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

NeuroTherapia, Inc.

Status: Active, not recruiting

Conditions: Multiple Sclerosis

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05660187

23-045

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Ages ≥18
2. MS diagnosis within 24 months of randomization by 2017 McDonald Criteria.
3. Confirmatory MRI within 12 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 design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

Telehealth care

Experimental group

Description:

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.

Treatment:

Other: Multiple Sclerosis Clinical Care Delivery via telehealth

In-Clinic care

Active Comparator group

Description:

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.

Treatment:

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