Telehealth vs In-Clinic Care for Multiple Sclerosis

(VIRTUAL-MS Trial)

Not currently recruiting at 1 trial location

Overseen By Meredith Dever, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The Cleveland Clinic

Disqualifiers: Neutropenia, Wound care, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 24 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether telehealth (online healthcare through video calls) can match the effectiveness of in-person visits for treating multiple sclerosis (MS). MS patients often encounter challenges such as mobility issues and financial costs, which make regular clinic visits difficult. Telehealth might offer a more accessible and cost-effective alternative. The trial compares clinical outcomes, costs, and patient satisfaction between telehealth and traditional in-clinic care. Individuals diagnosed with MS in the last two years who have internet access may consider participating. As an unphased trial, this study provides a unique opportunity for participants to contribute to innovative research that could enhance access to care for MS patients.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that telehealth care for MS is safe?

Research has shown that telehealth for multiple sclerosis (MS) is generally safe and well-received. Studies have found that telehealth can simplify access to care for MS patients and help save money. This is particularly beneficial for those with mobility challenges or financial difficulties. Telehealth enables patients to receive care from home, a significant advantage for those with mobility issues.

No specific reports indicate negative effects from using telehealth for MS care. The main challenges involve understanding remote examinations and communicating with patients, but these do not compromise safety. Overall, telehealth has improved the quality of life for MS patients by providing regular and easy-to-access care. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about exploring telehealth for Multiple Sclerosis (MS) care because it offers a flexible and potentially more accessible way to deliver comprehensive care. Unlike traditional in-clinic visits, telehealth allows patients to connect with their neurologists from home, which could be particularly beneficial for those with mobility challenges or those living far from healthcare facilities. This approach might also provide a more personalized care experience, as it can be adapted to fit the specific needs and symptoms of each patient. By comparing telehealth with standard in-clinic visits, researchers hope to determine if telehealth can maintain or even improve the quality of MS care while offering greater convenience.

What evidence suggests that this trial's treatments could be effective for multiple sclerosis?

This trial will compare telehealth care with in-clinic care for people with Multiple Sclerosis (MS). Research has shown that telehealth can effectively provide care for people with MS. Studies have found that patients are as satisfied with virtual visits as with in-person ones, appreciating their healthcare provider's communication and understanding. Telehealth also eases access to necessary care, which can be difficult due to physical challenges and a shortage of specialists. Early evidence suggests that telehealth can help reduce the costs of MS care. Overall, telehealth appears to be a good alternative to traditional clinic visits for MS patients. ^{1 2 6 7 8}

Who Is on the Research Team?

Riley Bove, MD

Principal Investigator

University of California, San Francisco

Marisa McGinley, DO

Principal Investigator

The Cleveland Clinic

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

You had an MRI scan within 6 months before joining the study.

You have been diagnosed with multiple sclerosis using specific criteria within the past year.

Exclusion Criteria

Inability to provide informed consent

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)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

In-person visits at baseline including clinical assessments, patient reported outcomes, and medical history review

1 visit

1 visit (in-person)

Treatment

Participants receive follow-up MS care via scheduled telehealth or standard in-clinic visits every 6 months

24 months

4 visits (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Multiple Sclerosis Clinical Care Delivery via standard in clinic visits
• Multiple Sclerosis Clinical Care Delivery via telehealth

Trial Overview

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.

How Is the Trial Designed?

Group I: Telehealth care Experimental Treatment 1 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 care Active Control 1 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.

Multiple Sclerosis Clinical Care Delivery via standard in clinic visits is already approved in United States, European Union for the following indications:

Approved in United States as Standard In-Clinic Visits for:

• Multiple Sclerosis Clinical Care

Approved in European Union as Standard In-Clinic Visits for:

• Multiple Sclerosis Clinical Care

Who Is Running the Clinical Trial?

The Cleveland Clinic

Lead Sponsor

Trials

1,072

Recruited

1,377,000+

University of California, San Francisco

Collaborator

Trials

2,636

Recruited

19,080,000+

University of Washington

Collaborator

Trials

1,858

Recruited

2,023,000+

Published Research Related to This Trial

A survey of 94 healthcare providers revealed that telemedicine use for multiple sclerosis (MS) care surged from 44.4% to 84.2% during the COVID-19 pandemic, indicating its growing importance in providing access to specialty care.

Despite high satisfaction rates (93.0%) with telemedicine visits, many providers (84.6%) found it challenging to conduct full examinations, suggesting that while telemedicine is effective, it may have limitations in comprehensive patient assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telemedicine and Multiple Sclerosis: A Survey of Health Care Providers Before and During the COVID-19 Pandemic. Keszler, P., Maloni, H., Miles, Z., et al.[2022]

A feasibility study involving 60 patients with multiple sclerosis showed that teleconsultation (TC) is a viable option, with 82.4% of scheduled sessions completed, indicating strong patient engagement.

While the intervention did not significantly improve functional status or reduce medical costs, patients reported high satisfaction with the quality of care and technical aspects of the teleconsultation, suggesting it could be a beneficial addition to standard care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Innovating Care in Multiple Sclerosis: Feasibility of Synchronous Internet-Based Teleconsultation for Longitudinal Clinical Monitoring. Sadeghi, N., Eelen, P., Nagels, G., et al.[2022]

Virtual house calls (VHCs) for patients with multiple sclerosis (MS) were found to be feasible and comparable to in-clinic visits, with no significant difference in the number of completed visits among 36 participants.

Participants reported high satisfaction with VHCs, noting cost and time savings, and 97.1% would recommend telemedicine visits, highlighting the convenience and effectiveness of this care delivery method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of telemedicine versus in-person visits for persons with multiple sclerosis: A randomized crossover study of feasibility, cost, and satisfaction. Robb, JF., Hyland, MH., Goodman, AD.[2020]

The Optimise:MS study has recruited over 2,000 participants from 14 hospitals in the UK to assess the safety profile of disease-modifying therapies (DMTs) for multiple sclerosis (MS) in real-world settings, focusing on serious adverse events (SAEs).

The study's statistical analysis plan is designed to address complex confounding factors and will provide valuable insights into the long-term outcomes of DMTs, including the effects of treatment switching and pregnancy outcomes, which are often not covered in randomized controlled trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Challenges and Opportunities of Real-World Data: Statistical Analysis Plan for the Optimise:MS Multicenter Prospective Cohort Pharmacovigilance Study. Waddingham, E., Miller, A., Dobson, R., et al.[2022]

eHealth technologies, including mobile apps, significantly improve access to care and health outcomes for patients with multiple sclerosis (MS) by enabling self-management and remote monitoring, addressing barriers like mobility and travel costs.

The review identified 28 eHealth solutions that support various aspects of MS management, highlighting their potential to enhance patient engagement and streamline healthcare delivery, although challenges to widespread adoption remain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Use of Digital and Remote Communication Technologies as a Tool for Multiple Sclerosis Management: Narrative Review. Marziniak, M., Brichetto, G., Feys, P., et al.[2020]

A survey of 613 multiple sclerosis patients revealed that 54% were open to telemedicine visits, with acceptance influenced by factors like higher income and familiarity with technology.

While many patients appreciated the time-saving aspect of telemedicine, 71% expressed concerns about the inability to measure physical parameters during virtual visits, highlighting the need for improved telemedicine solutions tailored to patient needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient's point of view on the use of telemedicine in multiple sclerosis: a web-based survey. Landi, D., Ponzano, M., Nicoletti, CG., et al.[2022]

A study of 50 televideo visits in an MS and neuroimmunology clinic showed that 98% of patients found the telemedicine technology easy to use, and 96% felt their clinical goals were met, indicating high patient satisfaction and efficacy of remote care.

Telemedicine significantly reduced travel burdens for patients, averaging 160 miles saved, and decreased indirect costs related to time off work and caregiver responsibilities, demonstrating its potential to enhance accessibility and convenience in healthcare.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinic to in-home telemedicine reduces barriers to care for patients with MS or other neuroimmunologic conditions. Bove, R., Garcha, P., Bevan, CJ., et al.[2022]

The REGIMS registry is a multicenter observational study in Germany that collects data on the side effects of immunotherapies for multiple sclerosis, providing valuable insights into the long-term safety of these treatments.

By the end of 2019, REGIMS had recruited 1000 patients, primarily women with relapse-remitting MS, demonstrating the registry's ability to gather high-quality, real-world data despite facing logistical challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chances and Challenges of Registry-Based Pharmacovigilance in Multiple Sclerosis: Lessons Learnt from the Implementation of the Multicenter REGIMS Registry. Simbrich, A., Thibaut, J., Khil, L., et al.[2022]

A 12-week telerehabilitation program, called TeleCAM, is being tested on 820 people with multiple sclerosis (MS) to provide accessible exercise and rehabilitation services at home, potentially overcoming barriers faced by those in rural, low-income areas.

The study will evaluate the effectiveness of TeleCAM compared to traditional in-clinic therapy (DirectCAM) by measuring patient-centered health outcomes like pain, fatigue, and quality of life, as well as physical functioning measures, to ensure benefits are realized across diverse demographics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rationale and design of the tele-exercise and multiple sclerosis (TEAMS) study: A comparative effectiveness trial between a clinic- and home-based telerehabilitation intervention for adults with multiple sclerosis (MS) living in the deep south. Rimmer, JH., Thirumalai, M., Young, HJ., et al.[2021]

Telehealth interventions (TIs) have the potential to improve healthcare delivery and quality of life for individuals with multiple sclerosis (MS), as suggested by a systematic review of randomized controlled trials.

This systematic review will analyze data from various studies to assess the effectiveness of TIs, aiming to fill knowledge gaps and provide evidence for clinical practice and policy-making regarding MS care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of telehealth interventions for people with multiple sclerosis: A systematic review and meta-analysis protocol. Heidari-Soureshjani, R., Daneshvar, M., Mohammadi, T., et al.[2023]

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