NCT03797768

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,438

participants targeted

Target at P75+ for not_applicable chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Dec 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 7, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 9, 2019

Completed
12 months until next milestone

Study Start

First participant enrolled

December 25, 2019

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2021

Completed
Last Updated

January 28, 2021

Status Verified

March 1, 2020

Enrollment Period

1.4 years

First QC Date

January 7, 2019

Last Update Submit

January 25, 2021

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

  • Forced Expiratory Volume in 1 second

    Mean difference in FVE1 between intervention and control arm

    1 year

Secondary Outcomes (1)

  • Proportion of risk factors of COPD between intervention and control arm

    1 year

Study Arms (2)

Intervention

EXPERIMENTAL
Behavioral: Behavioural-FCHV Visit

Control

NO INTERVENTION

Interventions

Behavioural-FCHV VisitBEHAVIORAL

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.

Intervention

Eligibility Criteria

Age40 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University

Aarhus, 8000, Denmark

Location

Related Publications (2)

  • 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.

    PMID: 33061350BACKGROUND

  • 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.

    PMID: 34289879DERIVED

Related Links

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Tara Ballav Adhikari, MScPH

    Department of Public Health, Aarhus University, Aarhus, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2019

First Posted

January 9, 2019

Study Start

December 25, 2019

Primary Completion

May 10, 2021

Study Completion

September 30, 2021

Last Updated

January 28, 2021

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)