Clinical trial NCT02285023: The Validity, Reliability and Interpretability of Thai-version of Chronic Urticaria Quality of Life Questionnaire
Official title: Cross-Cultural of the Validity, Reliability and Interpretability of Thai-version of Chronic Urticaria Quality of Life Questionnaire (CU-Q2oL)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Urticaria
Keywords: Chronic urticaria
CU-Q2oL
Lead sponsor: Mahidol University
Sponsor class: OTHER
Collaborators: name: Uniuversity of Genua, Italy
First posted: 2014-11-06
Enrollment: 166
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who were diagnosed as chronic urticaria.

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Cross-Cultural Validity of Thai-version CU-Q2oL
timeFrame: 4 week
Secondary outcomes:
measure: Mean Total Score and Domain of Thai CU-Q2oL Scores From the Thai Version to Investigate Reliability of Thai-Version CU-Q2oL
timeFrame: baseline
measure: Change in Thai CU-Q2oL Scores From Baseline for Responders and Non-Responders
timeFrame: baseline and 2 weeks
measure: Area Under the Curve for Thai CUQ2oL Scores in the Responder Group
timeFrame: baseline and 2 weeks
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Siriraj Hospital, Mahidol University
Study officials:
affiliation: Mahidol University
name: Kanokwalai Kulthanan, MD
role: PRINCIPAL_INVESTIGATOR
References: