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

Roche

Status: Enrolling

Conditions: Relapsing Remitting Multiple Sclerosis

Treatments: Device: MS Care Platform (icobrain ms and icompanion ms)

Study type: Observational

Funder types: Industry

Identifiers

NCT05949580

MN44358

Details and patient eligibility

About

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.

Full 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).

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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])

Trial design

500 participants in 1 patient group

People with RRMS

Description:

Participants with relapsing-remitting multiple sclerosis (RRMS) will have to complete various questionnaire from which data will be collected for patient-reported outcomes (PROs) using the icompanion patient app and the HCPs will complete various questionnaires using the icompanion HCP portal.

Treatment:

Device: MS Care Platform (icobrain ms and icompanion ms)