Chronic Urticaria Clinical Trial
— CU-Q2oLOfficial title:
Cross-Cultural of the Validity, Reliability and Interpretability of Thai-version of Chronic Urticaria Quality of Life Questionnaire (CU-Q2oL)
Verified date | September 2018 |
Source | Mahidol University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 166 |
Est. completion date | October 2015 |
Est. primary completion date | February 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Thailand | Siriraj Hospital, Mahidol University | Bangkok |
Lead Sponsor | Collaborator |
---|---|
Mahidol University | Uniuversity of Genua, Italy |
Thailand,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cross-Cultural Validity of Thai-version CU-Q2oL | 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. | 4 week | |
Secondary | Mean Total Score and Domain of Thai CU-Q2oL Scores From the Thai Version to Investigate Reliability of Thai-Version CU-Q2oL | - 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. |
baseline | |
Secondary | Change in Thai CU-Q2oL Scores From Baseline for Responders and Non-Responders | - Investigate the smallest reduction in the Thai CU-Q2oL that patients recognized as a meaningful improvement. | baseline and 2 weeks | |
Secondary | Area Under the Curve for Thai CUQ2oL Scores in the Responder Group | 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. |
baseline and 2 weeks |
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