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

NCT05660187 | Active Not Recruiting DMC

• 1 other identifier: 23-045
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Multiple Sclerosis

Keywords

Multiple sclerosis; MS; telehealth; healthcare delivery

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with disability progression

  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).

  Baseline to 24 months

Secondary Outcomes (2)

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

  Baseline to 24 months

• Compare major healthcare costs

  Baseline to 24 months

Study Arms (2)

Telehealth care

EXPERIMENTAL

Telehealth visits will be performed using institutionally-approved, secure, web-based teleconferencing. The standard neurology visits will occur every 6 months with their established neurology clinician via telehealth. The comprehensive care will be offered via telehealth or within the patient's local community. The comprehensive care visits will be adapted for the individual participants' needs and symptoms, consistent with standard clinical care.

Other: Multiple Sclerosis Clinical Care Delivery via telehealth

In-Clinic care

ACTIVE COMPARATOR

Standard neurology visits will be conducted in-clinic visits every 6 months with their established neurology clinician. The comprehensive MS care visits will be conducted in-clinic. The comprehensive care visits will be adapted for the individual participants' needs and symptoms, consistent with standard clinical care.

Other: Multiple Sclerosis Clinical Care Delivery via standard in clinic visits

Interventions

Multiple Sclerosis Clinical Care Delivery via telehealth OTHER

Intervention includes clinical care delivered via telehealth

Telehealth care

Multiple Sclerosis Clinical Care Delivery via standard in clinic visits OTHER

Intervention includes clinical care delivered via standard in clinic visits

In-Clinic care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Cleveland Clinic: lead
• University of California, San Francisco: collaborator
• University of Washington: collaborator

Study Sites (2)

University of California San Francisco

San Francisco, California, 94158, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Related Publications (1)

• McGinley M, Carlson JJ, Reihm J, Plow M, Roser M, Sisodia N, Cohen JA, Misra-Hebert AD, Lazar AA, Bove R. Virtual versus usual in-office care for multiple sclerosis: The VIRTUAL-MS multi-site randomized clinical trial study protocol. Contemp Clin Trials. 2024 Jul;142:107544. doi: 10.1016/j.cct.2024.107544. Epub 2024 Apr 23.

  PMID: 38657731 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Ambulatory Care

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Marisa McGinley, DO

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

• Riley Bove, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 13, 2022
• First Posted: December 21, 2022
• Study Start: March 31, 2023
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 28, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)