Trial document



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  DRKS00027510

Trial Description

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Title

Survey investigating the need for support services in German health care system for Post-Covid/Long-Covid (Covid-19) patients

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Trial Acronym

CLUE

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URL of the Trial

https://www.ukbonn.de/neurodegeneration/forschung/klinische-forschung/

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Brief Summary in Lay Language

We want to understand long-term needs of post-Covid/long-Covid patients in Germany that are not currently being met by the health care system. We also ask how and whether patients have been informed about health care supports available to them. Next, we ask what symptoms exist. In a next step, we ask which health care services are already being used in which disciplines. We also ask what offerings patients feel they need for their specific symptoms that are not currently being met by the German health care system.

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Brief Summary in Scientific Language

The present study aims to understand the specific residual psychological, physical, lung- heart medical problems and needs Post-Covid/Long-Covid patients not currently met by the health care system.
The goal is to assess the information, symptom and discipline-specific needs for aftercare. As a first step, we ask symptoms exist. As a next step, what health-care offerings in what specialities have already been utilized.
As a third step, we ask what kinds of medical or rehabilitation after-care patients perceive as necessary or desirable. This will be broken down into categories such as individual or group psychotherapy, specific type of rehabilitation therapies (ergo, physiotherapy).
Further, the need for better access to online information, telephone consultations/hotlines, consultations for their families and caregivers within Germany will be asked.
Lastly, the degree to which Post-/Long-Covid patients feel taken seriously by those in their local context (family, friends, colleagues, employers, teachers, etc.) or understood by healthcare providers and insurers will be ascertained.
This study will enable a fast assessment of the gaps in the after-care of Post-/Long-Covid in Germany

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

Yes

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Description IPD sharing plan:

Individual participant data will not be collected. Data that underlie results reported in the article will be made available. The study protocol will be made available. Data will be made available beginning 3 months and ending after 3 years following article publication. Researchers who provide a methodologically sound proposal may have access to the data. Data will be made available for analyses aimed at in the approved proposal, as well as for meta analyses. Proposals should be directed to catherine.widmann@ukbonn.de

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Organizational Data

  •   DRKS00027510
  •   2022/02/04
  •   [---]*
  •   yes
  •   Approved
  •   483/21, Ethik-Kommission der Medizinischen Fakultät der Rheinischen Friedrich-Wilhelms-Universität Bonn
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Secondary IDs

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Health Condition or Problem studied

  •   U07.2 -  Emergency use of U07.2
  •   U07.1 -  Emergency use of U07.1
  •   U07.0 -  Emergency use of U07.0
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Interventions/Observational Groups

  •   Individuals 18 years of age or older who.
    1) have had a COVID-19 infection in the past, and
    2) have lived in Germany after the acute phase, or
    3) have been treated for COVID-19 infection in Germany.

    The one-time anonymous online assessment will first ask a series of questions regarding type of health system support service information participants have obtained (i.e., whether they were given sufficient
    information (passively) or whether they actively sought information).
    Next we ask what support services they have already received and whether they feel this was
    sufficient. We also ask whether services were not available to them which they were informed
    may help them.
    Further, we ask about the timing of their active SARS-CoV-2 infection and vaccine status.
    The next series of questions relates to Post-Covid/ Long-Covid patient’s symptoms. Symptom
    categories encompass pulmonary, cardiological, general physical state, neuropsychological
    and psychological classifications. Both the symptom severity in the last 4 weeks (Not at all, once per week or less, two to four times per
    week/ half of the time, five times per week/ almost always) and the extent of daily life
    interference (Not at all, mildly, moderately, strongly, severely) will be examined on a five point
    Likert-scale.
    After each symptom category, specific therapeutic options will be shown, so participants can
    indicate whether they wish to receive support in that respective category. Lastly, participants
    have the opportunity to indicate other support possibilities that were not named beforehand.

    The questionnaire takes approximately 20-30 minutes. Pauses can be taken any time.
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Characteristics

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

Not applicable. Not applicable. The aim of the study is to assess the potential gaps in the German healthcare system for post-covid/long-covid patients. Hence, we will assess gaps in knowledge obtained by patients, types and duration of symptoms post-Covid and gaps in offerings to patients.

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Secondary Outcome

Not applicable.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2022/02/15
  •   5000
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   130   Years
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Additional Inclusion Criteria

Over 18
Self-reported COVID-19 infection case in Germany or Covid-19 treatment in Germany

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Exclusion Criteria

under 18 years of age
No case of COVID-19 infection or no Covid-19 treatment in Germany or no stay in Germany after acute phase of Covid-19 infection

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Addresses

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    • Universitätsklinikum Bonn Klinik für Neurodegenerative Erkrankungen und Gerontopsychiatrie/ Sektion Neurodegeneration
    • Ms.  Dipl.-Psych.  Catherine N.  Widmann 
    • Venusberg-Campus 1
    • 53127  Bonn
    • Germany
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    • Universitätsklinikum Bonn Klinik für Neurodegeneration und Gerontopsychiatrie/Sektion Gerontopsychiatrie
    • Ms.  Dr. rer nat.  Bettina  Bewernick 
    • Venusberg-Campus 1
    • 53127  Bonn
    • Germany
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    • Unviersitätsklinikum Bonn Klinik und Poliklinik für Psychiatrie und Psychotherapie
    • Ms.  Dr. rer nat.  Silke  Lux 
    • Venusberg-Campus 1
    • 53127  Bonn
    • Germany
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    • Universitätsklinikum Bonn Klinik und Poliklinik für Psychosomatische Medizin und Psychotherapie
    • Mr.  Prof. Dr. med. Dipl.-Psych.  Rupert  Conrad 
    • Venusberg-Campus 1
    • 53127  Bonn
    • Germany
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    • Universitätsklinikum Bonn Klinik und Poliklinik für Psychosomatische Medizin und Psychotherapie
    • Mr.  Dr. phil. Dipl.-Psych.  Ingo  Wegener 
    • Venusberg-Campus 1
    • 53127  Bonn
    • Germany
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    • Universitätsklinikum Bonn Herzzentrum Bonn Sektion Pneumonologie
    • Mr.  Univ. Prof. Dr. med.  Dirk  Skowasch 
    • Venusberg-Campus 1
    • 53127  Bonn
    • Germany
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    • Universitätsklinikum Bonn Herzzentrum Sektion Kardiologie
    • Mr.  Univers. Prof. Dr. med.  Sebastian  Zimmer 
    • Venusberg-Campus 1
    • 53127  Bonn
    • Germany
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    • Universitätsklinikum Bonn Klinik für Neurodegenerative Erkrankungen und Gerontopsychiatrie/ Sektion Neurodegeneration
    • Ms.  Dipl.-Psych.  Catherine N.  Widmann 
    • Venusberg-Campus 1
    • 53127  Bonn
    • Germany
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    • Universitätsklinikum Bonn Klinik für Neurodegenerative Erkrankungen und Gerontopsychiatrie/ Sektion Neurodegeneration
    • Ms.  Dipl.-Psych.  Catherine N.  Widmann 
    • Venusberg-Campus 1
    • 53127  Bonn
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Bonn Klinik für Neurodegenerative Erkrankungen und Gerontopsychiatrie/ Sektion Neurodegeneration
    • Ms.  Dipl.-Psych.  Catherine N.  Widmann 
    • Venusberg-Campus 1
    • 53127  Bonn
    • Germany
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.