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

June 5, 2024 updated by: EMD Serono Research & Development Institute, Inc.

Next-Gen MS: A Prospective, Cluster-randomized Study Evaluating the Impact of "Feed-forward" Patient Reported Outcomes Data to Clinical Teams Managing Adults Living With MS in a Learning Health System for MS Research

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 Overview

Status

Terminated

Conditions

Study Type

Observational

Enrollment (Actual)

1594

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209
        • Alabama Neurology Associates
    • District of Columbia
      • Washington, District of Columbia, United States, 20057
        • Georgetown University
    • Georgia
      • Atlanta, Georgia, United States, 30327
        • Atlanta NeuroScience Institute
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
    • Michigan
      • Owosso, Michigan, United States, 48867
        • The Memorial Hospital, d.b.a Memorial Healthcare
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Oklahoma Medical Research Foundation
    • Texas
      • Austin, Texas, United States, 78759
        • The University of Texas of Austin
      • San Antonio, Texas, United States, 78229
        • The University of Texas Health Science Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Participants from United States with Multiple sclerosis (MS) will be included.

Description

Inclusion Criteria:

  • Participants willing and able to provide written informed consent
  • Participants with clinical diagnosis of Multiple Sclerosis (MS)

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Feed-forward PRO
Participants in this group will participate in monthly learning collaborative webinars. Feed-forward of patient reported outcomes (PRO) data collected from the main study (NCT04735406) will be used.
Control Group (Usual Care)
Participants in the control group will receive usual care practices during the clinical encounters.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change From Baseline in Health-Related Quality of Life 14 Item (HR-QoL-14)
Time Frame: Baseline up to 18 Months
Baseline up to 18 Months

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Baseline up to 18 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

EMD Serono Research & Development Institute, Inc.

Investigators

  • Study Director: Medical Responsible, Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 2, 2021

Primary Completion (Actual)

February 19, 2024

Study Completion (Actual)

February 19, 2024

Study Registration Dates

First Submitted

May 25, 2021

First Submitted That Met QC Criteria

May 25, 2021

First Posted (Actual)

May 28, 2021

Study Record Updates

Last Update Posted (Actual)

June 6, 2024

Last Update Submitted That Met QC Criteria

June 5, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MS200077_0013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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