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

Terminated
Conditions
Multiple Sclerosis (MS)
Registration Number
NCT04907305
Lead Sponsor
EMD Serono Research & Development Institute, Inc.
Brief Summary

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).

Detailed Description

Not available

Recruitment & Eligibility

Status
TERMINATED
Sex
All
Target Recruitment
1594
Inclusion Criteria
  • Participants willing and able to provide written informed consent
  • Participants with clinical diagnosis of Multiple Sclerosis (MS)
Exclusion Criteria
  • None

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Change From Baseline in Health-Related Quality of Life 14 Item (HR-QoL-14)Baseline up to 18 Months
Secondary Outcome Measures
NameTimeMethod
Percentage of Participants with >=1-point Increase from Baseline in Patient Determined Disease Steps (PDDS) Sustained Via Consecutive Measures Over 3 MonthsBaseline up to 18 Months

Trial Locations

Locations (8)

Atlanta Neuroscience Institute

🇺🇸

Atlanta, Georgia, United States

Beth Israel Deaconess Medical Center

🇺🇸

Boston, Massachusetts, United States

Alabama Neurology Associates

🇺🇸

Birmingham, Alabama, United States

Oklahoma Medical Research Foundation

🇺🇸

Oklahoma City, Oklahoma, United States

The University of Texas Health Science Center

🇺🇸

San Antonio, Texas, United States

The University of Texas of Austin

🇺🇸

Austin, Texas, United States

The Memorial Hospital, d.b.a Memorial Healthcare

🇺🇸

Owosso, Michigan, United States

Georgetown University

🇺🇸

Washington, District of Columbia, United States

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