跳至主要内容
临床试验/NCT03797768
NCT03797768Unknown不适用

Protocol for Community-based Management of Chronic Obstructive Pulmonary Disease in Nepal: a Community-based Cluster Randomized Controlled Trial

University of Aarhus2 个研究点 分布在 1 个国家目标入组 1,438 人开始时间: 2019年12月25日最近更新:
适应症

试验速览

阶段
不适用
入组人数
1,438
试验地点
2
主要终点
Forced Expiratory Volume in 1 second

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
40 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

结局指标

主要结局

Forced Expiratory Volume in 1 second

时间窗: 1 year

Mean difference in FVE1 between intervention and control arm

次要结局

  • Proportion of risk factors of COPD between intervention and control arm(1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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