|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
German Clinical Trials Register |
|
Last refreshed on:
|
8 April 2024 |
|
Main ID: |
DRKS00013971 |
|
Date of registration:
|
23/04/2018 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
The German Itch Questionnaire, validation in different diagnoses
|
|
Scientific title:
|
The German Itch Questionnaire, validation in different diagnoses |
|
Date of first enrolment:
|
12/01/2018 |
|
Target sample size:
|
360 |
|
Recruitment status: |
Complete |
|
URL:
|
http://drks.de/search/en/trial/DRKS00013971 |
|
Study type:
|
observational |
|
Study design:
|
Allocation: ; Masking: ; Control: ; Assignment: ; Study design purpose: other
|
|
Phase:
|
|
|
|
Countries of recruitment
|
|
Austria
|
Germany
|
Switzerland
| | | | | |
|
Contacts
|
|
Name:
|
Elke
Weisshaar |
|
Address:
|
Voßstraße 2
69115
Heidelberg
Germany |
|
Telephone:
|
06221/568752 |
|
Email:
|
Elke.Weisshaar@med.uni-heidelberg.de |
|
Affiliation:
|
Universitätsklinikum Heidelberg, Berufsdermatologie |
|
|
Name:
|
Elke
Weisshaar |
|
Address:
|
Voßstraße 2
69115
Heidelberg
Germany |
|
Telephone:
|
06221/568752 |
|
Email:
|
elke.weisshaar@med.uni-heidelberg.de |
|
Affiliation:
|
Universitätsklinikum Heidelberg, Berufsdermatologie |
| |
|
Key inclusion & exclusion criteria
|
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
Age minimum:
18 Years
Age maximum:
None
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
F45.8
|
|
L29.9
|
|
Pruritus, unspecified
|
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
L29.9
F45.8
|
|
Other somatoform disorders
|
|
L29.8
|
|
Other pruritus
|
|
Intervention(s)
|
|
Group 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.
|
|
Primary Outcome(s)
|
|
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(s)
|
|
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.
|
|
Source(s) of Monetary Support
|
|
Keine fremden Finanzmittel / no external funds
|
|
Ethics review
|
Status: Approved
Approval date: 24/11/2017
Contact:
ethikkommission-I@med.uni-heidelberg.de
Ethikkommission der Medizinischen Fakultät Heidelberg
+49-6221-338220
ethikkommission-I@med.uni-heidelberg.de
|
|