Community Program for Chronic Respiratory Diseases
(INTERLUNG Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if a community health volunteer-led program can improve lung health for people in Bhaktapur, Nepal, who are at risk of chronic respiratory diseases like asthma or COPD. The program, a multi-component respiratory health intervention, focuses on reducing tobacco smoke, air pollution, and respiratory infections while promoting physical activity. Participants are divided into two groups: one receives regular health advice and support, while the other continues with their normal care. Residents of Bhaktapur who often experience coughing, wheezing, or have had asthma or tuberculosis might be a good fit for this study. As a Phase 4 trial, this research involves an FDA-approved treatment and aims to understand how it can benefit more patients.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.
What is the safety track record for the community health worker-delivered multi-component respiratory health intervention?
Research has shown that programs led by community health workers are generally safe and well-tolerated. Studies have found that these programs help people manage conditions like asthma and COPD without significant side effects. For example, community health workers have successfully improved asthma control and quality of life without major problems. They teach people how to reduce triggers at home, and no serious adverse events have been reported.
This study is in Phase 4, indicating that earlier stages have already tested the treatment for safety. Earlier phases focus heavily on safety, so by the time a study reaches Phase 4, the treatment is generally considered safe. It is now being tested in real-world settings to confirm its benefits and any long-term effects.12345Why are researchers enthusiastic about this trial?
Researchers are excited about this community health worker-delivered intervention for chronic respiratory diseases because it takes a comprehensive, hands-on approach to improving respiratory health. Unlike standard treatments that may focus on medication and occasional doctor visits, this intervention includes home visits by trained community health workers who provide guidance and tools like HEPA air purifiers and vacuum cleaners to reduce environmental risk factors. It also emphasizes preventive measures such as tobacco cessation, mask usage during high pollution or illness seasons, and vaccinations against flu and pneumonia. This holistic approach aims not just to treat symptoms but to enhance overall respiratory health by addressing environmental and behavioral factors.
What evidence suggests that this community health program is effective for improving lung health in chronic respiratory diseases?
Research shows that programs led by community health workers can improve lung health. In this trial, participants in the intervention arm will receive a multi-component intervention delivered by community health workers. This intervention aims to reduce environmental and infectious respiratory risk factors and promote healthy behaviors. Studies have found that such programs enhance asthma management by improving communication between families and healthcare providers. Participants often experience significant improvements in asthma control, with benefits continuing even after the program ends. Evidence also suggests that community health workers can help reduce diseases like chronic obstructive pulmonary disease (COPD). This approach effectively manages breathing problems by encouraging healthier habits and reducing risk factors.13678
Who Is on the Research Team?
William Checkley, MD, PhD
Principal Investigator
Johns Hopkins University
Are You a Good Fit for This Trial?
This trial is for people aged 9 or older living in Bhaktapur, Nepal, who have reduced lung function and at least one risk factor for breathing problems (like cough, wheezing, past TB, asthma diagnosis, smoking history, or exposure to dust/smoke). Participants must be willing to attend regular visits over about 40 months.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Initial assessment including spirometry, questionnaires, and accelerometry
Intervention/Control
Participants receive either the multi-component intervention or usual care
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Community health worker-delivered multi-component respiratory health intervention
Trial Overview
The study tests if a program led by community health workers—focusing on reducing smoke and pollution exposure, preventing infections with vaccines/masks/handwashing, and promoting safe physical activity—can improve lung health compared to usual care. Participants are randomly assigned to the intervention or control group.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Participants randomized to the intervention arm will receive a community health worker-delivered, multi-component intervention designed to reduce environmental and infectious respiratory risk factors and promote healthy behaviors over a 40-month follow-up period. Components include tobacco cessation counseling for participants who use tobacco; use of N95/KN95 masks during periods of high ambient air pollution; use of surgical masks and handwashing during household respiratory illness or viral seasons; provision and use of a HEPA air purifier with periodic filter replacement and a HEPA-filter vacuum cleaner; promotion of regular physical activity through goal setting and self-monitoring; facilitation of annual influenza vaccination for household members; and pneumococcal conjugate vaccination (PCV20) for eligible participants. These components are reinforced through regular home visits by trained community health volunteers.
Participants randomized to the usual care (control) arm will continue routine healthcare and daily practices and will not receive the study intervention during the 40-month follow-up period. Control participants will complete the same schedule of research assessments as the intervention arm, including spirometry, questionnaires, accelerometry, and other study measurements conducted at baseline and every four months. The participant will not receive community health worker visits, vaccines facilitated through the study, air purifiers, vacuum cleaners, masks, or behavioral counseling during the trial. At the conclusion of the study, control households will receive educational materials and will be offered an air purifier and vacuum cleaner.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Johns Hopkins University
Lead Sponsor
National Institute of Environmental Health Sciences (NIEHS)
Collaborator
Medstar Health Research Institute
Collaborator
Tribhuvan University
Collaborator
Georgetown University
Collaborator
Tribhuvan University, Nepal
Collaborator
Citations
Community Health Workers' Role in Supporting Pediatric ...
CHW-led interventions can assist in decreasing asthma disparities by 1) enhancing asthma management through improved communication between families, health care ...
Outcomes of a Remote Multi-Component Asthma ...
Conclusion: Findings demonstrate positive outcomes of an asthma program delivered remotely by a CBO. They add to the evidence regarding CBO ...
Community Health Worker Asthma Interventions for Children ...
Both intervention groups showed significant improvement in asthma control scores over time. Asthma control was maintained after interventions ended.
Community Health Workers: Delivering Home-Based ...
74 The results from the intervention suggest that home-based asthma programs are likely to be more successful with a clear connection to a clinical provider. In ...
Role of Community Health Workers in Chronic Obstructive ...
The authors concluded that a CHW-based intervention to support management of acute exacerbations of COPD did not result in any significant ...
The INTERvening for LUNG Health Trial (INTERLUNG)
This research study is being done to find out whether a community health volunteer-delivered, multi-component program can improve lung ...
Community Health Workers at Scale In New York City
viii Research shows that. CHW-led interventions significantly improve chronic disease outcomesix,x and contribute to increased self- efficacy, medication ...
Community Health Workers Linking Clinics and Schools ...
This randomized clinical trial investigates if the participation of community health workers in an intervention to connect home, school, ...
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