U07.1
Conditions
Interventions
Group 1: SARS-CoV-2 PCR-positive patients are offered the use of monitoring devices and an associated app in the emergency department. If patients consent to the study, the data collected will be eval
Sponsors
Uniklinik RWTH Aachen
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Evidence of a positive test for SARS-CoV-2. - The subject has reached the age of 18. - The subject has access to a smartphone for personal use. - The subject is in an outpatient setting at the time of study conduct. - Recruitment will be via the central emergency department for mildly symptomatic or asymptomatic, but PCR-positive, subjects whose current condition does not require an inpatient stay. - Subjects must be confident in their own use of the monitoring devices and associated app in the physician-patient interview. The attending medical staff must share this opinion.
Exclusion criteria
Exclusion criteria: - Lack of consent/incapacity to consent - Minority - Desire to abort/withdrawal of consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| User compliance is defined in terms of measurement adherence as the primary endpoint. It is calculated as the ratio of measurements performed to target (1x/d), i.e. as [number of actual measurements]/[number of target measurements] and, in order not to disproportionately consider days with overfulfillment of the usage target, also as the ratio of the binary quantity [daily target of measurements achieved or exceeded]/[number of days].The joint assessment of these values should represent the primary endpoint. User compliance will be monitored over the different periods of participation. | — |
Secondary
| Measure | Time frame |
|---|---|
| The following data will be collected as part of the COVID-19@Home study: - Current symptoms and subjective complaints - Vital signs (pulse, blood pressure, body temperature, oxygen saturation) in the acute phase - Questionnaires on the current patient situation - Survey of relevant previous illnesses, medication schedule - Medical interventions, consultations and inpatient stays during the period of the COVID-19 disease as well as the transfer of the collected measured values in this context - Basal user statistics (e.g., number of measurement entries per parameter per day, change in frequency of use during the disease period) - Qualitative interviews (with participants and physicians on experiences with COVID-19 and home monitoring in the context of the study) - Usability/user acceptance questionnaire (participants and physicians) Based on the data collected, further implications for the use of a telemonitoring approach as well as possible improvements in the treatment management of COVID-19 patients will be derived. | — |
Countries
Germany
Contacts
Public ContactLukas Niekrenz
Uniklinik RWTH AachenMedizinsche Klinik V
Outcome results
None listed