GECo: Implementation and Effectiveness of COPD Case-Finding in Low and Middle Income Countries (GECo1)

Global Excellence in COPD Outcomes: Implementation and Effectiveness of COPD Case-Finding in Low and Middle Income Countries

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.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease

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 Type: Observational
• Enrollment (Actual): 10709

Contacts and Locations

• Study Contact: Name: John Hurst, PhD FRCP; Phone Number: +442074726260; Email: j.hurst@ucl.ac.uk
• Study Contact Backup: Name: William Checkley; Email: wcheckl1@jhmi.edu

Study Locations

• Nepal
  • Kathmandu, Nepal
    • Institute of Medicine
• Peru
  • Lima, Peru
    • Universidad Peruana Cayetano Heredia
• Uganda
  • Makerere, Uganda
    • Makerere University Lung Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fidelity - Proportion of Questionnaires with Missing Data Fields	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.	12 months
Health Economics	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.	12 months
Process Evaluation - Actual number of participants recruited against target.	Total number of participants successfully recruited into the study against the target figure determined by the power calculations.	12 months
Fidelity - Spirometry Quality Control Failures	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.	12 months

Collaborators and Investigators

• Sponsor: University College, London
• Collaborators: Johns Hopkins University; Makerere University; Universidad Peruana Cayetano Heredia; University of York; Tribhuvan University Teaching Hospital, Institute Of Medicine.; Asociacion Benefica Prisma
• Investigators: Principal Investigator: John Hurst, PhD FRCP, University College, London

Publications and helpful links

General Publications

• Siddharthan T, Pollard SL, Quaderi SA, Mirelman AJ, Cardenas MK, Kirenga B, Rykiel NA, Miranda JJ, Shrestha L, Chandyo RK, Cattamanchi A, Michie S, Barber J, Checkley W, Hurst JR; GECo Study Investigators. Effectiveness-implementation of COPD case finding and self-management action plans in low- and middle-income countries: global excellence in COPD outcomes (GECo) study protocol. Trials. 2018 Oct 19;19(1):571. doi: 10.1186/s13063-018-2909-8.
• Robertson NM, Siddharthan T, Pollard SL, Alupo P, Flores-Flores O, Rykiel NA, Romani ED, Ascencio-Dias I, Kirenga B, Checkley W, Hurst JR, Quaderi S; GECo Investigators. Development and Validity Assessment of a Chronic Obstructive Pulmonary Disease Knowledge Questionnaire in Low- and Middle-Income Countries. Ann Am Thorac Soc. 2021 Aug;18(8):1298-1305. doi: 10.1513/AnnalsATS.202007-884OC.

Helpful Links

• Trial Twitter account - @COPDGECo
• The Johns Hopkins Center for Global NCD Research and Training
• Primary publication

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2018
• Primary Completion (Actual): March 9, 2020
• Study Completion (Actual): March 9, 2020

Study Registration Dates

• First Submitted: November 17, 2017
• First Submitted That Met QC Criteria: December 1, 2017
• First Posted (Actual): December 7, 2017

Study Record Updates

• Last Update Posted (Estimated): June 16, 2023
• Last Update Submitted That Met QC Criteria: June 14, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: COPD; LMIC; Spirometry; PEF; COPD Diagnosis; Case Finding
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Chronic Disease; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: 16/0630_CF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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