Clinical trial NCT04399109: Evaluation of a Remote Monitoring Smartphone Application and Care Model of COVID-19 Patients in the Community (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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: COVID
Lead sponsor: Prince of Wales Hospital, Sydney
Sponsor class: OTHER_GOV
Collaborators: name: The University of New South Wales
name: The George Institute
name: South Eastern Sydney Local Health District
First posted: 2020-05-22
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Rate of avoidable Emergency Department presentations per diagnosed COVID-19 case
timeFrame: 12 months
measure: All cause mortality per diagnosed COVID-19 case All-cause mortality rate at 30 days per diagnosed COVID-19 case
timeFrame: 30 days
Secondary outcomes:
measure: Rate of hospital admission per diagnosed COVID case
timeFrame: 12 months
measure: Rate of MBS claims for un-referred visits to general practitioners and analogous COVID-19 MBS telehealth items per diagnosed COVID case
timeFrame: 12 months
measure: Average length of stay (LOS) for admitted patients per diagnosed COVID case
timeFrame: 12 months
measure: Rate of admission to Intensive Care Unit (ICU) for admitted patients per diagnosed COVID case
timeFrame: 12 months
measure: Time from presentation to admission to ICU for patients admitted to ICU per diagnosed COVID case
timeFrame: 12 months
measure: Rate of intubation in admitted patients per diagnosed COVID case
timeFrame: 12 months
measure: Rate of readmission within 30 days of discharge in admitted patients per diagnosed COVID case
timeFrame: 30 days
measure: All-cause mortality at 90 days per diagnosed COVID case
timeFrame: 90 days
measure: Rate of avoidable Emergency Department presentations with COVID-19 diagnosis per 100,000 population, during trial period
timeFrame: 12 months
measure: Rate of hospital admission with COVID-19 diagnosis per 100,000 population, during trial period
timeFrame: 12 months
measure: Rate of admission to ICU with COVID-19 diagnosis per 100,000 population during trial period
timeFrame: 12 months
measure: Rate of mortality with COVID-19 cause of death per 100,000 population, during trial period
timeFrame: 12 months
measure: Qualitative assessment of TCC-COVID app usability via a subjective feedback questionnaire provided to all patients enrolled in the study.
timeFrame: 12 months
measure: Cost-effectiveness of TCC-COVID by measuring the incremental cost per death averted, per ICU admission averted and per length of stay in ICU
timeFrame: 12 months
measure: Rate of hospital bed days with COVID-19 diagnosis per 100,000 population, during trial period
timeFrame: 12 months
measure: Rate of ICU bed days with COVID-19 diagnosis per 100,000 population, during trial period
timeFrame: 12 months
measure: Qualitative assessment of KIOLA physician portal usability via a subjective feedback questionnaire
timeFrame: 12 months
Other outcomes:
Locations:
city: Caringbah
country: Australia
facility: The Sutherland Hospital
state: New South Wales
city: Kogarah
country: Australia
facility: St George Hospital
state: New South Wales
city: Randwick
country: Australia
facility: Prince of Wales Hospital
state: New South Wales
Study officials:
affiliation: Prince of Wales Hospital
name: Sze-Yuan Ooi
role: PRINCIPAL_INVESTIGATOR
References: