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| Name | Class |
|---|---|
| University of California, San Francisco | OTHER |
| University of Washington | OTHER |
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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.
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:
The researchers will also explore other clinical outcomes, treatment adherence, digital outcomes, patient experience, and clinician experience.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telehealth care | Experimental | 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. |
|
| In-Clinic care | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multiple Sclerosis Clinical Care Delivery via telehealth | Other | Intervention includes clinical care delivered via telehealth |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with disability progression | The primary outcome will be disability worsening in one of the Multiple Sclerosis Functional Composite components at 24 months. Worsening is defined as 20% worsening in Timed 25 foot walking speed (T25FW), 20% worsening in the 9 hole peg test (9HPT), 20% worsening in Low Contrast Letter Acuity (LCLA) or a 4 point decrease in the Symbol Digit Modalities Test (SDMT). | Baseline to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Patient Satisfaction Questionnaire Short Form (PSQ-18) | The secondary outcome will assess patient and clinical care team satisfaction via the Patient Satisfaction Questionnaire Short Form (PSQ-18) short form. Minimum value is 1 and maximum value is 5 for each question, where 5 means a better outcome. | Baseline to 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marisa McGinley, DO | The Cleveland Clinic | Principal Investigator |
| Riley Bove, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Francisco | San Francisco | California | 94158 | United States | ||
| Cleveland Clinic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38657731 | Derived | McGinley M, Carlson JJ, Reihm J, Plow M, Roser M, Sisodia N, Cohen JA, Misra-Hebert AD, Lazar AA, Bove R. Virtual versus usual in-office care for multiple sclerosis: The VIRTUAL-MS multi-site randomized clinical trial study protocol. Contemp Clin Trials. 2024 Jul;142:107544. doi: 10.1016/j.cct.2024.107544. Epub 2024 Apr 23. |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| ID | Term |
|---|---|
| D000553 | Ambulatory Care |
| ID | Term |
|---|---|
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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| Multiple Sclerosis Clinical Care Delivery via standard in clinic visits | Other | Intervention includes clinical care delivered via standard in clinic visits |
|
| Compare major healthcare costs |
The secondary outcome will compare major healthcare costs as measured by total non-medication costs. |
| Baseline to 24 months |
| Cleveland |
| Ohio |
| 44195 |
| United States |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |