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

February 28, 2016 updated by: Mahidol University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

169

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10700
        • Siriraj Hospital Mahidol University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients who were diagnosed as chronic urticaria

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Urticaria Control Test
  • Evaluation by UAS28, PatGA-LS, PhyGA-LS
  • Fill the UCT and DLQI questionnaire
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4 week
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
4 week
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.
4 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Collaborators

Charite University, Berlin, Germany

Investigators

  • Principal Investigator: Kanokwalai Kulthanan, MD, Mahidol University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

October 17, 2014

First Submitted That Met QC Criteria

November 4, 2014

First Posted (Estimate)

November 6, 2014

Study Record Updates

Last Update Posted (Estimate)

March 1, 2016

Last Update Submitted That Met QC Criteria

February 28, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Urticaria Control Test

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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