We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02285049
First Posted: November 6, 2014
Last Update Posted: March 1, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Charite University, Berlin, Germany
Information provided by (Responsible Party):
Mahidol University
  Purpose
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.

Condition Intervention
Chronic Urticaria Other: Urticaria Control Test

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Cross-Cultural of the Validity, Reliability and Interpretability of Thai-version of Urticaria Control Test (UCT)

Resource links provided by NLM:


Further study details as provided by Mahidol University:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.


Enrollment: 169
Study Start Date: November 2014
Study Completion Date: January 2016
Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients who were diagnosed as chronic urticaria
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02285049


Locations
Thailand
Siriraj Hospital Mahidol University
Bangkok, Thailand, 10700
Sponsors and Collaborators
Mahidol University
Charite University, Berlin, Germany
Investigators
Principal Investigator: Kanokwalai Kulthanan, MD Mahidol University
  More Information

Responsible Party: Mahidol University
ClinicalTrials.gov Identifier: NCT02285049     History of Changes
Other Study ID Numbers: Urticaria Control Test
First Submitted: October 17, 2014
First Posted: November 6, 2014
Last Update Posted: March 1, 2016
Last Verified: February 2016

Keywords provided by Mahidol University:
Chronic urticaria
Urticaria Control Test

Additional relevant MeSH terms:
Urticaria
Skin Diseases, Vascular
Skin Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases