Analysis of the Reliability and Validity of the Chinese Version of CC-QoL

Chronic Cough Clinical Trial

Official title:

Analysis of the Reliability and Validity of the Chinese Version of Child Cough-specific Quality of Life Questionnaire(CC-QoL)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05362097
• Other study ID #: GuangzhouIRD-LSUN3
• Status: Recruiting
• Start date: March 5, 2023
• Est. completion date: May 5, 2026

Study information

• Verified date: March 2023
• Source: Guangzhou Institute of Respiratory Disease
• Contact: lihong Sun, doctor
• Phone: 02083062284
• Email: sunlihong[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

At present, there is no research scale designed for the quality of life of children with chronic cough in China, most of them use the cough scale designed for adults to evaluate the quality of life of children. In China, more and more attention has been paid to evaluate and improve the quality of life of children with chronic cough, but cough specific quality of life measurement tools for adults and parents are mostly used, and the Chinese translation version of CQLQ and LCQ is still the main method. There is still no cough specific quality of life measurement tool for children with chronic cough in China. Cc-qol, a specific scale for chronic cough in children, has not been promoted, and no relevant verification of the applicability, validity and reliability of the Chinese version has been found. Therefore, this study aims to verify and compare the applicability, reliability and validity of CC-QOL Chinese version in China through questionnaire survey and follow-up of children with chronic cough.

Description:

Descriptive Score: CC-QOL, CET,VAS, Peds-QOL,SCAS and Verbal category Score (VCD); descriptive score: DESCRIPTIVE score; descriptive score: DESCRIPTIVE score; descriptive score: DESCRIPTIVE score; To evaluate the reliability and validity of Cc-QOL in evaluating children's quality of life in China, Compare and analyze Leicester cough questionnaire(LCQ) and child chronic cough-specific quality of life measure Cc-qol was used to evaluate the quality of life in children with chronic cough.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: May 5, 2026
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 14 Years

Eligibility

Inclusion Criteria:

• 1.Age 7-14;

• 2.Disease duration > 4 weeks;

• 3.Spontaneous cough as the main or only clinical symptom?

Exclusion Criteria:

• Chest X-ray was unremarkable, excluding cystic fibrosis, typical asthma or dyspnea, and other underlying diseases.

Related Conditions & MeSH terms

• Chronic Cough
• Cough

Intervention

Other:
• The reliability and validity of the Chinese version of CC-QoL
Cc-qol, LCQ, and VCD were repeated 1-2 times before and 1-13 weeks after treatment.

Locations

Country	Name	City	State
China	Guangzhou institute of respiratory disease	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangzhou Institute of Respiratory Disease

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Validity	Validity mainly evaluates the accuracy, validity and correctness of the scale, that is, the deviation between the measured value and the true target value.Validity is meant to reflect whether a measuring tool can effectively measure what it is intended to measure, that is, the extent to which the actual measured results agree with the expected results.	At first visit, before medication, 2 weeks and 6 weeks after treatment initiation
Primary	Reliability	Reliability refers to the reliability, stability and consistency of the survey results, that is, accuracy.It is generally believed that reliability reflects the variation degree caused by measurement error or observation error, that is, random error.Common indicators: Common indicators: It is generally believed that Cronbach's alpha should be above 0.7. Retest reliability: the same questionnaire is used to measure the same group of respondents repeatedly at different times, and the consistency between the two results is retest reliability.	At first visit, before medication, 2 weeks and 6 weeks after treatment initiation
Secondary	Sensitivity	To evaluate the sensitivity of the questionnaire to measurements before and after treatment	At first visit, before medication, 2 weeks and 6 weeks after treatment initiation