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

NCT06922942 | Active Not Recruiting FDA Device

• 1 other identifier: ADS-MS-FLOWER-2025
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 4

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

Outcome Measures

Primary Outcomes (1)

• To assess the ease of integrating the MSCopilot dashboard into clinical workflows for neurologists and the ease of use at home for patients with multiple sclerosis.

  Descriptive analysis and acceptance criteria of a minimum score of \>2/4 on neurologists' questionnaires regarding the ease of integrating the MSCopilot dashboard into clinical workflows Descriptive analysis and acceptance criteria of a minimum score of \>2/4 on patients' questionnaires regarding the ease of use of MSCopilot at home

  For neurologists: Day 180 (+/- 30 days) and for patients: Day 1, Day 90 and Day 180 (+/- 30 days)

Secondary Outcomes (11)

• To assess the integration of MSCopilot dashboard and application into routine clinical practice as well as perceived value for both HCPs and patients.

  At Day 180 ± 30days

• To assess patients' ability to use MSCopilot at home without supervision.

  Day 1 (+/- 30 days)

• To assess patients' ability to use MSCopilot at home without supervision.

  Day 90 (+/-30 days)

• To assess the need for patient support when using MSCopilot at home

  Day 180 (+/-30 days)

• To assess patient adherence to MSCopilot use in routine clinical practice.

  Day 1 to Day 180 (+/-30 days)

Study Arms (1)

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

EXPERIMENTAL

Device: MSCopilot Flower mobile application

Interventions

MSCopilot Flower mobile application DEVICE

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• For patients
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ad scientiam: lead

Study Sites (4)

Jenny Feng

New Orleans, Louisiana, 70121, United States

Location

Robert Naismith

St Louis, Missouri, 63110, United States

Location

Gabriel Pardo

Oklahoma City, Oklahoma, 73104, United States

Location

Leorah Freeman

Austin, Texas, 78712, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2025
• First Posted: April 11, 2025
• Study Start: August 12, 2025
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: October 2, 2025

Record last verified: 2025-10

Locations

US (4)