Protocol for Community-based Management of Chronic Obstructive Pulmonary Disease in Nepal: a Community-based Cluster Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic Obstructive Pulmonary Disease
- Sponsor
- University of Aarhus
- Enrollment
- 1438
- Locations
- 1
- Primary Endpoint
- Forced Expiratory Volume in 1 second
- Last Updated
- 5 years ago
Overview
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.
Investigators
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.
Outcomes
Primary Outcomes
Forced Expiratory Volume in 1 second
Time Frame: 1 year
Mean difference in FVE1 between intervention and control arm
Secondary Outcomes
- Proportion of risk factors of COPD between intervention and control arm(1 year)