Trial document





This trial has been registered retrospectively.
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  DRKS00013971

Trial Description

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Title

The German Itch Questionnaire, validation in different diagnoses

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Chronic pruritus (defined as pruritus lasting six weeks or longer) is a widespread symptom in dermatology, but also occurs in other diseases, e. g. chronic kidney diseases or chronic liver diseases. It is still difficult to measure chronic pruritus, for this a questionnaire would be useful. Up to now, there is neither a standardized national nor international questionnaire.
In 2008, a first German language questionnaire for assessing chronic pruritus (AGP questionnaire) was developed on the basis of an already existing questionnaires that will again be revised. The aim of the current study is 1st to differentiate between various diagnoses, 2nd to develop different modules for different diseases and 3rd to develop a German standardized questionnaire which will be comprehensively used.
The current version of this questionnaire comprises five modules for the patient (anamnesis, itch-specific anamnesis, itch-specific therapy, itch-specific quality of life and sleep) as well as two modules for the treating physician (clinical classification of itch and comorbidities). Now, the revised questionnaire should be reevaluated. 10 study centres take part (8 in Germany, 1 in Switzerland and 1 in Austria). We include 9 different diagnoses; per diagnosis 40 patients will be recruited, so in total, we will recruit 360 patients.

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Brief Summary in Scientific Language

Chronic pruritus (defined as pruritus lasting six weeks or longer) is a widespread symptom in dermatology, but also occurs in other diseases, e. g. chronic kidney diseases, chronic liver diseases, or carcinoma. It is still difficult to measure chronic pruritus, for this a questionnaire would be useful. Up to now, there is neither a standardized national nor international questionnaire.
In 2008, a first German language questionnaire for assessing chronic pruritus (AGP questionnaire) was developed on the basis of already existing questionnaires that will again be revised. The aim of the current study is 1st to differentiate between various diagnoses, 2nd to develop different modules for different diseases and 3rd to develop a German standardized questionnaire which will be comprehensively used.
The questionnaire is devided in five modules for the patient (anamnesis, itch-specific anamnesis, itch-specific therapy, itch-specific quality of life and sleep). The current version of this questionnaire comprises questions on cause, intensity and quality of pruritus, general health status, socio-demographic data, itch-specific therapies, quality of life, and pruritus cognition. Pruritus will be classified by an international concerted classification system through clinical picture and aetiology (IFSI-classification). Comorbidities will be recorded by the Charlson-Comorbidity-Score. Now, the revised questionnaire should be reevaluated. 10 study centres take part (8 in Germany, 1 in Switzerland and 1 in Austria). We include 9 different diagnoses (itch in dermatological patients (urticaria, psoriasis, atopic eczema), patients with pruritus and kidney disease, patients with pruritus and liver disease, patients with pruritus and chronic prurigo, pruritus of multifactorial genesis, somatoform pruritus or neuropahtic pruritus. Per diagnosis, 40 patients will be recruited, so in total, we will recruit 360 patients.

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Organizational Data

  •   DRKS00013971
  •   2018/04/23
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  •   yes
  •   Approved
  •   S-594/2017, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
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Secondary IDs

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Health Condition or Problem studied

  •   urticaria, psoriasis, atopic eczema, patients with pruritus and kidney disease, patients with pruritus and liver disease, patients with pruritus and chronic prurigo, pruritus of multifactorial genesis, somatoform pruritus or neuropahtic pruritus
  •   L29.8 -  Other pruritus
  •   L29.9 -  Pruritus, unspecified
  •   F45.8 -  Other somatoform disorders
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Interventions/Observational Groups

  •   Patients with chronic itch will be questioned one or to times with five modules: general anamnesis, itch-specific anamnesis, itch-specific therapy, itch-specific quality of life and sleep. Simultaneously, the treating physician will classify the pruritus by the IFSI-classification as well as comorbidities by the Charlson-Comorbidity-Score.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   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

Hypothesis: Because of the itch-specific anamnesis, the questionnaire can differentiate between different diagnoses. The present study should provide intial approches of the validity. Therefore, construct validity and criterion validity will be assesd.

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Secondary Outcome

On a subsample, the retest-reliability of the itch-specific anamnesis will be assessed after 24 hours. On a second subsample, the sensitivity to change/ stability will be assessed after 1 week.

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Countries of Recruitment

  •   Germany
  •   Austria
  •   Switzerland
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Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
  • other 
  • Doctor's Practice 
  • University Medical Center 
  • Doctor's Practice 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2018/01/12
  •   360
  •   Multicenter trial
  •   International
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Inclusion Criteria

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

- patients with chronic pruritus >= 6 weeks
- written informed consent
- personal introduction in the study center
- capacity for consent

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Exclusion Criteria

- deficient knowledge of the language
- limited vigilance, e.g. dementia, sedatives

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Addresses

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    • Universitätsklinikum Heidelberg,Verantwortlich für Organisation der Studie und Ethikantrag / Responsible for organisation of study and ethics committee application: Prof. Elke Weisshaar
    • Voßstraße 2
    • 69115  Heidelberg
    • Germany
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    • Universitätsklinikum Heidelberg, Abteilung Klinische Sozialmedizin
    • Ms.  apl. Prof. Dr. med.  Elke  Weisshaar 
    • Voßstraße 2
    • 69115  Heidelberg
    • Germany
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    • Universitätsklinikum Heidelberg, Abteilung Klinische Sozialmedizin
    • Ms.  apl. Prof. Dr. med.  Elke  Weisshaar 
    • Voßstraße 2
    • 69115  Heidelberg
    • Germany
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Sources of Monetary or Material Support

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    • Keine fremden Finanzmittel / no external funds
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Status

  •   Recruiting ongoing
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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.