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

Tele-Sox：基于可穿戴设备和游戏化的远程医疗解决方案，用于预防肿瘤老年患者的静脉血栓栓塞

• 批准号: 10547300
• 负责人: Rosha Joshi
• 金额: $ 25.96万
• 依托单位: STEXOLE LLC
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-04-15 至 2025-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10547300
• 关键词: Acceleration; Achievement; Address; Adherence; Adopted; Age; Algorithms; Ankle; Anticoagulants; Area; Binding; Birds; Blood Vessels; Blood Volume; Blood flow; COVID-19 patient; Cellular Phone; Cessation of life; Clinical; Clinical effectiveness; Computer software; Data; Development; Devices; Diagnosis; Effectiveness; Elderly; Electromyography; Engineering; Ensure; Environment; Exercise; Feedback; Flying body movement; Frequencies; Gastrocnemius Muscle; Guidelines; Hemorrhage; Home; Hospitalization; Hospitals; Immobilization; Inpatients; Intervention; Interview; Joystick; Legal patent; Life; Lower Extremity; Malignant Neoplasms; Medicine; Mental Depression; Methods; Modeling; Monitor; Motivation; Motor; Movement; Muscle; Names; Nurses; Oncologist; Oncology; Operative Surgical Procedures; Participant; Patient Recruitments; Patients; Perception; Performance; Persons; Pharmaceutical Preparations; Phase; Play; Population; Populations at Risk; Portal System; Prevention; Prophylactic treatment; Protocols documentation; Publishing; Quality of life; Recommendation; Recovery; Recovery of Function; Regimen; Research; Rewards; Risk; Risk Reduction; Rotation; Sampling; Scanning; Secure; Series; Supervision; Surface; Surgeon; System; Tablets; Technology; Telemedicine; Testing; Time; Ultrasonography; Veins; Venous; Weight; animation; cancer type; care providers; college; commercialization; cost; design; dosage; evidence base; exercise program; exergame; exhaustion; feasibility testing; foot; health application; high risk; improved; improved mobility; in-home care; individual patient; innovation; interest; malignant breast neoplasm; mobile application; mortality; patient engagement; patient portal; pharmacologic; physical therapist; prevent; primary outcome; programs; prototype; readmission risk; remote patient monitoring; response; secondary outcome; sensor; success; tele-exercise; telehealth; telerehabilitation; tibialis anterior muscle; venous thromboembolism; virtual; visual feedback; wearable device; wearable sensor technology

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.

项目摘要/摘要 静脉血栓栓塞（VTE）是美国可预防医院死亡的主要原因，导致更大 每年超过100,000人死亡。高龄，手术，癌症，固定和住院是常见的 VTE的原因。总体而言，所有VTE病例中有20％发生在患有癌症的患者中。 VTE也很重要 在所有类型的癌症患者的诊断第一年中死亡率的预测指标。不仅有VTE的风险 由于长期固定，住院患者的风险仍高达3个月 释放。即使在出院后，VTE也很普遍。 当前的预防方法对VTE具有重大局限性。例如，使用药理学 由于出血并发症发生率增加，预防大部分仅限于住院环境。当前的 由于缺乏依从性，在家中的不切实际性，成本，成本， 和监督要求，尤其是在老年人中。 要解决上述限制，Stexole LLC与贝勒医学院（BCM）合作 设计和商业化创新的基于远程医学的智能袜子，名为Tele-Sox。这个设备 包括三个主要组成部分：1）传感器效果：专利的互动式游戏脚和脚踝 基于可穿戴传感器的锻炼计划，该传感器将集成到袜子中并启用交付 个性化基于游戏的下肢锻炼，确保改善VTE的静脉回报和预防； 2）一系列可调节的重量附加到个性化的电阻锻炼； 3）电信： 可以在平板电脑或智能手机上安装的移动应用程序可以与护理提供商以及 指导患者执行有效和个性化的锻炼任务和游戏化功能以参与 病人并提醒他/她建议每天需要剂量。 提议的平台的科学前提依赖于我们的初步研究，证明了 提议的Exergame计划仅在仅3分钟后增加静脉血流量平均增加49％ 互动和实际上有监督的重复脚和脚踝运动，同时减少了医院的弱点。 在第一阶段，最初的平台将得到改进，以使其适合家庭用途和精通技术的使用 用户（AIM 1）。此外，平台的概念证明将在方便的15个方便样本中进行评估 老年肿瘤学住院患者（50岁以上），以证明其可行性和概念效果以提高 响应3-5分钟使用设备的静脉回流（AIM 2）。最后，通过采访招聘 参与者和15位临床专家与该项目未与该项目相关，我们将评估利益的看法 使用。成功实现了第一阶段里程碑后，在第二阶段，游戏界面将 要进一步开发（更多游戏，患者的连通性），并将对其有效性进行测试 VTE的风险，提高移动性，降低再入院风险并提高生活质量。