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Community-based Management of Chronic Obstructive Pulmonary Disease in Nepal (COBIN-P)

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Behavioural-FCHV Visit
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chronic Obstructive Pulmonary Disease

Eligibility Criteria

40 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Aarhus University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

Outcomes

Primary Outcome Measures

Forced Expiratory Volume in 1 second
Mean difference in FVE1 between intervention and control arm

Secondary Outcome Measures

Proportion of risk factors of COPD between intervention and control arm

Full Information

First Posted
January 7, 2019
Last Updated
January 25, 2021
Sponsor
University of Aarhus
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1. Study Identification

Unique Protocol Identification Number
NCT03797768
Brief Title
Community-based Management of Chronic Obstructive Pulmonary Disease in Nepal
Acronym
COBIN-P
Official Title
Protocol for Community-based Management of Chronic Obstructive Pulmonary Disease in Nepal: a Community-based Cluster Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 25, 2019 (Actual)
Primary Completion Date
May 10, 2021 (Anticipated)
Study Completion Date
September 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
1438 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Behavioural-FCHV Visit
Intervention Description
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.
Primary Outcome Measure Information:
Title
Forced Expiratory Volume in 1 second
Description
Mean difference in FVE1 between intervention and control arm
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Proportion of risk factors of COPD between intervention and control arm
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tara Ballav Adhikari, MScPH
Organizational Affiliation
Department of Public Health, Aarhus University, Aarhus, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aarhus University
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33061350
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.
Results Reference
background
PubMed Identifier
34289879
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.
Results Reference
derived
Links:
URL
https://doi.org/10.2147/COPD.S268110
Description
Prevalence of Chronic Obstructive Pulmonary Disease and its Associated Factors in Nepal: Findings from a Community-based Household Survey

Learn more about this trial

Community-based Management of Chronic Obstructive Pulmonary Disease in Nepal

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