The MS-LINK™ Outcomes Study

NCT04735406 | Completed

• 1 other identifier: MS200077_0021
• Study Type: observational
• Target: 2,182
• Locations: 1 country
• Sites: 9

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.

Conditions

Multiple Sclerosis

Keywords

Expanded Disability Status Scale; Multiple Sclerosis; Patient Reported Outcomes Measurement Information System

Outcome Measures

Primary Outcomes (29)

• 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

Study Arms (1)

Multiple Sclerosis (MS)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants from United states and Canada with Multiple sclerosis (MS) will be included in this study.

You may qualify if:

• 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

You may not qualify if:

• Unable to complete questionnaires in English
• Unable to consistently access the Internet
• Participants participating in interventional clinical drug trials at baseline

Sponsors & Collaborators

• EMD Serono Research & Development Institute, Inc.: lead

Study Sites (9)

Alabama Neurology Associates

Birmingham, Alabama, 35209, United States

Location

Georgetown University

Washington D.C., District of Columbia, 20057, United States

Location

Atlanta Neuroscience Institute

Atlanta, Georgia, 30327, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Memorial healthcare

Owosso, Michigan, 48867, United States

Location

University of Nebraska medical Center

Omaha, Nebraska, 68198-7835, United States

Location

The Oklahoma Medical Research Foundation

Oklahoma City, Oklahoma, 73104, United States

Location

The University of Texas of Austin

Austin, Texas, 78759, United States

Location

University of Texas Health

San Antonio, Texas, 78229, United States

Location

Related Links

• Trial Awareness and Transparency website
• US Medical Information website, Medical Resources

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Medical Responsible

  Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2021
• First Posted: February 3, 2021
• Study Start: March 24, 2021
• Primary Completion: January 31, 2024
• Study Completion: May 31, 2024
• Last Updated: August 22, 2024

Record last verified: 2024-08

Locations

US (9)