Phase 4Not yet recruiting
The INTERvening for LUNG Health Trial (INTERLUNG)
The INTERvening for LUNG Health (INTERLUNG) Trial: A Pragmatic Hybrid Implementation-Effectiveness Trial of Community-Based Interventions to Improve Respiratory Health in Bhaktapur, Nepal
- Sponsor
- Johns Hopkins University (Academic or other)
- Enrolment
- 800 planned
- Conditions
- Spirometry
- Interventions
- Community health worker-delivered multi-component respiratory health intervention
- Ages
- children, adults, older adults
- Registry
- NCT07540000
Full record on ClinicalTrials.gov
From the registry
This research study is being done to find out whether a community health volunteer-delivered, multi-component program can improve lung health for people at risk of chronic respiratory diseases (such as asthma or COPD) in Bhaktapur, Nepal. The program focuses on reducing tobacco smoke exposure, reducing indoor and outdoor air pollution exposure, preventing respiratory infections (including vaccination and mask use during viral seasons), and encouraging safe physical activity. The "index participant" is the main enrolled participant in the household who is randomized to the intervention or control arm. The participant will be in the study for about 40 months and will have 11 research visits: one at baseline and then every 4 months through month 40. At visits, staff will do breathing tests (spirometry before and after an inhaled medicine), measure exhaled carbon monoxide, check blood pressure, measure height/weight at selected visits, and ask questions about symptoms, smoking, infections, vaccines, and quality of life. The participant will also wear an activity monitor (accelerometer)…
Primary outcomes
- Pre-bronchodilator FEV₁ Z-score at 40 months
History
Study completion expected
Primary completion expected
Expected to start
Last registry update
Registered