Community-based Management of Chronic Obstructive Pulmonary Disease in Nepal

NCT ID: NCT03797768

Last Updated: 2021-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

1438 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-25

Study Completion Date

2021-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Intervention

Group Type EXPERIMENTAL

Behavioural-FCHV Visit

Intervention Type BEHAVIORAL

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.

Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tara Ballav Adhikari, MScPH

Role: PRINCIPAL_INVESTIGATOR

Department of Public Health, Aarhus University, Aarhus, Denmark

Locations

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Aarhus University

Aarhus, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type BACKGROUND
PMID: 33061350 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34289879 (View on PubMed)

Related Links

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https://doi.org/10.2147/COPD.S268110

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

Other Identifiers

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AUTBA18

Identifier Type: -

Identifier Source: org_study_id

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