Leite Ana Paula Tussi, Antunes Géssica Luana, Santos Amanda Paz, Fernandes Ingrid Rodrigues, Costa Lauren Sezerá, Camargo Tássia Rolim, Aqua Camila Bonalume Dall', Boita Fernando Rovedder, da Silva Mota Alessandra, da Silva Mariana Motta Dias, Taube Mariah Prata Soldi Passos, da Rosa Bruna Silveira, Jones Marcus Herbert, Cruz Álvaro A, Friedrich Frederico, Pitrez Paulo M
Project Office, Social Responsibility, Institutional Development Support Program for the Unified Health System (PROADI-SUS), Hospital Moinhos de Vento (HMV), Rua Ramiro Barcelos, Porto Alegre, RS, 90035-001, Brazil.
School of Medicine, University of São Paulo (USP), São Paulo, Brazil.
Trials. 2025 Aug 6;26(1):276. doi: 10.1186/s13063-025-08983-8.
Asthma is one of the most prevalent chronic pulmonary diseases, affecting approximately 20 million Brazilian people. Most patients with asthma in Brazil present with uncontrolled disease, leading to high morbidity and mortality rates. Therefore, an effective educational intervention focused on asthma management in primary health care (PHC) is expected to reduce hospitalization rates, emergency visits, and direct public health costs, improving the quality of life of patients.
The CuidAR study is a controlled and randomized superiority trial conducted at cluster level, with two arms and a 1:1 allocation ratio. A total of 40 PHC centers will be selected, covering all macro-regions of Brazil. Twenty centers will be randomized to the intervention group (healthcare professional teams will undertake an asthma management program) and the other 20 centers will be randomized to the control group (current standard of care). This study aims to enroll 960 participants aged 6 to 65, all of whom have a physician-diagnosed case of uncontrolled asthma and meet the eligibility criteria. The primary outcome is the asthma-related hospitalization rate. Data collected will be analyzed after all participants have completed a 12-month follow-up period.
Empowering the multidisciplinary healthcare team on asthma management at a national level in the PHC centers, while addressing the substantial burden of asthma in Brazil, holds the potential to reduce asthma hospitalization rates in alignment with global health priorities, ultimately reducing direct public health costs.
Brazilian Registry of Clinical Trials (ReBEC) RBR-9xtq9p6. Registered on January 16, 2023, https://ensaiosclinicos.gov.br/rg/RBR-9xtq9p6 .
哮喘是最常见的慢性肺部疾病之一，影响着约2000万巴西人。巴西大多数哮喘患者的病情未得到控制，导致高发病率和死亡率。因此，在初级卫生保健（PHC）中开展一项针对哮喘管理的有效教育干预措施，有望降低住院率、急诊就诊次数和直接公共卫生成本，提高患者的生活质量。
CuidAR研究是一项在群组层面进行的对照随机优效性试验，分为两组，分配比例为1:1。共选择40个初级卫生保健中心，覆盖巴西所有大区。20个中心将被随机分配到干预组（医疗专业团队将开展哮喘管理项目），另外20个中心将被随机分配到对照组（现行标准护理）。本研究旨在招募960名6至65岁的参与者，他们均有医生诊断的未控制哮喘病例且符合入选标准。主要结局是哮喘相关住院率。在所有参与者完成12个月的随访期后，将对收集到的数据进行分析。
在初级卫生保健中心对多学科医疗团队进行哮喘管理培训，同时应对巴西哮喘的沉重负担，有可能按照全球卫生优先事项降低哮喘住院率，最终降低直接公共卫生成本。
巴西临床试验注册中心（ReBEC）RBR-9xtq9p6。于2023年1月16日注册，https://ensaiosclinicos.gov.br/rg/RBR-9xtq9p6 。
