MSCopilot Users' Feedback in Real Life - Outcomes Regarding Integration in Patients' pathWay and Users' ExpeRience

NCT ID: NCT06922942

Last Updated: 2025-10-02

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-12
• Study Completion Date: 2026-03-01

Brief Summary

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

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

MSCopilot Flower mobile application

Intervention Type: DEVICE

MSCopilot Flower includes active tests for walking, cognition, dexterity and vision, and e-questionnaires related to fatigue and Anxiety

Interventions

MSCopilot Flower mobile application

MSCopilot Flower includes active tests for walking, cognition, dexterity and vision, and e-questionnaires related to fatigue and Anxiety

Intervention Type: DEVICE

Eligibility 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

• 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):

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ad scientiam

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Jenny Feng

New Orleans, Louisiana, United States

Robert Naismith

St Louis, Missouri, United States

Gabriel Pardo

Oklahoma City, Oklahoma, United States

Leorah Freeman

Austin, Texas, United States

Countries

United States

Other Identifiers

ADS-MS-FLOWER-2025

Identifier Type: -

Identifier Source: org_study_id