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| Name | Class |
|---|---|
| University of Genua, Italy | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CU-Q2oL |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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All patients who were diagnosed as chronic urticaria.
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| Name | Affiliation | Role |
|---|---|---|
| Kanokwalai Kulthanan, MD | Mahidol University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Siriraj Hospital, Mahidol University | Bangkok | 10700 | Thailand |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | CU-Q2oL |
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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Patients diagnosed as chronic idiopathic urticarial were enrolled.
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| ID | Title | Description |
|---|---|---|
| BG000 | Chronic Idiopathic Urticaria Patients |
CU-Q2oL: The patients diagnosed as chronic idiopathic urticaria 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Number | Percentage | 4 week |
|
1 month
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Chronic Idiopathic Urticaria | Patients diagnosed as chronic idiopathic urticarial were enrolled. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Kanokvalai Kulthanan | Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University | (662)419-4333 | kanokvalai.kul@mahidol.ac.th |
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| ID | Term |
|---|---|
| D000080223 | Chronic Urticaria |
| ID | Term |
|---|---|
| D014581 | Urticaria |
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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|
| 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. | 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. | baseline and 2 weeks |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Urticaria Activity Score | The UAS is a specific questionnaire to determine the disease severity of CU patients over one week (UAS7). The UAS7 represents daily numbers of wheals (range: 0-none to 3-severe) and severity of pruritus (range: 0-none to 3-severe) for the 7 days with the maximum sum score of 42.15 The severity is classified as follows: severe (28-42), moderate (16-27), mild (7-15), well-controlled (1-6), and complete response (0). The UAS7 scores were recorded by the patient themselves seven days prior to each visit. | Mean | Standard Deviation | units on a scale |
|
| Dermatology Life Quality Index | The DLQI is an HRQoL questionnaire for general dermatologic diseases that was developed by Finlay and Khan. It comprises 10 questions corresponding to six domains: Symptoms and feeling, Daily activities, Leisure, Work and school, Personal relationships, and Treatment. The total DLQI score ranges from 0 to 30. Dr. Finlay previously gave formal permission to the first author to validate and use the Thai version of the DLQI questionnaire. The DLQI Scores of 0-1, 2-5, 6-10, 11-20, and 21-30 mean no effect, small effect, moderate effect, very large effect, extremely large effect on quality of life. | Mean | Standard Deviation | Score |
|
| CU-Q2OL | The Thai version of the CU-Q2oL questionnaire comprises 23 items categorized into three domains: domain I (sleep, leisure, concentration) domain II (symptomatic, eating limits), domain III (mental status, looks, impact on life activities). For each item, patients were asked to choose between five response values (scored 0-4) indicating the intensity of each item in the last 2 weeks. A total summed score across all items was calculated and transformed into scores ranging from 0 to 100, with a score of 100 indicating the worst HRQoL impairment. | Mean | Standard Deviation | units on a scale |
|
| Education | Participants completing at least primary school education | Number | participants |
|
The "% of variance" column tells you how much of the total variability (in all of the variables together) can be accounted for by each of these summary scales or factors. |
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| 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. | Mean score of domain I, II, III of Thai CU-Q2oL were correlated to mean score domain I, II, III of Thai DLQI, respectively | Posted | Mean | Standard Deviation | units on a scale | baseline |
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| 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. | Posted | Mean | Standard Deviation | score | baseline and 2 weeks |
|
|
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| 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. | Responder group | Posted | Mean | 95% Confidence Interval | probability | baseline and 2 weeks |
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| 0 |
| 166 |
| 0 |
| 166 |
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| D006969 |
| Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Domain III |
|