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Active, Not Recruiting

NCT Number: NCT05660187

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California San Francisco, San Francisco, California, United States

Loading trial locations.

About this study

The VIRTUAL-MS study aims to evaluate the impact of telehealth on MS care. The study will conduct a 24 month randomized controlled clinical trial at two Centers (Cleveland Clinic and University of California San Francisco) and will enroll 60 adult people with MS per Center with a recent diagnosis of MS. Participants will be randomized 1:1 to receive follow-up MS care via scheduled telehealth, or standard in-clinic, visits. All participants will have in-person visits at baseline and 24 months with in-person study visit including clinical assessments, patient reported outcomes, and medical history review. All participants will have clinical visits with their neurology clinician every 6 months (months 6, 12, and 18) via in-person or telehealth per randomized arm.

The primary objective of this study is to determine if MS care delivered via telehealth is non-inferior compared to in-clinic MS care as measured by worsening in one of the Multiple Sclerosis Functional Composite (MSFC) components at Month 24.

The secondary objectives of this study include the following:

  • To determine if MS care delivered via telehealth has superior patient satisfaction compared to in-person MS care as measured by baseline to 24 month change in PSQ-18.
  • To determine if MS care delivered via telehealth is more cost-effective than MS care delivered via in-person visits as measured by total non-medication costs over 24 months.

The researchers will also explore other clinical outcomes, treatment adherence, digital outcomes, patient experience, and clinician experience.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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)
  • Inability to provide informed consent

Treatment and study plan

Multiple Sclerosis Clinical Care Delivery via telehealth

Other

Intervention includes clinical care delivered via telehealth

Multiple Sclerosis Clinical Care Delivery via standard in clinic visits

Other

Intervention includes clinical care delivered via standard in clinic visits

Primary outcomes

  1. Proportion of patients with disability progression

    Time frame: Baseline to 24 months

    The primary outcome will be disability worsening in one of the Multiple Sclerosis Functional Composite components at 24 months. Worsening is defined as 20% worsening in Timed 25 foot walking speed (T25FW), 20% worsening in the 9 hole peg test (9HPT), 20% worsening in Low Contrast Letter Acuity (LCLA) or a 4 point decrease in the Symbol Digit Modalities Test (SDMT).

Secondary outcomes

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

    Time frame: Baseline to 24 months

    The secondary outcome will assess patient and clinical care team satisfaction via the Patient Satisfaction Questionnaire Short Form (PSQ-18) short form.

    Minimum value is 1 and maximum value is 5 for each question, where 5 means a better outcome.

  2. Compare major healthcare costs

    Time frame: Baseline to 24 months

    The secondary outcome will compare major healthcare costs as measured by total non-medication costs.

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Collaborators

  • University of California, San Francisco
  • University of Washington

Registry information

Official study title

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

Acronym: VIRTUAL-MS

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Dec 21, 2022
Registry last updated
Jan 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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