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

Relapsing Remitting Multiple Sclerosis

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

Inclusion Criteria6

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 Criteria4

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 \[SPMS\])

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.