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

Completed

• Conditions: Chronic Urticaria
• Interventions: Other: Urticaria Control Test

• Registration Number: NCT02285049
• Lead Sponsor: Mahidol University

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

Study Timeline

• Study First Submitted: 2014-10-17
• Study Start: 2014-11
• Study First Submitted QC: 2014-11-04
• Study First Posted: 2014-11-06
• Primary Completion: 2015-02
• Study Completion: 2016-01
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-28
• Last Update Posted: 2016-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 169

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Urticaria Control Test	Urticaria Control Test	* Evaluation by UAS28, PatGA-LS, PhyGA-LS * Fill the UCT and DLQI questionnaire

Primary Outcome Measures

Name	Time	Method
Convergent validity of Thai version of Urticaria Control Test	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.

Secondary Outcome Measures

Name	Time	Method
Interpretability of Thai version of Urticaria Control Test	4 week	- Investigate the Thai-version of UCT cut-off scores between mild, moderate and severe levels of urticaria control
Reliability of Thai version of Urticaria Control Test	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.
Screening accuracy (Responsiveness to Change) of Thai version of Urticaria Control Test	4 week	Investigate the correlation between UAS28 changes and Thai-version of UCT changes between the 1st and 2nd visits.

Trial Locations

Locations (1)

Siriraj Hospital Mahidol University; 🇹🇭 Bangkok, Thailand