Clinical trial NCT03365713: GECo: Implementation and Effectiveness of COPD Case-Finding in Low and Middle Income Countries
Official title: Global Excellence in COPD Outcomes: Implementation and Effectiveness of COPD Case-Finding in Low and Middle Income Countries
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
Spirometry
COPD Diagnosis
PEF
Case Finding
LMIC
Lead sponsor: University College, London
Sponsor class: OTHER
Collaborators: name: Johns Hopkins University
name: Universidad Peruana Cayetano Heredia
name: Asociacion Benefica Prisma
name: Makerere University
name: University of York
name: Tribhuvan University Teaching Hospital, Institute Of Medicine.
First posted: 2017-12-07
Enrollment: 10709
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Sensitivity, Specificity and Positive Predictive Value of Simple Case Finding tools
timeFrame: 12 months
Secondary outcomes:
measure: Process Evaluation - Actual number of participants recruited against target.
timeFrame: 12 months
measure: Fidelity - Spirometry Quality Control Failures
timeFrame: 12 months
measure: Fidelity - Proportion of Questionnaires with Missing Data Fields
timeFrame: 12 months
measure: Health Economics
timeFrame: 12 months
Other outcomes:
Locations:
city: Kathmandu
country: Nepal
facility: Institute of Medicine
city: Lima
country: Peru
facility: Universidad Peruana Cayetano Heredia
city: Makerere
country: Uganda
facility: Makerere University Lung Institute
Study officials:
affiliation: University College, London
name: John Hurst, PhD FRCP
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.