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Chronic Obstructive Pulmonary DiseaseGECo1NCT03365713

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

An observational study of Chronic Obstructive Pulmonary Disease, run by University College, London at 3 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 40 years and olderHealthy volunteers can take part
Conditions the study is for
Chronic Obstructive Pulmonary Disease
How many people
10,709 participants
Where
3 sitesin 3 countries
Study dates
8 Jan 2018to 9 Mar 2020
How long will I take part?
12 Months
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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).

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

3 sites in 3 countries.

3 sites in 3 countries

Nepal1 site

  • Institute of Medicine

    Kathmandu

Other trials in Nepal

Peru1 site

  • Universidad Peruana Cayetano Heredia

    Lima

Other trials in Peru

Uganda1 site

  • Makerere University Lung Institute

    Makerere

Other trials in Uganda

About this study

Official title: 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.

Read the 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.

Keywords
COPD, Spirometry, COPD Diagnosis, PEF, Case Finding, LMIC
Medical subject headings
Pulmonary Disease, Chronic Obstructive

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 12 months

Secondary outcomes (4)

  1. 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.

    Measured: 12 months

  2. 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.

    Measured: 12 months

  3. 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.

    Measured: 12 months

  4. 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.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Dec 2017
  2. Study start8 Jan 2018
  3. Primary completion9 Mar 2020
  4. Study completion9 Mar 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
10,709 participants (actual)
Target duration
12 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT03365713
Sponsor's protocol ID
16/0630_CF
Acronym
GECo1
Status last verified
Jun 2023
First submitted
17 Nov 2017
Last updated
18 Jun 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 33476252

  • 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.

    PubMed 30340648

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Obstructive Pulmonary Disease, run by University College, London at 3 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Nepal, Peru, Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sensitivity, Specificity and Positive Predictive Value of Simple Case Finding tools (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03365713, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2023.

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GECo1 Clinical Trial NCT03365713 | AzTrials