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Community-based Management of Chronic Obstructive Pulmonary Disease in Nepal

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03797768
Acronym
COBIN-P
Enrollment
1438
Registered
2019-01-09
Start date
2019-12-25
Completion date
2021-09-30
Last updated
2021-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease

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.

Interventions

BEHAVIORALBehavioural-FCHV Visit

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.

Sponsors

University of Aarhus
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
40 Years to 90 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Forced Expiratory Volume in 1 second1 yearMean difference in FVE1 between intervention and control arm

Secondary

MeasureTime frame
Proportion of risk factors of COPD between intervention and control arm1 year

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026