ACTIVE_NOT_RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-03-31
Study Completion:2027-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05660187

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Ages ≥18
  2. 2. MS diagnosis within 24 months of randomization by 2017 McDonald Criteria.
  3. 3. Confirmatory MRI within 12 months prior to randomization.
  4. 4. Access to either mobile device, laptop or PC with internet connection to be able to conduct virtual visits
  5. 5. Participant's neurologist and/or advanced practice provider are participating in the study
  1. 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. 2. Inability to provide informed consent

Contacts and Locations

Principal Investigator

Marisa McGinley, DO
PRINCIPAL_INVESTIGATOR
The Cleveland Clinic
Riley Bove, MD
PRINCIPAL_INVESTIGATOR
University of California, San Francisco

Study Locations (Sites)

University of California San Francisco
San Francisco, California, 94158
United States
Cleveland Clinic
Cleveland, Ohio, 44195
United States

Collaborators and Investigators

Sponsor: The Cleveland Clinic

  • Marisa McGinley, DO, PRINCIPAL_INVESTIGATOR, The Cleveland Clinic
  • Riley Bove, MD, PRINCIPAL_INVESTIGATOR, University of California, San Francisco

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-03-31
Study Completion Date2027-12-31

Study Record Updates

Study Start Date2023-03-31
Study Completion Date2027-12-31

Terms related to this study

Keywords Provided by Researchers

  • Multiple sclerosis
  • MS
  • telehealth
  • healthcare delivery

Additional Relevant MeSH Terms

  • Multiple Sclerosis