Clinical trial NCT04735406: The MS-LINK™ Outcomes Study
Official title: The MS-LINK™ Outcomes Study: A Comprehensive Prospective Longitudinal Assessment of Patient and Clinical Reported Outcomes in Multiple Sclerosis Patients Across North America
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Keywords: Expanded Disability Status Scale
Multiple Sclerosis
Patient Reported Outcomes Measurement Information System
Lead sponsor: EMD Serono
Sponsor class: INDUSTRY
First posted: 2021-02-03
Enrollment: 2182
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants from United states and Canada with Multiple sclerosis (MS) will be included in this study.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Patient-determined Disease Steps (PDDS) Scale Score
timeFrame: Baseline up to 3 years
measure: Patient Reported Outcomes Measurement Information System (PROMIS) Multiple Sclerosis (MS) Fatigue Score
timeFrame: Baseline up to 3 years
measure: Patient Reported Outcomes Measurement Information System (PROMIS) Multiple Sclerosis (MS) Physical Function Score
timeFrame: Baseline up to 3 years
measure: Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety Score
timeFrame: Baseline up to 3 years
measure: Patient Reported Outcomes Measurement Information System (PROMIS) MS Cognitive Function Score
timeFrame: Baseline up to 3 years
measure: Patient Health Questionnaire 9-Item (PHQ9) Score
timeFrame: Baseline up to 3 years
measure: Wasson Health Confidence Scale Score
timeFrame: Baseline up to 3 years
measure: Health-related Quality of Life Assessed by Centers for Disease Control and Prevention Health-Related Quality of Life Measure (CDC HRQoL-14)
timeFrame: Baseline up to 3 years
measure: Work Productivity and Activity Impairment Questionnaire-Multiple Sclerosis (WPAI-MS) Score
timeFrame: Baseline up to 3 years
measure: Number of Participants with Reasons for Discontinued Disease-Modifying Therapies (DMT)
timeFrame: Baseline up to 3 years
measure: Number of Participants with Current Use of Disease-Modifying Therapies (DMT)
timeFrame: Baseline up to 3 years
measure: Duration of Disease-Modifying Therapies (DMT) use
timeFrame: Baseline up to 3 years
measure: Number of Participants With Adherence to Treatment as Assessed by Multiple Sclerosis Treatment Adherence Questionnaire (MS-TAQ)
timeFrame: Baseline up to 3 years
measure: Occurrence of Relapses
timeFrame: Baseline up to 3 years
measure: Occurrence of Multiple Sclerosis (MS) Symptoms
timeFrame: Baseline up to 3 years
measure: Number of Utilization of Healthcare Resources by Participants
timeFrame: Baseline up to 3 years
measure: Well-being of Participant Assessed by Physical Activity Diary
timeFrame: Baseline up to 3 years
measure: Number of Participants with Response to Health Priorities and Goals
timeFrame: Baseline up to 3 years
measure: Expanded Disability Status Scale (EDSS) Score
timeFrame: Baseline up to 3 years
measure: Multiple Sclerosis Functional Composite (MSFC) Score
timeFrame: Baseline up to 3 years
measure: Timed 25-Foot Walk Test
timeFrame: Baseline up to 3 years
measure: 9-Hole Peg Test (9HPT) Score
timeFrame: Baseline up to 3 years
measure: Paced Auditory Serial Addition Test (PASAT) Score
timeFrame: Baseline up to 3 years
measure: Symbol Digit Modalities Test (SDMT)
timeFrame: Baseline up to 3 years
measure: Processing Speed Test (PST)
timeFrame: Baseline up to 3 years
measure: Number of Participants with Magnetic resonance imaging (MRI) History
timeFrame: Baseline up to 3 years
measure: Number of Participants with History of Fall
timeFrame: Baseline up to 3 years
measure: Number of Participants with Adverse Events of Interest
timeFrame: Baseline up to 3 years
measure: Number of Participants with Symptoms of Coronavirus (COVID)
timeFrame: Baseline up to 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Alabama Neurology Associates
state: Alabama
city: Washington
country: United States
facility: Georgetown University
state: District of Columbia
city: Atlanta
country: United States
facility: Atlanta Neuroscience Institute
state: Georgia
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Owosso
country: United States
facility: Memorial healthcare
state: Michigan
city: Omaha
country: United States
facility: University of Nebraska medical Center
state: Nebraska
city: Oklahoma City
country: United States
facility: The Oklahoma Medical Research Foundation
state: Oklahoma
city: Austin
country: United States
facility: The University of Texas of Austin
state: Texas
city: San Antonio
country: United States
facility: University of Texas Health
state: Texas
Study officials:
affiliation: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
name: Medical Responsible
role: STUDY_DIRECTOR
References: