Trial document

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DRKS-ID: 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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Organizational Data

DRKS-ID: DRKS00010072
Date of Registration in DRKS: 2016/02/22
Date of Registration in Partner Registry or other Primary Registry: [---]*
Investigator Sponsored/Initiated Trial (IST/IIT): yes
Ethics Approval/Approval of the Ethics Committee: Approved
(leading) Ethics Committee No.: 33/16, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg

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Secondary IDs

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Health Condition or Problem studied

ICD10: D86 - Sarcoidosis
ICD10: R05 - Cough

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Interventions/Observational Groups

Arm 1: 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

Study Type: Non-interventional
Study Type Non-Interventional: Other
Allocation: Single arm study
Blinding: Open (masking not used)
Who is blinded: [---]*
Control: Uncontrolled/Single arm
Purpose: Other
Assignment: Single (group)
Phase: N/A
Off-label Drug use: 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

DE: Germany

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Locations of Recruitment

University Medical Center Pneumologie, Freiburg im Breisgau

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Recruitment

Planned/Actual: Actual
(Anticipated or Actual) Date of First Enrollment: 2016/02/18
Target Sample Size: 250
Monocenter/Multicenter trial: Monocenter trial
National/International: National

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Inclusion Criteria

Gender: Both, male and female
Minimum Age: 18 Years
Maximum Age: 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

Primary Sponsor
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- Universitätsklinikum FreiburgAbteilung Pneumologie
- Killianstr. 5
- 79106 Freiburg
- Germany
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- Telephone: [---]*
- Fax: [---]*
- E-mail: [---]*
- URL: [---]*
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Contact for Scientific Queries
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- Universitätsklinikum FreiburgAbteilung Pneumologie
- Mr. Dr. Jonas Schupp
- Killianstr. 5
- 79106 Freiburg
- Germany
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- Telephone: 076127037090
- Fax: [---]*
- E-mail: jonas.schupp at uniklinik-freiburg.de
- URL: [---]*
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Contact for Public Queries
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- Universitätsklinikum FreiburgAbteilung Pneumologie
- Mr. Dr. Jonas Schupp
- Killianstr. 5
- 79106 Freiburg
- Germany
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- Telephone: 076127037090
- Fax: [---]*
- E-mail: jonas.schupp at uniklinik-freiburg.de
- URL: [---]*
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Sources of Monetary or Material Support

Institutional budget, no external funding (budget of sponsor/PI)
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- Universitätsklinikum FreiburgAbteilung Pneumologie
- Killianstr. 5
- 79106 Freiburg
- Germany
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- Telephone: [---]*
- Fax: [---]*
- E-mail: [---]*
- URL: [---]*
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Status

Recruitment Status: Recruiting complete, follow-up complete
Study Closing (LPLV): 2016/10/31

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Trial Publications, Results and other Documents

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