The MS-LINK™ Outcomes Study

Study Overview
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Brief Summary
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The Multiple Sclerosis (MS) Leadership and Innovation Network (MS-LINK™) is comprised of networks working cooperatively to advance Multiple Sclerosis (MS) science and improve MS participant outcomes. In this study participants will be followed from the time of consent through the lifetime of the study (currently 3 years), unless the participant chooses to withdraw from the study. Collection of participant's medical history, including MS and treatment history, will be automated through extraction from the participant's electronic medical record (EMR) and other health information systems (for example, radiology). Participants will complete patient-reported outcomes (PROs) and other health-related information digitally. Participating participants will have access to their own data in an ongoing manner via a web-based Participant Portal.

Official Title
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The MS-LINK™ Outcomes Study: A Comprehensive Prospective Longitudinal Assessment of Patient and Clinical Reported Outcomes in Multiple Sclerosis Patients Across North America

Conditions
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Multiple Sclerosis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants willing and able to provide written informed consent Participants willing to be contacted while participating in the study for recruitment into sub-studies that may be relevant to them Participants willing and able to complete PROs on a monthly basis and document events of interest as they occur Participants willing to participate in additional follow up at the site for at least three years Exclusion Criteria: Unable to complete questionnaires in English Unable to consistently access the Internet Participants participating in interventional clinical drug trials at baseline

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Multiple Sclerosis (MS)<br>Data from the participants with diagnosed MS treated and untreated will be part of this study. Medical records of participants will be used to collect demographics and data pertaining to Multiple Sclerosis (MS) management. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-determined Disease Steps (PDDS) Scale Score |  | Baseline up to 3 years | 
| Patient Reported Outcomes Measurement Information System (PROMIS) Multiple Sclerosis (MS) Fatigue Score |  | Baseline up to 3 years | 
| Patient Reported Outcomes Measurement Information System (PROMIS) Multiple Sclerosis (MS) Physical Function Score |  | Baseline up to 3 years | 
| Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety Score |  | Baseline up to 3 years | 
| Patient Reported Outcomes Measurement Information System (PROMIS) MS Cognitive Function Score |  | Baseline up to 3 years | 
| Patient Health Questionnaire 9-Item (PHQ9) Score |  | Baseline up to 3 years | 
| Wasson Health Confidence Scale Score |  | Baseline up to 3 years | 
| Health-related Quality of Life Assessed by Centers for Disease Control and Prevention Health-Related Quality of Life Measure (CDC HRQoL-14) |  | Baseline up to 3 years | 
| Work Productivity and Activity Impairment Questionnaire-Multiple Sclerosis (WPAI-MS) Score |  | Baseline up to 3 years | 
| Number of Participants with Reasons for Discontinued Disease-Modifying Therapies (DMT) |  | Baseline up to 3 years | 
| Number of Participants with Current Use of Disease-Modifying Therapies (DMT) |  | Baseline up to 3 years | 
| Duration of Disease-Modifying Therapies (DMT) use |  | Baseline up to 3 years | 
| Number of Participants With Adherence to Treatment as Assessed by Multiple Sclerosis Treatment Adherence Questionnaire (MS-TAQ) |  | Baseline up to 3 years | 
| Occurrence of Relapses |  | Baseline up to 3 years | 
| Occurrence of Multiple Sclerosis (MS) Symptoms |  | Baseline up to 3 years | 
| Number of Utilization of Healthcare Resources by Participants |  | Baseline up to 3 years | 
| Well-being of Participant Assessed by Physical Activity Diary | Participants can opt-in to use the Patient Portal to track their well-being in up to 9 domains like Sleep, Mood, Pain, Exercise, Mobility, Wellness, Energy, Bladder Function, Leisure activities. | Baseline up to 3 years | 
| Number of Participants with Response to Health Priorities and Goals | Responses of participants regarding concern of Multiple Sclerosis (MS) for next visit, priority and wellness goals, and how close they are completing the goal will be recorded. | Baseline up to 3 years | 
| Expanded Disability Status Scale (EDSS) Score |  | Baseline up to 3 years | 
| Multiple Sclerosis Functional Composite (MSFC) Score |  | Baseline up to 3 years | 
| Timed 25-Foot Walk Test |  | Baseline up to 3 years | 
| 9-Hole Peg Test (9HPT) Score |  | Baseline up to 3 years | 
| Paced Auditory Serial Addition Test (PASAT) Score |  | Baseline up to 3 years | 
| Symbol Digit Modalities Test (SDMT) |  | Baseline up to 3 years | 
| Processing Speed Test (PST) |  | Baseline up to 3 years | 
| Number of Participants with Magnetic resonance imaging (MRI) History |  | Baseline up to 3 years | 
| Number of Participants with History of Fall |  | Baseline up to 3 years | 
| Number of Participants with Adverse Events of Interest |  | Baseline up to 3 years | 
| Number of Participants with Symptoms of Coronavirus (COVID) |  | Baseline up to 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Expanded Disability Status Scale, Multiple Sclerosis, Patient Reported Outcomes Measurement Information System