NCT04399109

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

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.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,000 (estimated)
• Sponsor: Dr Sze-Yuan Ooi · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• COVID

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2020-05-20
• Primary completion: 2021-05-19
• Completion: 2021-05-19
• First posted: 2020-05-22
• Last updated: 2020-05-22

Locations

3 sites across 1 country: Australia