Actively Recruiting
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)
Led by Hoffmann-La Roche · Updated on 2026-01-20
500
Participants Needed
5
Research Sites
39 weeks
Total Duration
On this page
Sponsors
H
Hoffmann-La Roche
Lead Sponsor
I
icometrix
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the usability and value of a care management platform designed for people with relapsing-remitting multiple sclerosis (RRMS). This observational study aims to improve monitoring and medical care by integrating digital solutions, including artificial intelligence analysis of brain MRI scans and a mobile app for patient-reported health data. The study will collect data prospectively over two years, with additional information gathered at baseline to compare medical practice before the platform's introduction. The platform includes icobrain ms, an AI-based system that measures brain volume and abnormalities from MRI scans to detect early disease changes. It also features icompanion ms, which offers a free mobile app and website for participants to record health and medication information, and a web portal for healthcare professionals to review this data along with MRI reports. Participants with RRMS will complete questionnaires through the app, while healthcare providers will use the portal to complete related assessments. Participants will be involved for at least two years, during which they will provide patient-reported outcomes and undergo MRI scans. Researchers will assess usability scores of the app and web portal, changes in perceptions of disease progression, time needed for MRI reviews and visit preparations, medication adherence, and health literacy. Engagement with the platform and factors influencing its use by healthcare professionals will also be monitored throughout the study period.
CONDITIONS
Brief Title
Study to Evaluate the Usability and Value of Integrated Digital Solutions in Medical Care of Participants With Multiple Sclerosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to comply with the study protocol, including having a smartphone and being able and willing to access the icompanion ms patient app regularly
- Smartphone must meet minimum system requirements (Android 5.0 or above, iOS 11 or above)
- Have a valid email address for app registration
- Definite diagnosis of relapsing-remitting multiple sclerosis (RRMS)
- Time since MS diagnosis is at least 1 year
- Medical history available for at least 1 year before enrollment
- Expanded Disability Status Scale (EDSS) score less than 5.5
You will not qualify if you...
- Contraindications to using the icompanion ms patient app or website as determined by investigator
- Inability to complete an MRI
- Currently participating in an interventional trial
- Diagnosis of progressive multiple sclerosis (primary or secondary progressive MS)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 months
Participants will use the MS care management platform, which includes a mobile application to report health and medication information, and healthcare professionals will use a web portal to access participant data and MRI reports.
Regular assessments via the participant app and healthcare professional portal throughout the study period
Duration - Up to 24 months
Participants' engagement with the platform and health status are monitored over time through questionnaires and data collected via the app and healthcare professional portal.
Monthly data collection and assessments up to 24 months
Trial Site Locations
Total: 5 locations
1
Minneapolis Clinic of Neurology
Golden Valley, Minnesota, United States, 55422
Actively Recruiting
2
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Actively Recruiting
3
Jersey Shore University Medical Centre
Neptune City, New Jersey, United States, 07753
Actively Recruiting
4
Universitaetsklinikum Carl Gustav Carus an der TU Dresden
Dresden, Germany, 01307
Actively Recruiting
5
Praxis Dr. med. Max Deist und Michael Ernst ?Sinsheim
Sinsheim, Germany, 74889
Actively Recruiting
Research Team
M
MN44358 https://forpatients.roche.com/
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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