Grant Proposal

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Embry-Riddle Aeronautical University *

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Medicine

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Jan 9, 2024

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Project Summary and Introduction This proposal presents a Wrist-worn COVID 19 Symptom Tracker in an effort to improve infection control through early detection of the disease. The implementation of this technology hopes to assist persons affected by the COVID 19 that have been released to their homes to feel more comfortable tracking their symptoms/ vital signs in an efficient manner. We believe that the device will be of great benefit to possible COVID 19 patients in the general population and their families. One of the main goals of our project is to have the watches available for purchase through medical insurance at the various hospitals by persons who suspect that they have COVID 19 and to patients recovering at home. Therefore, the device will be made available for the duration of the pandemic. We intend on consulting without a team of medical professionals in order to source the most accurate and efficient product. The device will be worn on a suspected COVID 19 patient’s wrist and using sensors it will monitor oxygen saturation, temperature, blood pressure, and heart rate of the patient. The “watch” will also be able to store this data. Rationale and Significance Ninety-Five percent of persons who have tested positive for the Covid 19 virus are sent home to recover and isolate after finding out that their test is positive (UC Davis Health, 2020). They are not hospitalized as their immediate symptoms are not life-threatening. However, individuals with conditions that make them more susceptible to further complications require constant surveillance (UC Davis Health, 2020). Typically, COVID-specific symptoms last approximately 3 weeks before a person fully recovers (UC Davis Health, 2020), therefore, they would have to monitor their condition for that recovery period at home. Furthermore, a study conducted by researchers in the Perelman School of Medicine at the University of Pennsylvania revealed that “ Roughly 1 in 10 patients diagnosed with COVID- 19 needed to return to the hospital within a week of discharge from an emergency department visit ” (Kilaru et al., 2020). The patients were prompted to return to the hospital to be admitted due to returning of symptoms like “ lower pulse oximetry levels ” and high temperature or “fever” were some of the most telling symptoms that resulted in return trips that resulted in admission (Kilaru et al., 2020). Monitoring of vital signs such as temperature and oxygen saturation plays an important role in treating the virus. The results of one study revealed that regardless of age patients will lower puls oximeter levels were a four times higher chance of requiring readmittance than those with a higher pulse oximeter (Penn Medicine News, 2020). Additionally, patients with increased body temperature are at a higher risk of requiring hospitalization than those closer to normal temperature. The researchers that conducted the study reported that “remote monitoring is a useful tool in caring for COVID-19 patients” (Penn Medicine News, 2020).

Unfortunately, with the rise in patients the space in the hospitals has become limited. For example, doctors at hospitals in Illinois had to send patience with “mild to moderate” immediate symptoms to recover at home to create more space at the hospital (Schencker, 2020) . The hospitals in Illinois launched a “COVID at home” program where the eligible COVID patients are sent home to recover. The at-home patients are equipped with a monitoring kit consisting of a thermometer, pulse oximeter, and logs to record (Schencker, 2020). The medical staff then does check in with the patients to ensure that their conditions do not worsen. Based on the situation the vital sign watch will be a very useful tool in helping both the patient and the medical professional to track the COVID 19 patients’ condition while creating more space in hospitals for more serious patients. The watch is one device that monitors the temperature, oxygen levels, heart rate, blood pressure and records the data. therefore, the patent will feel more comfortable and competent while monitoring their condition than with the kit of different instruments. Method Recently the Central Drugs Standard Control Organization (CDSCO) under the Ministry of Health and Family Welfare has granted the company GOQii, “a smart-tech-enabled preventive technology” company medical device registration for their GOQii Smart Vital (Legal Monitor Worldwide, 2020). The Smart Vital watch monitors heart rate, measures oxygen saturation, body temperature and acts as a fitness tracker (Singal, 2020). Furthermore, K.J. Somaiya Medical College and Research Centre has been conducting a seminal clinical study where doctors and other medical professionals are using the GOQii “advanced wearable technology” to monitor their COVID 19 patients and record real time health information on the patient (Legal Monitor Worldwide, 2020). The article revealed that “the initial results of the study are promising, and an absolute focus has been laid upon the accuracy of the device” (Legal Monitor Worldwide, 2020). Since the watches are produced in India upon receiving the grant our team will purchase and ship the device to the United States. This may take approximately 15 to 20 days. Upon Arrival, some sample watches will be sent to various hospitals so that doctors and other medical professionals can test the product to ensure that patients can use it with ease and comfort. They will ensure that it is appropriate for home use. Based on their feedback and approval of the watch by the Central Drugs Standard Control Organization (CDSCO) our team will present the watches to the Ministry of Health in the United States for sale. It is anticipated that the government through the Ministry of Health will purchase the watches and distribute them to various public health facilities to be distributed to the COVID 19 patients eligible for home recovery. Our team also intends on presenting the watches to privately owned health institutions for sale. The watches will continue to be made available once there

is a need during the pandemic. Our team will conduct quarterly progress reports to analyze the effectiveness of the vital sign tracker. We will conduct interviews with some medical staff and surveys with eligible, willing recovered patients. Problem Analysis Due to the pandemic, there have been closures or ports in the past due to rising cases. If the situation begins to worsen again this may cause a delay in shipping times. To combat this problem, we will carry out an investigation before placing an order to get an approximate number of watches needed by each interested healthcare facility. The orders that we place will include “emergency watches” which will be in addition to the estimate that we received from the healthcare facilities. Facilities and Equipment The fundamental equipment necessary for the success of our project is the GOQii Smart Vital watch. Figure 1. Image showing the GOQii Smart Vital Watch The watches will need to be stored in an appropriate storage facility or warehouse. Personnel Marketing Expert Principal Investigator Logistics Manager Accountants A volunteer from IEEE to assist with distribution to facilities.

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Budget Expenses Planned Totals $0 Storage $0 Shipping $0 Product costs $0 Staff $0 Conclusion

References Kilaru, A. S., Lee, K., Snider, C. K., Meisel, Z. F., Asch, D. A., Mitra, N., & Delgado, M. K. (2020). Return Hospital Admissions Among 1419 COVID‐19 Patients Discharged from Five U.S. Emergency Departments. Academic Emergency Medicine , 27 (10), 1039– 1042. https://doi.org/10.1111/acem.14117 Legal Monitor Worldwide (2020, December 3). Three GOQii wearables get medical device registration from CDSCO. Business Insights: Essentials. http://bi.gale.com.ezproxy.libproxy.db.erau.edu/essentials/article/GALE %7CA643583554?u=embry Penn Medicine News. (2020, September 15). Nearly 1 in 10 COVID Patients Return to Hospital After Being Sent Home from Emergency Department . Penn Medicine. https://www.pennmedicine.org/news/news-releases/2020/september/nearly-1-in-10- covid-patients-return-to-hospital-after-being-sent-home-from-emergency-department. Schencker, L. (2020, December 11). With beds in short supply, some Illinois hospital emergency rooms are sending Covid-19 patients home to recover. Chicago Tribune . https://www.chicagotribune.com/coronavirus/ct-coronavirus-hospitals-sending-covid- patients-home-illinois-20201211-hsjihn5h2vc5famcappyjscrsy-story.html. Singal, N. (2020, December 3). GOQii's Vital device range gets Medical Device Registration by CDSCO . Business Today. https://www.businesstoday.in/technology/news/story/goqii-vital-device-range-gets- medical-device-registration-by-cdsco-280528-2020-12-03. UC Davis Health . (2020, November 5). What to do if you test positive for COVID-19: A guide to recovery at home for patients, their families . What to do if you test positive for COVID-19 | Coronavirus | UC Davis Health. https://health.ucdavis.edu/coronavirus/updates/covid-19-recovery-at-home.html.

Grant Proposal

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