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

Tara Ballav Adhikari,Marieann Högman,Per Kallestrup,Arjun Karki,Torben Sigsgaard,Arne Drews,Brendan Cooper,Dinesh Neupane

doi:10.1186/s13063-021-05447-7

Abstract

BackgroundChronic 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.MethodThis 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 (FEV1) and FEV1/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.DiscussionThis 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 registrationClinicalTrials.gov NCT03797768. Registered on January 9, 2019.

Highlights

Chronic obstructive pulmonary disease (COPD) is one of the leading causes of death worldwide and the commonest of non-communicable diseases (NCDs) in Nepal
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
The Global Initiative for Chronic Obstructive Lung Disease (GOLD) defines COPD as “a common, preventable and treatable disease that is characterized by persistent respiratory symptoms and airflow limitation due to airway and/or alveolar abnormalities usually caused by significant exposure to noxious particles or gases” [4]

Summary

Introduction

Chronic obstructive pulmonary disease (COPD) is one of the leading causes of death worldwide and the commonest of non-communicable diseases (NCDs) in Nepal. Non-communicable diseases (NCDs) are the leading causes of morbidity and mortality, accounting for the deaths of 41 million people annually [1]. As of 2017, the Global Burden of Disease (GBD) study estimated that about 3.9 million people worldwide died of COPD, which is 5.7% of all deaths [1]. Far earlier than the World Health Organization (WHO) projection COPD to be the third most important cause of death worldwide by 2030 [3], the current estimation of the GBD study 2017 ranks it as the second killer disease globally [1]. COPD results from the interaction between genetic and environmental factors, including exposure to tobacco smoke, indoor and outdoor air pollution, and exposure to organic and inorganic dust, fumes, and gases [5]

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