CC BY-NC-ND 4.0 · Yearb Med Inform 2021; 30(01): 272-279
DOI: 10.1055/s-0041-1726487
Section 11: Public Health and Epidemiology Informatics
Working Group Contributions

Trials and Tribulations: mHealth Clinical Trials in the COVID-19 Pandemic

Praveen Indraratna
1   Department of Cardiology, Prince of Wales Hospital, Sydney, Australia
2   Prince of Wales Clinical School, The University of New South Wales, Sydney, Australia
,
Uzzal Biswas
3   Graduate School of Biomedical Engineering, The University of New South Wales, Sydney, Australia
,
Jennifer Yu
1   Department of Cardiology, Prince of Wales Hospital, Sydney, Australia
2   Prince of Wales Clinical School, The University of New South Wales, Sydney, Australia
,
Guenter Schreier
4   AIT Austrian Institute of Technology, Center for Health and Bioresources, Graz, Austria
,
Sze-Yuan Ooi
1   Department of Cardiology, Prince of Wales Hospital, Sydney, Australia
2   Prince of Wales Clinical School, The University of New South Wales, Sydney, Australia
,
Nigel H. Lovell
3   Graduate School of Biomedical Engineering, The University of New South Wales, Sydney, Australia
,
Stephen J. Redmond
3   Graduate School of Biomedical Engineering, The University of New South Wales, Sydney, Australia
5   School of Electrical and Electronic Engineering, University College Dublin, Dublin, Ireland
› Author Affiliations

Summary

Introduction: Mobile phone-based interventions in cardiovascular disease are growing in popularity. A randomised control trial (RCT) for a novel smartphone app-based model of care, named TeleClinical Care - Cardiac (TCC-Cardiac), commenced in February 2019, targeted at patients being discharged after care for an acute coronary syndrome or episode of decompensated heart failure. The app was paired to a digital sphygmomanometer, weighing scale and a wearable fitness band, all loaned to the patient, and allowed clinicians to respond to abnormal readings. The onset of the COVID-19 pandemic necessitated several modifications to the trial in order to protect participants from potential exposure to infection. The use of TCC-Cardiac during the pandemic inspired the development of a similar model of care (TCC-COVID), targeted at patients being managed at home with a diagnosis of COVID-19.

Methods: Recruitment for the TCC-Cardiac trial was terminated shortly after the World Health Organization announced COVID-19 as a global pandemic. Telephone follow-up was commenced, in order to protect patients from unnecessary exposure to hospital staff and patients. Equipment was returned or collected by a ‘no-contact’ method. The TCC-COVID app and model of care had similar functionality to the original TCC-Cardiac app. Participants were enrolled exclusively by remote methods. Oxygen saturation and pulse rate were measured by a pulse oximeter, and symptomatology measured by questionnaire. Measurement results were manually entered into the app and transmitted to an online server for medical staff to review.

Results: A total of 164 patients were involved in the TCC-Cardiac trial, with 102 patients involved after the onset of the pandemic. There were no hospitalisations due to COVID-19 in this cohort. The study was successfully completed, with only three participants lost to follow-up. During the pandemic, 5 of 49 (10%) of patients in the intervention arm were readmitted compared to 12 of 53 (23%) in the control arm. Also, in this period, 28 of 29 (97%) of all clinically significant alerts received by the monitoring team were managed successfully in the outpatient setting, avoiding hospitalisation. Patients found the user experience largely positive, with the average rating for the app being 4.56 out of 5. 26 patients have currently been enrolled for TCC-COVID. Recruitment is ongoing. All patients have been safely and effectively monitored, with no major adverse clinical events or technical malfunctions. Patient satisfaction has been high.

Conclusion: The TCC-Cardiac RCT was successfully completed despite the challenges posed by COVID-19. Use of the app had an added benefit during the pandemic as participants could be monitored safely from home. The model of care inspired the development of an app with similar functionality designed for use with patients diagnosed with COVID-19.



Publication History

Article published online:
21 April 2021

© 2021. IMIA and Thieme. This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/)

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