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

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.

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.

Study Overview

• Status: Unknown
• Conditions: COVID
• Intervention / Treatment: Device: TCC-COVID mHealth solution

• Study Type: Interventional
• Enrollment (Anticipated): 2000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Caringbah, New South Wales, Australia, 2229
      • Recruiting
      • The Sutherland Hospital
      • Contact: Benjamin Kwan; Phone Number: +61295407111; Email: Ben.Kwan@health.nsw.gov.au
      • Contact: Clarissa Susanto; Phone Number: +61295407111; Email: Clarissa.Susanto@health.nsw.gov.au
    • Kogarah, New South Wales, Australia, 2217
      • Recruiting
      • St George Hospital
      • Contact: Pamela Konecny; Phone Number: +61291131111; Email: Pam.Konecny@health.nsw.gov.au
      • Contact: Richard Sullivan; Phone Number: +61291131111; Email: Richard.Sullivan@health.nsw.gov.au
    • Randwick, New South Wales, Australia, 2031
      • Recruiting
      • Prince of Wales Hospital
      • Contact: Kristen Overton; Phone Number: +61296504000; Email: Kristen.Overton@health.nsw.gov.au
      • Contact: Jeffrey Post; Phone Number: +61296504000; Email: Jeffrey.Post@health.nsw.gov.au

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	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.
No Intervention: Control; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Outcome Measure	Measure Description	Time Frame
Rate of hospital admission per diagnosed COVID case	Data linkage to patient medical records	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	12 months
Average length of stay (LOS) for admitted patients per diagnosed COVID case	Data linkage to patient medical records	12 months
Rate of admission to Intensive Care Unit (ICU) for admitted patients per diagnosed COVID case	Data linkage to patient medical records	12 months
Time from presentation to admission to ICU for patients admitted to ICU per diagnosed COVID case	Data linkage to patient medical records	12 months
Rate of intubation in admitted patients per diagnosed COVID case	Data linkage to patient medical records	12 months
Rate of readmission within 30 days of discharge in admitted patients per diagnosed COVID case	Data linkage to patient medical records	30 days
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	Data linkage to patient medical records	12 months
Rate of hospital admission with COVID-19 diagnosis per 100,000 population, during trial period	Data linkage to patient medical records	12 months
Rate of admission to ICU with COVID-19 diagnosis per 100,000 population during trial period	Data linkage to patient medical records	12 months
Rate of mortality with COVID-19 cause of death per 100,000 population, during trial period	Data linkage to patient medical records	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.	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	12 months
Rate of hospital bed days with COVID-19 diagnosis per 100,000 population, during trial period	Data linkage to patient medical records	12 months
Rate of ICU bed days with COVID-19 diagnosis per 100,000 population, during trial period	Data linkage to patient medical records	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.	12 months

Collaborators and Investigators

• Sponsor: Dr Sze-Yuan Ooi
• Collaborators: The University of New South Wales; The George Institute; South Eastern Sydney Local Health District
• Investigators: Principal Investigator: Sze-Yuan Ooi, Prince of Wales Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2020
• Primary Completion (Anticipated): May 19, 2021
• Study Completion (Anticipated): May 19, 2021

Study Registration Dates

• First Submitted: May 21, 2020
• First Submitted That Met QC Criteria: May 21, 2020
• First Posted (Actual): May 22, 2020

Study Record Updates

• Last Update Posted (Actual): May 22, 2020
• Last Update Submitted That Met QC Criteria: May 21, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: PID00770

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No