NCT05362097

Brief 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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 15, 2022

Completed
20 days until next milestone

First Posted

Study publicly available on registry

May 5, 2022

Completed
10 months until next milestone

Study Start

First participant enrolled

March 5, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2024

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 5, 2026

Completed
Last Updated

March 2, 2023

Status Verified

March 1, 2023

Enrollment Period

1.8 years

First QC Date

April 15, 2022

Last Update Submit

March 1, 2023

Conditions

Keywords

reliability validity Cc-QOL

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (1)

  • Sensitivity

    At first visit, before medication, 2 weeks and 6 weeks after treatment initiation

Interventions

Cc-qol, LCQ, and VCD were repeated 1-2 times before and 1-13 weeks after treatment.

Eligibility Criteria

Age7 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-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)".

You may qualify if:

  • Age 7-14;
  • Disease duration \> 4 weeks;
  • Spontaneous cough as the main or only clinical symptom。

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guangzhou institute of respiratory disease

Guangzhou, Guangdong, 510120, China

RECRUITING

MeSH Terms

Conditions

Chronic Cough

Condition Hierarchy (Ancestors)

CoughRespiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

lihong Sun, doctor

CONTACT

yulian Yang, master

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 15, 2022

First Posted

May 5, 2022

Study Start

March 5, 2023

Primary Completion

December 30, 2024

Study Completion

May 5, 2026

Last Updated

March 2, 2023

Record last verified: 2023-03

Locations