Study Stopped
The study was terminated due to change in strategic priorities.
Next-Gen MS: Feed-forward PRO Data for MS Research
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
1 other identifier
observational
1,594
1 country
8
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2021
Typical duration for all trials
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 25, 2021
CompletedFirst Posted
Study publicly available on registry
May 28, 2021
CompletedStudy Start
First participant enrolled
November 2, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 19, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
February 19, 2024
CompletedJune 6, 2024
May 1, 2024
2.3 years
May 25, 2021
June 5, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Health-Related Quality of Life 14 Item (HR-QoL-14)
Baseline up to 18 Months
Secondary Outcomes (1)
Percentage of Participants with >=1-point Increase from Baseline in Patient Determined Disease Steps (PDDS) Sustained Via Consecutive Measures Over 3 Months
Baseline up to 18 Months
Study Arms (2)
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.
Eligibility Criteria
Participants from United States with Multiple sclerosis (MS) will be included.
You may qualify if:
- Participants willing and able to provide written informed consent
- Participants with clinical diagnosis of Multiple Sclerosis (MS)
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Alabama Neurology Associates
Birmingham, Alabama, 35209, United States
Georgetown University
Washington D.C., District of Columbia, 20057, United States
Atlanta Neuroscience Institute
Atlanta, Georgia, 30327, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
The Memorial Hospital, d.b.a Memorial Healthcare
Owosso, Michigan, 48867, United States
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma, 73104, United States
The University of Texas of Austin
Austin, Texas, 78759, United States
The University of Texas Health Science Center
San Antonio, Texas, 78229, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Responsible
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 25, 2021
First Posted
May 28, 2021
Study Start
November 2, 2021
Primary Completion
February 19, 2024
Study Completion
February 19, 2024
Last Updated
June 6, 2024
Record last verified: 2024-05