Motivational Interviewing and Air Cleaners for Smokers With COPD (MOVE COPD)

NCT ID: NCT03658538

Last Updated: 2025-09-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 144 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-03
• Study Completion Date: 2024-11-07

Brief Summary

COPD is characterized by lung injury and inflammation caused by noxious particles and gases, including those emanating from cigarette smoke and air pollution. Despite the clear detrimental impact of poor air quality on respiratory outcomes, regardless of smoking status, to investigators' knowledge, there are no studied environmental interventions targeting indoor air quality to improve respiratory health of smokers, thus ignoring a potential target for harm reduction. Investigators propose a randomized controlled intervention trial to test whether targeted reductions of multiple indoor pollutants (PM, SHS and NO2) in homes of smokers with COPD will improve respiratory outcomes. Investigators have chosen a potent, multimodal intervention (active air cleaners + Motivational intervention for SHS reduction) in order to maximize the opportunity to prove that there is a health benefit to active smokers with COPD from indoor air pollution reduction.

Detailed Description

People with COPD who have higher exposure to indoor pollutants, including particulate matter (PM), second hand smoke (SHS), and nitrogen dioxide (NO2) have worse respiratory morbidity including a higher risk of exacerbations. These effects are not obscured by smoking habit. Unfortunately, despite the clear detrimental impact of poor air quality on respiratory outcomes, regardless of smoking status, to investigators' knowledge, there are no studied environmental interventions targeting indoor air quality to improve respiratory health of smokers, thus ignoring a potential target for harm reduction.

Investigators propose a randomized controlled intervention trial to test whether targeted reductions of multiple indoor pollutants (PM, SHS and NO2) in homes of smokers with COPD will improve respiratory outcomes. Investigators have chosen a potent, multimodal intervention in order to maximize the opportunity to prove that there is a health benefit to active smokers with COPD from indoor air pollution reduction. After a one-month run in period in which all participants will receive smoking cessation strategies including Motivational Interviewing (MI) and nicotine replacement therapy, participants unable to quit smoking (n=120) will have 1:1 randomization to receive either 1) multi-component environmental intervention (active "high-efficiency particulate air"(HEPA) air cleaners + MI intervention for SHS reduction) or 2) sham air cleaners. Referrals to community resources for additional support will also be provided. Investigators aim to determine whether a multi-component environmental intervention (targeting PM, SHS and NO2 reduction) will improve respiratory morbidity (i.e., symptoms, quality of life, lung function and exacerbation risk) (Specific Aim #1) and intermediate outcome measures (i.e., markers of airway and systemic inflammation and oxidative stress) (Specific Aim #2) in smokers with COPD. Investigators anticipate that results from this study will inform clinical practice guidelines and health care policies aimed at reducing COPD morbidity and may have broader implications for indoor environmental recommendations for smokers with chronic disease.

Conditions

COPD, Chronic Obstructive Pulmonary Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

Active Treatment

The active treatment arm will receive two portable active HEPA air cleaners as well as 4 sessions of phone based motivational interviewing to support a home smoking ban and SHS reduction (in addition to the smoking cessation counseling received by all study participants).

Group Type: ACTIVE_COMPARATOR

Active HEPA Air Cleaner

Intervention Type: DEVICE

The active treatment arm will receive two active air cleaners with HEPA and carbon filters to support a home smoking ban and SHS reduction.

Motivational interviewing

Intervention Type: BEHAVIORAL

The active treatment arm will receive 4 sessions of phone based motivational interviewing to support a home smoking ban and SHS reduction (in addition to the smoking cessation counseling received by all study participants).

The Control arm will receive only continued counseling for smoking cessation.

Control Arm

Homes in the control group will receive Sham air cleaners that have the internal HEPA filter removed, but which will run normally, including similar noise, airflow and overall appearance compared to active air cleaners, thus blinding participants to filter status. The control arm will not receive phone based motivational interviewing to support a home smoking ban and SHS reduction, they will receive only smoking cessation counseling.

Group Type: SHAM_COMPARATOR

Sham Air Cleaner

Intervention Type: DEVICE

The Control arm will receive sham air cleaners

Interventions

Active HEPA Air Cleaner

The active treatment arm will receive two active air cleaners with HEPA and carbon filters to support a home smoking ban and SHS reduction.

Intervention Type: DEVICE

Motivational interviewing

The active treatment arm will receive 4 sessions of phone based motivational interviewing to support a home smoking ban and SHS reduction (in addition to the smoking cessation counseling received by all study participants).

The Control arm will receive only continued counseling for smoking cessation.

Intervention Type: BEHAVIORAL

Sham Air Cleaner

The Control arm will receive sham air cleaners

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Age ≥ 40 years,
• Physician diagnosis of COPD,
• Global Initiative for Obstructive Lung Disease (GOLD) Stage II-IV disease with Forced Expiratory Volume (FEV1)/ Forced Vital Capacity (FVC) <70% and FEV1 (% predicted) <80%. IF FEV1/FVC <70% and FEV1 (% predicted) ≥ 80%, additional requirement will apply/will be asked: COPD Assessment Test (CAT) score ≥ 10 OR exacerbation history during the last 12 months.
• Tobacco exposure ≥ 10 pack-years
• Current smoker with an exhaled Carbon Monoxide (eCO) ≥ 7 ppm to confirm smoking status. We will employ a combination of self-report and a biochemical marker to identify former-smokers. (If no eCO performed due to COronaVIrus Disease-19 (COVID-19) pandemic safety reasons, we will rely on self-report smoking status and self-report 7-day abstinence questionnaire answers)
• No home smoking ban. IF smoking is not allowed indoor (inside participant's home) then a "home air quality assessment visit" may be done.

Exclusion Criteria

• Chronic systemic corticosteroids,
• Other chronic lung disease including asthma,
• Living in location other than home (e.g., long term care facility)
• Home owner or occupant planning to move or change residence within study period.
• Air Cleaners drop off (home visits temporary criteria due to COVID-19).

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Environmental Health Sciences (NIEHS)

NIH

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nadia N Hansel, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins Bayview Campus

Baltimore, Maryland, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

R01ES029512

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00185955

Identifier Type: -

Identifier Source: org_study_id