Finding undiagnosed chronic lung problems in people with other long-term health conditions in Brazil
Case-Finding for Chronic Respiratory Diseases in People Living With Other Long-Term Conditions
This project will try two short questionnaires (COLA and SBQ) plus breathing tests to find undiagnosed asthma, COPD, or similar lung problems in people with long-term conditions who attend primary care in São Carlos and São Paulo, Brazil.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 859 (estimated) |
| Ages | 30 Years and up |
| Sex | All |
| Sponsor | University College, London Academic / other |
| Locations | 2 sites (São Carlos, São Paulo and 1 other locations) |
| Trial ID | NCT07050823 on ClinicalTrials.gov |
What this trial studies
This is a cross-sectional observational study enrolling about 859 adults with one or more non-respiratory long-term conditions who attend primary health care units in São Carlos and São Paulo. Participants will complete the COLA-6 questionnaire (and SBQ) and undergo lung function testing including post-bronchodilator spirometry and fractional exhaled nitric oxide (FeNO) to establish a reference diagnosis. The investigators will compare the questionnaire results against the spirometry gold standard and report diagnostic performance using receiver operating characteristic (ROC) curves and area under the curve. Routine PHC settings (Basic Health Units and Family Health Units) are used to reflect real-world case-finding in Brazilian primary care.
Who should consider this trial
Good fit: Adults attending primary health care in São Carlos or São Paulo with one or more diagnosed non-respiratory long-term conditions (for example cardiovascular disease, diabetes, or hypertension), who are clinically stable, able to complete questionnaires and perform spirometry, and not pregnant or currently treated for active pulmonary tuberculosis.
Not a fit: People already known to have asthma or COPD, those who are clinically unstable, pregnant, currently have an acute respiratory infection or active tuberculosis, have cognitive impairment preventing questionnaire completion, or have contraindications to spirometry are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the approach could help primary care teams find more people with previously undiagnosed chronic respiratory disease so they can get appropriate treatment earlier.
How similar studies have performed: Questionnaire-based case-finding combined with spirometry has shown promise in other low-resource and primary care settings, but performance varies by population and the COLA-6 tool's accuracy in Brazilian PHC is being specifically tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Attending primary health care services in Brasil. Diagnosed with one or more existing, non-respiratory long-term conditions such as cardiovascular disease, diabetes or hypertension. Exclusion Criteria: Clinically unstable in the past month (defined as worsening symptoms requiring emergency care or hospitalization). Current pregnancy. Active pulmonary tuberculosis or undergoing treatment for pulmonary tuberculosis. Current acute respiratory infection. Cognitive impairment that prevents understanding of the case-finding questionnaire, defined as MMSE score ≤20. Contraindications to spirometry. Declines to participate in the study.
Where this trial is running
São Carlos, São Paulo and 1 other locations
- Multiple primary care sites — São Carlos, São Paulo, Brazil (Recruiting)
- Multiple primary care sites — São Paulo, São Paulo, Brazil (Not_yet_recruiting)
Study contacts
- Principal investigator: John R Hurst, PhD FRCP — University College London Hospitals
- Study coordinator: Trial Manager
- Email: vivianecastello@ufscar.br
- Phone: (+5516) 99992-4777
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.