Evaluation of a Remote Monitoring Smartphone Application and Care Model of COVID-19 Patients in the Community (ReCOVER)

COVID Clinical Trial

— ReCOVER  

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04399109
• Other study ID #: PID00770
• Status: Recruiting
• Phase: N/A
• Start date: May 20, 2020
• Est. completion date: May 19, 2021

Study information

• Verified date: May 2020
• Source: Prince of Wales Hospital, Sydney
• Contact: Sze-Yuan Ooi
• Phone: +61293820700
• Email: SzeYuan.Ooi[@]ehc.com.au
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: May 19, 2021
• Est. primary completion date: May 19, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID

Intervention

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.

Locations

Country	Name	City	State
Australia	The Sutherland Hospital	Caringbah	New South Wales
Australia	St George Hospital	Kogarah	New South Wales
Australia	Prince of Wales Hospital	Randwick	New South Wales

Sponsors (4)

Lead Sponsor	Collaborator
Dr Sze-Yuan Ooi	South Eastern Sydney Local Health District, The George Institute, The University of New South Wales

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	12 months
Primary	All cause mortality per diagnosed COVID-19 case All-cause mortality rate at 30 days per diagnosed COVID-19 case		30 days
Secondary	Rate of hospital admission per diagnosed COVID case	Data linkage to patient medical records	12 months
Secondary	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	12 months
Secondary	Average length of stay (LOS) for admitted patients per diagnosed COVID case	Data linkage to patient medical records	12 months
Secondary	Rate of admission to Intensive Care Unit (ICU) for admitted patients per diagnosed COVID case	Data linkage to patient medical records	12 months
Secondary	Time from presentation to admission to ICU for patients admitted to ICU per diagnosed COVID case	Data linkage to patient medical records	12 months
Secondary	Rate of intubation in admitted patients per diagnosed COVID case	Data linkage to patient medical records	12 months
Secondary	Rate of readmission within 30 days of discharge in admitted patients per diagnosed COVID case	Data linkage to patient medical records	30 days
Secondary	All-cause mortality at 90 days per diagnosed COVID case		90 days
Secondary	Rate of avoidable Emergency Department presentations with COVID-19 diagnosis per 100,000 population, during trial period	Data linkage to patient medical records	12 months
Secondary	Rate of hospital admission with COVID-19 diagnosis per 100,000 population, during trial period	Data linkage to patient medical records	12 months
Secondary	Rate of admission to ICU with COVID-19 diagnosis per 100,000 population during trial period	Data linkage to patient medical records	12 months
Secondary	Rate of mortality with COVID-19 cause of death per 100,000 population, during trial period	Data linkage to patient medical records	12 months
Secondary	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.	12 months
Secondary	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	12 months
Secondary	Rate of hospital bed days with COVID-19 diagnosis per 100,000 population, during trial period	Data linkage to patient medical records	12 months
Secondary	Rate of ICU bed days with COVID-19 diagnosis per 100,000 population, during trial period	Data linkage to patient medical records	12 months
Secondary	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.	12 months