Active not recruitingOBSERVATIONAL

A Study to Compare Digital Disease Monitoring of Patients With csU (Telemedicine to Face-to-Face Visits) in Germany

This study is based in Germany and focuses on adults who have chronic spontaneous urticaria (CSU), often called chronic hives. It’s comparing two ways doctors monitor this condition: digital check-ups (like video calls or online forms) versus traditional face-to-face appointments. The main goal is to understand if digital monitoring helps patients report their symptoms more easily and regularly, and if this leads to better care. Researchers will also look at how patients and doctors feel about using tele-dermatology, including how easy it is to use and how well it works. This is an 'observational' study, meaning patients will continue with their usual care, and researchers will simply collect information about their experiences.

At a glance

Status

Active not recruiting

Sponsor

Novartis Pharmaceuticals

Enrolment target

116

Start

11 Jun 2024

Estimated completion

31 Dec 2025

Chronic Spontaneous Urticaria

What is this study about?

This study is investigating a common skin condition called chronic spontaneous urticaria (CSU), which is basically long-lasting hives that appear without a clear trigger. For many people with CSU, managing the condition requires regular check-ups with their doctor. This study wants to see if using digital technology, like online surveys or video calls with a dermatologist, can be just as good, or even better, than always going in for face-to-face appointments.

Today, many people are used to doing things online, and healthcare is no different. This study in Germany is looking at how patients with CSU are currently monitored – either through regular in-person visits or by using digital tools to check their symptoms. By comparing these two approaches, the researchers hope to learn if digital monitoring makes it simpler and quicker for patients to share how they're feeling and how their symptoms are impacting their daily lives.

Ultimately, the aim is to find out if these digital check-ups could improve the care patients receive. The study will also gather opinions from both patients and their doctors about using digital health services. They want to know if these services are easy to use, deliver good quality care, and are generally a helpful way to manage CSU.

Key takeaways

The study compares digital check-ups to in-person visits for chronic hives.
It aims to see if digital monitoring helps patients report symptoms more easily.
Your routine medical care for chronic spontaneous urticaria (CSU) will not change.
The study is observational, meaning no new treatments are given.
It's being conducted in Germany and focuses on adult patients.

Who may be eligible?

To be part of this study, you need to be an adult aged 18 or older and have a diagnosis of chronic spontaneous urticaria (CSU), also known as chronic hives. You must also be currently receiving medication or treatment for your CSU. Even if you have another type of long-lasting hives that can be triggered (like by pressure or cold), you might still be able to join.

A key requirement is that you feel comfortable and are able to use digital tools for your doctor visits, as the study involves monitoring through these methods. Before you start, you'll need to give your written permission to take part.

There are a few reasons why you might not be able to join. For example, if you are already involved in another clinical trial or research study at the same time, you wouldn't be eligible for this one.

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 18 years old or older?
Have you been diagnosed with chronic spontaneous urticaria (chronic hives)?
Are you currently receiving treatment or medication for your CSU?
Are you comfortable and able to use digital tools for doctor visits?
Are you NOT currently participating in any other clinical trials?

Answer every question to see your result.

What does participation involve?

If you join this study, your involvement will be quite straightforward because it's about observing your usual care. You won't be given any new or experimental treatments. Instead, the study will simply collect information about how your chronic spontaneous urticaria (CSU) is being monitored, either through your regular face-to-face visits or through digital check-ups, depending on what your doctor normally does.

You'll be asked to provide information about your symptoms and how you're feeling, often through questionnaires. If you're in the digital monitoring group, these might be provided automatically before or during your online interactions with your doctor. The study doesn't ask you to change your medication or how often you see your doctor; you'll continue with your routine medical care for CSU. The exact number of visits or digital check-ins will depend on your typical treatment plan, and the total length of your participation will align with how long your doctor would usually monitor your condition.

Potential risks and benefits

As this is an observational study that doesn't involve new medicines or procedures, the direct risks are very low. The main potential benefit is that your routine care might be slightly enhanced by more consistent symptom tracking, which could help your doctor manage your condition better. You also contribute to understanding how digital healthcare can improve services for people with chronic conditions. You are completely free to leave the study at any time without giving a reason, and this will not affect your ongoing medical care.

Locations (20)

Novartis Investigative Site
Verified postcode
Hamburg, Germany
Novartis Investigative Site
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Lingen, Germany
Novartis Investigative Site
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Koblenz, Germany
Novartis Investigative Site
Verified postcode
Leipzig, Germany
Novartis Investigative Site
Verified postcode
Halle, Germany
Novartis Investigative Site
Verified postcode
Ahaus, Germany
Novartis Investigative Site
Verified postcode
Berlin, Germany
Novartis Investigative Site
Verified postcode
Berlin, Germany
Novartis Investigative Site
Verified postcode
Bremen, Germany
Novartis Investigative Site
Verified postcode
Dortmund, Germany
Novartis Investigative Site
Verified postcode
Dresden, Germany
Novartis Investigative Site
Verified postcode
Freising, Germany

Common questions

What is chronic spontaneous urticaria (CSU)?

It's a type of chronic hives where itchy welts appear on your skin for six weeks or more, and there's no obvious trigger.

Is this study testing a new medicine?

No, this study isn't testing new medicines. It's looking at different ways doctors monitor patients with CSU, either in person or using digital tools.

What does 'digital monitoring' mean?

Digital monitoring could involve video calls with your doctor, using online forms to report your symptoms, or other electronic ways to check in on your health.

Do I have to live in Germany to join?

Yes, this specific study is being carried out in Germany, so you would need to be a patient there to participate.

Will my regular doctor visits change if I join?

No, the study aims to observe your usual care. Your doctor visits and ongoing treatment for CSU will continue as normal.