Virtual Versus Usual In-office Care for Multiple Sclerosis: A Randomized Trial (VIRTUAL-MS)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 120
- 试验地点
- 4
- 主要终点
- Proportion of patients with disability progression
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •MS diagnosis within 24 months of randomization by 2017 McDonald Criteria.
- •Confirmatory MRI within 12 months prior to randomization.
- •Access to either mobile device, laptop or PC with internet connection to be able to conduct virtual visits
- •Participant's neurologist and/or advanced practice provider are participating in the study
排除标准
- •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)
- •Inability to provide informed consent
研究组 & 干预措施
Telehealth care
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.
干预措施: Multiple Sclerosis Clinical Care Delivery via telehealth (Other)
In-Clinic care
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.
干预措施: Multiple Sclerosis Clinical Care Delivery via standard in clinic visits (Other)
结局指标
主要结局
Proportion of patients with disability progression
时间窗: Baseline to 24 months
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).
次要结局
- Compare major healthcare costs(Baseline to 24 months)
- Change in Patient Satisfaction Questionnaire Short Form (PSQ-18)(Baseline to 24 months)
研究者
Marisa McGinley
Principal Investigator
The Cleveland Clinic