NCT05949580

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)

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The MS care management platform consists of: A) icobrain ms, a cloud-based artificial intelligence (AI) solution to quantify brain volume and brain abnormalities and changes thereof on magnetic resonance imaging (MRI) scans and thereby providing insights into subclinical changes during disease progression in MS. B) icompanion ms, which consists of i) A free participant mobile application (app) and website to keep track of participant reported health and medications and prepare participants for the next consultation. ii) A web portal for healthcare professionals (HCPs), which is accessible via web browser. The MS care team will be able to access the participants' data entered via the participant app (active linking of systems by the participant required), as well as their participants' MRI images and icobrain ms volumetric brain reports automatically imported by the hospital picture archiving and communications system (PACS).

Conditions

• Relapsing Remitting Multiple Sclerosis

Interventions

Type	Name	Description
DEVICE	MS 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.

Timeline

• Start date: 2024-10-21
• Primary completion: 2027-06-30
• Completion: 2028-03-31
• First posted: 2023-07-18
• Last updated: 2026-01-20

Locations

5 sites across 2 countries: United States, Germany

Regulatory

• FDA-regulated device study