Accurate Recognition of Exacerbation of Chronic Obstructive Pulmonary Disease (COPD)

It has been observed that COPD exacerbations are under-reported in China. One of the reasons for this is Chinese subjects with COPD cannot describe the symptoms of exacerbation mentioned in English. Hence this study aims to create a tool called CERT that will help Chinese physicians and subjects with COPD to recognize and report exacerbations. The study will be carried out in 4 stages: item identification, cognitive briefing, item reduction and creation of final CERTs. Two CERTs will be prepared, one for subjects with COPD and another for physicians. A total of approximately 200 subjects will be included in the study and each subject will contribute to only one step.

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Key information

Conditions

Airway Obstruction Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

GSK Investigational Site, Hangzhou, Zhejiang, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Male or female of age greater than or equal to 40 years.
Spirometrically confirmed COPD according to diagnostic criteria in Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2016.
A treated exacerbation of COPD within 3 months prior to the study visit.
Willing and able to provide informed consent, and able to participate in focus groups or cognitive interviews.
Literacy is not a requirement for any of the groups.

Exclusion criteria

Current diagnosis of asthma or clinically relevant bronchiectasis. Note: Subjects with Asthma COPD Overlap Syndrome (ACOS) are eligible.
Subjects with a concurrent significant, uncontrolled, active medical condition or disease state of other organ diseases or systematic diseases; psychiatric condition; cognitive impairment or any other reasons that in the investigator's opinion, would place subjects at risk or interfere with study evaluation or affect participation in the study.

Treatment and study plan

Focus group interview

Other

Focus group interviews will take place to discuss the key domains of COPD exacerbation which then will be used in the formation of the draft item set.

Draft item set

Other

Items that form the draft item set will be subject to cognitive debriefing. Questions in the draft item set will collect information on whether the subjects with COPD have experienced that item during an exacerbation. Changes in this draft set will result in the formation of candidate item set.

Candidate item set

Other

Item reduction will be done using candidate item set and the subjects will be asked to respond to the candidate items on a 4-point scale in terms of how that item changed with the onset of the last episode. Item reduction will take into account frequency and magnitude of items, floor and ceiling items and consistency between regions. The candidate item set will then be used for generation of CERT.

Primary outcomes

COPD symptom item set to identify common phrases of COPD exacerbation

Time frame: Day 1

The most frequently used items to describe the symptomatic characteristics of the onset of an exacerbation will be identified from COPD symptom item set.
Preparation of COPD Exacerbation Recognition tool (CERT)

Time frame: Day 1

Two simple educational hand-outs called CERT will be prepared, one for the subjects with COPD and the other for the physicians which will help Chinese physicians and subjects in recognizing and reporting COPD exacerbations.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

Generation and Cognitive Testing of Informative and Suitable Items for a COPD Exacerbation Recognition Tool (CERT) for Detection of Exacerbations of COPD in Chinese Patients

Important dates

Study start: 2018
Primary completion: 2020
Study completion: 2020
First posted: May 31, 2017
Registry last updated: Aug 3, 2020

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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Completed