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基于社区的干预措施预防和管理尼泊尔慢性阻塞性肺疾病(COBIN-P 试验):一项整群随机对照试验的研究方案。

Community-based intervention for prevention and management of chronic obstructive pulmonary disease in Nepal (COBIN-P trial): study protocol for a cluster-randomized controlled trial.

机构信息

Department of Public Health, Section for Global Health, Aarhus University, Aarhus, Denmark.

COBIN Project, Nepal Development Society, Bharatpur, Chitwan, Nepal.

出版信息

Trials. 2021 Jul 21;22(1):474. doi: 10.1186/s13063-021-05447-7.

Abstract

BACKGROUND

Chronic obstructive pulmonary disease (COPD) is one of the leading causes of death worldwide and the commonest of non-communicable diseases (NCDs) in Nepal. Risk factors like indoor and outdoor air pollution, a high prevalence of smoking, and the lack of awareness of COPD make it a serious public health concern. However, no attempt has been made in Nepal to estimate its burden and address the disease at the community level.

METHOD

This study aims to evaluate the effect of a community-based health educational intervention administered by Female Community Health Volunteers (FCHVs) on the prevention and management of COPD. An open-label, two-group, community-based, cluster-randomized controlled trial will be implemented in the semi-urban area of Pokhara Metropolitan city (former Lekhnath Municipality) located in the Kaski district of Nepal. The estimated sample size of the intervention will be 1143. The unit of randomization is the ward (administrative unit) of the study area. The follow-up survey will be conducted immediately after 12 months of FCHVs-led interventions. The difference in the rate of decline of forced expiratory volume in 1 s (FEV) and FEV/FVC (forced vital capacity) ratio are the primary outcomes and the change in the proportion of modifiable risk factors of COPD, health-related quality of life scores, and change in knowledge of COPD will be secondary outcomes.

DISCUSSION

This study will estimate the burden of COPD, the magnitude of risk factors and generate evidence to mobilize community health workers for COPD prevention and management at the community level in Nepal.

TRIAL REGISTRATION

ClinicalTrials.gov NCT03797768 . Registered on January 9, 2019.

摘要

背景

慢性阻塞性肺疾病(COPD)是全球主要死因之一,也是尼泊尔最常见的非传染性疾病(NCD)之一。室内外空气污染、吸烟高发和对 COPD 缺乏认识等危险因素使其成为严重的公共卫生问题。然而,尼泊尔尚未尝试评估其负担并在社区层面解决该疾病。

方法

本研究旨在评估由女性社区卫生志愿者(FCHV)实施的基于社区的健康教育干预对 COPD 的预防和管理的效果。将在尼泊尔卡斯基地区的博克拉大都市(前莱克纳特市)半城市地区实施一项开放标签、两组、基于社区、整群随机对照试验。干预组的估计样本量为 1143 人。随机单位为研究区域的 wards(行政单位)。在 FCHV 主导干预 12 个月后立即进行随访调查。1 秒用力呼气量(FEV)和 FEV/FVC(用力肺活量)比值下降率的差异是主要结局,COPD 可改变的危险因素比例、健康相关生活质量评分的变化和 COPD 知识的变化将是次要结局。

讨论

本研究将评估 COPD 的负担、危险因素的严重程度,并为动员社区卫生工作者在尼泊尔社区一级预防和管理 COPD 提供证据。

试验注册

ClinicalTrials.gov NCT03797768. 于 2019 年 1 月 9 日注册。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7e0f/8293490/68e41510d6a1/13063_2021_5447_Fig1_HTML.jpg

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