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

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

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.

Study Overview

• Status: Completed
• Conditions: Airway Obstruction
• Intervention / Treatment: Other: Focus group interview; Other: Draft item set; Other: Candidate item set

• Study Type: Observational
• Enrollment (Actual): 199

Contacts and Locations

Study Locations

• China
  • Chongqing, China, 400010
    • GSK Investigational Site
  • Shenyang, China
    • GSK Investigational Site
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects having COPD attending the outpatient respiratory specialist clinics of tier 3 hospitals for their disease will be included in the study.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Subjects included in Focus groups; 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.	Other: Focus group interview; 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.
Subjects included in cognitive interviews; 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.	Other: Draft item set; 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.
Subjects included in candidate item set; Approximately 150 subjects with COPD will respond to the questions in candidate item set.	Other: Candidate item set; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
COPD symptom item set to identify common phrases of COPD exacerbation	The most frequently used items to describe the symptomatic characteristics of the onset of an exacerbation will be identified from COPD symptom item set.	Day 1
Preparation of COPD Exacerbation Recognition tool (CERT)	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.	Day 1

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 29, 2018
• Primary Completion (ACTUAL): May 29, 2020
• Study Completion (ACTUAL): May 29, 2020

Study Registration Dates

• First Submitted: May 2, 2017
• First Submitted That Met QC Criteria: May 26, 2017
• First Posted (ACTUAL): May 31, 2017

Study Record Updates

• Last Update Posted (ACTUAL): August 3, 2020
• Last Update Submitted That Met QC Criteria: July 31, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: China; Cognitive testing; COPD exacerbation; CERT
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency; Airway Obstruction
• Other Study ID Numbers: 201098

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No