Telemonitoring of patients after COVID-19 hospitalization: study design and baseline characteristics

Abstract

Abstract Funding Acknowledgements Type of funding sources: Public grant(s) – National budget only. Main funding source(s): This study is part of the research and development project “Telemed50000” and is supported by the German Federal Ministry of Economic affairs and Climate Action on the basis of a decision by the German Bundestag. Background There is a robust evidence about the beneficial effects of telemedicine in heart failure (HF) patients causing an implementation process of this method of digital care in the health care systems of several European countries. It remains unclear whether it’s feasible to prevent complications of pre-existing comorbidities as well as detecting the onset of other clinical complications after discharge due to COVID-19 using telemonitoring on a daily basis. Purpose The primary endpoint of this study is to detect unplanned clinical events during a one year follow-up after hospitalization due to COVID-19 with a standard non-invasive telemonitoring system used for HF patients. The definition of unplanned clinical event includes: telemedical emergency interventions, admission to emergency room, unplanned hospitalization and all-cause death. Methods and study design Inclusion criteria were age ≥18 years and a PCR- positive Sars-CoV-2 infection with acute respiratory symptoms requiring hospitalization. The follow-up period was one year with a clinical onsite visit at baseline, a telemedical visit after 6 months (phone-call) and a final onsite visit after 12 months. Recruitment took place from February 2021 until February 2022 at 5 hospitals located in 3 different federal states across Germany (Figure 1). The telemedical system, including 5 telemedical devices, was installed at the patient´s home during a nurse-led visit (n=83) or it was installed by themselves, video-guided, after sending the telemedical equipment by a parcel service (n=26). The daily transferred vital parameter, included body weight, systolic and diastolic blood pressure, pulse rate, a three channel electrocardiogram (ECG) and peripheral capillary oxygen saturation (SPO2). A 2-miutes voice recording of standardized text was required once a week. Data were sent to a telemedicine centre (TMC). All parameters were reviewed by physicians and nurses of the TMC from Monday to Friday (8 am to 4 pm). A six minutes walking test (6MWT) was performed during the nurse led home visit at baseline (n=37), if the patients were able to do the test. A second 6MWT was required at final visit. Health-related quality of life was measured by the Patient Reported Outcomes Measurement Information System (PROMIS)-29 questionnaire at baseline, after 6 and 12 months. Telemedical interventions were only initiated in case of a life-threatening emergency. Conclusions The established telemedical approach for HF patients, is also an appropriate tool to investigate the long-term recovery process, in particular to detect systemic sequelae in a cohort of COVID-19 patients. The Telemed-COVID-19 trial will provide prospective epidemiological data about the frequency of unplanned clinical events after hospitalization due to COVID-19 because of the daily telemedical transfer of vital parameters.