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

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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. / Adhikari, Tara Ballav; Neupane, Dinesh; Karki, Arjun; Drews, Arne; Cooper, Brendan; Högman, Marieann; Sigsgaard, Torben; Kallestrup, Per.

I: Trials, Bind 22, Nr. 1, 21.07.2021, s. 474.

Publikation: Bidrag til tidsskrift/Konferencebidrag i tidsskrift /Bidrag til avisTidsskriftartikelForskningpeer review

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@article{c654b55fdff246d495704014fa676bf0,
title = "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",
abstract = "BACKGROUND: Chronic obstructive pulmonary disease (COPD) is one of the leading causes of death worldwide and the commonest of non-communicable diseases (NCDs) in Nepal. Risk factors like indoor and outdoor air pollution, a high prevalence of smoking, and the lack of awareness of COPD make 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.METHOD: This study aims to evaluate the effect of a community-based health educational intervention administered by Female Community Health Volunteers (FCHVs) on the prevention and management of COPD. An open-label, two-group, community-based, cluster-randomized controlled trial will be implemented in the semi-urban area of Pokhara Metropolitan city (former Lekhnath Municipality) located in the Kaski district of Nepal. The estimated sample size of the intervention will be 1143. The unit of randomization is the ward (administrative unit) of the study area. The follow-up survey will be conducted immediately after 12 months of FCHVs-led interventions. The difference in the rate of decline of forced expiratory volume in 1 s (FEV1) and FEV1/FVC (forced vital capacity) ratio are the primary outcomes and the change in the proportion of modifiable risk factors of COPD, health-related quality of life scores, and change in knowledge of COPD will be secondary outcomes.DISCUSSION: This study will estimate the burden of COPD, the magnitude of risk factors and generate evidence to mobilize community health workers for COPD prevention and management at the community level in Nepal.TRIAL REGISTRATION: ClinicalTrials.gov NCT03797768 . Registered on January 9, 2019.",
keywords = "COPD, Community health worker, Nepal, Female Community Health Volunteers, cluster randomized controlled trial",
author = "Adhikari, {Tara Ballav} and Dinesh Neupane and Arjun Karki and Arne Drews and Brendan Cooper and Marieann H{\"o}gman and Torben Sigsgaard and Per Kallestrup",
note = "{\textcopyright} 2021. The Author(s).",
year = "2021",
month = jul,
day = "21",
doi = "10.1186/s13063-021-05447-7",
language = "English",
volume = "22",
pages = "474",
journal = "Current Controlled Trials in Cardiovascular Medicine (Print)",
issn = "1468-6708",
publisher = "BioMed Central Ltd.",
number = "1",

}

RIS

TY - JOUR

T1 - Community-based intervention for prevention and management of chronic obstructive pulmonary disease in Nepal (COBIN-P trial)

T2 - study protocol for a cluster-randomized controlled trial

AU - Adhikari, Tara Ballav

AU - Neupane, Dinesh

AU - Karki, Arjun

AU - Drews, Arne

AU - Cooper, Brendan

AU - Högman, Marieann

AU - Sigsgaard, Torben

AU - Kallestrup, Per

N1 - © 2021. The Author(s).

PY - 2021/7/21

Y1 - 2021/7/21

N2 - BACKGROUND: Chronic obstructive pulmonary disease (COPD) is one of the leading causes of death worldwide and the commonest of non-communicable diseases (NCDs) in Nepal. Risk factors like indoor and outdoor air pollution, a high prevalence of smoking, and the lack of awareness of COPD make 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.METHOD: This study aims to evaluate the effect of a community-based health educational intervention administered by Female Community Health Volunteers (FCHVs) on the prevention and management of COPD. An open-label, two-group, community-based, cluster-randomized controlled trial will be implemented in the semi-urban area of Pokhara Metropolitan city (former Lekhnath Municipality) located in the Kaski district of Nepal. The estimated sample size of the intervention will be 1143. The unit of randomization is the ward (administrative unit) of the study area. The follow-up survey will be conducted immediately after 12 months of FCHVs-led interventions. The difference in the rate of decline of forced expiratory volume in 1 s (FEV1) and FEV1/FVC (forced vital capacity) ratio are the primary outcomes and the change in the proportion of modifiable risk factors of COPD, health-related quality of life scores, and change in knowledge of COPD will be secondary outcomes.DISCUSSION: This study will estimate the burden of COPD, the magnitude of risk factors and generate evidence to mobilize community health workers for COPD prevention and management at the community level in Nepal.TRIAL REGISTRATION: ClinicalTrials.gov NCT03797768 . Registered on January 9, 2019.

AB - BACKGROUND: Chronic obstructive pulmonary disease (COPD) is one of the leading causes of death worldwide and the commonest of non-communicable diseases (NCDs) in Nepal. Risk factors like indoor and outdoor air pollution, a high prevalence of smoking, and the lack of awareness of COPD make 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.METHOD: This study aims to evaluate the effect of a community-based health educational intervention administered by Female Community Health Volunteers (FCHVs) on the prevention and management of COPD. An open-label, two-group, community-based, cluster-randomized controlled trial will be implemented in the semi-urban area of Pokhara Metropolitan city (former Lekhnath Municipality) located in the Kaski district of Nepal. The estimated sample size of the intervention will be 1143. The unit of randomization is the ward (administrative unit) of the study area. The follow-up survey will be conducted immediately after 12 months of FCHVs-led interventions. The difference in the rate of decline of forced expiratory volume in 1 s (FEV1) and FEV1/FVC (forced vital capacity) ratio are the primary outcomes and the change in the proportion of modifiable risk factors of COPD, health-related quality of life scores, and change in knowledge of COPD will be secondary outcomes.DISCUSSION: This study will estimate the burden of COPD, the magnitude of risk factors and generate evidence to mobilize community health workers for COPD prevention and management at the community level in Nepal.TRIAL REGISTRATION: ClinicalTrials.gov NCT03797768 . Registered on January 9, 2019.

KW - COPD

KW - Community health worker

KW - Nepal

KW - Female Community Health Volunteers

KW - cluster randomized controlled trial

U2 - 10.1186/s13063-021-05447-7

DO - 10.1186/s13063-021-05447-7

M3 - Journal article

C2 - 34289879

VL - 22

SP - 474

JO - Current Controlled Trials in Cardiovascular Medicine (Print)

JF - Current Controlled Trials in Cardiovascular Medicine (Print)

SN - 1468-6708

IS - 1

ER -