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

NCT ID: NCT02285023

Last Updated: 2019-02-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 166 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2015-10-31

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.

Detailed Description

1. 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.

2. 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.

Conditions

Chronic Urticaria

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

CU-Q2oL

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

CU-Q2oL

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Uniuversity of Genua, Italy

OTHER

Sponsor Role: collaborator

Mahidol University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kanokwalai Kulthanan, MD

Role: PRINCIPAL_INVESTIGATOR

Mahidol University

Locations

Siriraj Hospital, Mahidol University

Bangkok, , Thailand

Countries

Thailand

Other Identifiers

Thai-version of CU-Q2oL

Identifier Type: -

Identifier Source: org_study_id