Evaluating Care Pathways for Chronic Respiratory Diseases in Brazil
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 473
- 试验地点
- 1
- 主要终点
- Barriers and facilitators to accessing care for those with newly diagnosed / suspected chronic respiratory disease in primary healthcare services in Brazil.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •No consent to take part in MARES3.
结局指标
主要结局
Barriers and facilitators to accessing care for those with newly diagnosed / suspected chronic respiratory disease in primary healthcare services in Brazil.
时间窗: A single assessment visit conducted six months following diagnosis (participants from MARES1) / identification of being at high risk for chronic respiratory disease (participants from MARES2).
Barriers and facilitators to accessing care for those with newly diagnosed / suspected chronic respiratory disease in primary healthcare services in Brazil, assessed at qualitative interviews.
次要结局
- Spirometry(A single assessment visit conducted six months following diagnosis (participants from MARES1) / identification of being at high risk for chronic respiratory disease (participants from MARES2).)
- Disease Control Questionnaire(A single assessment visit conducted six months following diagnosis (participants from MARES1) / identification of being at high risk for chronic respiratory disease (participants from MARES2).)
- FeNO(A single assessment visit conducted six months following diagnosis (participants from MARES1) / identification of being at high risk for chronic respiratory disease (participants from MARES2).)