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ClinicalTrials.gov ID

NCT07134855

Lead Sponsor

University College, LondonOTHER

Overall Status

Not yet recruiting

Study Type

Observational

Enrollment

473Estimated

Last Update Posted

Aug 21, 2025Actual

Start Date

Sep 1, 2025Estimated

Primary Completion Date

Jul 31, 2027Estimated

Completion Date

Jul 31, 2028Estimated

Official Title

Evaluating Care Pathways for Chronic Respiratory Diseases in Brazil

Brief Summary

The investigators aim to investigate how individuals attending primary healthcare (PHC) services in Brazil for treatment of non-communicable diseases (NCDs), identified there as having abnormal spirometry or as being at high risk for lung health problems (such as asthma and chronic obstructive pulmonary disease-COPD, collectively referred to as chronic respiratory disease (CRDs)) using the COLA-6 questionnaire, are able to access diagnostic testing and treatment.

The investigators will re-assess people diagnosed with abnormal spirometry in the MARES1 study (NCT07050823) or identified as being at high-risk for CRDs in the MARES2 study (NCT07093021). The estimated sample size is 309 from MARES1 and 164 from MARES2 for a total sample size of 473.

Qualitative interviews will be conducted with a diverse subsample of 30 participants to explore their experience accessing CRD diagnosis and treatment, including barriers and facilitators, while all participants will undergo basic data collection and spirometry.

Detailed Description

The investigators aim to investigate how individuals attending primary healthcare (PHC) services in Brazil for treatment of non-communicable diseases (NCDs), identified there as having abnormal spirometry or as being at high risk for lung health problems (such as asthma and chronic obstructive pulmonary disease-COPD, collectively referred to as chronic respiratory disease (CRDs)) using the COLA-6 questionnaire, are able to access diagnostic testing and treatment.

The study will be carried out in PHC services, including Basic Health Units (BHUs) and Family Health Units (FHUs), located in the municipalities of São Carlos and São Paulo, both in the state of São Paulo, Brazil.

Individuals are being followed up after participation in MARES1 study (NCT07050823) and MARES2 study (NCT07093021), and had been originally recruited from PHC services, including BHUs and FHUs, located in the municipalities of São Carlos and São Paulo, Brazil. People were recruited if they were attending a PHC service for care of a NCD.

At the research visit, all participants will be asked about access to care. In addition, all participants will have application of the CAAT questionnaire, and the ACQ-7 questionnaire for those with asthma, and all participants will have measurement of pre- and post-bronchodilator spirometry and Fraction of Exhaled Nitric Oxide (FeNO).

A semi-structured interviews will be conducted with a sample of 30 patients diagnosed with abnormal spirometry results: 10 with COPD, 10 with asthma, and 10 with PRISm or restriction. These face-to-face interviews will use open-ended questions, be audio-recorded, transcribed, and anonymized before analysis. Participants will be randomly selected to ensure diversity in gender, age, socioeconomic status, and employment background. The interview will explore how participants accessed healthcare services for diagnostic confirmation and treatment, and how this process affected their health status. Topics will include barriers and facilitators, how doubts were clarified, the type of education they received regarding the disease, diagnosis, and treatment, and whether any changes occurred in their lifestyle or routine following diagnosis or treatment.

The qualitative analysis of the interviews will follow Braun and Clarke, which consists of six phases: 1) Familiarization with the data set; 2) Coding; 3) Generation of initial themes; 4) Development and review of themes; 5) Refinement, definition and naming of themes; and 6) Writing. Descriptive statistics will be used to describe responses to questionnaires and lung function testing, including changes from the values recorded at recruitment to MARES1 and MARES2.

• Chronic Obstructive Pulmonary Disease (COPD)
• Asthma
• Preserved Ratio Impaired Spirometry (PRISM)

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

Participated in MARES1 and MARES2, which recruited people with non-communicable diseases attending primary healthcare services in Brazil, identified as being at high-risk for, or confirmed as having chronic respiratory diseases.

Exclusion Criteria:

• No consent to take part in MARES3.

Observational Model

Case-Only

Time Perspective

Cross-Sectional

Lead Sponsor

University College, LondonOTHER

Collaborators

Universidade Federal de Sao CarlosOTHER

vivianecastello@ufscar.br(+5516) 99992 4777