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