Trial document





This trial has been registered retrospectively.
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  DRKS00023393

Trial Description

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Title

Handling and coping with the corona pandemic (Covid-19) and its physical and psychological effects

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Trial Acronym

CoPa

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The study analyses the health and psychological impact of the measures taken in the context of the corona pandemic to slow down the spread of the corona virus, to protect public health and not to overburden the German health system. To this end, adults are being asked several times online how they deal with the current corona pandemic, how they cope with it and what their health and psychological burdens are, in order to gain insights into helpful courses of action and, if necessary, to be able to derive recommendations for future similar extraordinary situations.

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Brief Summary in Scientific Language

The health emergency of international proportions declared by the WHO in January 2020 due to the corona pandemic has also led to far-reaching government measures in Germany, which are intended to slow down the spread of the SARS CoV-2 virus in order to protect people's health and not overload the capacities of the German health system. Representative surveys indicate an increase in fears and concerns among the population associated with the pandemic. So far there is hardly any systematic scientific evidence on this. In the past, it has been shown that epidemics lead to a significantly increased stress level in the population and that the coping capacities of society as a whole correlate negatively with the epidemic-associated event frequency. In a recent report, the International Red Cross lists numerous fear reactions to a pandemic. These can be repressed and mutually reinforcing when dealing with infectious diseases. It is to be feared that as a result of the pandemic mental illnesses will be reactivated, exacerbate and their incidence will increase. Experts have published a number of recommendations for primary and secondary prevention of anxiety and stress in the general population. These are based on publications by the WHO on the COVID 19 pandemic, the United Nations Inter-Agency Standing Committee (IASC) and the International Red Cross. Against this background, the study aims to evaluate the health and psychological impact of the measures taken in the context of the corona pandemic to limit the spread of the corona virus. To this end, adults are repeatedly asked online how they are coping with the current corona pandemic, how they cope with it and what their health burdens are, in order to gain insights into helpful courses of action and, if necessary, to derive recommendations for future similar exceptional situations.

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

Yes

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Description IPD sharing plan:

An anonymised survey data set can be requested after the study via the study officer.

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Organizational Data

  •   DRKS00023393
  •   2020/10/26
  •   [---]*
  •   yes
  •   Approved
  •   20-118, Ethik-Kommission Universität zu Lübeck Medizinische Fakultät des Universitätsklinikums Schleswig-Holstein
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Secondary IDs

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

  •   COVID-19
  •   mental diseases
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Interventions/Observational Groups

  •   Population sample is surveyed online several times (1st survey in April 2020, 2nd survey in November 2020, possibly further surveys depending on the pandemic events) using the following survey instruments:
    - General self-efficacy short scale (ASKU) to record subjective competence expectations
    - EORTc-QLQ30 (Question 29 - General health status)
    - EORTc-QLQ30 (Question 30 Quality of life)
    - List of comorbidities
    - Patient Health Questionnaire for Depression and Anxiety (PHQ-4)
    - Stress and Coping Inventory (SCI)
    - Oslo-3 Social Support Scale (Oslo-3)
    - Big Five Inventory (BIG 5)
    - Sociodemographic
    In addition, questions are used that were developed on the basis of the WHO's recommendations on activities to maintain well-being in isolation and on distance. They refer to specific behavioural patterns in connection with the corona pandemic, personal experiences with quarantine/isolation, a possible Covid-19 disease and satisfaction with societal constraints.
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Characteristics

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

- EORTc-QLQ30 (Question 29 - General health status)
- EORTc-QLQ30 (Question 30 Quality of life)
- Comorbidities
- Patient Health Questionnaire for Depression and Anxiety (PHQ-4)
- Stress and Coping Inventory (SCI)

Interview dates:
1st survey in April 2020,
2nd survey in November 2020,
if necessary, further surveys depending on the pandemic


Survey methodology:
1. online survey according to link distribution via social media
2. survey to e-mail addresses provided during the initial survey

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Secondary Outcome

- activities to maintaining the well-being
- personal experience with quarantine/isolation
- possible Covid-19 disease
- Satisfaction with social restrictions

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2020/04/05
  •   5000
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Persons aged 16 and over
Informed consent to study
German language skills sufficient

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Exclusion Criteria

Persons under 16 years of age

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Addresses

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    • Universität zu Lübeck
    • Ratzeburger Allee 160
    • 23562  Lübeck
    • Germany
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    •   [---]*
    •   [---]*
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    • Universität zu LübeckInstitut für Sozialmedizin und Epidemiologie
    • Ms.  Elke  Peters 
    • Ratzeburger Allee 160
    • 23562  Lübeck
    • Germany
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    • Universität zu LübeckInstitut für Sozialmedizin und Epidemiologie
    • Ms.  Elke  Peters 
    • Ratzeburger Allee 160
    • 23562  Lübeck
    • Germany
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Sources of Monetary or Material Support

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    • Universität zu Lübeck Institut für Sozialmedizin und Epidemiologie
    • Ratzeburger Allee 160
    • 23562  Lübeck
    • Germany
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    •   [---]*
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Status

  •   Recruiting complete, follow-up continuing
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  •   5698
  •   5698
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* This entry means the parameter is not applicable or has not been set.