Clinical trial NCT03797768: Community-based Management of Chronic Obstructive Pulmonary Disease in Nepal
Official title: Protocol for Community-based Management of Chronic Obstructive Pulmonary Disease in Nepal: a Community-based Cluster Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2019-01-09
Enrollment: 1438
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Forced Expiratory Volume in 1 second
timeFrame: 1 year
Secondary outcomes:
measure: Proportion of risk factors of COPD between intervention and control arm
timeFrame: 1 year
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University
Study officials:
affiliation: Department of Public Health, Aarhus University, Aarhus, Denmark
name: Tara Ballav Adhikari, MScPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Adhikari TB, Acharya P, Hogman M, Neupane D, Karki A, Drews A, Cooper BG, Sigsgaard T, Kallestrup P. Prevalence of Chronic Obstructive Pulmonary Disease and its Associated Factors in Nepal: Findings from a Community-based Household Survey. Int J Chron Obstruct Pulmon Dis. 2020 Sep 29;15:2319-2331. doi: 10.2147/COPD.S268110. eCollection 2020.
citation: Adhikari TB, Neupane D, Karki A, Drews A, Cooper B, Hogman M, Sigsgaard T, Kallestrup P. 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. Trials. 2021 Jul 21;22(1):474. doi: 10.1186/s13063-021-05447-7.