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NCT Number: NCT04735406

The MS-LINK™ Outcomes Study

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Alabama Neurology Associates, Birmingham, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Patient-determined Disease Steps (PDDS) Scale Score

    Time frame: Baseline up to 3 years

  2. Patient Reported Outcomes Measurement Information System (PROMIS) Multiple Sclerosis (MS) Fatigue Score

    Time frame: Baseline up to 3 years

  3. Patient Reported Outcomes Measurement Information System (PROMIS) Multiple Sclerosis (MS) Physical Function Score

    Time frame: Baseline up to 3 years

  4. Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety Score

    Time frame: Baseline up to 3 years

  5. Patient Reported Outcomes Measurement Information System (PROMIS) MS Cognitive Function Score

    Time frame: Baseline up to 3 years

  6. Patient Health Questionnaire 9-Item (PHQ9) Score

    Time frame: Baseline up to 3 years

  7. Wasson Health Confidence Scale Score

    Time frame: Baseline up to 3 years

  8. Health-related Quality of Life Assessed by Centers for Disease Control and Prevention Health-Related Quality of Life Measure (CDC HRQoL-14)

    Time frame: Baseline up to 3 years

  9. Work Productivity and Activity Impairment Questionnaire-Multiple Sclerosis (WPAI-MS) Score

    Time frame: Baseline up to 3 years

  10. Number of Participants with Reasons for Discontinued Disease-Modifying Therapies (DMT)

    Time frame: Baseline up to 3 years

  11. Number of Participants with Current Use of Disease-Modifying Therapies (DMT)

    Time frame: Baseline up to 3 years

  12. Duration of Disease-Modifying Therapies (DMT) use

    Time frame: Baseline up to 3 years

  13. Number of Participants With Adherence to Treatment as Assessed by Multiple Sclerosis Treatment Adherence Questionnaire (MS-TAQ)

    Time frame: Baseline up to 3 years

  14. Occurrence of Relapses

    Time frame: Baseline up to 3 years

  15. Occurrence of Multiple Sclerosis (MS) Symptoms

    Time frame: Baseline up to 3 years

  16. Number of Utilization of Healthcare Resources by Participants

    Time frame: Baseline up to 3 years

  17. Well-being of Participant Assessed by Physical Activity Diary

    Time frame: 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.

  18. Number of Participants with Response to Health Priorities and Goals

    Time frame: 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.

  19. Expanded Disability Status Scale (EDSS) Score

    Time frame: Baseline up to 3 years

  20. Multiple Sclerosis Functional Composite (MSFC) Score

    Time frame: Baseline up to 3 years

  21. Timed 25-Foot Walk Test

    Time frame: Baseline up to 3 years

  22. 9-Hole Peg Test (9HPT) Score

    Time frame: Baseline up to 3 years

  23. Paced Auditory Serial Addition Test (PASAT) Score

    Time frame: Baseline up to 3 years

  24. Symbol Digit Modalities Test (SDMT)

    Time frame: Baseline up to 3 years

  25. Processing Speed Test (PST)

    Time frame: Baseline up to 3 years

  26. Number of Participants with Magnetic resonance imaging (MRI) History

    Time frame: Baseline up to 3 years

  27. Number of Participants with History of Fall

    Time frame: Baseline up to 3 years

  28. Number of Participants with Adverse Events of Interest

    Time frame: Baseline up to 3 years

  29. Number of Participants with Symptoms of Coronavirus (COVID)

    Time frame: Baseline up to 3 years

Sponsors and collaborators

Lead sponsor

EMD Serono Research & Development Institute, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Feb 3, 2021
Registry last updated
Aug 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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