Next-Gen MS: Feed-forward PRO Data for MS Research

EMD Serono Research & Development Institute, Inc.1,594 enrolled

Overview

This Next Generation learning health system for Multiple Sclerosis (Next-Gen MS) study is a sub-study of the MS-LINK™ Outcomes Study (NCT04735406). The study aims to examine the effects of using feed forward Patient Reported Outcomes (PROs) data in real-world Multiple Sclerosis (MS) care settings. The study will be conducted within an emerging Learning Healthcare System (LHS).

Study Type

OBSERVATIONAL

Enrollment

1,594

Conditions

Multiple Sclerosis (MS)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Participants willing and able to provide written informed consent * Participants with clinical diagnosis of Multiple Sclerosis (MS) Exclusion Criteria: * None

Locations (8)

Alabama Neurology Associates

Birmingham, Alabama, United States

Georgetown University

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

Atlanta Neuroscience Institute

Atlanta, Georgia, United States

Beth Israel Deaconess Medical Center

Outcomes

Primary Outcomes

Change From Baseline in Health-Related Quality of Life 14 Item (HR-QoL-14)

Time frame: Baseline up to 18 Months

Secondary Outcomes

Percentage of Participants with >=1-point Increase from Baseline in Patient Determined Disease Steps (PDDS) Sustained Via Consecutive Measures Over 3 Months

Time frame: Baseline up to 18 Months

Data from ClinicalTrials.gov

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