Tele-Sox: A Tele-Medicine solution based on wearables and gamification to prevent Venous thromboembolism in Oncology Geriatric Patients

项目摘要/摘要 静脉血栓栓塞症(VTE)是美国可预防的住院死亡的主要原因，导致 每年有超过10万人死亡。高龄、手术、癌症、制动和住院是很常见的。 静脉血栓形成的原因。总体而言，20%的VTE病例发生在患有癌症的患者中。VTE也是一个重要的 所有类型癌症患者确诊后第一年死亡率的预测因子。不仅是VTE的风险 在住院患者中，由于长时间不动，其风险仍然很高，直到3个月后 出院。静脉血栓栓塞在新冠肺炎患者中也非常普遍，即使在出院后也是如此。 目前预防VTE的方法有很大的局限性。例如，药理学的使用 由于出血并发症的发生率增加，预防措施大多局限于住院环境。当前 非药物干预由于缺乏依从性、家庭护理不切实际、成本、 和监管要求，特别是在老年人口中。 为了解决上述限制，STEXOLE LLC与贝勒医学院(BCM)建立了合作伙伴关系 设计并商业化一款基于远程医疗的创新智能袜子，名为Tele-Sox。这个设备 包括三个主要组成部分：1)传感器--EffGame：一款基于脚和脚踝的专利互动游戏 基于可穿戴传感器的锻炼计划，它将集成到袜子中，使交付 个性化的游戏化肢体锻炼，确保改善静脉回流，预防静脉血栓形成； 2)袜子上的一系列可调重量附件，以进行个性化的阻力锻炼；3)远程医疗：A 可安装在平板电脑或智能手机上的移动应用程序支持与护理人员以及 引导患者执行有效和个性化的运动任务和游戏化功能以参与 并提醒患者每日所需运动量的推荐量。 建议平台的科学前提依赖于我们初步的研究，证明了 建议的运动计划，仅在3分钟后，静脉血流量平均增加49% 交互式和虚拟监督的重复足部和脚踝练习，同时减少医院获得性虚弱。 在第一阶段，将对初始平台进行改进，使其适合家庭使用和非技术人员 用户(目标1)。此外，平台的概念证明将以15个方便的样本进行评估 老年肿瘤科住院患者(50岁以上)论证其可行性及提高疗效的概念证明 静脉回流反应设备使用3-5分钟(目标2)。最后，通过面试招聘人员 参与者和15名与该项目无关的临床专家，我们将评估他们对受益的感知和易用性 使用。在成功实现第一阶段的里程碑之后，在第二阶段期间，游戏界面将 将进一步开发(更多的游戏，患者的互联)，并将测试其有效性，以减少 减少VTE风险，改善机动性，降低再入院风险，提高生活质量。

PROJECT SUMMARY/ABSTRACT Venous thromboembolism (VTE) is a leading cause of preventable hospital death in the US resulting in greater than 100,000 deaths annually. Advanced age, surgery, cancer, immobilization, and hospitalization are common causes of VTE. Overall, 20% of all VTE cases occurs in patients who have cancer. VTE was also a significant predictor of mortality during the first year of diagnosis in patients with all types of cancer. Not only the risk of VTE is high in the hospitalized patients because of long immobility, its risk remains elevated up to 3 months after discharge. VTE is also highly prevalent among COVID-19 patients even after the hospital discharge. Current methods of prophylaxis for VTE have significant limitations. For instance, the use of pharmacologic prophylaxis is mostly limited to the inpatient setting, due to increased rates of bleeding complications. Current non-pharmacological interventions are inefficient due to lack of compliance, impracticality for in-home care, cost, and supervision requirements especially in elderly population. To address the limitations described above STEXOLE LLC is partnered with Baylor College of Medicine (BCM) to design and commercialize an innovative tele-medicine-based smart sock named Tele-SOX. This device includes three major components: 1) Sensor-Exergame: a patented interactive game- based foot and ankle exercise program based on a wearable sensor, which will be integrated into the sock and enables delivering personalized game-based lower extremity exercise, ensuring improving venous return and prevention of VTE; 2) a series of adjustable weights add-on to socks to personalized resistive exercise; 3) tele- medicine: a mobile application installable on a tablet or a smart phone enables interaction with care providers as well as guiding patients to execute effective and personalized exercise tasks and gamification features to engage patient and remind him/her for recommended dosage of needed exergame per day. The scientific premise of the proposed platform relies on our initial study demonstrating effectiveness of the proposed exergame program on increasing venous blood flow volume on average by 49% after just 3-minute interactive and virtually supervised repetitive foot and ankle exercise, while reducing hospital acquired weakness. During Phase I, the initial platform will be improved to make it suitable for home-based use and non-tech savvy users (Aim 1). In addition, the proof of concept of the platform will be assessed in a convenient sample of 15 geriatric oncology inpatients (age 50+) to demonstrate its feasibility and proof of concept efficacy to improve venous-return flow in response to 3-5 min usage of the device (Aim 2). Finally, by interviewing recruited participants and 15 clinical experts unaffiliated with the project, we will assess perception of benefit and ease of use. After successful achievement of the milestones of the Phase I, During Phase II, the gaming interface will be further developed (more games, inter-connectivity of patients), and will be tested for its effectiveness to reduce risk of VTE, improve mobility, reduce readmission risk, and enhancing the quality of life.