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

Part of paid clinical trials in Golden Valley, Minnesota.

Sponsor
Hoffmann-La Roche
Study ID
NCT05949580
Status
Recruiting
Apply to this trial

Conditions

  • Relapsing Remitting Multiple Sclerosis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • MS Care Platform (icobrain ms and icompanion ms) — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Oct 21, 2024
Status verified
Jan 2026
Primary completion
Jun 30, 2027
Completion
Mar 31, 2028

Study Design

Enrollment
500 participants (estimated)

Arms

  • Arm: People with RRMS
    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.

Primary Outcome Measure

HCPs: Median of the System Usability Scale (SUS) Score Reported by Radiologists and Neurologists at Month 6 [ Time Frame: Month 6 ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Minneapolis Clinic of NeurologyGolden ValleyMinnesota55422-
Hackensack University Medical CenterHackensackNew Jersey07601-
Jersey Shore University Medical CentreNeptune CityNew Jersey07753-

Find similar trials in Golden Valley, MN

By research site
Minneapolis Clinic of Neurology· Golden Valley, MNHackensack University Medical Center· Hackensack, NJJersey Shore University Medical Centre· Neptune City, NJ

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