Evaluating a digital platform for managing multiple sclerosis care

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)

This study is testing a digital platform to see if it helps people with relapsing remitting multiple sclerosis manage their care better over two years.

Quick facts

• Study type: Observational
• Enrollment: 500 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Hoffmann-La Roche (industry)
• Locations: 5 sites (Golden Valley, Minnesota and 4 other locations)
• Trial ID: NCT05949580 on ClinicalTrials.gov

What this trial studies

This observational study aims to assess the usability and value of a digital care management platform specifically designed for individuals with relapsing remitting multiple sclerosis (RRMS). The study will collect data over two years, including a baseline evaluation of medical practices prior to the platform's introduction. The platform includes icobrain, an AI solution for analyzing MRI scans, and icompanion, a mobile app for patients to track their health and medications. Healthcare professionals will have access to patient data and MRI reports through a dedicated web portal.

Who should consider this trial

Good fit: Ideal candidates include individuals diagnosed with relapsing remitting multiple sclerosis who have been diagnosed for at least one year and can use a smartphone app.

Not a fit: Patients with progressive forms of multiple sclerosis or those unable to complete an MRI may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the monitoring and management of multiple sclerosis, leading to better patient outcomes.

How similar studies have performed: Other studies have shown promise in using digital platforms for chronic disease management, suggesting potential success for this approach.

Eligibility criteria

Inclusion Criteria:

* Able to comply with the study protocol, including having a smartphone and being able and willing to access the icompanion ms patient app on a regular basis. To use all functionalities of the icompanion ms patient app, the user's smartphone must comply with the minimum system requirements (Android version 5.0 or above, iOS version 11 or above)
* Have a valid email address (for registration of icompanion ms)
* Have a definite diagnosis of RRMS
* Time since MS diagnosis ≥1 year
* Medical history recorded for at least 1 year before enrollment
* Expanded Disability Status Scale (EDSS) \<5.5

Exclusion Criteria:

* Any contra-indications to using icompanion ms patient app or website, as per the investigator's discretion
* Inability to complete an MRI
* Currently involved in an interventional trial
* Diagnosis of progressive MS (primary progressive multiple sclerosis \[PPMS\] or secondary progressive multiple sclerosis \[SPMS\])

Where this trial is running

Golden Valley, Minnesota and 4 other locations

• Minneapolis Clinic of Neurology — Golden Valley, Minnesota, United States (RECRUITING)
• Hackensack University Medical Center — Hackensack, New Jersey, United States (RECRUITING)
• Jersey Shore University Medical Centre — Neptune City, New Jersey, United States (RECRUITING)
• Universitaetsklinikum Carl Gustav Carus an der TU Dresden — Dresden, Germany (RECRUITING)
• Praxis Dr. med. Max Deist und Michael Ernst ?Sinsheim — Sinsheim, Germany (RECRUITING)

Study contacts

• Study coordinator: MN44358 https://forpatients.roche.com/

Conditions: Relapsing Remitting Multiple Sclerosis, icobrain, icompanion, Multiple Sclerosis, Medical device, Patient app, Digital, Care management