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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04399109




Registration number
NCT04399109
Ethics application status
Date submitted
21/05/2020
Date registered
22/05/2020
Date last updated
22/05/2020

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.
Secondary ID [1] 0 0
PID00770
Universal Trial Number (UTN)
Trial acronym
ReCOVER
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COVID 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - TCC-COVID mHealth solution

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.

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


Treatment: Devices: 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.

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
12 months
Primary outcome [2] 0 0
All cause mortality per diagnosed COVID-19 case All-cause mortality rate at 30 days per diagnosed COVID-19 case
Timepoint [2] 0 0
30 days
Secondary outcome [1] 0 0
Rate of hospital admission per diagnosed COVID case - Data linkage to patient medical records
Timepoint [1] 0 0
12 months
Secondary outcome [2] 0 0
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
Timepoint [2] 0 0
12 months
Secondary outcome [3] 0 0
Average length of stay (LOS) for admitted patients per diagnosed COVID case - Data linkage to patient medical records
Timepoint [3] 0 0
12 months
Secondary outcome [4] 0 0
Rate of admission to Intensive Care Unit (ICU) for admitted patients per diagnosed COVID case - Data linkage to patient medical records
Timepoint [4] 0 0
12 months
Secondary outcome [5] 0 0
Time from presentation to admission to ICU for patients admitted to ICU per diagnosed COVID case - Data linkage to patient medical records
Timepoint [5] 0 0
12 months
Secondary outcome [6] 0 0
Rate of intubation in admitted patients per diagnosed COVID case - Data linkage to patient medical records
Timepoint [6] 0 0
12 months
Secondary outcome [7] 0 0
Rate of readmission within 30 days of discharge in admitted patients per diagnosed COVID case - Data linkage to patient medical records
Timepoint [7] 0 0
30 days
Secondary outcome [8] 0 0
All-cause mortality at 90 days per diagnosed COVID case
Timepoint [8] 0 0
90 days
Secondary outcome [9] 0 0
Rate of avoidable Emergency Department presentations with COVID-19 diagnosis per 100,000 population, during trial period - Data linkage to patient medical records
Timepoint [9] 0 0
12 months
Secondary outcome [10] 0 0
Rate of hospital admission with COVID-19 diagnosis per 100,000 population, during trial period - Data linkage to patient medical records
Timepoint [10] 0 0
12 months
Secondary outcome [11] 0 0
Rate of admission to ICU with COVID-19 diagnosis per 100,000 population during trial period - Data linkage to patient medical records
Timepoint [11] 0 0
12 months
Secondary outcome [12] 0 0
Rate of mortality with COVID-19 cause of death per 100,000 population, during trial period - Data linkage to patient medical records
Timepoint [12] 0 0
12 months
Secondary outcome [13] 0 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] 0 0
12 months
Secondary outcome [14] 0 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] 0 0
12 months
Secondary outcome [15] 0 0
Rate of hospital bed days with COVID-19 diagnosis per 100,000 population, during trial period - Data linkage to patient medical records
Timepoint [15] 0 0
12 months
Secondary outcome [16] 0 0
Rate of ICU bed days with COVID-19 diagnosis per 100,000 population, during trial period - Data linkage to patient medical records
Timepoint [16] 0 0
12 months
Secondary outcome [17] 0 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] 0 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

- 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
Minimum age
18 Years
Maximum age
No limit
Gender
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:

- Cognitive impairment

- Impaired dexterity

- Visual impairment

- Language barrier

3. Patient residing outside the SESLHD catchment area during their period of isolation

Study design
Purpose of the study
Supportive Care
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
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
The Sutherland Hospital - Caringbah
Recruitment hospital [2] 0 0
St George Hospital - Kogarah
Recruitment hospital [3] 0 0
Prince of Wales Hospital - Randwick
Recruitment postcode(s) [1] 0 0
2229 - Caringbah
Recruitment postcode(s) [2] 0 0
2217 - Kogarah
Recruitment postcode(s) [3] 0 0
2031 - Randwick

Funding & Sponsors
Primary sponsor type
Other
Name
Dr Sze-Yuan Ooi
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
The University of New South Wales
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
The George Institute
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
South Eastern Sydney Local Health District
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

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
https://clinicaltrials.gov/show/NCT04399109
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Sze-Yuan Ooi
Address 0 0
Prince of Wales Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Sze-Yuan Ooi
Address 0 0
Country 0 0
Phone 0 0
+61293820700
Fax 0 0
Email 0 0
SzeYuan.Ooi@ehc.com.au
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04399109