Multiple Sclerosis (MS) Clinical Trial
Official title:
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
Verified date | May 2024 |
Source | EMD Serono |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This Next Generation learning health system for Multiple Sclerosis (Next-Gen MS) study is a sub-study of the MS-LINKā¢ 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).
Status | Terminated |
Enrollment | 1594 |
Est. completion date | February 19, 2024 |
Est. primary completion date | February 19, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Participants willing and able to provide written informed consent - Participants with clinical diagnosis of Multiple Sclerosis (MS) Exclusion Criteria: - None |
Country | Name | City | State |
---|---|---|---|
United States | Atlanta Neuroscience Institute | Atlanta | Georgia |
United States | The University of Texas of Austin | Austin | Texas |
United States | Alabama Neurology Associates | Birmingham | Alabama |
United States | Beth Israel Deaconess Medical Center | Boston | Massachusetts |
United States | Oklahoma Medical Research Foundation | Oklahoma City | Oklahoma |
United States | The Memorial Hospital, d.b.a Memorial Healthcare | Owosso | Michigan |
United States | The University of Texas Health Science Center | San Antonio | Texas |
United States | Georgetown University | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
EMD Serono Research & Development Institute, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change From Baseline in Health-Related Quality of Life 14 Item (HR-QoL-14) | Baseline up to 18 Months | ||
Secondary | 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 |
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