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

NCT03365713 | Completed DMC

• 1 other identifier: 16/0630_CF
• Study Type: observational
• Target: 10,709
• Locations: 3 countries
• Sites: 3

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD; Spirometry; COPD Diagnosis; PEF; Case Finding; LMIC

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Process Evaluation - Actual number of participants recruited against target.

  12 months

• Fidelity - Spirometry Quality Control Failures

  12 months

• Fidelity - Proportion of Questionnaires with Missing Data Fields

  12 months

• Health Economics

  12 months

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University College, London: lead
• Johns Hopkins University: collaborator
• Universidad Peruana Cayetano Heredia: collaborator
• Asociacion Benefica Prisma: collaborator
• Makerere University: collaborator
• University of York: collaborator
• Tribhuvan University Teaching Hospital, Institute Of Medicine.: collaborator

Study Sites (3)

Institute of Medicine

Kathmandu, Nepal

Location

Universidad Peruana Cayetano Heredia

Lima, Peru

Location

Makerere University Lung Institute

Makerere, Uganda

Location

Related Publications (2)

• 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.

  PMID: 33476252 DERIVED

• 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.

  PMID: 30340648 DERIVED

Related Links

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

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• John Hurst, PhD FRCP

  University College, London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2017
• First Posted: December 7, 2017
• Study Start: January 8, 2018
• Primary Completion: March 9, 2020
• Study Completion: March 9, 2020
• Last Updated: June 18, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

PE (1); UG (1); NE (1)