Case-Finding for Chronic Respiratory Diseases in People Living With Other Long-Term Conditions
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 859
- 试验地点
- 1
- 主要终点
- Discriminative accuracy of the 'COLA' case-finding questionnaire for diagnosis of abnormal spirometry
研究概览
简要总结
The investigators aim to make it easier to find people with undiagnosed long-term lung health problems (such as asthma, and chronic obstructive pulmonary disease, COPD, collectively called 'Chronic Respiratory Diseases', CRDs) living in Brasil.
Because people with undiagnosed CRDs often have other medical problems too, such as heart problems, high blood pressure and diabetes (collectively called 'Long Term Conditions', LTC), the investigators will look for undiagnosed CRD in people with LTC when they are attending appointments at local health centres in the cities of Sao Carlos and Sao Paulo.
To look for undiagnosed CRDs the investigators will use two questionnaire-based methods called 'COLA' and 'SBQ'. These are quick and simple to do. All participants will also have tests of their lung function completed including spirometry and Fractional Exhaled Nitric Oxide so that the investigators can make a definite diagnosis of CRDs. When the study is complete, the investigators will examine how well the COLA and SBQ questionnaires perform in identifying people with a definite diagnosis of CRD.
In total, the investigators aim to recruit 859 people.
详细描述
This study aims to evaluate the discriminative capacity of the COLA-6 questionnaire in identifying individuals with chronic respiratory diseases (CRDs) who attend primary health care (PHC) services in Brasil, for the treatment of other long-term conditions (LTCs). To achieve this, the investigators will conduct a cross-sectional observational study enrolling 859 individuals with one or more existing LTCs who are receiving care in PHC services. The COLA-6 questionnaire will be administered, and its results will be compared to gold-standard post-bronchodilator spirometry. The performance of the case-finding tool will be assessed using the area under a receiver operating characteristic (ROC) curve.
This study will be conducted in PHC services, including Basic Health units (BHUs) and Family Health Units (FHUs), located in the municipalities of São Carlos and São Paulo, both situated in the state of São Paulo, Brasil. The municipality of São Carlos has a population of 254,857 inhabitants and a gross domestic product (GDP) of R$55,044.88 per capita, with 34 PHC units. In contrast, São Paulo, the state capital, has a population of 11,451,999 inhabitants and a per capita GDP of R$66,872.84, and is served by 471 PHC units.
Individuals will be recruited from PHC services, including BHUs and FHUs, located in the municipalities of São Carlos and São Paulo, Brasil. Eligible individuals with NCDs will be identified through three main strategies: (1) individuals attending BHUs/FHUs with an established LTC profile (e.g., scheduled consultations or monitoring for hypertension, diabetes, etc.); (2) individuals with LTCs identified by community health agents through proactive outreach; and (3) individuals with LTCs who attend PHC services and become aware of the study through passive recruitment methods such as posters, information shared by staff or other patients, and invitations extended during service days. Additionally, posters containing the research team's contact information will be displayed, and invitations will be extended during service days at the BHUs/FHUs. All recruitment procedures will be conducted in accordance with ethical principles, ensuring the protection of participants' rights to privacy and autonomy.
Data collection will be conducted in a single visit by a member of the UFSCar research team. All eligible participants will provide written Informed Consent prior study procedures. The following procedures will be carried out:
Initial assessment;
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
- •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.
排除标准
- •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 ≤
- •Contraindications to spirometry.
- •Declines to participate in the study.
结局指标
主要结局
Discriminative accuracy of the 'COLA' case-finding questionnaire for diagnosis of abnormal spirometry
时间窗: Baseline: all assessments are conducted at one visit and the discriminative accuracy of the 'COLA' case-finding questionnaire for diagnosis of abnormal spirometry will use the COLA and spirometry data from the single visit.
The investigators will report the sensitivity, specificity, positive and negative predictive value for the ability of the 'COLA' case-finding questionnaire to identify people with abnormal post-bronchodilator spirometry.
次要结局
- Discriminative accuracy of the 'SBQ' (symptom based questionnaire) case-finding questionnaire for diagnosis of overall, and specific patterns of abnormal spirometry(Baseline: all assessments are conducted at one visit and the discriminative accuracy of the 'SBQ' case-finding questionnaire for diagnosis of abnormal spirometry will use the SBQ and spirometry data from the single visit.)
- Discriminative accuracy of the 'COLA' case-finding questionnaire for diagnosis of specific patterns of abnormal spirometry(Baseline: all assessments are conducted at one visit and the discriminative accuracy of the 'COLA' case-finding questionnaire for diagnosis of asthma, COPD and PRISm will use the COLA and spirometry data from the single visit.)