Telehealth vs In-Clinic Care for Multiple Sclerosis

(VIRTUAL-MS Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Riley Bove, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: The Cleveland Clinic

Disqualifiers: Neutropenia, Wound care, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of telehealth as a treatment for multiple sclerosis?

Research shows that telehealth can improve access to care and enhance the quality of life for people with multiple sclerosis by reducing barriers like travel costs and mobility issues. Studies indicate that telehealth is a feasible and well-received alternative to in-person visits, with patients expressing satisfaction with the quality of care and technical aspects of teleconsultations. ^{1 2 3 4 5}

Is telehealth care for multiple sclerosis safe compared to in-clinic care?

Research indicates that telehealth care for multiple sclerosis is generally safe and well-received by patients, with no significant differences in health outcomes compared to in-clinic care. Patients reported satisfaction with the quality of care and technical aspects of telehealth services. ^{1 3 6 7 8}

How does telehealth for multiple sclerosis differ from traditional treatments?

Telehealth for multiple sclerosis offers a unique approach by providing remote access to care through virtual visits, which can be more convenient for patients with mobility or geographic limitations. This method allows for continuous monitoring and management of the condition without the need for frequent in-person clinic visits, making it a novel alternative to traditional in-clinic care. ^{1 3 5 9 10}

Research Team

Riley Bove, MD

Principal Investigator

University of California, San Francisco

Marisa McGinley, DO

Principal Investigator

The Cleveland Clinic

Eligibility Criteria

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.

I am 18 years old or older.

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)

Trial Timeline

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

Treatment Details

Interventions

• Multiple Sclerosis Clinical Care Delivery via standard in clinic visits (Behavioural Intervention)
• Multiple Sclerosis Clinical Care Delivery via telehealth (Behavioural Intervention)

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.

Participant Groups

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.

Who Is Running the Clinical Trial?

The Cleveland Clinic

Lead Sponsor

Trials

1,072

Recruited

1,377,000+

David Peter

The Cleveland Clinic

Chief Medical Officer

MD, board-certified in Hospice and Palliative Medicine

Tomislav Mihaljevic

The Cleveland Clinic

Chief Executive Officer since 2018

MD from University of Zagreb School of Medicine

University of California, San Francisco

Collaborator

Trials

2,636

Recruited

19,080,000+

Suresh Gunasekaran

University of California, San Francisco

Chief Executive Officer since 2022

MBA from Southern Methodist University

Dr. Lukejohn Day

University of California, San Francisco

Chief Medical Officer

MD from Stanford University School of Medicine

University of Washington

Collaborator

Trials

1,858

Recruited

2,023,000+

Dr. Timothy H. Dellit

University of Washington

Chief Executive Officer since 2023

MD from University of Washington

Dr. Anneliese Schleyer

University of Washington

Chief Medical Officer since 2023

MD, MHA

Findings from Research

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 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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Telemedicine and Multiple Sclerosis: A Survey of Health Care Providers Before and During the COVID-19 Pandemic. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Clinic to in-home telemedicine reduces barriers to care for patients with MS or other neuroimmunologic conditions. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Innovating Care in Multiple Sclerosis: Feasibility of Synchronous Internet-Based Teleconsultation for Longitudinal Clinical Monitoring. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

The effectiveness of telehealth interventions for people with multiple sclerosis: A systematic review and meta-analysis protocol. [2023]

5. Canada pubmed.ncbi.nlm.nih.gov

The Use of Digital and Remote Communication Technologies as a Tool for Multiple Sclerosis Management: Narrative Review. [2020]

6. New Zealand 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. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Challenges and Opportunities of Real-World Data: Statistical Analysis Plan for the Optimise:MS Multicenter Prospective Cohort Pharmacovigilance Study. [2022]

8. United States 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. [2021]

9. Netherlands 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. [2020]

10. Italy pubmed.ncbi.nlm.nih.gov

Patient's point of view on the use of telemedicine in multiple sclerosis: a web-based survey. [2022]