Clinical trial NCT06674395: Validation of Urdu Version of Leicester Cough Questionnaire (LCQ)
Official title: Cross Cultural Validation of Urdu Version of Leicester Cough Questionnaire (LCQ)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COPD
Keywords: cough
patient reported outcome measures
pulmonary diseases
validation study
translations
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-11-05
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with Chronic Obstructive Pulmonary Diseases

Brief summary: Leicester Cough Questionnaire (LCQ) is a patient reported, 19-item tool, and it comprised physical, psychological, and social elements. The objective of the study is to cross culturally adapt LCQ in Urdu language and to find the reliability and validity in patients of COPD.

It is a three-stage study. Leicester Cough Questionnaire (LCQ) will be adapted in Urdu and will be first tested for its content validity by using content validity index (CVI).

In the second stage, the Urdu version of the Leicester Cough Questionnaire (LCQ) will be pilot run; tested for its validity and reliability. In the third stage, the Urdu version of the Leicester Cough Questionnaire (LCQ) will be tested for its validity and reliability in patients with COPD.

114 Patients with COPD will be selected according to inclusion criteria. Intra class correlation coefficient (ICC), Cronbach's alpha and factor analysis will be used to analyze the data.

Detailed description: Cough is a common symptom of asthma, COPD, and bronchiectasis, little is known about how it affects health status; therefore any negative effects may go unnoticed in these situations. Leicester Cough Questionnaire (LCQ) is a patient reported, 19-item tool, and it comprised physical, psychological, and social elements. To the extent of author's knowledge, this widely used Leicester Cough Questionnaire (LCQ) has not been translated and validated for Urdu-speaking patients with COPD.

The objective of the study is to cross culturally adapt LCQ in Urdu language using international guidelines used for translation of instrument from its source language to target language and to find the reliability, validity, sensitivity, and specificity of the Urdu version of Leicester Cough Questionnaire (LCQ) in patients of COPD. It is a three-stage study.

Leicester Cough Questionnaire (LCQ) will be adapted in Urdu and will be first tested for its content validity by using content validity index (CVI). In the second stage, the Urdu version of the Leicester Cough Questionnaire (LCQ) will be pilot run; tested for its validity and reliability. In the third stage, the Urdu version of the Leicester Cough Questionnaire (LCQ) will be tested for its validity and reliability in patients with COPD. 114 Patients with COPD will be selected according to inclusion criteria. Intra class correlation coefficient (ICC), Cronbach's alpha and factor analysis will be used to analyze the data.

Eligibility criteria: Inclusion Criteria:

* Subjects with GOLD II, III and IV Chronic Obstructive Pulmonary Diseases
* Having age18 years or more
* subjects having chronic cough (\> 8 weeks)
* Subjects understanding Urdu

Exclusion Criteria:

* A previous history of other lung disorders
* Pregnant females, subjects having Infections
* Any systemic disorder which is unstable
* Subjects who are not willing to participate
* subject with Cognitive \& speech disorders

Primary outcomes:
measure: Leicester Cough Questionnaire (LCQ)
timeFrame: At Baseline and after 1 week
measure: St. George Respiratory Questionnaire
timeFrame: At Baseline and after 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Gujranwala
country: Pakistan
facility: Gujranwala Medical College Teaching Hospital
state: Punjab
Study officials:
affiliation: Riphah International University
name: Wajeeha Zia, PhD*
role: PRINCIPAL_INVESTIGATOR
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