This trial is active, not recruiting.

Condition chronic urticaria
Treatment cu-q2ol
Sponsor Mahidol University
Collaborator Uniuversity of Genua, Italy
Start date November 2014
End date February 2015
Trial size 166 participants
Trial identifier NCT02285023, Thai-version of CU-Q2oL


In the majority of patients with the chronic urticaria, the etiology is unclear, leading to difficulties in treatment and high rates of recurrence. According to the International EAACI/GA2LEN/EDF/WAO Guidelines (the Dermatology Section of the European Academy of Allergology and Clinical Immunology(EAACI), the Global Allergy and Asthma European Network (GA2LEN), the European Dermatology Forum (EDF) and the World Allergy Organization (WAO) in Urticaria, using the Chronic Urticaria Quality of Life Questionnaire in a routine management is the key for a better treatment outcome. To translate this questionnaire into Thai is essential in our subject of interest in order to effectively apply it to local patients. The Thai-version questionnaire will encourage enhanced as well as impactful therapeutic options for Thai chronic urticaria patients.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective
Evaluation by the Urticaria Activity Score (UAS7) Fill the DLQI and CU-Q2oL questionnaire
The patients will be explained how to complete the Urticaria Activity Score (UAS7) form for evaluating their severity of chronic urticaria symptoms at home. At the 2nd visit, collect the 1st UAS7 assessment. Assessment the severity of chronic urticaria symptoms. The patients fill the 1st DLQI and CU-Q2oL questionnaire and get the 2nd UAS7 form and two-week appointment to follow up. At the 3th visit, collect the 2nd UAS7 assessment. Assessment the severity of chronic urticaria symptoms. The patients fill the 2nd DLQI and CU-Q2oL questionnaire.

Primary Outcomes

Validity of Thai-version CU-Q2oL
time frame: 4 week

Secondary Outcomes

Reliability of Thai-version CU-Q2oL
time frame: 4 week
Interpretability of Thai-version CU-Q2oL
time frame: 4 week
Responsiveness to Change
time frame: 4 week

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Age 18 years old or above - Diagnosed as chronic urticaria based on "The EAACI/GA(2)LEN/EDF/WAO Guideline - Literate in Thai language and can complete the questionnaire by themselves Exclusion Criteria: - Have other active skin diseases - Have a psychiatric problem - Cannot understand the questionnaire by themselves.

Additional Information

Official title Cross-Cultural of the Validity, Reliability and Interpretability of Thai-version of Chronic Urticaria Quality of Life Questionnaire (CU-Q2oL)
Principal investigator Kanokwalai Kulthanan, MD
Description 1. Adaption of the Cu-Q2oL questionnaire into Thai version by using forward-backward translation that is independently performed by two bilingual translators. The original Italian version is translated into Thai by two Thai native speakers, then the study team reviews the Thai-version Cu-Q2oL questionnaire for items comprehensibility and integrates the first consensus version which re-translated into Italian by an Italian native speaker afterwards. The comparison between the backward Italian version Cu-Q2oL questionnaire and the original Cu-Q2oL is carried out to find out whether there are any misconception and mistranslation in the intermediary forward version of questionnaire. After that, the second consensus version will be tested on 15 chronic urticaria patients to detect any misunderstanding points based on patients' comments. Finally, this Thai-version of CU-Q2oL questionnaire will be used to investigate the validity, reliability, interpretability and minimal clinical important difference. 2. To investigate the validity, reliability and interpretability of Thai-version of Chronic Urticaria Quality of Life Questionaire (CU-Q2oL), the severity of chronic urticaria symptoms will be assessed by investigators and patients using the Urticaria Activity Score (UAS7), the DLQI and CU-Q2oL questionnaire.
Trial information was received from ClinicalTrials.gov and was last updated in February 2015.
Information provided to ClinicalTrials.gov by Mahidol University.