Participate in a Clinical Trial

Without the participation of people with MS, it would be impossible to develop new and better therapies and other interventions.

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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Ages ≥18. 2. MS diagnosis within 12 months of randomization by 2017 McDonald Criteria. 3. Confirmatory MRI within 6 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05660187
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	The Cleveland Clinic
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Marisa McGinley, DORiley Bove, MD
Principal Investigator Affiliation	The Cleveland ClinicUniversity of California, San Francisco
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Multiple Sclerosis

Additional Details

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.

Arms & Interventions

Arms

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.

Interventions

Other: - Multiple Sclerosis Clinical Care Delivery via telehealth

Intervention includes clinical care delivered via telehealth

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

Intervention includes clinical care delivered via standard in clinic visits

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of California San Francisco, San Francisco, California

Status

Recruiting

Address

University of California San Francisco

San Francisco, California, 94158

Site Contact

Kanishka Koshal

[email protected]

415-353-8053

Cleveland Clinic, Cleveland, Ohio

Status