Mobile Health Study and Enhanced Symptom Monitoring to Prevent Severe Illness From COVID-19 in Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 128
- 试验地点
- 2
- 主要终点
- Number of Participants With Manifestations of Severe Disease
研究概览
简要总结
The established Insight(TM) mHealth Platform, a component of the Stephenson Cancer Center (SCC) mHealth Shared Resource will be used to create the "Symptom Tracker" app. The Symptom Tracker (Insight(TM)) app will enable real-time monitoring of cancer patient symptoms that are consistent with early signs of SARS-CoV-2 infection in this high-risk population by automatically (and securely) transferring this information to health care providers. The primary aim of this study is to determine the feasibility, ease of use, and perceived utility of this app to monitor symptoms and health risk behaviors among cancer patients currently receiving chemotherapy.
详细描述
A total of 500 treatment-seeking males and females will be asked to complete daily monitoring of symptoms via smartphone app. Those who screen positive for COVID-19 will be triaged to emergency or non-emergency medical treatment and will receive a study supplied device to measure their oxygen level and heart rate and be instructed in the device's use. They will be prompted to enter vital signs data (such as oxygen level) daily (and as indicated by changes in status) and questions from the app will change to assess the severity of COVID-19 related symptoms and inform changes in level of care, to emergency or non-emergency medical management as indicated by self-reporting. The proposed study will assess the impact of heightened symptom and vital sign monitoring on the early identification of severe manifestations of COVID-19 in this high-risk population (Aim 2). It is hypothesized that this will significantly improve COVID-19 related morbidity and mortality compared to the national and international rates currently reported in the literature.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Demonstrate > 6th grade English literacy level (i.e., phone based EMAs require >6th grade literacy)
- •Present for care at the Stephenson Cancer Center at the University of Oklahoma Health Sciences Center
- •Are currently receiving systemic chemotherapy by intravenous infusion or by orally delivered medication
- •Are greater than or equal to 18 years of age
- •Are willing and able to complete surveys on their personal smartphone or a study provided smartphone
- •Are willing and able to provide informed consent
排除标准
- 未提供
结局指标
主要结局
Number of Participants With Manifestations of Severe Disease
时间窗: up to 24 weeks
Yes/No; Yes = there were manifestations of severe disease; No = there were no manifestations of severe disease. Those who are marked as Yes are reported below in the Outcome measure data table
Number of Participants With SARS-CoV-2 Related ICU Admission
时间窗: up to 24 weeks
Yes/No; Yes = there were SARS-CoV-2 related ICU admissions; No = there were no SARS-CoV-2 related ICU admissions. Those who are marked as Yes are reported below in the Outcome measure data table
Number of Participants With SARS-CoV-2 That Needed Invasive Mechanical Ventilation
时间窗: up to 24 weeks
Yes/No; Yes = participant had SARS-CoV-2 and needed invasive mechanical ventilation; No = participant had SARS-CoV-2 and did not need invasive mechanical ventilation. Those who are marked as Yes are reported below in the Outcome measure data table
Proportion of Smartphone Based Surveys Completed
时间窗: up to 24 weeks
Proportion of completed smartphone-based daily surveys divided by the total number of surveys a participant is staged to receive (daily for 24 weeks = 168 surveys total)
Number of Participants With SARS-CoV-2 Related Hospital Admission
时间窗: up to 24 weeks
Yes/No; Yes = there were SARS-CoV-2 related hospital admissions; No = there were no SARS-CoV-2 related hospital admissions. Those who are marked as Yes are reported below in the Outcome measure data table
Mortality Number for Participants Who Reported SARS-CoV-2 Positive and Got Enhanced Monitoring
时间窗: up to 24 weeks
Yes/No; Yes = participant mortality reported; No = participant mortality not reported. Those who are marked as Yes are reported below in the Outcome measure data table
次要结局
- Percent of Participants Satisfied With Monitoring and Use of mHealth Application(24 weeks)