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Telehealth vs In-Clinic Care for Multiple Sclerosis (VIRTUAL-MS Trial)

N/A

Recruiting

Led By Marisa McGinley, DO

Research Sponsored by The Cleveland Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Ages ≥18

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if telehealth can make MS care more accessible and reduce costs, while maintaining quality and patient satisfaction.

Who is the study for?

The VIRTUAL-MS trial is for adults over 18 with a recent Multiple Sclerosis (MS) diagnosis confirmed by MRI. It's designed for those who can consent to participate and don't have other health issues that need close monitoring, like severe low white blood cell count or wounds needing frequent care.

What is being tested?

This study compares MS care via telehealth to traditional in-clinic visits. It aims to see if remote care can match clinic-based care in terms of clinical outcomes, costs, and patient satisfaction while also identifying what makes telehealth work well.

What are the potential side effects?

Since this trial compares different methods of delivering healthcare rather than testing new medications, there are no direct side effects from drugs. However, participants may experience differences in the convenience or effectiveness of their MS management.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Proportion of patients with disability progression

Secondary study objectives

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

Compare major healthcare costs

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Telehealth careExperimental Treatment1 Intervention

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.

Group II: In-Clinic careActive Control1 Intervention

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.

0 / 1Eligibility criteria met