Skip to main content
OpenTrials
Completed

NCT Number: NCT02285049

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Urticaria Chronic Disease Disease Attributes Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases Urticaria

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Siriraj Hospital Mahidol University

Bangkok, 10700, Thailand

About this study

  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Urticaria Control Test

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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

  3. 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.

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Collaborators

  • Charite University, Berlin, Germany

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Nov 6, 2014
Registry last updated
Mar 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.