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

RECRUITINGSponsored by Hoffmann-La Roche
Actively Recruiting
SponsorHoffmann-La Roche
Started2024-10-21
Est. completion2027-06-30
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations3 sites

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

Age: 18 Years+Healthy volunteers accepted
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 \[SPMS\])

Conditions2

Multiple SclerosisRelapsing Remitting Multiple Sclerosis

Locations3 sites

Minnesota

1 site
Minneapolis Clinic of Neurology
Golden Valley, Minnesota, 55422

New Jersey

2 sites
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Jersey Shore University Medical Centre
Neptune City, New Jersey, 07753

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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