Community-based Management of Chronic Obstructive Pulmonary Disease in Nepal

Not Applicable

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Behavioral: Behavioural-FCHV Visit

• Registration Number: NCT03797768
• Lead Sponsor: University of Aarhus

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-01-07
• Study First Submitted QC: 2019-01-07
• Study First Posted: 2019-01-09
• Study Start: 2019-12-25
• Status Verified: 2020-03
• Last Update Submitted: 2021-01-25
• Last Update Posted: 2021-01-28
• Primary Completion: 2021-05-10
• Study Completion: 2021-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1438

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Behavioural-FCHV Visit	-

Primary Outcome Measures

Name	Time	Method
Forced Expiratory Volume in 1 second	1 year	Mean difference in FVE1 between intervention and control arm

Secondary Outcome Measures

Name	Time	Method
Proportion of risk factors of COPD between intervention and control arm	1 year

Trial Locations

Locations (1)

Aarhus University; 🇩🇰 Aarhus, Denmark