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The study was terminated due to change in strategic priorities.
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Health-Related Quality of Life 14 Item (HR-QoL-14) | Baseline up to 18 Months |
| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
Exclusion Criteria:
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Participants from United States with Multiple sclerosis (MS) will be included.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Responsible | Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alabama Neurology Associates | Birmingham | Alabama | 35209 | United States | ||
| Georgetown University |
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| Label | URL |
|---|---|
| Trial Awareness and Transparency website | View source |
| US Medical Information website, Medical Resources | View source |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| 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 |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |