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

Not Applicable

Active, not recruiting

• Conditions: Multiple Sclerosis

• Registration Number: NCT06922942
• Lead Sponsor: Ad scientiam

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-04-01
• Study First Submitted QC: 2025-04-09
• Study First Posted: 2025-04-11
• Study Start: 2025-08-12
• Status Verified: 2025-10
• Last Update Submitted: 2025-10-01
• Last Update Posted: 2025-10-02
• Primary Completion: 2026-03-01
• Study Completion: 2026-03-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 60

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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.	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 Outcome Measures

Name	Time	Method
To assess patient adherence to MSCopilot use in routine clinical practice.	Day 1 to Day 180 (+/-30 days)	Descriptive analysis of the mobile application's adherence data, including: Number of performed tests, Number of performed sessions, Number of completed questionnaires.
To assess user behavior based on usage analytics data from the MSCopilot mobile app and the dashboard.	Day 1 to Day 180 (+/-30 days)	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
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	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
To assess patients' ability to use MSCopilot at home without supervision.	Day 90 (+/-30 days)	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
To assess the need for patient support when using MSCopilot at home	Day 180 (+/-30 days)	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)
To assess the effectiveness of HCPs onboarding/training in ensuring successful patient onboarding.	After patient inclusion visit (90 days)	Descriptive analysis of patient questionnaires Descriptive analysis and acceptance criteria of a minimum score of \>2/4 for each item, of patient questionnaires
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)	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
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)	Descriptive analysis of how HCPs socio-demographic factors affect their behavior toward MSCopilot dashboard.

Trial Locations

Locations (4)

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