Cross-Cultural of the Validity, Reliability and Interpretability of Thai-version of Urticaria Control Test
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|ClinicalTrials.gov Identifier: NCT02285049|
Recruitment Status : Completed
First Posted : November 6, 2014
Last Update Posted : March 1, 2016
|Condition or disease||Intervention/treatment|
|Chronic Urticaria||Other: Urticaria Control Test|
- 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.
- 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
|Study Type :||Observational|
|Actual Enrollment :||169 participants|
|Official Title:||Cross-Cultural of the Validity, Reliability and Interpretability of Thai-version of Urticaria Control Test (UCT)|
|Study Start Date :||November 2014|
|Actual Primary Completion Date :||February 2015|
|Actual Study Completion Date :||January 2016|
Urticaria Control Test
Other: Urticaria Control Test
- Convergent validity of Thai version of Urticaria Control Test [ Time Frame: 4 week ]Compare the relationship among Urticaria Activity Score (UAS28), Patient's global assessment of disease severity (PatGA-LS), Physician's global assessment of disease control (PhyGA-LS), Dermatology Life Quality Index (DLQI) and Thai-version UCT.
- Reliability of Thai version of Urticaria Control Test [ Time Frame: 4 week ]
- Investigate the internal consistency of Thai-version of UCT by using Cronbach's alpha coefficient.
- Investigate the intraclass correlation coefficient of Thai-version of UCTscores in the patients who had no clinical change and obtained stable scores between 1st and 2nd visits.
- Interpretability of Thai version of Urticaria Control Test [ Time Frame: 4 week ]- Investigate the Thai-version of UCT cut-off scores between mild, moderate and severe levels of urticaria control
- Screening accuracy (Responsiveness to Change) of Thai version of Urticaria Control Test [ Time Frame: 4 week ]Investigate the correlation between UAS28 changes and Thai-version of UCT changes between the 1st and 2nd visits.
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02285049
|Siriraj Hospital Mahidol University|
|Bangkok, Thailand, 10700|
|Principal Investigator:||Kanokwalai Kulthanan, MD||Mahidol University|