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)

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Device
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Minnesota
Minneapolis Clinic of Neurology
RECRUITING
Golden Valley
New Jersey
Hackensack University Medical Center
RECRUITING
Hackensack
Jersey Shore University Medical Centre
RECRUITING
Neptune City
Other Locations
Germany
Universitaetsklinikum Carl Gustav Carus an der TU Dresden
RECRUITING
Dresden
Praxis Dr. med. Max Deist und Michael Ernst ?Sinsheim
RECRUITING
Sinsheim
Contact Information
Primary
MN44358 https://forpatients.roche.com/
global-roche-genentech-trials@gene.com
888-662-6728 (U.S. Only)
Time Frame
Start Date: 2024-10-21
Estimated Completion Date: 2028-03-31
Participants
Target number of participants: 500
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: icometrix
Leads: Hoffmann-La Roche

This content was sourced from clinicaltrials.gov