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Study to Evaluate the Usability and Value of Integrated Digital Solutions in Medical Care of Participants With Multiple Sclerosis
NCT05949580 · Hoffmann-La Roche
In plain English
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Official title
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)
About this study
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).
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 \[SPMS\])
Study design
Enrollment target: 500 participants
Age groups: adult, older_adult
Timeline
Starts: 2024-10-21
Estimated completion: 2028-03-31
Last updated: 2026-01-20
Interventions
Device: MS Care Platform (icobrain ms and icompanion ms)
Primary outcomes
- • HCPs: Median of the System Usability Scale (SUS) Score Reported by Radiologists and Neurologists at Month 6 (Month 6)
- • HCPs: Median of the SUS Score Reported by Radiologists and Neurologists at Month 12 (Month 12)
- • HCPs: Median of the SUS Score Reported by Radiologists and Neurologists at Month 24 (Month 24)
Sponsor
Hoffmann-La Roche · industry
With: icometrix
Contacts & investigators
ContactMN44358 https://forpatients.roche.com/ · contact · global-roche-genentech-trials@gene.com · 888-662-6728 (U.S. Only)
InvestigatorClinical Trials · study_director, icometrix
All locations (5)
Minneapolis Clinic of NeurologyRecruiting
Golden Valley, Minnesota, United States
Hackensack University Medical CenterRecruiting
Hackensack, New Jersey, United States
Jersey Shore University Medical CentreRecruiting
Neptune City, New Jersey, United States
Universitaetsklinikum Carl Gustav Carus an der TU DresdenRecruiting
Dresden, Germany
Praxis Dr. med. Max Deist und Michael Ernst ?SinsheimRecruiting
Sinsheim, Germany