Clinical trial NCT02285049: Cross-Cultural of the Validity, Reliability and Interpretability of Thai-version of Urticaria Control Test
Official title: Cross-Cultural of the Validity, Reliability and Interpretability of Thai-version of Urticaria Control Test (UCT)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Urticaria
Keywords: Chronic urticaria
Urticaria Control Test
Lead sponsor: Mahidol University
Sponsor class: OTHER
Collaborators: name: Charite University, Berlin, Germany
First posted: 2014-11-06
Enrollment: 169
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: Chronic urticaria symptoms commonly fluctuate from day by day. Consequently the clinical presentation of a patient in each visit is not representative of the current disease status. Dermatologists are trying to integrate an evaluation process of each treatment visit regarding both clinical condition and life quality concern. The Urticaria Control Test is the key for a better treatment outcome in a routine management. To translate this questionnaire into Thai is essential in our subject of interest for offering local patients a higher well-being standard. The Thai-version test will encourage enhanced as well as impactful therapeutic options for Thai chronic urticaria patients.

Detailed description: 1. Independently adaption of the UCT questionnaire into Thai version by using forward-backward translation by two bilingual translators. The original German version is translated into Thai by two Thai native speakers, then the study team reviews the Thai-version UCT questionnaire for items comprehensibility and integrates the first consensus version which re-translated into German by German native speaker afterwards. The comparison between the backward German version UCT questionnaire and the original UCT is carried out to find out any misconception and mistranslation in the intermediary forward version of questionnaire. The second version will be tested on 15 chronic urticaria patients to detect any misunderstanding points. Finally, this Thai-version of UCT 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 Urticaria Control Test, the severity of urticaria symptoms will be assessed by investigators and patients using UAS28, Patient's global assessment of disease severity (PatGA-LS), Physician's global assessment of disease control (PhyGA-LS), the UCT and DLQI 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: the 2013 revision and update" by dermatologists
* 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: Convergent validity of Thai version of Urticaria Control Test
timeFrame: 4 week
Secondary outcomes:
measure: Reliability of Thai version of Urticaria Control Test
timeFrame: 4 week
measure: Interpretability of Thai version of Urticaria Control Test
timeFrame: 4 week
measure: Screening accuracy (Responsiveness to Change) of Thai version of Urticaria Control Test
timeFrame: 4 week
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: