COVID
Conditions
Brief summary
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.
Interventions
DEVICETCC-COVID mHealth solution
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.
Sponsors
The University of New South Wales
The George Institute
South Eastern Sydney Local Health District
Dr Sze-Yuan Ooi
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age greater or equal to 18 years 2. Able to provide informed consent 3. Proven diagnosis of COVID-19 based on positive virology testing 4. Patients who are being managed at home OR those who are being discharged from hospital for ongoing home-based care in isolation. 5. Access to a smartphone or device that is compatible with the TCC-COVID app * Any iPhone or iPad running iOS 9 or above (essentially any iPhone 5 or above) * Any Android phone that is operating Android 7.0 or above 6. Speaks adequate English
Exclusion criteria
1. Patient meets clinical criteria for hospital-based care. 2. Inability to use the TCC-COVID app and pulse oximeter due to reasons including but not limited to: * Cognitive impairment * Impaired dexterity * Visual impairment * Language barrier 3. Patient residing outside the SESLHD catchment area during their period of isolation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of avoidable Emergency Department presentations per diagnosed COVID-19 case | 12 months | Definition based on potentially avoidable general practitioner-type presentations as specified in the National Healthcare |
| All cause mortality per diagnosed COVID-19 case All-cause mortality rate at 30 days per diagnosed COVID-19 case | 30 days | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Average length of stay (LOS) for admitted patients per diagnosed COVID case | 12 months | Data linkage to patient medical records |
| Rate of admission to Intensive Care Unit (ICU) for admitted patients per diagnosed COVID case | 12 months | Data linkage to patient medical records |
| Time from presentation to admission to ICU for patients admitted to ICU per diagnosed COVID case | 12 months | Data linkage to patient medical records |
| Rate of intubation in admitted patients per diagnosed COVID case | 12 months | Data linkage to patient medical records |
| Rate of readmission within 30 days of discharge in admitted patients per diagnosed COVID case | 30 days | Data linkage to patient medical records |
| All-cause mortality at 90 days per diagnosed COVID case | 90 days | — |
| Rate of avoidable Emergency Department presentations with COVID-19 diagnosis per 100,000 population, during trial period | 12 months | Data linkage to patient medical records |
| Rate of hospital admission per diagnosed COVID case | 12 months | Data linkage to patient medical records |
| Rate of admission to ICU with COVID-19 diagnosis per 100,000 population during trial period | 12 months | Data linkage to patient medical records |
| Rate of mortality with COVID-19 cause of death per 100,000 population, during trial period | 12 months | Data linkage to patient medical records |
| Qualitative assessment of TCC-COVID app usability via a subjective feedback questionnaire provided to all patients enrolled in the study. | 12 months | The feedback questionnaire was designed specifically for this study. |
| Cost-effectiveness of TCC-COVID by measuring the incremental cost per death averted, per ICU admission averted and per length of stay in ICU | 12 months | From NSW Health data linkage |
| Rate of hospital bed days with COVID-19 diagnosis per 100,000 population, during trial period | 12 months | Data linkage to patient medical records |
| Rate of ICU bed days with COVID-19 diagnosis per 100,000 population, during trial period | 12 months | Data linkage to patient medical records |
| Qualitative assessment of KIOLA physician portal usability via a subjective feedback questionnaire | 12 months | 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. |
| Rate of hospital admission with COVID-19 diagnosis per 100,000 population, during trial period | 12 months | Data linkage to patient medical records |
| Rate of MBS claims for un-referred visits to general practitioners and analogous COVID-19 MBS telehealth items per diagnosed COVID case | 12 months | Data linkage to MBS database and patient medical records |
Countries
Australia
Contacts
Primary ContactSze-Yuan Ooi
Backup ContactNigel Lovell
Outcome results
None listed