NCT02285049

Cross-Cultural of the Validity, Reliability and Interpretability of Thai-version of Urticaria Control Test

Cross-Cultural of the Validity, Reliability and Interpretability of Thai-version of Urticaria Control Test (UCT)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 169 (actual)
• Sponsor: Mahidol University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Chronic Urticaria

Interventions

Type	Name	Description
OTHER	Urticaria Control Test	* The patients get the 1st UAS28 form and four-week appointment to follow up. * Collect completed UAS28 assessment, Patient's global assessment of disease severity (PatGA-LS) and Physician's global assessment of disease control (PhyGA-LS) * Then patients fill the 1st UCT and DLQI questionnaire by themselves. * The patients get the 2nd UAS28 form and four-week appointment to follow up. * At the 2nd visit, collect completed UAS28 assessment. Assessment the severity of chronic urticaria symptoms by Patient's global assessment of disease severity (PatGA-LS) and Physician's global assessment of disease control (PhyGA-LS). The patients fill the UCT and DLQI and questionnaire by themselves.

Timeline

• Start date: 2014-11-01
• Primary completion: 2015-02-01
• Completion: 2016-01-01
• First posted: 2014-11-06
• Last updated: 2016-03-01

Locations

1 site across 1 country: Thailand