Clinical trial NCT06922942: MSCopilot Users' Feedback in Real Life - Outcomes Regarding Integration in Patients' pathWay and Users' ExpeRience
Official title: MS-FLOWER: MSCopilot Users' Feedback in Real Life - Outcomes Regarding Integration in Patients' pathWay and Users' ExpeRience
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Multiple Sclerosis
Lead sponsor: Ad scientiam
Sponsor class: OTHER
First posted: 2025-04-11
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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


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 (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

Primary outcomes:
measure: 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.
timeFrame: For neurologists: Day 180 (+/- 30 days) and for patients: Day 1, Day 90 and Day 180 (+/- 30 days)
Secondary outcomes:
measure: To assess the integration of MSCopilot dashboard and application into routine clinical practice as well as perceived value for both HCPs and patients.
timeFrame: At Day 180 ± 30days
measure: To assess patients' ability to use MSCopilot at home without supervision.
timeFrame: Day 1 (+/- 30 days)
measure: To assess patients' ability to use MSCopilot at home without supervision.
timeFrame: Day 90 (+/-30 days)
measure: To assess the need for patient support when using MSCopilot at home
timeFrame: Day 180 (+/-30 days)
measure: To assess patient adherence to MSCopilot use in routine clinical practice.
timeFrame: Day 1 to Day 180 (+/-30 days)
measure: To assess user behavior based on usage analytics data from the MSCopilot mobile app and the dashboard.
timeFrame: Day 1 to Day 180 (+/-30 days)
measure: To assess the effectiveness of HCPs onboarding/training in ensuring successful patient onboarding.
timeFrame: At the end of inclusion period (90 days)
measure: To assess the effectiveness of HCPs onboarding/training in ensuring successful patient onboarding.
timeFrame: After patient inclusion visit (90 days)
measure: 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
timeFrame: After onboarding/training session (Day 0)
measure: To assess the variances in user behavior and adherence to MSCopilot use according to socio-demographic factors and EDSS scores.
timeFrame: Day 1 to Day 180 (+/-30 days)
measure: To assess the variances in user behavior and adherence to MSCopilot use according to socio-demographic factors and EDSS scores.
timeFrame: Day 1 to Day 180 (+/-30 days)
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: Jenny Feng
state: Louisiana
city: St Louis
country: United States
facility: Robert Naismith
state: Missouri
city: Oklahoma City
country: United States
facility: Gabriel Pardo
state: Oklahoma
city: Austin
country: United States
facility: Leorah Freeman
state: Texas
city: Kirkland
country: United States
facility: Theodore Brown,
state: Washington
Study officials:
References: