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

Chronic Obstructive Pulmonary Disease Clinical Trial

— GECo1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03365713
• Other study ID #: 16/0630_CF
• Status: Completed
• Start date: January 8, 2018
• Est. completion date: March 9, 2020

Study information

• Verified date: June 2023
• Source: University College, London
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10709
• Est. completion date: March 9, 2020
• Est. primary completion date: March 9, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
Nepal	Institute of Medicine	Kathmandu
Peru	Universidad Peruana Cayetano Heredia	Lima
Uganda	Makerere University Lung Institute	Makerere

Sponsors (7)

Lead Sponsor	Collaborator
University College, London	Asociacion Benefica Prisma, Johns Hopkins University, Makerere University, Tribhuvan University Teaching Hospital, Institute Of Medicine., Universidad Peruana Cayetano Heredia, University of York

Countries where clinical trial is conducted

Nepal,  Peru,  Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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	12 months
Secondary	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
Secondary	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

External Links

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