An interventional study of TCC-COVID mHealth solution in COVID, sponsored by Dr Sze-Yuan Ooi. Status unknown at 3 sites in Australia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-05-22.
Sponsored by Dr Sze-Yuan Ooi · Not applicable, Interventional, and Supportive care
This is a multi-site, prospective, non-randomised trial assessing the implementation of a smartphone application-based model of care for patients with COVID-19 infection managed in community isolation. We will recruit 2000 COVID +ve patients aged 18 years and over who are managed at home. The objective will be to describe the rates of avoidable presentations to ED and 30 day all case mortality per diagnosed COVID-19 case and to compare these to a propensity matched and synthetic control group.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's planned enrollment of 2,000 is above the median of 100 across 4,099 interventional studies indexed under COVID-19.
Browse COVID-19 studies →This is the only study on the registry with Dr Sze-Yuan Ooi as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Access to a smartphone or device that is compatible with the TCC-COVID app
Exclusion Criteria:
Inability to use the TCC-COVID app and pulse oximeter due to reasons including but not limited to:
TCC-COVID is an app-based model of care which includes a smartphone app and a pulse oximeter that measures oxygen saturation, pulse rate and collects symptoms, connected to a back-end clinical database with inbuilt data analytics.
Device: TCC-COVID mHealth solution
Propensity matched and synthetic control groups will be utilised from another local health district not participating in the ReCOVER study. The control group will not be actively recruited at the same time as the intervention. The control group will be matched via data linkage at the completion of the trial. However, it is not a historical control, as the control standard of care treatment will be provided simultaneously as our intervention
Patients place their index finger in the pulse oximeter to measure their oxygen saturation and pulse rate twice a day, which will take approximately 5 minutes each time. Patients then enter the results into the TCC-COVID app twice daily, and complete a symptom questionnaire via the TCC-COVID app once daily, which will take approximately 5 minutes. The symptom questionnaire was designed specifically for this study. The measurements and information are directly connected to a clinician interface (KIOLA database) which provides the data of all patients in aggregate and an easy to use responsive format with customisable alerts. The alerts identify if the oxygen saturation levels are low or the pulse rate is out of range. The alerts also identify if a measurement has not been completed in a timely manner and the central monitoring service will contact the patient to check on their safety or if they are experiencing any technical issues. The overall duration of participation will be 14 days.
Rate of avoidable Emergency Department presentations per diagnosed COVID-19 case
Definition based on potentially avoidable general practitioner-type presentations as specified in the National Healthcare
Time frame: 12 months
All cause mortality per diagnosed COVID-19 case All-cause mortality rate at 30 days per diagnosed COVID-19 case
Time frame: 30 days
Rate of hospital admission per diagnosed COVID case
Data linkage to patient medical records
Time frame: 12 months
Rate of MBS claims for un-referred visits to general practitioners and analogous COVID-19 MBS telehealth items per diagnosed COVID case
Data linkage to MBS database and patient medical records
Time frame: 12 months
Average length of stay (LOS) for admitted patients per diagnosed COVID case
Data linkage to patient medical records
Time frame: 12 months
Rate of admission to Intensive Care Unit (ICU) for admitted patients per diagnosed COVID case
Data linkage to patient medical records
Time frame: 12 months
Time from presentation to admission to ICU for patients admitted to ICU per diagnosed COVID case
Data linkage to patient medical records
Time frame: 12 months
Rate of intubation in admitted patients per diagnosed COVID case
Data linkage to patient medical records
Time frame: 12 months
Rate of readmission within 30 days of discharge in admitted patients per diagnosed COVID case
Data linkage to patient medical records
Time frame: 30 days
All-cause mortality at 90 days per diagnosed COVID case
Time frame: 90 days
Rate of avoidable Emergency Department presentations with COVID-19 diagnosis per 100,000 population, during trial period
Data linkage to patient medical records
Time frame: 12 months
Rate of hospital admission with COVID-19 diagnosis per 100,000 population, during trial period
Data linkage to patient medical records
Time frame: 12 months
Rate of admission to ICU with COVID-19 diagnosis per 100,000 population during trial period
Data linkage to patient medical records
Time frame: 12 months
Rate of mortality with COVID-19 cause of death per 100,000 population, during trial period
Data linkage to patient medical records
Time frame: 12 months
Qualitative assessment of TCC-COVID app usability via a subjective feedback questionnaire provided to all patients enrolled in the study.
The feedback questionnaire was designed specifically for this study.
Time frame: 12 months
Cost-effectiveness of TCC-COVID by measuring the incremental cost per death averted, per ICU admission averted and per length of stay in ICU
From NSW Health data linkage
Time frame: 12 months
Rate of hospital bed days with COVID-19 diagnosis per 100,000 population, during trial period
Data linkage to patient medical records
Time frame: 12 months
Rate of ICU bed days with COVID-19 diagnosis per 100,000 population, during trial period
Data linkage to patient medical records
Time frame: 12 months
Qualitative assessment of KIOLA physician portal usability via a subjective feedback questionnaire
Completed by all physicians and research nurses entering data into the portal and monitoring patients throughout the study. The feedback questionnaire was designed specifically for this study.
Time frame: 12 months
Plan to share: No
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This study is status unknown, as verified in May 2020. You cannot join it, but the record below documents what was studied.
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