RECRUITINGOBSERVATIONAL

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)

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - 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 \[SPMS\]) Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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 \[SPMS\])

Treatments Being Tested

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.

Locations (5)

Minneapolis Clinic of Neurology

Golden Valley, Minnesota, United States

Hackensack University Medical Center

Hackensack, New Jersey, United States

Jersey Shore University Medical Centre

Neptune City, New Jersey, United States

Universitaetsklinikum Carl Gustav Carus an der TU Dresden

Dresden, Germany

Praxis Dr. med. Max Deist und Michael Ernst ?Sinsheim

Sinsheim, Germany