Chronic CoughNCT05362097
Analysis of the Reliability and Validity of the Chinese Version of CC-QoL
An observational study of Chronic Cough, run by Guangzhou Institute of Respiratory Disease at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 7 to 14 years
- Conditions the study is for
- Chronic Cough
- What is being tested?
- The reliability and validity of the Chinese version of CC-QoL
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 5 Mar 2023to 5 May 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 14 years
- All sexes
- No healthy volunteers
- Child
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)".
Who may be able to join
- 1.Age 7-14；
- 2.Disease duration > 4 weeks；
- 3.Spontaneous cough as the main or only clinical symptom。
Who cannot join
- Chest X-ray was unremarkable, excluding cystic fibrosis, typical asthma or dyspnea, and other underlying diseases.
Trial locations and contacts
1 site in 1 country.
yulian Yang, master contact
China1 site, 1 recruiting
- Recruiting
Guangzhou institute of respiratory disease
Guangzhou, Guangdong, 510120
Lihong Sun, master, +86-13719240285, sunlihong9797@126.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Cough
- Being tested
- The reliability and validity of the Chinese version of CC-QoL
- Keywords
- reliability validity Cc-QOL
- Medical subject headings
- Chronic Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The reliability and validity of the Chinese version of CC-QoLOther
Cc-qol, LCQ, and VCD were repeated 1-2 times before and 1-13 weeks after treatment.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: At first visit, before medication, 2 weeks and 6 weeks after treatment initiation
Secondary outcomes (1)
Sensitivity
To evaluate the sensitivity of the questionnaire to measurements before and after treatment
Measured: At first visit, before medication, 2 weeks and 6 weeks after treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2022
- Study start5 Mar 2023 (estimated)
- Primary completion30 Dec 2024 (estimated)
- Study completion5 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic CoughStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou Institute of Respiratory Disease
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LI-HONG SUN, Guangzhou Institute of Respiratory Disease
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05362097
- Sponsor's protocol ID
- GuangzhouIRD-LSUN3
- Status last verified
- Mar 2023
- First submitted
- 15 Apr 2022
- Last updated
- 2 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Reliability and Validity of the Chinese Version of Child Cough-specific Quality of Life Questionnaire(CC-QoL)
- ClinicalTrials.gov ID
- NCT05362097
- Acronym / sponsor ID
- GuangzhouIRD-LSUN3
- Conditions
- Chronic Cough
- Keywords
- reliability validity Cc-QOL
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Guangzhou Institute of Respiratory DiseaseUniversity, hospital or other
- Study start
- 5 Mar 2023 (estimated)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 5 May 2026 (estimated)
- First posted
- 5 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 7 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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)".
Key inclusion criteria (3 listed)
- 1.Age 7-14；
- 2.Disease duration > 4 weeks；
- 3.Spontaneous cough as the main or only clinical symptom。
Key exclusion criteria (1 listed)
- Chest X-ray was unremarkable, excluding cystic fibrosis, typical asthma or dyspnea, and other underlying diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The reliability and validity of the Chinese version of CC-QoLCc-qol, LCQ, and VCD were repeated 1-2 times before and 1-13 weeks after treatment. | Other | – |
Primary outcome
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.
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.
1 secondary outcome
Sensitivity
Time frame: At first visit, before medication, 2 weeks and 6 weeks after treatment initiation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
yulian Yang, master contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Cough, run by Guangzhou Institute of Respiratory Disease at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact lihong Sun, doctor (02083062284, sunlihong@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validity (time frame: At first visit, before medication, 2 weeks and 6 weeks after treatment initiation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2023.