Community-based Management of Chronic Obstructive Pulmonary Disease in Nepal

Study Overview
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Brief Summary
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Chronic Obstructive Pulmonary Disease (COPD) is the fourth most important cause of death worldwide and is one of the commonest non-communicable diseases (NCDs) in Nepal. The presence of risk factors like indoor and outdoor air pollution, the high prevalence of smoking and lack of general awareness of COPD makes 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. This community-based cluster randomized controlled study aims to fulfil that gap through mobilization of Female Community Health Workers (FCHVs) who will be trained to perform a certain set of health promotion activities aimed at prevention of the disease and its progression. Baseline and follow-up surveys will be conducted to compare the intervention and control groups. This study has the potential to generate evidence in helping address NCDs in Nepal and also other similar resource-limited countries.

Official Title
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Protocol for Community-based Management of Chronic Obstructive Pulmonary Disease in Nepal: a Community-based Cluster Randomized Controlled Trial

Conditions
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Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Behavioral: Behavioural-FCHV Visit


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Capable of performing spirometry Aged greater than and equal to 40 years Full time residents in the study area and will be in the study area for at least one year Exclusion Criteria: Younger than 40 years of age Self-reported pregnancy having active pulmonary tuberculosis or being on medications for pulmonary tuberculosis thoracic, abdominal or eye surgery in the last six months History of Mental illness MI in past 8 weeks prior to study Hospital admission in the past six months for cardiac illness Those who decline to provide consent to the study will be excluded.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br> | Behavioral: Behavioural-FCHV Visit<br>* Female Community Health Volunteer will visit selected households on average 3 times a year for providing health promotion messages on improving lung health status and avoiding risk factors to COPD.<br>|
| No Intervention: Control<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Forced Expiratory Volume in 1 second | Mean difference in FVE1 between intervention and control arm | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of risk factors of COPD between intervention and control arm |  | 1 year |