The INTERvening for LUNG Health Trial

ConditionSpirometry

Trial statusNot yet recruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexAll

Age9+

SponsorJohns Hopkins University

About this trial

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) for 2 weeks at baseline and at follow-up visits. If individual is a household member (not the index participant), the participant may be asked to complete baseline and follow-up assessments every 4 months through month 40, will receive the influenza vaccine and will primarily be asked to use masks and handwashing during household respiratory illness episodes (only if the index participant is randomized to the intervention) and will not be asked to wear an activity monitor. If the participant is in the pilot phase, participation will last about 2 months. the participant will complete baseline procedures and pilot follow-up visits during those 2 months instead of the full 40-month schedule.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥9 years at enrollment.

Resident of the Bhaktapur district and member of a household willing to participate in study procedures.

Pre-bronchodilator FEV1/FVC at or below the 10th percentile (Z-score ≤ -1.28) based on Global Lung Function Initiative reference equations.

usual cough or phlegm, wheezing in the past 12 months, self-reported prior pulmonary tuberculosis, physician-diagnosed asthma, ever smoking, or occupational exposure to dust or smoke.

Disqualifiers

Medical condition that precludes safe performance of spirometry.

Acute respiratory illness at the time of enrollment that would prevent reliable baseline spirometry testing.

Plans to move out of the study area during the follow-up period. Inability or unwillingness to comply with study procedures or follow-up visits.

Any other condition that, in the opinion of the investigators, would interfere with participation or interpretation of study results.

Trial design

Design model

Parallel

Treatments tested in this trial

Community health worker-delivered multi-component respiratory health intervention
Behavioral
Participants receive a community health worker-delivered, multi-component intervention designed to reduce environmental and infectious respiratory risk factors and promote healthy behaviors over 40 months. 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 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. Intervention activities are reinforced through regular home visits by trained community health volunteers.

Treatment groups

800 Participants

are divided into 2 treatment groups

Group A: Usual care (control) armNo intervention 0 interventions

Group B: InterventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Pre-bronchodilator FEV₁ Z-score at 40 months

Mean pre-bronchodilator FEV₁ Z-score measured by spirometry using Global Lung Function Initiative reference equations. The primary analysis will compare mean values between intervention and control groups at the end of follow-up. Lung function will be expressed as Global Lung Function Initiative (GLI) z-scores. A Z-score of 0 represents the population mean.Values below 0 indicate lower lung function and values above 0 indicate higher lung function. The study is powered to detect a difference of 0.25 standard deviations between arms.

Time frame

40 months

Secondary outcomes

Pre-bronchodilator FVC Z-score

Mean pre-bronchodilator forced vital capacity (FVC) Z-score measured by spirometry using Global Lung Function Initiative reference equations. A Z-score of 0 represents the population mean.Values below 0 indicate lower lung function and values above 0 indicate higher lung function. The study is powered to detect a difference of 0.25 standard deviations between arms.

Time frame

40 months

Pre-bronchodilator FEV₁/FVC Z-score

Mean pre-bronchodilator FEV₁/FVC Z-score measured by spirometry using Global Lung Function Initiative reference equations. A Z-score of 0 represents the population mean.Values below 0 indicate lower lung function and values above 0 indicate higher lung function. The study is powered to detect a difference of 0.25 standard deviations between arms.

Time frame

40 months

Post-bronchodilator Spirometry Z-scores

Post-bronchodilator spirometry measurements (FEV1, FVC, and FEV1/FVC Z-scores) obtained 15 minutes after administration of inhaled bronchodilator. A Z-score of 0 represents the population mean.Values below 0 indicate lower lung function and values above 0 indicate higher lung function. The study is powered to detect a difference of 0.25 standard deviations between arms.

Time frame

40 months

Respiratory Health-Related Quality of Life

Health-related quality of life measured using the St. George's Respiratory Questionnaire (SGRQ). Scores range from 0 to 100, with higher scores indicating worse respiratory health status. The minimal clinically important difference for the SGRQ is 4 points.

Time frame

40 months

Other outcomes

Program Sustainability Assessment Tool

The Program Sustainability Assessment Tool (PSAT) score measures the program's capacity for long-term sustainability across domains such as funding stability, partnerships, organizational capacity, evaluation, and strategic planning, with higher scores indicating greater readiness to sustain intervention activities beyond the study period. The Program Sustainability Assessment Tool (PSAT) score ranges from 1 to 7, with higher scores indicating greater capacity of the program to sustain intervention activities over time across domains such as funding stability, partnerships, organizational capacity, evaluation, and strategic planning.

Time frame

40 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Johns Hopkins University

Lead sponsor

Medstar Health Research Institute

Collaborator

Tribhuvan University, Nepal

Collaborator

Georgetown University

Collaborator

National Institute of Environmental Health Sciences (NIEHS)

Collaborator

Source ClinicalTrials.gov

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