VIRtual Versus UsuAL In-office Care for Multiple Sclerosis (VIRTUAL-MS

Virtual Versus Usual In-office Care for Multiple Sclerosis: A Randomized Trial (VIRTUAL-MS)

Running, not recruitingNot a drug-phase studyMS (type not specified)NCT05660187

What it found

Still running

No result yet.

What was tested

Treatment tested

  • Multiple Sclerosis Clinical Care Delivery via telehealth

Compared with

  • Multiple Sclerosis Clinical Care Delivery via standard in clinic visits

What it measured

Main measures

  • Proportion of patients with disability progression

    Baseline to 24 months

    Disability progressionVisionThinking and memoryWalking and mobility

Other measures (2)

  • Change in Patient Satisfaction Questionnaire Short Form (PSQ-18)

    Baseline to 24 months

    Quality of life (reported by participants)

  • Compare major healthcare costs

    Baseline to 24 months

Who could take part

MS (type not specified) · 18 and over

Show the full criteria

Inclusion criteria

1. Ages ≥18 2. MS diagnosis within 24 months of randomization by 2017 McDonald Criteria. 3. Confirmatory MRI within 12 months prior to randomization. 4. Access to either mobile device, laptop or PC with internet connection to be able to conduct virtual visits 5. Participant's neurologist and/or advanced practice provider are participating in the study

Exclusion criteria

1. Clinically relevant condition that, in the opinion of the PI, could preclude participation in the study (e.g. neutropenia or wound care requiring frequent monitoring) 2. Inability to provide informed consent

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

The current standard of outpatient MS care depends on in-clinic visits, but MS patients face many barriers to accessing this care. These barriers include those resulting from the disease itself, such as physical limitations, driving restrictions and financial limitations, and they are further compounded by an overall shortage of neurologists. Furthermore, MS care has a significant economic impact, with the estimated indirect and direct costs for treating MS in the US estimated to be > $85.4 billion. Therefore, there is a need to improve access to and reduce cost of MS care, and telehealth is a potential solution. The VIRTUAL-MS study has been designed to evaluate the impact of telehealth care on MS clinical outcomes, costs, and satisfaction compared to in-person care. Additionally, the study aims to evaluate facilitators and barriers to telehealth use to inform widespread implementation.

Papers

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History

    1. Started

      Mar 2023

    2. Main results due

      Dec 2027

    3. Finished

      Dec 2027

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