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

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Conditions studied: Relapsing Remitting Multiple Sclerosis

In brief

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.

Key facts

Study ID

NCT05949580

Run by

Hoffmann-La Roche

People needed

500

Starts

2024-10-21

Expected to finish

2028-03-31

Last updated by the study team

2026-07-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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])

Where it is running

• 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
• Hospital General Universitario Dr. Balmis — Alicante/alacant, Alicante, Spain
• Hospital Universitario de Gran Canaria — Las Palmas, Spain

Full record on ClinicalTrials.gov

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