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

NCT02285023 | Completed Results

• 1 other identifier: Thai-version of CU-Q2oL
• Study Type: observational
• Target: 166
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Urticaria

Keywords

Chronic urticaria; CU-Q2oL

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

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

  baseline

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

  baseline and 2 weeks

• Area Under the Curve for Thai CUQ2oL Scores in the Responder Group

  baseline and 2 weeks

Study Arms (1)

CU-Q2oL

* Evaluation by the Urticaria Activity Score (UAS7) * Fill the DLQI and CU-Q2oL questionnaire

Other: CU-Q2oL

Interventions

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.

CU-Q2oL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients who were diagnosed as chronic urticaria.

You may qualify if:

• 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

You may not qualify if:

• Have other active skin diseases
• Have a psychiatric problem
• Cannot understand the questionnaire by themselves.

Sponsors & Collaborators

• Mahidol University: lead
• University of Genua, Italy: collaborator

Study Sites (1)

Siriraj Hospital, Mahidol University

Bangkok, 10700, Thailand

Location

MeSH Terms

Conditions

Chronic Urticaria

Condition Hierarchy (Ancestors)

Urticaria; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Prof. Kanokvalai Kulthanan
• Organization: Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University

kanokvalai.kul@mahidol.ac.th

(662)419-4333

Study Officials

• Kanokwalai Kulthanan, MD

  Mahidol University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2014
• First Posted: November 6, 2014
• Study Start: November 1, 2014
• Primary Completion: February 1, 2015
• Study Completion: October 1, 2015
• Last Updated: February 8, 2019
• Results First Posted: February 8, 2019

Record last verified: 2018-09

Locations

TH (1)