NCT03170999

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 199 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.
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.
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.

Timeline

• Start date: 2018-01-29
• Primary completion: 2020-05-29
• Completion: 2020-05-29
• First posted: 2017-05-31
• Last updated: 2020-08-03

Locations

3 sites across 1 country: China