Community-based Management of Chronic Obstructive Pulmonary Disease in Nepal

Overview

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

Interventions

  • 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, tba@ph.au.dk

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