. For parents too, we'll be looking at their quality of life and health knowledge. We hope this research will show if digital health tools can be a good way to support these children and their families in building healthier lifestyles.

Key takeaways

A study for children aged 8-13 with moderate/complex congenital heart disease.
Uses a digital programme and a special fitness watch to boost activity.
Aims to improve activity, quality of life, and health knowledge for children and parents.
Will last for 12 weeks and involve remote assessments.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To take part in this study, children need to be between 8 and 14 years old. They must have a congenital heart condition that is considered moderate or complex. Also, their heart condition shouldn't be causing significant symptoms that limit their everyday activities, meaning they can generally do their usual tasks without too much trouble.

Parents or guardians must be willing and able to give written permission for their child to join the study.

Children won't be able to join if they have learning difficulties or other conditions that would make it very hard for them to understand and follow the study tasks. They also can't take part if their heart doctor has advised them not to participate in sports or physical activity.

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 14 years old?
Does your child have a heart condition they were born with which has been described by their doctor as moderate or complex?
Is your child generally able to do their usual activities without major symptoms?
Is their heart doctor happy for them to take part in physical activity?
Does your child not have significant learning difficulties that would make it hard to understand tasks?

Answer every question to see your result.

What does participation involve?

If you and your child decide to take part, the study will last for 12 weeks. Your child will receive a special fitness watch, a Garmin Vivofit Jr. 2, to wear. This watch will track their physical activity continuously throughout the study period. You and your child will also engage with a digital programme designed to encourage healthy lifestyles.

Throughout the 12 weeks, there will be assessments to measure things like your child's activity levels, quality of life, and understanding of health. We'll also look at your quality of life and health knowledge as a parent. These assessments will likely involve filling out questionnaires or taking part in short activities. There aren't any specific medications involved, and you won't need to visit a hospital or clinic just for this study; everything will be conducted digitally or remotely. The exact time commitment will be explained in full detail before you decide to join.

Potential risks and benefits

Taking part in this study may offer several potential benefits. Your child might become more physically active and learn more about healthy living, which could improve their overall well-being and quality of life. As a parent, you might also find your quality of life and understanding of health improves. There are minimal risks involved in this study; the fitness tracker is safe to wear, and the digital programme is designed to be helpful and engaging. There is always the potential for uncomfortable feelings when discussing health, but support will be available. Remember, your participation is completely voluntary, and you are free to withdraw your child from the study at any time, for any reason, without it affecting their medical care.

Locations (1)

Department of Paediatric Cardiology and Congenital Heart Defects, German Heart Center of the State Bavaria (Munich), Technical University of Munich (TUM)
Verified postcode
München, Germany· Recruiting

Common questions

What is 'congenital heart disease'?

Congenital heart disease means a heart condition that a child is born with, rather than developing later in life.

What is a 'digital health intervention'?

It's a health programme delivered using technology, like a website, an app, or in this case, a special fitness tracker and online content.

Will my child have to do intense exercise?

No, the study aims to encourage moderate to vigorous activity that is safe for your child, reviewed by their heart doctor, and in line with their abilities. It's about being more active, not extreme exercise.

What is a 'Garmin Vivofit Jr. 2'?

It's a type of fitness tracker, like a small smartwatch, designed for children. It monitors steps and activity levels.

What does 'NYHA Class I or II' mean?

This refers to how much a heart condition limits a person's activity. Class I means no limits from symptoms, and Class II means slight limits with ordinary activity, but no symptoms at rest.

How to find out more

Jan Müller, Prof. Dr.

j.mueller@tum.de ‭0176 21149304‬ Official trial record

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