Evaluation and feasibility study of telemedicine-based self-sampling for SARS-CoV-2

Evaluation and feasibility study of telemedicine-based self-sampling for SARS-CoV-2 - 2MINF02 (egePan)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00027093

Enrollment

100

Registered

2021-12-03

Start date

2021-10-01

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19 U07.1

Interventions

Group 1: App-guided scheduling and reporting Group 2: Standard of care (SOC)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Indication for SARS-CoV-2 testing as per local recommendation - Access for using an Android or iOS-Smartphone that is compatible with the Study software application - Age =18 years - Informed consent

Exclusion criteria

Exclusion criteria: - Current active, laboratory confirmed SARS-CoV-2 infection - Mental deficiency or any other condition that results in lacking understanding of the provided study information

Design outcomes

Primary

Measure	Time frame
Feasibility of a completely telemedicine-based SARS-CoV-2 testing	—

Secondary

Measure	Time frame
1. Feasibility of a completely telemedicine/App-guided SARS-CoV-2 diagnostic approach with self-sampling compared to SOC. 2. To evaluate the feasibility of subject selection by a telemedicine/App-guided SARS-CoV-2 diagnostic approach as compared to SOC. 3. To evaluate the feasibility of telemedicine-enabled shipment of samples. 4. To assess the feasibility of syntactical and semantical interoperable data processing and storage following international standards (such as HL7 V2.x with LOINC and HL7 FHIR for GeCCO data), enabling patient-focused telemedicine App/web-based result communication as compared to SOC. Completeness and correctness of data is validated by comparison to relevant FHIR profiles (e.g. the GeCCO data set). 5. To assess feasibility of an automated, low barrier extraction of pseudonymised GDPR-compliant subject/patient-data from a data integration center (MeDIZ) into the Macro4 study data base and DIS for provision for COVID-19 data exchange platform (CODEX), as compared to manual EDC. 6. To evaluate patient satisfaction and patient-reported outcomes of the intervention group as compared to SOC 7. To assess timely effectiveness of a complete telemedicine approach for SARS-CoV-2 testing as compared to SOC. 8. To compare both study arms with regard to cost-efficiency and effects.	—

Measure

Time frame

1. Feasibility of a completely telemedicine/App-guided SARS-CoV-2 diagnostic approach with self-sampling compared to SOC. 2. To evaluate the feasibility of subject selection by a telemedicine/App-guided SARS-CoV-2 diagnostic approach as compared to SOC. 3. To evaluate the feasibility of telemedicine-enabled shipment of samples. 4. To assess the feasibility of syntactical and semantical interoperable data processing and storage following international standards (such as HL7 V2.x with LOINC and HL7 FHIR for GeCCO data), enabling patient-focused telemedicine App/web-based result communication as compared to SOC. Completeness and correctness of data is validated by comparison to relevant FHIR profiles (e.g. the GeCCO data set). 5. To assess feasibility of an automated, low barrier extraction of pseudonymised GDPR-compliant subject/patient-data from a data integration center (MeDIZ) into the Macro4 study data base and DIS for provision for COVID-19 data exchange platform (CODEX), as compared to manual EDC. 6. To evaluate patient satisfaction and patient-reported outcomes of the intervention group as compared to SOC 7. To assess timely effectiveness of a complete telemedicine approach for SARS-CoV-2 testing as compared to SOC. 8. To compare both study arms with regard to cost-efficiency and effects.

—

Countries

Germany

Contacts

Public ContactChristoph Spinner

IZAR

izar@mri.tum.de089/41402451

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026