RecruitingOBSERVATIONAL

Study to Evaluate the Usability and Value of Integrated Digital Solutions in Medical Care of Participants With Multiple Sclerosis

This study explores a new digital system designed to better help people with Relapsing Remitting Multiple Sclerosis (RRMS). Researchers want to find out how useful and easy to use this 'MS care platform' is in real-life medical care. The platform has two main parts: a smart computer program (called icobrain ms) that uses Artificial Intelligence (AI) to look at brain scans and spot very small changes over time, and a patient app and website (called icompanion ms) where you can track your health and prepare for appointments. There's also a system for your healthcare team to see this information. This study will follow people for two years, and also look at their medical notes from the year before they started using the platform. The goal is to see if these digital tools improve how people with MS are monitored and cared for.

At a glance

Status

Recruiting

Sponsor

Hoffmann-La Roche

Enrolment target

500

Start

21 Oct 2024

Estimated completion

31 Mar 2028

Relapsing Remitting Multiple Sclerosis

What is this study about?

This study is investigating a new digital system, or 'platform', designed to help people living with Relapsing Remitting Multiple Sclerosis (RRMS). The main idea is to see how useful and easy to use these digital tools are in everyday medical care. The researchers want to find out if they can help doctors keep a closer eye on your condition and provide better care.

The digital platform has two key parts. Firstly, there's a clever computer program called 'icobrain ms'. This uses Artificial Intelligence (AI), which is like very smart computer software, to analyse your brain scans (MRIs). It can spot tiny changes in your brain size or any new areas of damage that might be too small for the eye to easily see. This helps doctors understand how your MS might be progressing over time, even if you don't feel any changes yet.

Secondly, there's 'icompanion ms', which includes a free mobile phone app and a website for you to use. With this, you can keep a record of how you're feeling, what medicines you're taking, and prepare for your next doctor's appointment. There's also a part for your healthcare team, where they can see the information you enter (if you agree to share it) and access your brain scan results from icobrain ms. This study will follow people for two years, and also look back at their medical history from the year before they started using the platform. Essentially, they want to understand if bringing all this information together digitally can improve how MS is monitored and managed.

Key takeaways

This study explores a new digital system for managing RRMS.
It uses AI to analyse brain scans and a mobile app to track your health.
The goal is to see if these tools improve MS monitoring and care.
Participation involves using a smartphone app and sharing health data.
You need a smartphone and email, and an RRMS diagnosis of at least one year.
It's about evaluating digital tools, not testing new medications.

Who may be eligible?

To join this study, you need to have a confirmed diagnosis of Relapsing Remitting Multiple Sclerosis (RRMS) and have been diagnosed for at least one year. Your doctor would also need to have notes about your health stretching back for at least one year before you start the study.

It's important that you have a smartphone that can run the study's app (Android version 5.0 or newer, or iPhone iOS version 11 or newer), and you should be comfortable using it regularly. You'll also need a valid email address to sign up for the app. The study is looking for people whose MS-related disability is not too severe, specifically with an Expanded Disability Status Scale (EDSS) score less than 5.5. Essentially, this means you can walk without needing help for at least 100 metres.

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.

Do you have a definite diagnosis of Relapsing Remitting MS (RRMS)?
Have you been diagnosed with MS for at least one year?
Do you have a smartphone that can run recent apps (iPhone 11+ or Android 5.0+)?
Do you have a valid email address you use regularly?
Can you generally walk without needing constant help for about 100 metres or more?

Answer every question to see your result.

What does participation involve?

If you take part in this study, you'll be using a special mobile app and website called 'icompanion ms' regularly to track your health and medicines. Your healthcare team will also use 'icobrain ms', a computer program that analyses your MRI brain scans to look for changes over time. The study will collect information for two years while you're using these tools. They will also look back at your medical notes and brain scans from the year before you started using the platform to compare. You won't have to take any new medications just for this study, as it's focused on how well the digital tools work. The total duration of active participation and data collection will be for two years, with pre-study data also being reviewed.

Potential risks and benefits

Participating in this study might help improve how your MS is monitored, potentially giving you and your healthcare team a clearer, more up-to-date picture of your condition through detailed brain scan analysis and personal health tracking. However, it involves regularly using an app and sharing your health information, which might feel like extra commitment. There's also the chance you might experience technical issues with the app. You are free to stop participating in the study at any time, for any reason, without it affecting your usual medical care.

Locations (5)

Minneapolis Clinic of Neurology
Verified postcode
Golden Valley, United States· Recruiting
Hackensack University Medical Center
Verified postcode
Hackensack, United States· Recruiting
Jersey Shore University Medical Centre
Verified postcode
Neptune City, United States· Recruiting
Universitaetsklinikum Carl Gustav Carus an der TU Dresden
Verified postcode
Dresden, Germany· Recruiting
Praxis Dr. med. Max Deist und Michael Ernst ?Sinsheim
Verified postcode
Sinsheim, Germany· Recruiting

Common questions

What is Relapsing Remitting Multiple Sclerosis (RRMS)?

RRMS is a type of MS where you have periods of new or worsening symptoms (relapses) followed by periods of recovery (remissions).

What is an MRI scan?

An MRI (Magnetic Resonance Imaging) is a type of scan that uses strong magnets and radio waves to create detailed pictures of the inside of your body, including your brain.

What is AI (Artificial Intelligence)?

AI is computer software that can perform tasks that usually require human intelligence, like analysing medical images to spot patterns and changes.

Do I need any special equipment to join?

Yes, you'll need your own smartphone (iPhone 11 or newer, or Android 5.0 or newer) and a valid email address to use the study app.

Will my doctor know I'm in the study?

Yes, your healthcare team will be involved as the study looks at how they use the digital platform too.

How to find out more

MN44358 https://forpatients.roche.com/

global-roche-genentech-trials@gene.com 888-662-6728 (U.S. Only) Official trial record

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