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

NCT04399109 | Unknown DMC

• 1 other identifier: PID00770
• Study Type: interventional
• Target: 2,000
• Locations: 1 country
• Sites: 3

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.

Conditions

COVID

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (17)

• Rate of hospital admission per diagnosed COVID case

  12 months

• Rate of MBS claims for un-referred visits to general practitioners and analogous COVID-19 MBS telehealth items per diagnosed COVID case

  12 months

• Average length of stay (LOS) for admitted patients per diagnosed COVID case

  12 months

• Rate of admission to Intensive Care Unit (ICU) for admitted patients per diagnosed COVID case

  12 months

• Time from presentation to admission to ICU for patients admitted to ICU per diagnosed COVID case

  12 months

Study Arms (2)

TCC-COVID mHealth solution

ACTIVE COMPARATOR

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

Control

NO INTERVENTION

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

Interventions

TCC-COVID mHealth solution DEVICE

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.

TCC-COVID mHealth solution

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age greater or equal to 18 years
• Able to provide informed consent
• Proven diagnosis of COVID-19 based on positive virology testing
• Patients who are being managed at home OR those who are being discharged from hospital for ongoing home-based care in isolation.
• 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
• Speaks adequate English

You may not qualify if:

• Patient meets clinical criteria for hospital-based care.
• 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
• Patient residing outside the SESLHD catchment area during their period of isolation

Sponsors & Collaborators

• Dr Sze-Yuan Ooi: lead
• The University of New South Wales: collaborator
• The George Institute: collaborator
• South Eastern Sydney Local Health District: collaborator

Study Sites (3)

The Sutherland Hospital

Caringbah, New South Wales, 2229, Australia

RECRUITING

St George Hospital

Kogarah, New South Wales, 2217, Australia

RECRUITING

Prince of Wales Hospital

Randwick, New South Wales, 2031, Australia

RECRUITING

Study Officials

• Sze-Yuan Ooi

  Prince of Wales Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sze-Yuan Ooi

CONTACT

+61293820700; SzeYuan.Ooi@ehc.com.au

Nigel Lovell

CONTACT

+61293858100; n.lovell@unsw.edu.au

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Coronary Care Unit and Senior Staff Cardiologist

Study Record Dates

• First Submitted: May 21, 2020
• First Posted: May 22, 2020
• Study Start: May 20, 2020
• Primary Completion: May 19, 2021
• Study Completion: May 19, 2021
• Last Updated: May 22, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

AU (3)