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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Device: MSCopilot Flower mobile application

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Louisiana
    • New Orleans, Louisiana, United States, 70121
      • Jennifer Feng
      • Contact: Jennifer Feng, Dr; Phone Number: (504) 842-3038; Email: jennifer.flowers@ochsner.org
  • Missouri
    • St Louis, Missouri, United States, 63110
      • Robert Naismith
      • Contact: Robert Naismith, Dr; Phone Number: 314.362.3402; Email: naismithr@wustl.edu
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • Gabriel Pardo
      • Contact: Gabriel Pardo, Dr; Phone Number: 503-494-7772; Email: yadavv@ohsu.edu
  • Texas
    • Austin, Texas, United States, 78712
      • Leorah Freeman
      • Contact: Leorah Freeman, Dr; Phone Number: 512-495-5355; Email: Leorah.Freeman@austin.utexas.edu
  • Washington
    • Kirkland, Washington, United States, 98034
      • Theodore Brown,
      • Contact: Theodore Brown, Dr; Phone Number: 424- 899-5414; Email: trbrown@evergreenhealthcare.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Performance of digital tests at home at day 0 (D0), D30, D60, D90, D120, D150 and D180	Device: MSCopilot Flower mobile application; MSCopilot Flower includes active tests for walking, cognition, dexterity and vision, and e-questionnaires related to fatigue and Anxiety

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess the integration of MSCopilot dashboard and application into routine clinical practice as well as perceived value for both HCPs and patients.	Descriptive analysis of neurologists' questionnaires, to be completed after each investigator's last visit, regarding the Health Care Profesionnals (HCPs) dashboard Descriptive analysis and acceptance criteria of a minimum score of >2/4 for each item, of neurologists' questionnaires after the last visit on the HCPs dashboard Descriptive analysis of patients' questionnaires after the last visit regarding MSCopilot app and dashboard use by the HCPs. Descriptive analysis and acceptance criteria of a minimum score of >2/4 for each item in patients' questionnaires, to be completed after the follow-up visit, regarding MSCopilot application and dashboard use by HCPs	At Day 180 ± 30days
To assess patients' ability to use MSCopilot at home without supervision.	Descriptive analysis of patient questionnaires Acceptance criteria of a minimum of >2/4 for each item, of patient questionnaires	Day 1 (+/- 30 days)
To assess patients' ability to use MSCopilot at home without supervision.	Descriptive analysis of patient questionnaires at mid-study Descriptive analysis and acceptance criteria of a minimum score of >2/4 for each item, of patient questionnaires at mid-study	Day 90 (+/-30 days)
To assess the need for patient support when using MSCopilot at home	Descriptive analysis of nurses or medical assistants' questionnaires (if applicable) Descriptive analysis and acceptance criteria of a minimum score of >2/4 for each item, of nurses or medical assistants' questionnaires (if applicable)	Day 180 (+/-30 days)
To assess patient adherence to MSCopilot use in routine clinical practice.	Descriptive analysis of the mobile application's adherence data, including: Number of performed tests, Number of performed sessions, Number of completed questionnaires.	Day 1 to Day 180 (+/-30 days)
To assess user behavior based on usage analytics data from the MSCopilot mobile app and the dashboard.	Quantitative analysis of real-world utilization patterns of the MSCopilot mobile app through analytics data Quantitative analysis of real-world utilization patterns of the HCPs dashboard through analytics data	Day 1 to Day 180 (+/-30 days)
To assess the effectiveness of HCPs onboarding/training in ensuring successful patient onboarding.	Descriptive analysis of HCPs (neurologists) questionnaires Descriptive analysis and acceptance criteria of a minimum score of >2/4 for each item, of HCPs (neurologists) questionnaires	At the end of inclusion period (90 days)
To assess the effectiveness of HCPs onboarding/training in ensuring successful patient onboarding.	Descriptive analysis of patient questionnaires Descriptive analysis and acceptance criteria of a minimum score of >2/4 for each item, of patient questionnaires	After patient inclusion visit (90 days)
To assess the adequacy of the onboarding/training process for HCPs, including neurologists, nurses, and medical assistants, focusing on clarity, satisfaction, and confidence in using MSCopilot	Descriptive analysis of HCPs questionnaires post-onboarding/training session Descriptive analysis and acceptance criteria of a minimum score of >2/4 for each item in HCPs questionnaires post-onboarding/training	After onboarding/training session (Day 0)
To assess the variances in user behavior and adherence to MSCopilot use according to socio-demographic factors and EDSS scores.	Descriptive analysis of how socio-demographic factors and EDSS scores affect patient behavior and adherence to MSCopilot mobile application.	Day 1 to Day 180 (+/-30 days)
To assess the variances in user behavior and adherence to MSCopilot use according to socio-demographic factors and EDSS scores.	Descriptive analysis of how HCPs socio-demographic factors affect their behavior toward MSCopilot dashboard.	Day 1 to Day 180 (+/-30 days)

Collaborators and Investigators

• Sponsor: Ad scientiam

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2025
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: April 1, 2025
• First Submitted That Met QC Criteria: April 9, 2025
• First Posted (Actual): April 11, 2025

Study Record Updates

• Last Update Posted (Actual): April 11, 2025
• Last Update Submitted That Met QC Criteria: April 9, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Autoimmune Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Multiple Sclerosis
• Other Study ID Numbers: ADS-MS-FLOWER-2025

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No