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Completed

NCT Number: NCT03365713

GECo: 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.

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Key information

Conditions

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

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Institute of Medicine, Kathmandu, Nepal

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About this study

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.

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Sensitivity, Specificity and Positive Predictive Value of Simple Case Finding tools

    Time frame: 12 months

    Sensitivity, Specificity and Positive Predictive Value of the case-finding questionnaires with and without peak-expiratory flow (PEF), compared to spirometry.

Secondary outcomes

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

    Time frame: 12 months

    Total number of participants successfully recruited into the study against the target figure determined by the power calculations.

  2. Fidelity - Spirometry Quality Control Failures

    Time frame: 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.

  3. Fidelity - Proportion of Questionnaires with Missing Data Fields

    Time frame: 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.

  4. Health Economics

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University College, London

Other

Collaborators

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

Registry information

Official study title

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

Acronym: GECo1

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Dec 7, 2017
Registry last updated
Jun 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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