Community-based Management of Chronic Obstructive Pulmonary Disease in Nepal


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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: August 30, 2020


  • 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.

Arms, Groups and Cohorts

  • Experimental: Intervention
  • No Intervention: Control

Clinical Trial Outcome Measures

Primary Measures

  • Forced Expiratory Volume in 1 second
    • Time Frame: 1 year
    • Mean difference in FVE1 decline rate among intervention and control arm

Secondary Measures

  • Proportion of risk factors of COPD between intervention and control arm
    • Time Frame: 1 year

Participating in This Clinical Trial

Inclusion Criteria

  • Capable of performing spirometry
  • Aged greater than and equal to 30 years
  • Full time residents in the study area and will be in the study area for than one year

Exclusion Criteria

  • Younger than 30 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
  • A blood pressure > 180/100 mmHg.
  • Those who decline to provide consent to the study will be excluded.

Gender Eligibility: All

Minimum Age: 30 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Aarhus
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Tara Ballav Adhikari, Principal Investigator, Aarhus University, Department of Public Health
  • Overall Contact(s)
    • Tara Ballav Adhikari, 31883420,

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