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

Completed

• Conditions: Airway Obstruction
• Interventions: Other: Draft item set; Other: Focus group interview; Other: Candidate item set

• Registration Number: NCT03170999
• Lead Sponsor: GlaxoSmithKline

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-05-02
• Study First Submitted QC: 2017-05-26
• Study First Posted: 2017-05-31
• Study Start: 2018-01-29
• Primary Completion: 2020-05-29
• Study Completion: 2020-05-29
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-31
• Last Update Posted: 2020-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 199

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Subjects included in cognitive interviews	Draft item set	Approximately 9 subjects with COPD will be involved in cognitive interviews and will be asked to respond to all of the items in the draft item set.
Subjects included in Focus groups	Focus group interview	Approximately 45 subjects with COPD will participate in the focus group interviews for item identification. The group may contain subjects who are functionally illiterate and at least one third women will be recruited.
Subjects included in candidate item set	Candidate item set	Approximately 150 subjects with COPD will respond to the questions in candidate item set.

Primary Outcome Measures

Name	Time	Method
COPD symptom item set to identify common phrases of COPD exacerbation	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)	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.

Trial Locations

Locations (1)

GSK Investigational Site; 🇨🇳 Shenyang, China