Abstract：
BACKGROUND: Multiple sclerosis (MS) affects nearly 1 million people and is estimated to cost $85.4 billion in the United States annually. People with MS have significant barriers to receiving care and telemedicine could substantially improve access to specialized, comprehensive care. In cross-sectional analyses, telemedicine has been shown to be feasible, have high patient and clinician satisfaction, reduce patient costs and burden, and enable a reasonable assessment of disability. However, no studies exist evaluating the longitudinal impact of telemedicine care for MS. Here we describe the study protocol for VIRtual versus UsuAL In-office care for Multiple Sclerosis (VIRTUAL-MS). The main objective of the study is to evaluate the impact of telemedicine for MS care on: patient clinical outcomes, economic costs, patient, and clinician experience.
METHODS: This two-site randomized clinical trial will enroll 120 adults with a recent diagnosis of MS and randomize 1:1 to receive in-clinic vs. telemedicine care for 24 months. The primary outcome of the study is worsening in any one of the four Multiple Sclerosis Functional Composite 4 (MSFC4) measures at 24 months. Other study outcomes include patient and clinician satisfaction, major healthcare costs, Expanded Disability Status Scale, treatment adherence, and digital outcomes.
CONCLUSIONS: The results of this study will directly address the key gaps in knowledge about longitudinal telemedicine-enabled care in an MS population. It will inform clinical care implementation as well as design of trials in MS and other chronic conditions.
BACKGROUND: NCT05660187.
METHODS: This two-site randomized clinical trial will enroll 120 adults with a recent diagnosis of MS and randomize 1:1 to receive in-clinic vs. telemedicine care for 24 months. The primary outcome of the study is worsening in any one of the four Multiple Sclerosis Functional Composite 4 (MSFC4) measures at 24 months. Other study outcomes include patient and clinician satisfaction, major healthcare costs, Expanded Disability Status Scale, treatment adherence, and digital outcomes.
CONCLUSIONS: The results of this study will directly address the key gaps in knowledge about longitudinal telemedicine-enabled care in an MS population. It will inform clinical care implementation as well as design of trials in MS and other chronic conditions.
BACKGROUND: NCT05660187.
摘要：
背景：多发性硬化症（MS）影响近100万人，在美国每年估计花费854亿美元。患有MS的人在接受护理方面存在重大障碍，远程医疗可以大大改善获得专业，全面护理。在横截面分析中，远程医疗已经被证明是可行的，有很高的患者和临床医生满意度，降低患者成本和负担，并能够对残疾进行合理的评估。然而,没有研究评估远程医疗护理对MS的纵向影响。在这里，我们描述了多发性硬化症（VIRTUAL-MS）的虚拟与常规办公室护理的研究方案。该研究的主要目的是评估远程医疗对MS护理的影响：患者临床结果，经济成本,病人,和临床医生的经验。
方法：这项双中心随机临床试验将招募120名最近诊断为MS的成年人，并以1：1的比例随机分配接受临床与24个月的远程医疗护理。该研究的主要结果是在24个月时，四个多发性硬化功能复合4（MSFC4）测量值中的任何一个都会恶化。其他研究结果包括患者和临床医生满意度，主要医疗费用，扩展的残疾状态量表，治疗依从性，数字结果。
结论：这项研究的结果将直接解决MS人群中有关纵向远程医疗支持护理知识的关键差距。它将为MS和其他慢性疾病的临床护理实施以及试验设计提供信息。
背景：NCT05660187。
方法：这项双中心随机临床试验将招募120名最近诊断为MS的成年人，并以1：1的比例随机分配接受临床与24个月的远程医疗护理。该研究的主要结果是在24个月时，四个多发性硬化功能复合4（MSFC4）测量值中的任何一个都会恶化。其他研究结果包括患者和临床医生满意度，主要医疗费用，扩展的残疾状态量表，治疗依从性，数字结果。
结论：这项研究的结果将直接解决MS人群中有关纵向远程医疗支持护理知识的关键差距。它将为MS和其他慢性疾病的临床护理实施以及试验设计提供信息。
背景：NCT05660187。
