Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000524998
Ethics application status
Approved
Date submitted
24/04/2020
Date registered
28/04/2020
Date last updated
28/04/2020
Date data sharing statement initially provided
28/04/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of a remote monitoring smartphone application and care model of COVID-19 patients in the community (ReCOVER)
Scientific 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, on avoidable hospital presentations..
Secondary ID [1] 301115 0
None
Universal Trial Number (UTN)
Trial acronym
ReCOVER
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) 317209 0
COVID-19 317242 0
Condition category
Condition code
Infection 315346 315346 0 0
Other infectious diseases
Respiratory 315347 315347 0 0
Other respiratory disorders / diseases
Public Health 315376 315376 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
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.
Intervention code [1] 317419 0
Treatment: Devices
Comparator / control treatment
A propensity matched and synthetic control group will be chosen 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.
Control group
Active

Outcomes
Primary outcome [1] 323598 0
Rate of avoidable Emergency Department presentations per diagnosed COVID-19 case, using a definition based on potentially avoidable general practitioner-type presentations as specified in the National Healthcare Agreement
Timepoint [1] 323598 0
12 months
Primary outcome [2] 323599 0
All-cause mortality rate at 30 days per diagnosed COVID-19 case
Timepoint [2] 323599 0
30 days
Secondary outcome [1] 382312 0
Rate of hospital admission per diagnosed COVID case via data linkage to patient medical records
Timepoint [1] 382312 0
12 months
Secondary outcome [2] 382313 0
Rate of MBS claims for un-referred visits to general practitioners and analogous COVID-19 MBS telehealth items per diagnosed COVID case through data linkage to MBS database and patient medical records
Timepoint [2] 382313 0
12 months
Secondary outcome [3] 382314 0
Average length of stay (LOS) for admitted patients per diagnosed COVID case via data linkage to patient medical records
Timepoint [3] 382314 0
12 months
Secondary outcome [4] 382315 0
Rate of admission to Intensive Care Unit (ICU) for admitted patients per diagnosed COVID case via data linkage to patient medical records
Timepoint [4] 382315 0
12 months
Secondary outcome [5] 382316 0
Time from presentation to admission to ICU for patients admitted to ICU per diagnosed COVID case via data linkage to patient medical records
Timepoint [5] 382316 0
12 months
Secondary outcome [6] 382317 0
Rate of intubation in admitted patients per diagnosed COVID case via data linkage to patient medical records
Timepoint [6] 382317 0
12 months
Secondary outcome [7] 382318 0
Rate of readmission within 30 days of discharge in admitted patients per diagnosed COVID case via data linkage to patient medical records
Timepoint [7] 382318 0
Within 30 days of initial hospital discharge
Secondary outcome [8] 382319 0
All-cause mortality at 90 days per diagnosed COVID case
Timepoint [8] 382319 0
90 days
Secondary outcome [9] 382320 0
Rate of avoidable Emergency Department presentations with COVID-19 diagnosis per 100,000 population, during trial period via data linkage to patient medical records
Timepoint [9] 382320 0
12 months
Secondary outcome [10] 382321 0
Rate of hospital admission with COVID-19 diagnosis per 100,000 population, during trial period via data linkage to patient medical records
Timepoint [10] 382321 0
12 months
Secondary outcome [11] 382322 0
Rate of admission to ICU with COVID-19 diagnosis per 100,000 population during trial period via data linkage to patient medical records
Timepoint [11] 382322 0
12 months
Secondary outcome [12] 382323 0
Rate of mortality with COVID-19 cause of death per 100,000 population, during trial period via data linkage to patient medical records
Timepoint [12] 382323 0
12 months
Secondary outcome [13] 382324 0
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.
Timepoint [13] 382324 0
12 months
Secondary outcome [14] 382325 0
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
Timepoint [14] 382325 0
12 months
Secondary outcome [15] 382419 0
Rate of hospital bed days with COVID-19 diagnosis per 100,000 population, during trial period via data linkage to patient medical records
Timepoint [15] 382419 0
12 months
Secondary outcome [16] 382420 0
Rate of ICU bed days with COVID-19 diagnosis per 100,000 population, during trial period via data linkage to patient medical records
Timepoint [16] 382420 0
12 months
Secondary outcome [17] 382421 0
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.
Timepoint [17] 382421 0
12 months

Eligibility
Key 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
o Any iPhone or iPad running iOS 9 or above (essentially any iPhone 5 or above)
o Any Android phone that is operating Android 7.0 or above
6. Speaks adequate English
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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:
o Cognitive impairment
o Impaired dexterity
o Visual impairment
o Language barrier
3. Patient residing outside the SESLHD catchment area during their period of isolation

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
All patients enrolled will be given the one intervention, i.e. single group. The control group will be matched via data linkage after the study is complete.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
This is a device intervention, so the study size will be determined by the availability of equipment, and the number of patients who meet study criteria. It is anticipated that 2,000 pulse oximeters will be available, although this number may increase.
Descriptive statistics will be employed to characterise the study participants with respect to demographics, past medical history and their clinical progress, as well as number and type of interactions during the monitoring period, and any hospital admissions directly following the monitoring period.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
28/04/2020
Actual
Date of last participant enrolment
Anticipated
1/12/2020
Actual
Date of last data collection
Anticipated
30/04/2021
Actual
Sample size
Target
2000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 16543 0
Prince of Wales Hospital - Randwick
Recruitment hospital [2] 16544 0
St George Hospital - Kogarah
Recruitment hospital [3] 16545 0
The Sutherland Hospital - Caringbah
Recruitment postcode(s) [1] 30105 0
2031 - Randwick
Recruitment postcode(s) [2] 30106 0
2217 - Kogarah
Recruitment postcode(s) [3] 30107 0
2229 - Caringbah

Funding & Sponsors
Funding source category [1] 305559 0
Government body
Name [1] 305559 0
South Eastern Sydney Local Health District
Country [1] 305559 0
Australia
Primary sponsor type
Government body
Name
South Eastern Sydney Local Health District
Address
District Executive Unit, Level 4
The Sutherland Hospital & Community Health Service
Cnr The Kingsway & Kareena Road
Caringbah
NSW 2229
Country
Australia
Secondary sponsor category [1] 305964 0
University
Name [1] 305964 0
University of New South Wales
Address [1] 305964 0
High St
Kensington
NSW 2052
Country [1] 305964 0
Australia
Other collaborator category [1] 281294 0
Other Collaborative groups
Name [1] 281294 0
The George Institute for Global Health
Address [1] 281294 0
Level 5, 1 King St
Newtown
NSW 2042
Country [1] 281294 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305865 0
St Vincent's Hospital Human Research Ethics Committee
Ethics committee address [1] 305865 0
97-105 Boundary Street
Darlinghurst
NSW 2010
Ethics committee country [1] 305865 0
Australia
Date submitted for ethics approval [1] 305865 0
Approval date [1] 305865 0
15/04/2020
Ethics approval number [1] 305865 0
2020/ETH00706

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 101858 0
Dr Sze-Yuan Ooi
Address 101858 0
Director, Coronary Care Unit and Senior Staff Cardiologist
Prince of Wales Hospital
320 Barker St
Randwick
NSW 2031
Country 101858 0
Australia
Phone 101858 0
+61 296504959
Fax 101858 0
Email 101858 0
[email protected]
Contact person for public queries
Name 101859 0
Sze-Yuan Ooi
Address 101859 0
Director, Coronary Care Unit and Senior Staff Cardiologist
Prince of Wales Hospital
320 Barker St
Randwick
NSW 2031
Country 101859 0
Australia
Phone 101859 0
+61 296504959
Fax 101859 0
Email 101859 0
[email protected]
Contact person for scientific queries
Name 101860 0
Sze-Yuan Ooi
Address 101860 0
Director, Coronary Care Unit and Senior Staff Cardiologist
Prince of Wales Hospital
320 Barker St
Randwick
NSW 2031
Country 101860 0
Australia
Phone 101860 0
+61 296504959
Fax 101860 0
Email 101860 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Medical data pertaining to an individual will not be made public. Only aggregate summary data will be published.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.