Objectives: Chronic obstructive pulmonary disease (COPD) disproportionately affects low- and middle-income countries. Health systems are ill prepared to manage the increase in COPD cases. Methods: We performed a pilot effectiveness-implementation randomized field trial of a community health worker (CHW)-supported, 1-year self-management intervention in individuals with COPD grades B-D. The study took place in low-resource settings of Nepal, Peru, and Uganda. The primary outcome was the St. George's Respiratory Questionnaire (SGRQ) score at 1 year. We evaluated differences in moderate to severe exacerbations, all-cause hospitalizations, and the EuroQol score (EQ-5D-3 L) at 12 months. Measurements and Main Results: We randomly assigned 239 participants (119 control arm, 120 intervention arm) with grades B-D COPD to a multicomponent, CHW-supported intervention or standard of care and COPD education. Twenty-five participants (21%) died or were lost to follow-up in the control arm compared with 11 (9%) in the intervention arm. At 12 months, there was no difference in mean total SGRQ score between the intervention and control arms (34.7 vs. 34.0 points; adjusted mean difference, 1.0; 95% confidence interval, -4.2, 6.1; P = 0.71). The intervention arm had a higher proportion of hospitalizations than the control arm (10% vs. 5.2%; adjusted odds ratio, 2.2; 95% confidence interval, 0.8, 7.5; P = 0.15) at 12 months. Conclusions: A CHW-based intervention to support self-management of acute exacerbations of COPD in three resource-poor settings did not result in differences in SGRQ scores at 1 year. Fidelity was high, and intervention engagement was moderate. Although these results cannot differentiate between a failed intervention or implementation, they nonetheless suggest that we need to revisit our strategy. Clinical trial registered with www.clinicaltrials.gov (NCT03359915).

中文翻译：

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三个低收入和中等收入国家的慢性阻塞性肺疾病自我管理：一项试点随机试验。

目标：慢性阻塞性肺疾病 (COPD) 对低收入和中等收入国家造成不成比例的影响。卫生系统没有做好应对慢性阻塞性肺病病例增加的准备。方法：我们对社区卫生工作者 (CHW) 支持的 BD 级慢性阻塞性肺病患者进行了为期 1 年的自我管理干预，进行了一项试点有效性实施随机现场试验。这项研究是在尼泊尔、秘鲁和乌干达的资源匮乏地区进行的。主要结果是 1 年时的圣乔治呼吸问卷 (SGRQ) 评分。我们评估了 12 个月时中度至重度病情加重、全因住院治疗和 EuroQol 评分 (EQ-5D-3 L) 的差异。测量和主要结果：我们将 239 名 BD COPD 等级的参与者（119 名对照组，120 名干预组）随机分配到多组分、CHW 支持的干预或标准护理和 COPD 教育中。对照组有 25 名参与者 (21%) 死亡或失访，而干预组有 11 名参与者 (9%) 死亡或失访。12 个月时，干预组和对照组之间的平均 SGRQ 总分没有差异（34.7 分与 34.0 分；调整后平均差，1.0；95% 置信区间，-4.2，6.1；P = 0.71）。12 个月时，干预组的住院比例高于对照组（10% vs. 5.2%；调整优势比，2.2；95% 置信区间，0.8、7.5；P = 0.15）。结论：在三个资源匮乏的地区，基于 CHW 的干预措施支持 COPD 急性加重的自我管理，但 1 年时 SGRQ 评分并未出现差异。保真度很高，干预参与度适中。尽管这些结果无法区分失败的干预或实施，但它们仍然表明我们需要重新审视我们的策略。在 www.clinicaltrials.gov 注册的临床试验 (NCT03359915)。