Official Title
ReCOVER (Remote COVID-19 Evaluation and Response): a Prospective Non-randomised Controlled Trial to Evaluate the Effect of a Novel Smartphone Application-centric Model of Care for the Remote Monitoring of COVID-19 Patients in the Community.
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.

Unknown status
COVID

Device: TCC-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.

Eligibility Criteria

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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Australia
Locations

The Sutherland Hospital
Caringbah, New South Wales, Australia

St George Hospital
Kogarah, New South Wales, Australia

Prince of Wales Hospital
Randwick, New South Wales, Australia

Contacts

Sze-Yuan Ooi
+61293820700
SzeYuan.Ooi@ehc.com.au

Nigel Lovell
+61293858100
n.lovell@unsw.edu.au

Sze-Yuan Ooi, Principal Investigator
Prince of Wales Hospital

Dr Sze-Yuan Ooi
NCT Number
MeSH Terms
COVID-19