An observational study in Chronic Urticaria, sponsored by Mahidol University. Completed at 1 site in Thailand. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-02-08.
Sponsored by Mahidol University · 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.
237 studies on the registry are indexed under Urticaria; 26 are open to participants now.
This study's enrollment of 166 is close to the median of 162 across 52 observational studies indexed under Urticaria.
Browse Urticaria studies →Mahidol University is the lead sponsor of 730 studies on the registry; 118 are open to participants now.
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All patients who were diagnosed as chronic urticaria.
Exclusion Criteria:
* Evaluation by the Urticaria Activity Score (UAS7) * Fill the DLQI and CU-Q2oL questionnaire
Other: CU-Q2oL
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.
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.
Time frame: 4 week
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.
Time frame: baseline
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.
Time frame: baseline and 2 weeks
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.
Time frame: baseline and 2 weeks
Patients diagnosed as chronic idiopathic urticaria were invited to participate in the study at the Allergy clinic in the Department of Dermatology, Siriraj Hospital, Mahidol University, Bangkok, Thailand.
| Milestone | CU-Q2oL |
|---|---|
| Started | 166 |
| Completed | 166 |
| Not completed | 0 |
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.
| Percentage | Extraction Sums of Square Loading (% of Variance) | Rotation Sums of Squared Loading (% of Variance) |
|---|---|---|
| Domain I (item 7,8,11-14 of CUQoL) | 43.71 | 22.11 |
| Domain II( Item 1-6, 9-10, 17 of CUQoL) | 9.41 | 20.21 |
| Domain III (Item 15-16, 18-23 of CUQoL) | 7.33 | 18.13 |
- 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.
| units on a scale | Mean Score of Thai CUQ2oL at Baseline | Mean Score of Thai DLQI at Baseline |
|---|---|---|
| Domain I | 23.19 ± 21.7 | 1.86 ± 1.4 |
| Domain II | 19.09 ± 16.6 | 1.79 ± 1.5 |
| Domain III | 18.37 ± 17.5 | 1.85 ± 2.5 |
- Investigate the smallest reduction in the Thai CU-Q2oL that patients recognized as a meaningful improvement.
| score | Responder (Mean) | Non-responders (Mean) |
|---|---|---|
| Change in Thai CU-Q2oL Scores From Baseline for Responders and Non-Responders | 7.3 ± 9.4 | 28.4 ± 15.3 |
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.
| probability | Area Under the Curve |
|---|---|
| Area Under the Curve for Thai CUQ2oL Scores in the Responder Group | 0.90 (0.84 to 0.97) |
Collected over 1 month. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Chronic Idiopathic Urticaria | — | 0/166 (0%) | 0/166 (0%) |
Patients diagnosed as chronic idiopathic urticarial were enrolled.
| Age, Categorical(Participants) | Chronic Idiopathic Urticaria Patients |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 166 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | Chronic Idiopathic Urticaria Patients |
|---|---|
| Female | 131 |
| Male | 35 |
| Region of Enrollment(participants) | Chronic Idiopathic Urticaria Patients |
|---|---|
| Thailand | 166 |
| Urticaria Activity Score(units on a scale) | Chronic Idiopathic Urticaria Patients |
|---|---|
| Mean | 8.8 ± 9.6 |
| Dermatology Life Quality Index(Score) | Chronic Idiopathic Urticaria Patients |
|---|---|
| Mean | 4.67 ± 5.3 |
| CU-Q2OL(units on a scale) | Chronic Idiopathic Urticaria Patients |
|---|---|
| Mean | 19.91 ± 15.9 |
| Education(participants) | Chronic Idiopathic Urticaria Patients |
|---|---|
| Number | 166 |
Plan to share: Undecided
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Mahidol University