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

Not Applicable

• Conditions: COVID
• Interventions: Device: TCC-COVID mHealth solution

• Registration Number: NCT04399109
• Lead Sponsor: Dr Sze-Yuan Ooi

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-05
• Study Start: 2020-05-20
• Study First Submitted: 2020-05-21
• Study First Submitted QC: 2020-05-21
• Last Update Submitted: 2020-05-21
• Study First Posted: 2020-05-22
• Last Update Posted: 2020-05-22
• Primary Completion: 2021-05-19
• Study Completion: 2021-05-19

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2000

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TCC-COVID mHealth solution	TCC-COVID mHealth solution	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Average length of stay (LOS) for admitted patients 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
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 ICU bed days with COVID-19 diagnosis per 100,000 population, during trial period	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
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 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
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
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.
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 hospital admission 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
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
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 hospital admission with COVID-19 diagnosis per 100,000 population, during trial period	12 months	Data linkage to patient medical records

Trial Locations

Locations (3)

Prince of Wales Hospital; 🇦🇺 Randwick, New South Wales, Australia

St George Hospital; 🇦🇺 Kogarah, New South Wales, Australia

The Sutherland Hospital; 🇦🇺 Caringbah, New South Wales, Australia