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Chronic respiratory diseases (CRDs), such as asthma and chronic obstructive pulmonary disease (COPD), are among the leading non-communicable diseases (NCDs) worldwide. However, diagnosing CRDs in low-income and middle-income countries (LMICs) remains challenging due to limited access to spirometry and trained professionals. Aggravating the burden, CRDs often coexist with other NCDs, increasing healthcare costs, reducing quality of life and elevating mortality. These challenges highlight the need for simple case-finding approaches for CRDs, such as the COPD in Low-Income and Middle-Income Countries Assessment (COLA-6) questionnaire, to support prompt identification and appropriate care within NCD services in LMICs.
To evaluate the discriminative accuracy, feasibility and implementation of the COLA-6 questionnaire in identifying and managing CRDs in Brazilian Primary Healthcare (PHC) services for NCDs.
The Multimorbidity Approach for REspiratory Solutions (MARES) study consists of three work packages to be conducted in PHC services in São Carlos/SP and São Paulo/SP, Brazil.
MARES-1: A cross-sectional observational study enrolling 859 individuals with at least one NCD receiving care in PHC. The COLA-6 questionnaire will be administered by the research team and compared with quality-assured spirometry. The Chronic Airways Assessment Test (CAAT), Asthma Control Questionnaire (ACQ-7) and fractional exhaled nitric oxide (FeNO) will also be assessed. The diagnostic performance of COLA-6 for identifying CRDs—including COPD, asthma, preserved ratio impaired spirometry, restriction and overlaps—will be assessed using area under receiver operating characteristic curves and 95% CIs.
MARES-2: A cross-sectional observational study enrolling 20 healthcare professionals (physicians, physiotherapists, community health agents and nurses) from five PHC services. These professionals will apply the COLA-6 during routine NCD care to a total sample of 1000 patients. Qualitative interviews will be conducted to explore barriers and facilitators to the implementation of COLA-6, using deductive thematic analysis.
MARES-3: A longitudinal, prospective observational study in which patients from MARES-1 and MARES-2 will be reassessed at 6-month follow-up. A total sample of 473 participants with abnormal spirometry, a diagnosis of CRD or high risk for CRDs is expected. Participants will undergo spirometry, and a subset will be interviewed to explore their healthcare experiences through qualitative thematic analysis. Access to diagnostic and treatment services in Brazil will be assessed. Changes in spirometry values, FeNO, CAAT and ACQ-7 scores from baseline to 6 months in patients from MARES-1 will be analysed.
This study has been approved by the Ethics Committees of Federal University of São Carlos and University of Santo Amaro (UNISA). Ethical approval was also granted by the University College London. Results will be disseminated through peer-reviewed medical journals and presentations at international conferences. Results will improve identification of CRDs, addressing a significant gap in current PHC settings.
Patients living with chronic obstructive pulmonary disease (COPD) experience periods of disease stability and exacerbations (ECOPD). COPD imposes a negative and impactful extrapulmonary impairment and commonly overlaps with multimorbidity, particularly cardiovascular disease. Pulmonary rehabilitation (PR) aims to improve physical activity (PA) and quality of life, while behavioural change interventions (BCIs) aim to promote lifestyle changes and autonomy. However, after ECOPD, a variety of barriers often delay patient referral to PR. This study aims to assess the effects of a BCI for patients after ECOPD, focusing on cardiovascular health, PA and functionality. Additionally, the study will assess 6-month sustainability of PA and conduct a cost-utility analysis comparing a non-intervention group in the Unified Health System.
This randomised clinical trial will assess patients with ECOPD over 12 weeks using a BCI based on self-determination theory to increase daily steps. First, the cardiovascular and functional profile will be evaluated. Afterwards, the patients will receive an accelerometer to monitor the PA level. After 7 days, questionnaires will be applied on quality of life, symptoms and motivational levels for PA. Patients will be randomised into control group or intervention groups, both will receive educational booklets and IG will also receive an educational interview. PA will be tracked using activPAL accelerometer at weeks 1, 4 and 12, and follow-up at 6 months. Data analysis will include unpaired Student’s t-test or Mann-Whitney test for group comparison, and a linear mixed model to assess intervention effects over time. Economic evaluation, using STATA (V.14), will involve correlation analysis, and p
This study has been approved by the Federal University of São Carlos’ Ethics Committee, Irmandade Santa Casa de Misericórdia de São Carlos and Base Hospital of São José do Rio Preto. All procedures will be conducted in accordance with the Declaration of Helsinki, Good Clinical Practice guidelines and applicable regulatory requirements. All results will be presented in peer-reviewed medical journals and international conferences.
Brazilian Registry of Clinical Trials under the registration number RBR-6m9pwb7.
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