The German Itch Questionnaire, validation in different diagnoses
Organizational Data
- DRKS-ID:
- DRKS00013971
- Recruitment Status:
- Recruiting complete, study complete
- Date of registration in DRKS:
- 2018-04-23
- Last update in DRKS:
- 2021-02-05
- Registration type:
- Retrospective
Acronym/abbreviation of the study
No Entry
URL of the study
No Entry
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.
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.
Health condition or problem studied
- Free text:
- 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
- ICD10:
- L29.8 - Other pruritus
- ICD10:
- L29.9 - Pruritus, unspecified
- ICD10:
- F45.8 - Other somatoform disorders
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- 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.
Endpoints
- 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.
- 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.
Study Design
- Purpose:
- Other
- Retrospective/prospective:
- No Entry
- Study type:
- Non-interventional
- Longitudinal/cross-sectional:
- No Entry
- Study type non-interventional:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting complete, study complete
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Austria
- Germany
- Switzerland
- Number of study centers:
- Multicenter study
- Recruitment location(s):
-
- University medical center Medizin 1 Erlangen
- University medical center Kompetenzzentrum chronischer Pruritus Münster
- Doctor's practice Bad Bentheim
- University medical center Dermatologische Klinik und Poliklinik München
- University medical center Hautklinik und Poliklinik Mainz
- Other Institut für Medizinische Psychologie Gießen
- Doctor's practice Wiesbaden
- University medical center Dermatologie und Venerologie Graz
- Medical center Dermatologie – Allergologie Aarau
- University medical center Berufsdermatologie Heidelberg
Recruitment period and number of participants
- Planned study start date:
- No Entry
- Actual study start date:
- 2018-01-12
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- 2020-12-31
- Target Sample Size:
- 360
- Final Sample Size:
- 362
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- no maximum age
- Additional Inclusion Criteria:
- - patients with chronic pruritus >= 6 weeks - written informed consent - personal introduction in the study center - capacity for consent
Exclusion Criteria
- deficient knowledge of the language - limited vigilance, e.g. dementia, sedatives
Addresses
Primary Sponsor
- Address:
- Universitätsklinikum Heidelberg,Verantwortlich für Organisation der Studie und Ethikantrag / Responsible for organisation of study and ethics committee application: Prof. Elke WeisshaarVoßstraße 269115 HeidelbergGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Universitätsklinikum Heidelberg, Berufsdermatologieapl. Prof. Dr. med. Elke WeisshaarVoßstraße 269115 HeidelbergGermany
- Telephone:
- 06221/568752
- Fax:
- 06221/565019
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Contact for Public Queries
- Address:
- Universitätsklinikum Heidelberg, Berufsdermatologieapl. Prof. Dr. med. Elke WeisshaarVoßstraße 269115 HeidelbergGermany
- Telephone:
- 06221/568752
- Fax:
- 06221/565019
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Principal Investigator
- Address:
- Universitätsklinikum Heidelberg, Berufsdermatologieapl. Prof. Dr. med. Elke WeisshaarVoßstraße 269115 HeidelbergGermany
- Telephone:
- 06221/568752
- Fax:
- 06221/565019
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Sources of Monetary or Material Support
No Entry
- Address:
- Keine fremden Finanzmittel / no external funds
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Ethics Committee
Address Ethics Committee
- Address:
- Ethikkommission der Medizinischen Fakultät HeidelbergAlte Glockengießerei 11/169115 HeidelbergGermany
- Telephone:
- +49-6221-338220
- Fax:
- +49-6221-3382222
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2017-10-27
- Ethics committee number:
- S-594/2017
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2017-11-24
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No Entry
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry