Page 17 - ASYMPTOMATIC COVID-19 QUARANTINE DIGITAL SOLUTION: A PROOF-OF-CONCEPT STUDY (NMRR-20-2761-57684)

ASYMPTOMATIC COVID-19 QUARANTINE DIGITAL SOLUTION: A PROOF-OF-CONCEPT
STUDY
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3. METHODOLOGY

This study was conducted in accordance with the “Malaysian Guidelines for Good
Clinical Practice” and registered with the National Medical Research Register (NMRR-

20-2761-57684) and approved by the Medical Research and Ethics Committee,

Ministry of Health, Malaysia (KKM/NIHSEC/P21-135(8)).

This proof-of-concept study involved 71 patients asymptomatic rRT-PCR positive

COVID-19 patients from the low risk COVID-19 quarantine & treatment centre –
MAEPS. Patients who fulfilled the inclusion and exclusion criteria will be recruited for

the study after signing the informed consent.

For the purpose of this POC, three different wearable devices with biosensors from
various vendors were used. These devices applied various method to obtain the

acquired information and those wearables were:

1. ProvenPac Beta (CQ01)

• Automated measurements of vital signs through placement of the
biosensor either on the forehead or index finger. Patients were needed

to check in to the customed mobile application in order to measure the
vital signs.

2. Respiree (CQ02)
• Automated measurements of vital signs through placement of the

biosensor either or the chest and finger.

3. Blueguard (CQ03)

• Automated measurements of vital signs through continuous placement
of the biosensor on the wrist.

TECHNICAL REPORT

DIGITAL HEALTH RESEARCH AND INNOVATION

INSTITUTE FOR CLINICAL RESEARCH
NATIONAL INSTITUTES OF HEALTH