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NCT Number: NCT02285023

The Validity, Reliability and Interpretability of Thai-version of Chronic Urticaria Quality of Life Questionnaire

In the majority of patients with the chronic urticaria, the etiology is unclear, leading to difficulties in treatment and high rates of recurrence. According to the International EAACI/GA2LEN/EDF/WAO Guidelines (the Dermatology Section of the European Academy of Allergology and Clinical Immunology(EAACI), the Global Allergy and Asthma European Network (GA2LEN), the European Dermatology Forum (EDF) and the World Allergy Organization (WAO) in Urticaria, using the Chronic Urticaria Quality of Life Questionnaire in a routine management is the key for a better treatment outcome. To translate this questionnaire into Thai is essential in our subject of interest in order to effectively apply it to local patients. The Thai-version questionnaire will encourage enhanced as well as impactful therapeutic options for Thai chronic urticaria patients.

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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

  • Adaption of the Cu-Q2oL questionnaire into Thai version by using forward-backward translation that is independently performed by two bilingual translators. The original Italian version is translated into Thai by two Thai native speakers, then the study team reviews the Thai-version Cu-Q2oL questionnaire for items comprehensibility and integrates the first consensus version which re-translated into Italian by an Italian native speaker afterwards. The comparison between the backward Italian version Cu-Q2oL questionnaire and the original Cu-Q2oL is carried out to find out whether there are any misconception and mistranslation in the intermediary forward version of questionnaire. After that, the second consensus version will be tested on 15 chronic urticaria patients to detect any misunderstanding points based on patients' comments. Finally, this Thai-version of CU-Q2oL 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 Chronic Urticaria Quality of Life Questionaire (CU-Q2oL), the severity of chronic urticaria symptoms will be assessed by investigators and patients using the Urticaria Activity Score (UAS7), the DLQI and CU-Q2oL 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
  • 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

CU-Q2oL

Other

The patients will be explained how to complete the Urticaria Activity Score (UAS7) form for evaluating their severity of chronic urticaria symptoms at home.

At the 2nd visit, collect the 1st UAS7 assessment. Assessment the severity of chronic urticaria symptoms. The patients fill the 1st DLQI and CU-Q2oL questionnaire and get the 2nd UAS7 form and two-week appointment to follow up.

At the 3th visit, collect the 2nd UAS7 assessment. Assessment the severity of chronic urticaria symptoms. The patients fill the 2nd DLQI and CU-Q2oL questionnaire.

Primary outcomes

  1. Cross-Cultural Validity of Thai-version CU-Q2oL

    Time frame: 4 week

    Cross-cultural validity is the degree to which the performance of the Thai CU-Q2oL items can adequately reflect the performance of the original CU-Q2oL items. Exploratory factor analysis was used to determine scales with proper item division of the Thai CU-Q2oL. Principal component analysis with varimax rotation was employed. An eigenvalue ≥ 1 was chosen as the criterion to retain domains. Each item was classified into the domain when loading with a domain loading ≥ 0.5.

Secondary outcomes

  1. Mean Total Score and Domain of Thai CU-Q2oL Scores From the Thai Version to Investigate Reliability of Thai-Version CU-Q2oL

    Time frame: baseline

    • The CU-Q2oL Questionnaire is a 23-item HRQoL questionnaire. It measures three dimensions (scales) of HRQoL: domain I (sleep, leisure, concentration), domain II (symptom, eating limits), and domain III (mental status, looks, impact on life activities) The scores of domain I of CUQ2oL range between 0 and 26. The scores of domain II of CUQ2oL range between 0 and 39.The scores of domain III of CUQ2oL between 0 and 35.

    The minimum possible score is 0 and the maximum possible score is 100 for total scale.

    -The DLQI scores range from 0-30. Domain I (leisure), Domain II (symptoms and feeling), and Domain III (daily activities, work, school, and personal relationships). Meaning of DLQI Scores: 0-1 = no effect, 2-5 = small effect, 6-10 = moderate effect, 11-20 = very large effect, 21-30 = extremely large effect.

    The higher the score, the more quality of life is impaired for both the CUQ2oL and the DLQI.

  2. Change in Thai CU-Q2oL Scores From Baseline for Responders and Non-Responders

    Time frame: baseline and 2 weeks

    • Investigate the smallest reduction in the Thai CU-Q2oL that patients recognized as a meaningful improvement.

  3. Area Under the Curve for Thai CUQ2oL Scores in the Responder Group

    Time frame: baseline and 2 weeks

    The receiver operating characteristic (ROC) analysis and area under the curve (AUC) are acceptable as the units of measure for assess the ability of a questionnaire to changes in patients' health-related quality of life (HRQoL) impairment over time that represents to responsiveness to change and minimal clinical important difference (MCID).

    The AUC of the ROC analysis of 1, 0.9, 0.8, 0.7 and 0.5 were considered perfect, excellent, good, fair, and no better than chance, respectively.

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Collaborators

  • University of Genua, Italy

Registry information

Official study title

Cross-Cultural of the Validity, Reliability and Interpretability of Thai-version of Chronic Urticaria Quality of Life Questionnaire (CU-Q2oL)

Acronym: CU-Q2oL

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Nov 6, 2014
Registry last updated
Feb 8, 2019

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.

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