Trial document



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  DRKS00010072

Trial Description

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Title

Validiation of the LCQ and KSQ questionnaires in German language

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The aim of this study is to validate two translated questionnaires (Leicester Cough Questionnaire (LCQ) and King's Sarcoidosis Questionnaire (KSQ)) in German-speaking patients. Patients with sarcoidosis are asked to answer two translated questionnaires (LCQ and KSQ) as well as the SF-36 questionnaire and a visual analogue scale.

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Brief Summary in Scientific Language

Validation of two translated questionnaires (LCQ and KSQ), comparison with the SF-36 questionnaire and evaluation of methodological quality criteria in patients with sarcoidosis.

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

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00010072
  •   2016/02/22
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  •   yes
  •   Approved
  •   33/16, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

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Health Condition or Problem studied

  •   D86 -  Sarcoidosis
  •   R05 -  Cough
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Interventions/Observational Groups

  •   Patients with sarcoidosis are asked to answer two translated questionnaires (LCQ and KSQ) as well as the SF-36 questionnaire and a visual analogue scale.
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Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Other
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Validation of two translated questionnaires (LCQ and KSQ). Comparison with the SF-36 questionnaire an a visual analog scale. Evaluation of methodological quality criteria.

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Secondary Outcome

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2016/02/18
  •   250
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Adult patients with sarcoidosis

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Exclusion Criteria

No willingness to participate. Insufficient German language skills. Cognitive, psychic or physical impairment making answering of questionnaires impossible.

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Addresses

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    • Universitätsklinikum FreiburgAbteilung Pneumologie
    • Killianstr. 5
    • 79106  Freiburg
    • Germany
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    • Universitätsklinikum FreiburgAbteilung Pneumologie
    • Mr.  Dr.  Jonas  Schupp 
    • Killianstr. 5
    • 79106  Freiburg
    • Germany
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    • Universitätsklinikum FreiburgAbteilung Pneumologie
    • Mr.  Dr.  Jonas  Schupp 
    • Killianstr. 5
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum FreiburgAbteilung Pneumologie
    • Killianstr. 5
    • 79106  Freiburg
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2016/10/31
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Trial Publications, Results and other Documents

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