Evaluation of a Remote Monitoring Smartphone Application and Care Model of COVID-19 Patients in the Community (ReCOVER)
NCT ID: NCT04399109
Last Updated: 2020-05-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
2000 participants
INTERVENTIONAL
2020-05-20
2021-05-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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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.
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.
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
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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The University of New South Wales
OTHER
The George Institute
OTHER
South Eastern Sydney Local Health District
OTHER_GOV
Dr Sze-Yuan Ooi
OTHER_GOV
Responsible Party
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Dr Sze-Yuan Ooi
Director, Coronary Care Unit and Senior Staff Cardiologist
Principal Investigators
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Sze-Yuan Ooi
Role: PRINCIPAL_INVESTIGATOR
Prince of Wales Hospital
Locations
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The Sutherland Hospital
Caringbah, New South Wales, Australia
St George Hospital
Kogarah, New South Wales, Australia
Prince of Wales Hospital
Randwick, New South Wales, Australia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PID00770
Identifier Type: -
Identifier Source: org_study_id
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