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

NCT ID: NCT02285049

Last Updated: 2016-03-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 169 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2016-01-31

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

Conditions

Chronic Urticaria

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Urticaria Control Test

• Evaluation by UAS28, PatGA-LS, PhyGA-LS
• Fill the UCT and DLQI questionnaire

Urticaria Control Test

Intervention Type: OTHER

• 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.

Interventions

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Charite University, Berlin, Germany

OTHER

Sponsor Role: collaborator

Mahidol University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kanokwalai Kulthanan, MD

Role: PRINCIPAL_INVESTIGATOR

Mahidol University

Locations

Siriraj Hospital Mahidol University

Bangkok, Bangkok, Thailand

Countries

Thailand

Other Identifiers

Urticaria Control Test

Identifier Type: -

Identifier Source: org_study_id