MSCopilot Users' Feedback in Real Life - Outcomes Regarding Integration in Patients' pathWay and Users' ExpeRience (MS-FLOWER)

Ad scientiam

Status: Active, not recruiting

Conditions: Multiple Sclerosis

Treatments: Device: MSCopilot Flower mobile application

Study type: Interventional

Funder types: Other

Identifiers

NCT06922942

ADS-MS-FLOWER-2025

Details and patient eligibility

About

This US multicenter, prospective cohort study aims to evaluate how MSCopilot can be seamlessly integrated into the current care pathway and identify potential optimizations to enhance its impact on both MS patients and clinicians, facilitating broader implementation. Specifically, the study will assess:

• The overall integration of MSCopilot into routine clinical practice,
• Patients' ability to use MSCopilot at home without supervision,
• The need for patient support when using MSCopilot at home,
• User behavior based on usage analytics data from the MSCopilot mobile app and dashboard,
• Patient adherence to MSCopilot use in routine clinical practice,
• The adequacy of the onboarding/training process for HCPs,
• The effectiveness of HCPs onboarding/training in ensuring successful patient onboarding,
• The variances in user behavior and adherence to MSCopilot use according to socio-demographic factors and EDSS scores

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

For patients

• 18 years and older
• With a confirmed and documented MS diagnosis, per the 2010 Revised
• McDonald criteria
• With an EDSS score ranging from 0 to 6.5
• Able to monitor their disease from home (i.e. not hospitalized or under medical assistance).
• Having a personal smartphone with a mobile operating system above 16 for IOS (iPhone) and 8 for Android and having access to a good internet connection.
• Able to read language in which the mobile application is available and able to understand pictograms Having read the information sheet and signed the informed consent form

For HCPs:

• Licensed neurologists trained in the management of Multiple Sclerosis patients and allowed to conduct clinical studies within their departments
• If applicable: nurses or medical assistants specifically trained in the management of Multiple Sclerosis and allowed to participate in clinical studies within their departments
• Ability to use a computer

Exclusion Criteria (for patients):

• Pregnant and nursing women
• Person under guardianship or curatorship
• Inability to use a smartphone application
• Patient who previously participated in a study using MSCopilot

Early termination criteria (for patients):

• exclusion criteria,
• death,
• abandon,
• loss of follow-up,
• investigator's decision

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Performance of digital tests at home at day 0 (D0), D30, D60, D90, D120, D150 and D180

Experimental group

Treatment:

Device: MSCopilot Flower mobile application