Abstract
Background Covid-19 remains a challenge to individual health and health care resources worldwide. Telemedical surveillance might minimize hospitalization and direct patient-physician-contacts. Yet, randomized clinical trials evaluating telemedical management of Covid-19 patients are lacking.
Methods COVID SMART is a randomized, open label, controlled clinical trial investigating whether telemedicine reduces the primary endpoint of hospitalization or any unscheduled utilization of an emergency medical service within 30 days of follow-up. Key secondary endpoints included mortality and primary endpoint components. We enrolled acutely infected SARS-CoV2 patients suitable for outpatient care. All presented with ≥1 risk factor for an adverse Covid-19 course. Patients were randomized 1:1 into a control group receiving standard of care and an intervention group receiving smartphone-based assessment of oxygen saturation, heart rate and electrocardiogram, and telemedical counselling via a 24/7 emergency hotline.
Results Of 607 enrolled patients (mean age 46.7±13.5 years), 304 were randomized into the intervention and 303 into the control group. The primary endpoint occurred in 6.9% (n=21) of the intervention and in 9.6% (n=29) of the control group (hazard ratio 0.72, 95% confidence interval 0.41–1.26; p=0.24). No deaths occurred during follow-up. Fewer intervention group participants utilized outpatient-based emergency medical services (hazard ratio 0.43, 95% confidence interval 0.20–0.90; p=0.03).
Conclusions COVID SMART is the first randomized clinical trial assessing the benefit of telemedicine in an acute respiratory infectious disease. Whereas telemedical management did not reduce the primary endpoint of hospitalization, fewer intervention group patients used outpatient-based emergency services, suggesting a potential benefit for less-acutely infected individuals.
Trial registration clinicaltrials.gov (NCT04471636)
Footnotes
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Conflict of Interest: ASvF declares to be granted support from the German Research Foundation.
Conflict of Interest: CS reports speaker honoraria from AstraZeneca outside the submitted work.
Conflict of Interest: PdV reports being an employee of Withings, the manufacturer of Scanwatch, the smart watch that was used in this trial.
Conflict of Interest: MFS declares being granted support from the German Centre for Cardiovascular Research and with travel support from Biotronik.
Conflict of Interest: All other authors declare no potential conflict of interest.
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- Received March 23, 2024.
- Accepted April 16, 2024.
- Copyright ©The authors 2024
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