GECo: Implementation and Effectiveness of COPD Case-Finding in Low and Middle Income Countries

Completed

• Conditions: Chronic Obstructive Pulmonary Disease

• Registration Number: NCT03365713
• Lead Sponsor: University College, London

Brief Summary

This study will test how well short questionnaires, with and without a simple breathing test called 'peak flow', can identify people with COPD compared to the gold-standard diagnostic test called spirometry. We will test this in 10,500 people from three low- and middle-income countries, namely Nepal, Peru and Uganda. We will also examine the feasibility of implementing our case-finding intervention at scale.

Detailed Description

The investigators will determine whether case-finding for COPD can be facilitated using 5-item questionnaires with and without a measurement of Peak-Flow. The investigators hypothesise that 5-item questionnaires will be a valid case-finding tool for COPD in LMIC and will be acceptable and feasible for use in these settings.

1. Clinical Aim: Determine the diagnostic accuracy of the case-finding questionnaires with and without PEF.

2. Implementation Aim: Assess the appropriateness, acceptability and feasibility of using questionnaires and PEF to identify COPD cases from the perspective of local community members, community health workers, local health centre physicians and ministries of health.

The design of the intervention will be informed by formative work prior to commencement of the main study.

Study fieldworkers will enroll and screen a randomly-selected age- and sex-stratified population sample of adults aged ≥40 years; a total of 10,500 between the following three countries in the catchment areas of existing community census areas in Bhaktapur (Nepal), Lima (Peru), and Nakaseke (Uganda).

The investigators will report the sensitivity, specificity and positive predictive value of the case-finding questionnaire, with and without PEF, in relation to a gold standard COPD diagnosis made at spirometry (post-bronchodilator FEV1/VC ratio \<LLN, with a history of significant respiratory exposure to tobacco smoke or biomass). The investigators will construct ROC curves to visualise trade-offs in sensitivity and specificity across a range of questionnaire cut off values.

The investigators will also examine the feasibility of implementing a 5 item questionnaire +/- PEF intervention at scale.

Study Timeline

• Study First Submitted: 2017-11-17
• Study First Submitted QC: 2017-12-01
• Study First Posted: 2017-12-07
• Study Start: 2018-01-08
• Primary Completion: 2020-03-09
• Study Completion: 2020-03-09
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-14
• Last Update Posted: 2023-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10709

Inclusion Criteria

• Male or female participants aged ≥40 years
• Full-time resident in the area (living in area > 6 months)
• Able to perform adequate quality spirometry
• Capable of providing informed consent

Exclusion Criteria

• Pregnancy (self-reported)
• Currently has active pulmonary TB or is taking medications for pulmonary TB

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sensitivity, Specificity and Positive Predictive Value of Simple Case Finding tools	12 months	Sensitivity, Specificity and Positive Predictive Value of the case-finding questionnaires with and without peak-expiratory flow (PEF), compared to spirometry.

Secondary Outcome Measures

Name	Time	Method
Health Economics	12 months	Health-related productivity costs measured as hours of lost work from COPD and related symptoms.; Inequalities in productivity costs according to illness severity and wealth status.
Fidelity - Spirometry Quality Control Failures	12 months	Extent to which delivery adheres to the protocol developed. Spirometry delivery - Only tests which meet both acceptability and repeatability criteria as per ERS/ATS (European Respiratory Society / American Thoracic Society) guidelines will be accepted.; Spirometry interpretation - All Spirometry preformed will be over-read locally, and a proportion (see below) will be over-read centrally. Two separate researchers, at each site, adequately trained in both spirometry delivery and interpretation will separately perform interpretation of all spriometry carried out in the field, to ensure correct interpretation in relation to a gold standard COPD diagnosis made at spirometry (post-bronchodilator FEV1/VC ratio \<LLN, with a history of significant respiratory exposure to tobacco smoke or biomass) . Of these, 10% will be over-read centrally by the principal investigators to ensure quality assurance.
Process Evaluation - Actual number of participants recruited against target.	12 months	Total number of participants successfully recruited into the study against the target figure determined by the power calculations.
Fidelity - Proportion of Questionnaires with Missing Data Fields	12 months	Extent to which delivery adheres to the protocol developed. The investigators will report the proportion of incomplete questionnaires (any questionnaires with one or more missing data fields) in total and at each individual site.

Trial Locations

Locations (3)

Makerere University Lung Institute; 🇺🇬 Makerere, Uganda

Universidad Peruana Cayetano Heredia; 🇵🇪 Lima, Peru

Institute of Medicine; 🇳🇵 Kathmandu, Nepal