Trial document




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  DRKS00023685

Trial Description

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Title

Acceptance, benefits and effectiveness of the CoronaWarn-App (COVID-19 warning app)

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Trial Acronym

Corona-Warn-App

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The aim of the study is to scientifically investigate the acceptance, the benefit and the effectiveness of the Corona-Warn-App.
For this purpose, patients who have tested positive for SARS-coV-2 and are being treated in an outpatient or inpatient setting by a study center are asked to fill out a questionnaire.
This questionnaire includes specific questions about whether the patients have and use the app and general data such as age and gender.


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Brief Summary in Scientific Language

The study will examine the benefits, effectiveness and acceptance of the German Corona-Warn-App.
Within the study, patients who tested positive for SARS-cov-2 and are treated in a study center as outpatients or inpatients will receive a questionnaire.
The questionnaire contains questions about the app such as:
Do the patients have the app?
Do the patients use the app?
How do the patients use the app?
The questionnaire also includes general questions about the patient such as:
age
Gender
Educational background
Use of smartphones.

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Do you plan to share individual participant data with other researchers?

No

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Description IPD sharing plan:

No.

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Organizational Data

  •   DRKS00023685
  •   2020/12/18
  •   [---]*
  •   yes
  •   Approved
  •   467_20B, Ethik-Kommission der Friedrich-Alexander-Universität Erlangen-Nürnberg
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   U07 -  Emergency use of U07
  •   U99.0 -  [---]*
  •   COVID-19
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Interventions/Observational Groups

  •   Patients with evidence of infection with SARS-coV-2 to fill out a one-time questionnaire for the use of the corona warning app (COVID-19-Warn app).
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Prevention
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Primary endpoint is the benefit of the corona warning app regarding whether SARS-coV-2 positive patients use the app and were warned by it.

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Secondary Outcome

Correlation of app usage with general patient data.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
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Recruitment

  •   Planned
  •   2020/12/18
  •   500
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Infection with SARS-coV-2

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Exclusion Criteria

lack of ability to consent

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Addresses

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    • Medizinische Klinik 1 des Universitätsklinikums Erlangen
    • Ulmenweg 18
    • 91054  Erlangen
    • Germany
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    • Universitätsklinikum ErlangenMedizinische Klinik 1
    • Mr.  Prof. Dr. med.  Maximilian  Waldner 
    • Ulmenweg 18
    • 91054  Erlangen
    • Germany
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    • Universitätsklinikum ErlangenMedizinische Klinik 1
    • Mr.  Dr. med.  Daniel  Klett 
    • Ulmenweg 18
    • 91054  Erlangen
    • Germany
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    • Medizinische Klinik 1 des UK Erlangen
    • Mr.  Dr. med.  André  Jefremow 
    • Ulmenweg 8
    • 91054  Erlangen
    • Germany
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    • Medizinische Klinik 1 des UK Erlangen
    • Mr.  Dr. med.  André  Jefremow 
    • Ulmenweg 18
    • 91054  Erlangen
    • Germany
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Sources of Monetary or Material Support

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    • Medizinische Klinik 1 des Universitätsklinikums Erlangen
    • Ulmenweg 18
    • 91054  Erlangen
    • Germany
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Status

  •   Recruiting planned
  •   [---]*
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Trial Publications, Results and other Documents

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