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
|Condition or disease|
|Chronic Obstructive Pulmonary Disease|
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.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||10500 participants|
|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|
- 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.
- 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.
- 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.
- 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.
- 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.
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
|Contact: John Hurst, PhD FRCPemail@example.com|
|Contact: William Checkleyfirstname.lastname@example.org|
|Principal Investigator:||John Hurst, PhD FRCP||University College, London|