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临床试验/NCT07093021
NCT07093021尚未招募不适用

Feasibility of Implementing the COLA-6 Case-Finding Tool to Identify Chronic Respiratory Disease in Primary Health Care in Brazil

University College, London1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2025年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
1,000
试验地点
1
主要终点
Barriers and facilitators to implementing the COLA-6 case-finding tool.

研究概览

简要总结

The investigators aim to evaluate whether it is feasible for healthcare professionals to implement a case-finding tool to identify individuals at high risk for chronic respiratory diseases (CRDs) during routine care for non-communicable diseases (NCDs) in primary healthcare services in Brazil.

The investigators will complete a cross-sectional observational study involving 20 healthcare professionals (physicians, physiotherapists, community health agents, and nurses) from five primary healthcare services who will apply the COLA-6 tool during routine NCD care. A total sample of 1,000 patients is expected. Qualitative interviews will be conducted with healthcare professionals to explore barriers and facilitators to implementing COLA-6 in clinical practice.

详细描述

The investigators will assess the feasibility of healthcare professionals implementing the COLA-6 case-finding tool to identify individuals at high-risk of chronic respiratory diseases (CRDs) in primary health care (PHC) settings for non-communicable disease (NCD) care in Brazil. CRDs include asthma and chronic obstructive pulmonary disease (COPD). The COLA-6 ("COPD in Low- and Middle-Income Countries Assessment") is a validated and simple case-finding strategy designed to identify individuals at risk for CRDs in low- and middle-income country (LMIC) settings.

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.

The study will include two main participant groups:

(1) individuals with one or more NCDs who receive care from PHC services, and (2) healthcare professionals (HCPs) working in these settings.

HCPs will be recruited from BHUs and FHUs in São Carlos and São Paulo.

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

入选标准

  • HCP: providing care to people with NCDs in PHC settings in Brazil. PATIENTS: attending for NCD care at a PHC setting in Brazil.

排除标准

  • HCP: not received training to deliver COLA-
  • not provided informed consent
  • clinically unstable in the past month
  • current pregnancy
  • active tuberculosis or being on treatment for tuberculosis
  • cognitive impairment that would prevent understanding of the case-finding tool
  • contra-indications to lung function testing.

结局指标

主要结局

Barriers and facilitators to implementing the COLA-6 case-finding tool.

时间窗: At study completion: qualitative interviews will be completed after each HCP has completed 50 uses of COLA-6.

Barriers and facilitators to implementing the COLA-6 case-finding tool, assessed at qualitative interviews.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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