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

Launched by HOFFMANN-LA ROCHE · Jul 10, 2023

Keywords

ClinConnect Summary

This clinical trial is studying how well a digital care management platform can help people with Relapsing Remitting Multiple Sclerosis (RRMS) manage their condition. The goal is to see if using this platform improves the monitoring and overall care of patients with MS in everyday medical practice. Over two years, researchers will gather data to compare the care patients received before and after they start using this digital tool.

To be eligible for this study, participants should be between 65 and 74 years old, have a confirmed diagnosis of RRMS for at least a year, and have a smartphone that meets certain technical requirements. It’s important that they are able and willing to use the icompanion MS patient app regularly. Participants will need to complete an initial assessment and will be monitored over the course of the study, helping researchers understand the benefits of this new approach to MS care.

Gender

ALL

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 \[SPMS\])