The MS-LINK™ Outcomes Study
- Conditions
- Multiple Sclerosis
- Registration Number
- NCT04735406
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2182
- 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
- Unable to complete questionnaires in English
- Unable to consistently access the Internet
- Participants participating in interventional clinical drug trials at baseline
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Timed 25-Foot Walk Test Baseline up to 3 years Wasson Health Confidence Scale Score Baseline up to 3 years Number of Participants with Current Use of Disease-Modifying Therapies (DMT) 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 Number of Participants with History of Fall Baseline up to 3 years Patient-determined Disease Steps (PDDS) Scale Score Baseline up to 3 years Work Productivity and Activity Impairment Questionnaire-Multiple Sclerosis (WPAI-MS) Score Baseline up to 3 years Well-being of Participant Assessed by Physical Activity Diary Baseline up to 3 years 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.
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 Health Questionnaire 9-Item (PHQ9) Score 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 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 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 Number of Participants with Reasons for Discontinued 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 Response to Health Priorities and Goals Baseline up to 3 years 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.
Paced Auditory Serial Addition Test (PASAT) Score 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 Adverse Events of Interest Baseline up to 3 years Number of Participants with Symptoms of Coronavirus (COVID) Baseline up to 3 years Symbol Digit Modalities Test (SDMT) Baseline up to 3 years 9-Hole Peg Test (9HPT) Score Baseline up to 3 years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (9)
The Oklahoma Medical Research Foundation
🇺🇸Oklahoma City, Oklahoma, United States
Alabama Neurology Associates
🇺🇸Birmingham, Alabama, United States
Atlanta Neuroscience Institute
🇺🇸Atlanta, Georgia, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Memorial healthcare
🇺🇸Owosso, Michigan, United States
University of Texas Health
🇺🇸San Antonio, Texas, United States
Georgetown University
🇺🇸Washington, District of Columbia, United States
University of Nebraska medical Center
🇺🇸Omaha, Nebraska, United States
The University of Texas of Austin
🇺🇸Austin, Texas, United States