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

NCT ID: NCT03170999

Last Updated: 2020-08-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 199 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-01-29
• Study Completion Date: 2020-05-29

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.

Conditions

Airway Obstruction

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Focus group interview

Intervention Type: 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.

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.

Draft item set

Intervention Type: 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.

Subjects included in candidate item set

Approximately 150 subjects with COPD will respond to the questions in candidate item set.

Candidate item set

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Hangzhou, Zhejiang, China

GSK Investigational Site

Chongqing, , China

GSK Investigational Site

Shenyang, , China

Countries

China

Other Identifiers

201098

Identifier Type: -

Identifier Source: org_study_id