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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
California
University of California San Francisco
RECRUITING
San Francisco
Ohio
Cleveland Clinic
RECRUITING
Cleveland
Contact Information
Primary
Meredith Dever, MPH
deverm@ccf.org
216 444-5441
Time Frame
Start Date: 2023-03-31
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 120
Treatments
Experimental: Telehealth care
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.
Active_comparator: In-Clinic care
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.
Related Therapeutic Areas
Sponsors
Collaborators: University of Washington, University of California, San Francisco
Leads: The Cleveland Clinic

This content was sourced from clinicaltrials.gov