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

Dr Sze-Yuan Ooi

Status: Unknown

Conditions: COVID

Treatments: Device: TCC-COVID mHealth solution

Study type: Interventional

Funder types: Other

Identifiers

NCT04399109

PID00770

Details and patient eligibility

About

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.

Enrollment: 2,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,000 participants in 2 patient groups

TCC-COVID mHealth solution

Active Comparator group

Description:

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.

Treatment:

Device: TCC-COVID mHealth solution

Control

No Intervention group

Description:

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