使用非专业健康教练的慢性阻塞性肺疾病患者自我管理支持的随机试验方案。

IF 1.9 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials Pub Date : 2025-09-22 DOI:10.1016/j.cct.2025.108095

Nikita Agrawal , Meredith Case , Peter K. Lindenauer , Danielle McDermott , Keith M. Diaz , Jennifer Oscherician Utkin , Juan Wisnivesky , Alex Federman

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引用次数: 0

摘要

慢性阻塞性肺疾病（COPD）的成功管理以患者自我管理行为（SMB）为中心，如控制者药物依从性、行动计划的使用、戒烟等。慢性阻塞性肺病患者在有效的自我管理方面面临许多障碍，包括医疗合并症、认知和精神健康障碍以及社会经济因素。自我管理不善对慢性阻塞性肺病患者的不良健康结果有显著影响。然而，先前的研究表明，改善SMB的干预措施必须是多方面的，并针对个体患者的特定障碍进行定制，才能最有效。这项随机对照研究将在300名患有全球慢性阻塞性肺疾病倡议（GOLD） B级或e级的成人中测试为期6个月的自我管理支持干预，该干预被称为支持COPD成人自我管理行为（SAMBA）。它使用健康教练来识别和解决中小企业的障碍，支持以家庭为基础的肺部康复，并促进使用必要的抗生素和口服皮质类固醇来早期治疗急性COPD恶化。SAMBA将与由普通COPD教育组成的时间和注意力匹配的对照治疗进行比较。我们假设接受SAMBA的患者比对照组患者有更好的COPD药物依从性，更强的运动能力，更改善的COPD症状和生活质量，更少的住院和急诊科就诊。临床试验注册号：nct06634810。

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Protocol for a randomized trial of self-management support for people with chronic obstructive pulmonary disease using lay health coaches

Successful management of chronic obstructive pulmonary disease (COPD) centers on patient self-management behaviors (SMB) such as controller medication adherence, use of action plans, smoking cessation and more. Individuals with COPD face a number of barriers to effective self-management, including medical comorbidities, cognitive and mental health disorders, and socioeconomic factors. Poor self-management contributes significantly to poor health outcomes in patients with COPD. However, prior research has demonstrated that interventions to improve SMB must be multifaceted and tailored to individual patients' specific barriers to be most effective. This randomized control study will test a 6-month self-management support intervention in 300 adults with Global Initiative for Chronic Obstructive Lung Disease (GOLD) classifications B or E. The intervention is called Supporting self-Management Behaviors in Adults with COPD (SAMBA). It uses health coaches to identify and address barriers to SMB, support home-based pulmonary rehabilitation, and promote use of as-needed antibiotics and oral corticosteroids for early treatment of acute COPD exacerbations. SAMBA will be compared to a time and attention matched control treatment consisting of general COPD education. We hypothesize that patients receiving SAMBA will have better COPD medication adherence, greater exercise capacity, more improved COPD symptoms and quality of life, and fewer hospitalizations and ED visits than control patients.

Clinical trial registration number

NCT06634810

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来源期刊

Contemporary clinical trials 医学-药学

CiteScore

3.70

自引率

4.50%

发文量

281

审稿时长

44 days

期刊介绍： Contemporary Clinical Trials is an international peer reviewed journal that publishes manuscripts pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from disciplines including medicine, biostatistics, epidemiology, computer science, management science, behavioural science, pharmaceutical science, and bioethics. Full-length papers and short communications not exceeding 1,500 words, as well as systemic reviews of clinical trials and methodologies will be published. Perspectives/commentaries on current issues and the impact of clinical trials on the practice of medicine and health policy are also welcome.