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

March 1, 2023 updated by: LI-HONG SUN, Guangzhou Institute of Respiratory Disease

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

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.

Study Overview

Detailed 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.

Study Type

Observational

Enrollment (Anticipated)

180

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: yulian Yang, master

Study Locations

    • Guangdong
      • Guangzhou, Guangdong, China, 510120
        • Recruiting
        • Guangzhou Institute of Respiratory Disease
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 14 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The childr who conforms to the definition of "Chronic cough in children in the Guidelines for the Diagnosis and Treatment of Chronic Cough in Chinese Children (Revised in 2013)".

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Validity
Time Frame: At first visit, before medication, 2 weeks and 6 weeks after treatment initiation
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
Reliability
Time Frame: At first visit, before medication, 2 weeks and 6 weeks after treatment initiation

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity
Time Frame: At first visit, before medication, 2 weeks and 6 weeks after treatment initiation
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 5, 2023

Primary Completion (Anticipated)

December 30, 2024

Study Completion (Anticipated)

May 5, 2026

Study Registration Dates

First Submitted

April 15, 2022

First Submitted That Met QC Criteria

May 1, 2022

First Posted (Actual)

May 5, 2022

Study Record Updates

Last Update Posted (Actual)

March 2, 2023

Last Update Submitted That Met QC Criteria

March 1, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • GuangzhouIRD-LSUN3

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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