RecruitingNCT05949580

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

Study to Evaluate the Usability of Introducing Integrated Digital Solutions Into Clinical Practice and the Value of Their Use in the Medical Care of Patients With Multiple Sclerosis (MS)


Sponsor

Hoffmann-La Roche

Enrollment

500 participants

Start Date

Oct 21, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

The main purpose of this study is to assess the usability and value of the multiple sclerosis (MS) care management platform in terms of improved monitoring of people with MS (pwMS) in clinical practice. This is a two-year prospective data collection study with additional data collection at baseline evaluating medical practice over a period of at least one year before the introduction of the MS care management platform.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating a smartphone app called icompanion ms that helps people with relapsing-remitting multiple sclerosis (RRMS) track their health and communicate with their care team. Researchers want to understand how useful and valuable this type of digital tool is in everyday MS care. **You may be eligible if...** - You have been diagnosed with relapsing-remitting multiple sclerosis (RRMS) - Your MS diagnosis was confirmed at least 1 year ago - You have a smartphone capable of running the app (Android 5.0+ or iOS 11+) - You have a valid email address - Your disability level is mild to moderate (EDSS score below 5.5) - Your medical history has been recorded for at least 1 year **You may NOT be eligible if...** - You have progressive MS (primary or secondary progressive) - You are unable to complete an MRI scan - You are currently enrolled in another interventional clinical trial Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEMS Care Platform (icobrain ms and icompanion ms)

The MS care management platform consists of the following components: 1. icobrain ms which is a a cloud-based solution to quantify brain volume and brain abnormalities and changes thereof on MRI scans; 2. icompanion ms which consists of free participant mobile application (app) and a web portal for HCPs. The information collected in the icompanion ms patient app and icobrain ms is then brought together in the icompanion ms HCP web portal which allows a comprehensive overview of disease data for every single participant.


Locations(5)

Minneapolis Clinic of Neurology

Golden Valley, Minnesota, United States

Hackensack University Medical Center

Hackensack, New Jersey, United States

Jersey Shore University Medical Centre

Neptune City, New Jersey, United States

Universitaetsklinikum Carl Gustav Carus an der TU Dresden

Dresden, Germany

Praxis Dr. med. Max Deist und Michael Ernst ?Sinsheim

Sinsheim, Germany

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NCT05949580


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