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 VTEis 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 pharmacologicprophylaxis 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.
Public Health Relevance Statement: PROJECT NARRATIVES A significant proportion of geriatric oncology patients are at high risk of developing life-threatening venous thromboembolism (VTE). Current intervention methods, especially among older adults, are inefficient due to lack of compliance, impracticality for in-home care, cost, and supervision requirements. We are developing a smart sock, which enables interactive, practical, game-based foot and ankle exercise with tele-medicine feature that is tailored to improve venous return flow essential to prevent VTE as well as accelerate functional recovery posthospital discharge.
Project Terms: Acceleration; Achievement Attainment; Achievement; ages; Age; advanced age; elders; geriatric; late life; later life; older adult; older person; senior citizen; Elderly; Algorithms; Regio tarsalis; Ankle; Anticoagulant Agents; Anticoagulant Drugs; blood thinner; thrombopoiesis inhibitor; Anticoagulants; Birds; Aves; Avian; Blood Vessels; vascular; Blood Volume; malignant breast neoplasm; Breast Cancer; malignant breast tumor; Malignant Neoplasms; Cancers; Malignant Tumor; malignancy; neoplasm/cancer; Cessation of life; Death; Mental Depression; depression; Diagnosis; Pharmaceutical Preparations; Drugs; Medication; Pharmaceutic Preparations; drug/agent; Electromyography; Engineering; Environment; Exercise; Feedback; foot; Hemorrhage; Bleeding; blood loss; Hospitalization; Hospital Admission; Hospitals; Immobilization; orthopedic freezing; Inpatients; Interview; Lower Extremity; Lower Limb; Membrum inferius; Medicine; Methods; mortality; Motivation; Movement; body movement; Muscle; Muscle Tissue; muscular; Persons; Names; name; named; naming; Nurses; nurse; Legal patent; Patents; Patients; Perception; Play; Portal System; Publishing; Quality of life; QOL; Recommendation; Research; Rewards; Risk; Rotation; Computer software; Software; Supervision; Tablets; Technology; Testing; Time; Ultrasonography; Echography; Echotomography; Medical Ultrasound; Ultrasonic Imaging; Ultrasonogram; Ultrasound Diagnosis; Ultrasound Medical Imaging; Ultrasound Test; diagnostic ultrasound; sonogram; sonography; sound measurement; ultrasound imaging; ultrasound scanning; Veins; Weight; weights; Telemedicine; Guidelines; dosage; sensor; improved; Prophylaxis; Prophylactic treatment; Area; Surface; Clinical; Phase; Series; Ensure; Blood flow; Recovery; Groups at risk; People at risk; Persons at risk; Populations at Risk; Anterior Tibial Muscle; tibialis anterior; tibialis anterior muscle; gastrocnemius; Gastrocnemius Muscle; participant recruitment; Patient Recruitments; Oncologist; Oncology Cancer; Oncology; Venous; Life; animation; programs; exhaustion; Adopted; Frequencies; Scanning; Protocols documentation; Protocol; System; Operative Surgical Procedures; Operative Procedures; Surgical; Surgical Interventions; Surgical Procedure; surgery; interest; college; collegiate; Surgeon; Performance; success; visual feedback; Recovery of Function; functional recovery; Flying body movement; flying; Participant; Prevention; Devices; Modeling; Sampling; response; Intervention; Intervention Strategies; interventional strategy; Cell Phone; Cellular Telephone; Mobile Phones; iPhone; smart phone; smartphone; Cellular Phone; reduce risk; reduce risks; reduce that risk; reduce the risk; reduce these risks; reduces risk; reduces the risk; reducing risk; reducing the risk; risk-reducing; Risk Reduction; Molecular Interaction; Binding; Effectiveness; preventing; prevent; telehealth; Address; Adherence; Data; Motor; Monitor; Development; developmental; Joystick; cost; virtual; designing; design; Clinical effectiveness; Population; cancer type; innovate; innovative; innovation; health application; prototype; commercialization; high risk; telerehab; telerehabilitation; evidence base; primary outcome; secondary outcome; mobility enhancement; mobility improvement; optimized mobility; improved mobility; Regimen; Secure; mobile app; mobile device application; mobile application; individual patient; fitness program; exercise program; in-home care; physiotherapist; physical therapist; body sensor; body worn sensor; wearable biosensor; wearable sensor; wearable sensor technology; wearable electronics; wearable system; wearable technology; wearable tool; wearables; wearable device; care providers; re-admission risk; readmission risk; participant engagement; patient engagement; patient portal; exergame; venous thromboembolism; COVID infected patient; COVID patient; COVID positive patient; COVID-19 infected patient; COVID-19 positive patient; COVID19 patient; COVID19 positive patient; SARS-CoV-2 infected patient; SARS-CoV-2 patient; SARS-CoV-2 positive patient; coronavirus disease 2019 infected patient; coronavirus disease 2019 patient; coronavirus disease 2019 positive patient; coronavirus disease infected patient; coronavirus disease patient; coronavirus disease positive patient; coronavirus disease-19 patient; coronavirus patient; patient infected with COVID; patient infected with COVID-19; patient infected with SARS-CoV-2; patient infected with coronavirus disease; patient infected with coronavirus disease 2019; patient infected with severe acute respiratory syndrome coronavirus 2; patient with COVID; patient with COVID-19; patient with COVID19; patient with SARS-CoV-2; patient with coronavirus disease; patient with coronavirus disease 2019; patient with severe acute respiratory distress syndrome coronavirus 2; severe acute respiratory syndrome coronavirus 2 infected patient; severe acute respiratory syndrome coronavirus 2 patient; severe acute respiratory syndrome coronavirus 2 positive patient; COVID-19 patient; remote patient monitoring; tele-exercise; feasibility testing; homes; Home; pharmacologic
