Covid-19, Sars-CoV2
Conditions
Brief summary
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.
Detailed description
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.
Interventions
OTHERmHealth Assessments
Daily symptom tracker
Sponsors
National Cancer Institute (NCI)
University of Oklahoma
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Demonstrate \> 6th grade English literacy level (i.e., phone based EMAs require \>6th grade literacy) 2. Present for care at the Stephenson Cancer Center at the University of Oklahoma Health Sciences Center 3. Are currently receiving systemic chemotherapy by intravenous infusion or by orally delivered medication 4. Are greater than or equal to 18 years of age 5. Are willing and able to complete surveys on their personal smartphone or a study provided smartphone 6. Are willing and able to provide informed consent
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With SARS-CoV-2 Related Hospital Admission | 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 |
| Proportion of Smartphone Based Surveys Completed | 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 Manifestations of Severe Disease | 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 |
| Mortality Number for Participants Who Reported SARS-CoV-2 Positive and Got Enhanced Monitoring | 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 |
| Number of Participants With SARS-CoV-2 Related ICU Admission | 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Participants Satisfied With Monitoring and Use of mHealth Application | 24 weeks | 1. if the participants were satisfied with the number of assessments prompted by the smartphone application - yes/no - those who reported yes are in the outcome measure data table below 2. if the participants would be interested in using a similar smartphone app in the future if needed - yes/no - those who reported yes are in the outcome measure data table below |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| No Elevated Risk for COVID-19 Detected Continue daily mHealth assessments
mHealth Assessments: Daily symptom tracker | 121 |
| Elevated Risk for COVID-19 Detected Daily mHealth assessments and telemedicine/nurse triage. If non-emergent intervention, enhanced symptom monitoring will occur.
mHealth Assessments: Daily symptom tracker | 7 |
| Total | 128 |
Baseline characteristics
| Characteristic | Elevated Risk for COVID-19 Detected | Total | No Elevated Risk for COVID-19 Detected |
|---|---|---|---|
| Age, Continuous | 50.71 years STANDARD_DEVIATION 12.56 | 57.60 years STANDARD_DEVIATION 13.01 | 58 years STANDARD_DEVIATION 12.56 |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 11 Participants | 9 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 9 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 7 Participants | 7 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 4 Participants | 99 Participants | 95 Participants |
| Sex: Female, Male Female | 5 Participants | 99 Participants | 94 Participants |
| Sex: Female, Male Male | 2 Participants | 29 Participants | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 6 / 121 | 1 / 7 |
| other Total, other adverse events | 0 / 121 | 0 / 7 |
| serious Total, serious adverse events | 0 / 121 | 0 / 7 |
Outcome results
Primary
Mortality Number for Participants Who Reported SARS-CoV-2 Positive and Got Enhanced Monitoring
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
Time frame: up to 24 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| No Elevated Risk for COVID-19 Detected | Mortality Number for Participants Who Reported SARS-CoV-2 Positive and Got Enhanced Monitoring | 6 Participants |
| Elevated Risk for COVID-19 Detected | Mortality Number for Participants Who Reported SARS-CoV-2 Positive and Got Enhanced Monitoring | 1 Participants |
Primary
Number of Participants With Manifestations of Severe Disease
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
Time frame: up to 24 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| No Elevated Risk for COVID-19 Detected | Number of Participants With Manifestations of Severe Disease | 25 Participants |
| Elevated Risk for COVID-19 Detected | Number of Participants With Manifestations of Severe Disease | 5 Participants |
Primary
Number of Participants With SARS-CoV-2 Related Hospital Admission
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
Time frame: up to 24 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| No Elevated Risk for COVID-19 Detected | Number of Participants With SARS-CoV-2 Related Hospital Admission | 5 Participants |
| Elevated Risk for COVID-19 Detected | Number of Participants With SARS-CoV-2 Related Hospital Admission | 1 Participants |
Primary
Number of Participants With SARS-CoV-2 Related ICU Admission
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
Time frame: up to 24 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| No Elevated Risk for COVID-19 Detected | Number of Participants With SARS-CoV-2 Related ICU Admission | 0 Participants |
| Elevated Risk for COVID-19 Detected | Number of Participants With SARS-CoV-2 Related ICU Admission | 1 Participants |
Primary
Number of Participants With SARS-CoV-2 That Needed Invasive Mechanical Ventilation
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
Time frame: up to 24 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| No Elevated Risk for COVID-19 Detected | Number of Participants With SARS-CoV-2 That Needed Invasive Mechanical Ventilation | 0 Participants |
| Elevated Risk for COVID-19 Detected | Number of Participants With SARS-CoV-2 That Needed Invasive Mechanical Ventilation | 0 Participants |
Primary
Proportion of Smartphone Based Surveys Completed
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)
Time frame: up to 24 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No Elevated Risk for COVID-19 Detected | Proportion of Smartphone Based Surveys Completed | 0.46 proportion of daily surveys completed | Standard Deviation 0.38 |
| Elevated Risk for COVID-19 Detected | Proportion of Smartphone Based Surveys Completed | 0.44 proportion of daily surveys completed | Standard Deviation 0.25 |
Secondary
Percent of Participants Satisfied With Monitoring and Use of mHealth Application
1. if the participants were satisfied with the number of assessments prompted by the smartphone application - yes/no - those who reported yes are in the outcome measure data table below 2. if the participants would be interested in using a similar smartphone app in the future if needed - yes/no - those who reported yes are in the outcome measure data table below
Time frame: 24 weeks
Population: Participants who completed the follow-up assessments
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| No Elevated Risk for COVID-19 Detected | Percent of Participants Satisfied With Monitoring and Use of mHealth Application | satisfied with number of assessments | 49 Participants |
| No Elevated Risk for COVID-19 Detected | Percent of Participants Satisfied With Monitoring and Use of mHealth Application | interested in using a similar smartphone app if needed | 47 Participants |
| Elevated Risk for COVID-19 Detected | Percent of Participants Satisfied With Monitoring and Use of mHealth Application | satisfied with number of assessments | 3 Participants |
| Elevated Risk for COVID-19 Detected | Percent of Participants Satisfied With Monitoring and Use of mHealth Application | interested in using a similar smartphone app if needed | 4 Participants |