Community-based Management of Chronic Obstructive Pulmonary Disease in Nepal

Chronic Obstructive Pulmonary Disease Clinical Trial

— COBIN-P  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03797768
• Other study ID #: AUTBA18
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 25, 2019
• Est. completion date: September 30, 2021

Study information

• Verified date: March 2020
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1438
• Est. completion date: September 30, 2021
• Est. primary completion date: May 10, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Behavioral:
• Behavioural-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.

Locations

Country	Name	City	State
Denmark	Aarhus University	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

Adhikari TB, Acharya P, Högman 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Forced Expiratory Volume in 1 second	Mean difference in FVE1 between intervention and control arm	1 year
Secondary	Proportion of risk factors of COPD between intervention and control arm		1 year

External Links

•   Prevalence of Chronic Obstructive Pulmonary Disease and its Associated Factors in Nepal: Findings from a Community-based Household Survey