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UnknownNCT04363489

The CEDiD Study (COVID-19 Early Diagnosis in Doctors and Healthcare Workers)

Status
Unknown
Phase
Study type
Observational
Enrollment
60 (estimated)
Sponsor
King's College London · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Accepted

Summary

This is a prospective observational cohort study of healthcare workers working in high-risk COVID-19 clinical areas, monitoring heart rate, sleep and temperature, correlating with daily self-reported symptoms, oxygen saturations and PCR Swabs. It will provide information about how many healthcare workers develop COVID-19, what their clinical observations and symptoms are.

Detailed description

During the COVID-19 Pandemic, doctors and other healthcare workers who work in COVID+ wards, intensive care unit and the accident and emergency department are at high risk of developing COVID-19 infection. In April 2020, 14.6% of doctors were off sick with suspected or confirmed COVID-19 infection. Meanwhile, 17.9% of COVID+ patients are thought to be asymptomatic. Therefore, healthcare workers are also high-risk of spreading infection to patients, colleagues and their families. This is a prospective observational cohort study that leverages wearable medical device technology and data analytics to develop an algorithm for early detection of COVID-19 infection in healthcare workers. A total of 60 healthy healthcare workers working within high-risk COVID-19 clinical areas will be asked to wear a wearable medical device that measures their heart rate, skin temperature and sleep during non-working hours. They will take daily swabs for COVID-19 from themselves, measure their oxygen levels daily, and answer a survey of self-reported symptoms daily for the 30 day study period. These will then be analyzed to develop an algorithm for early detection of COVID-19 in healthcare workers, and help to inform future workforce decisions, to promote welfare and prevent the spread of COVID-19.

Conditions

Interventions

TypeNameDescription
DEVICEWearable Medical Device (Empatica E4)A wearable medical device (Empatica E4) which is a smart wristband that detects skin temperature, heart rate and sleep. It is CE and FDA approved.
DIAGNOSTIC_TESTCOVID-19 PCR SwabCOVID-19 PCR Swab will be self-taken by doctors every day. Fischer nasopharyngeal PCR Swabs
DIAGNOSTIC_TESTPulse OximeterParticipants will measure their oxygen saturations every day, and report them on the survey. Pulmolink A310 pulse oximeters

Timeline

Start date
2020-08-20
Primary completion
2021-05-30
Completion
2021-06-30
First posted
2020-04-27
Last updated
2021-03-19

Locations

1 site across 1 country: United Kingdom

Source: ClinicalTrials.gov record NCT04363489. Inclusion in this directory is not an endorsement.