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GECo: Implementation and Effectiveness of COPD Case-Finding in Low and Middle Income Countries (GECo1)

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ClinicalTrials.gov Identifier: NCT03365713
Recruitment Status : Not yet recruiting
First Posted : December 7, 2017
Last Update Posted : December 7, 2017
Sponsor:
Collaborators:
Johns Hopkins University
Universidad Peruana Cayetano Heredia
Asociación Benéfica Prisma
Makerere University
University of York
Tribhuvan University Teaching Hospital, Institute Of Medicine.
Information provided by (Responsible Party):
University College, London

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.

Condition or disease
Chronic Obstructive Pulmonary Disease

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.


Study Type : Observational [Patient Registry]
Estimated Enrollment : 10500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: Global Excellence in COPD Outcomes: Implementation and Effectiveness of COPD Case-Finding in Low and Middle Income Countries
Estimated Study Start Date : December 2017
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : February 2020



Primary Outcome Measures :
  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 PEF, compared to spirometry.


Secondary Outcome Measures :
  1. Process Evaluation - Actual number of participants recruited against target. [ Time Frame: 12 months ]
    To evaluate process, the investigators will report the 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. Spriometry delivery - Only tests which meet both acceptability and repeatability criteria as per ERS/ATS 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.




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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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).
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03365713


Contacts
Contact: John Hurst, PhD FRCP +442074726260 j.hurst@ucl.ac.uk
Contact: William Checkley wcheckl1@jhmi.edu

Sponsors and Collaborators
University College, London
Johns Hopkins University
Universidad Peruana Cayetano Heredia
Asociación Benéfica Prisma
Makerere University
University of York
Tribhuvan University Teaching Hospital, Institute Of Medicine.
Investigators
Principal Investigator: John Hurst, PhD FRCP University College, London

Additional Information:
Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT03365713     History of Changes
Other Study ID Numbers: 16/0630_CF
First Posted: December 7, 2017    Key Record Dates
Last Update Posted: December 7, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University College, London:
COPD
Spirometry
COPD Diagnosis
PEF
Case Finding
LMIC

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases