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Abstract Details

Identifying Challenges to MSCopilot® 's Integration into Multiple Sclerosis Standard Clinical Practice: Methodology of MS-FLOWER, An Ongoing U.S. Multicenter Pilot Study
Multiple Sclerosis
P5 - Poster Session 5 (11:45 AM-12:45 PM)
18-002
MS-FLOWER (NCT06922942) is a U.S. multicenter pilot study evaluating the feasibility, usability, and workflow integration of MSCopilot® in routine care, identifying optimization opportunities.
MSCopilot®, a clinically validated software-as-medical-device (SaMD), and its digital biomarkers measure key Multiple Sclerosis (MS)  functions (walking, vision, cognition, and dexterity) enabling people MS (PwMS) to remotely assess symptom progression. While prior studies confirmed that MSCopilot® scores correlate with the Expanded Disability Status Scale (EDSS) and revised MS Functional Composite (MSFC) scores, integrating the tool into routine clinical practice remains challenging.
This 6-month prospective study follows PwMS and their HCPs. PwMS complete MSCopilot® monthly digital tests and self-reported questionnaires, Patient Health Questionnaire (PHQ-8) and Modified Fatigue Impact Scale-5 (MFIS-5) at home. HCPs review results through a dedicated web dashboard. User experience and satisfaction questionnaires evaluating HCP training, onboarding process, ease of use of MSCopilot® at-home and clinical workflows integration are administered to both patients and HCPs at baseline and months 1, 3 and 6.
Four U.S. MS centers, 8 MS specialists, additional nurses and healthcare providers participate in this study. Started in August 2025, a record 6-week enrollment registered 62 patients with EDSS ranging from 0-6.5. Study completion is projected for March 2026. Analyses will focus on the SaMD readiness, patient adherence, user experience/behaviour and the integration of the MSCopilot® app and dashboard into clinical workflows. Understanding workflow dynamics and technical support needs is critical for seamless at-home use of MSCopilot®, patients and HCPs’ onboarding, and integration into clinical practice. Interim results will be available for the annual meeting.
Clinical integration of MSCopilot® could enhance disease monitoring, optimize clinical workflows, and improve patient engagement in Multiple Sclerosis management. This study paves the way for broader adoption of digital biomarkers in routine care, supporting personalized, data-driven management of PwMS in the U.S.
Authors/Disclosures
Leorah A. Freeman, MD, PhD (Dell Medical School, The University of Texas at Austin)
PRESENTER 		Dr. Freeman has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Dr. Freeman has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Hoffman La-Roche. Dr. Freeman has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Genentech, Inc. Dr. Freeman has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for EMD Serono. Dr. Freeman has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Horizon. Dr. Freeman has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi. Dr. Freeman has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for TG Therapeutics. Dr. Freeman has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Sanofi-Genzyme. Dr. Freeman has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Texas Neurological Society. Dr. Freeman has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for EMD Serono/ Merck. The institution of Dr. Freeman has received research support from Genentech. The institution of Dr. Freeman has received research support from PCORI. The institution of Dr. Freeman has received research support from EMD Serono. The institution of Dr. Freeman has received research support from Sanofi. The institution of Dr. Freeman has received research support from MSAA. The institution of Dr. Freeman has received research support from National Multiple Sclerosis Society.
Gabriel Pardo, MD, FAAN (Oklahoma Medical Research Foundation) Dr. Pardo has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Roche Genentech. Dr. Pardo has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Sanofi Genzyme. Dr. Pardo has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for EMD Serono. Dr. Pardo has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Novartis. Dr. Pardo has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for TG Therapeutics. Dr. Pardo has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Amgen . Dr. Pardo has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Bristol Myers Squibb. Dr. Pardo has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for EMD Serono. Dr. Pardo has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Novartis. Dr. Pardo has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Roche Genentech. Dr. Pardo has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Sanofi Genzyme. Dr. Pardo has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for TG Therapeutics. Dr. Pardo has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Amgen. Dr. Pardo has or had stock in Progentec Diagnostics.Dr. Pardo has or had stock in Cadenza Bio.
Jenny J. Feng, MD (Ochsner Clinic) Dr. Feng has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Dr. Feng has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Bristol Myers Squibb. Dr. Feng has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for TG Therapeutics. Dr. Feng has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Horizon.
Theodore R. Brown, MD (MS Center At Evergreen) Dr. Brown has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Astellas. The institution of Dr. Brown has received research support from Merck.
Térence Brochu Mr. Brochu has received personal compensation for serving as an employee of Ad Scientiam. Mr. Brochu has stock in Adscientiam.
Loic Carment (Ad Scientiam) Loic Carment has received personal compensation for serving as an employee of Ad Scientiam.
Clarissa Gorin, Other (Ad Scientiam) Dr. Gorin has received personal compensation for serving as an employee of Ad Scientiam.
Lissandra Klaeylé (Ad Scientiam) Lissandra Klaeylé has received personal compensation for serving as an employee of Ad Scientiam.
Saad Zinai Saad Zinai has received personal compensation for serving as an employee of AD Scientiam. Saad Zinai has stock in Ad Scientiam.
Jennifer Graves, MD, PhD (UCSD) Dr. Graves has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for TG Therapeutics. Dr. Graves has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Horizon. Dr. Graves has received personal compensation in the range of $5,000-$9,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for MSJ. The institution of Dr. Graves has received research support from Octave. The institution of Dr. Graves has received research support from Sanofi. The institution of Dr. Graves has received research support from EMD Serono.
Robert T. Naismith, MD, FAAN (Washington University) Dr. Naismith has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biogen. Dr. Naismith has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Bristol Myers Squib. Dr. Naismith has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Genentech. Dr. Naismith has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Genzyme. Dr. Naismith has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Lundbeck. Dr. Naismith has received personal compensation in the range of $500-$4,999 for serving as a Consultant for TG Therapeutics. Dr. Naismith has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Celltrion. Dr. Naismith has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Alexion. Dr. Naismith has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for EMD Serono. Dr. Naismith has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sandoz. Dr. Naismith has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Astoria. Dr. Naismith has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Impaact-Bio. Dr. Naismith has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Kyverna. Dr. Naismith has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Horizon. Dr. Naismith has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for NEJM Journal Watch.