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Study Protocol: VIRTUAL-MS
Objective
- Evaluate the impact of telemedicine for MS care on patient clinical outcomes, economic costs, patient, and clinician experience.
Methods
- Two-site randomized clinical trial with 120 adults recently diagnosed with MS
- Randomized 1:1 to receive in-clinic vs. telemedicine care for 24 months
- Primary outcome: worsening in any one of the four Multiple Sclerosis Functional Composite 4 (MSFC4) measures at 24 months
- Other study outcomes: patient and clinician satisfaction, major healthcare costs, Expanded Disability Status Scale, treatment adherence, and digital outcomes
Conclusion
- This study will address knowledge gaps about longitudinal telemedicine-enabled care in MS
- It will inform clinical care implementation and trial design in MS and other chronic conditions
Trial Registration
- NCT05660187
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