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Clinical Trials/NCT06922942
NCT06922942Active, not recruitingNot Applicable

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

Ad scientiam7 sites in 1 country60 target enrollmentStarted: August 12, 2025Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
60
Locations
7
Primary Endpoint
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.
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

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

Experimental

Intervention: MSCopilot Flower mobile application (Device)

Outcomes

Primary Outcomes

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.

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

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

Secondary Outcomes

  • To assess the variances in user behavior and adherence to MSCopilot use according to socio-demographic factors and EDSS scores.(Day 1 to Day 180 (+/-30 days))
  • 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 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))
  • To assess user behavior based on usage analytics data from the MSCopilot mobile app and the dashboard.(Day 1 to Day 180 (+/-30 days))
  • To assess the effectiveness of HCPs onboarding/training in ensuring successful patient onboarding.(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(After onboarding/training session (Day 0))
  • To assess the effectiveness of HCPs onboarding/training in ensuring successful patient onboarding.(At the end of inclusion period (90 days))
  • To assess patients' ability to use MSCopilot at home without supervision.(Day 1 (+/- 30 days))

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (7)

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