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

NCT ID: NCT04907305

Last Updated: 2024-06-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

1594 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-11-02

Study Completion Date

2024-02-19

Brief Summary

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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

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Conditions

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Multiple Sclerosis (MS)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Control Group (Usual Care)

Participants in the control group will receive usual care practices during the clinical encounters.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* None
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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EMD Serono Research & Development Institute, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Responsible

Role: STUDY_DIRECTOR

Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Locations

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Alabama Neurology Associates

Birmingham, Alabama, United States

Site Status

Georgetown University

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

Site Status

Atlanta Neuroscience Institute

Atlanta, Georgia, United States

Site Status

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Site Status

The Memorial Hospital, d.b.a Memorial Healthcare

Owosso, Michigan, United States

Site Status

Oklahoma Medical Research Foundation

Oklahoma City, Oklahoma, United States

Site Status

The University of Texas of Austin

Austin, Texas, United States

Site Status

The University of Texas Health Science Center

San Antonio, Texas, United States

Site Status

Countries

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United States

Related Links

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https://medical.emdserono.com/en_US/home.html

US Medical Information website, Medical Resources

Other Identifiers

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MS200077_0013

Identifier Type: -

Identifier Source: org_study_id

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