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Completed

NCT Number: NCT06674395

Validation of Urdu Version of Leicester Cough Questionnaire (LCQ)

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Gujranwala Medical College Teaching Hospital

Gujranwala, Punjab Province, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Leicester Cough Questionnaire (LCQ)

    Time frame: At Baseline and after 1 week

    LCQ is a 19-item cough measuring tool, created in 2003 by Birring et al., and it comprised physical, psychological, and social elements.

  2. St. George Respiratory Questionnaire

    Time frame: At Baseline and after 1 week

    Disease-specific instrument designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease.

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

Cross Cultural Validation of Urdu Version of Leicester Cough Questionnaire (LCQ)

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Nov 5, 2024
Registry last updated
Jan 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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