Motivational Interviewing + Air Cleaners for COPD

(MOVE-COPD Trial)

Recruiting at 1 trial location

Overseen By Wendy Lorizio

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Must not be taking: Corticosteroids

Disqualifiers: Asthma, Other lung disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

Duration: 6 months

144 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Nadia N Hansel, MD, MPH

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

The MOVE COPD trial is for current smokers over 40 years old with a physician's diagnosis of moderate to severe COPD. Participants must have smoked the equivalent of at least 10 packs of cigarettes per year and not enforce a smoking ban in their homes. They cannot have other chronic lung diseases, live outside their home, plan to move during the study period, or be on long-term systemic corticosteroids.

Inclusion Criteria

You are currently a smoker and have a high level of carbon monoxide in your breath.

I am 40 years old or older.

My doctor has diagnosed me with COPD.

Exclusion Criteria

I am on long-term steroids for another condition.

Home owner or occupant planning to move or change residence within study period

Living in location other than home (e.g., long term care facility)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Run-in

Participants receive smoking cessation strategies including Motivational Interviewing and nicotine replacement therapy

4 weeks

Treatment

Participants receive either active HEPA air cleaners and motivational interviewing or sham air cleaners

6 months

4 sessions (phone-based)

Follow-up

Participants are monitored for changes in COPD health status, dyspnea, quality of life, and systemic markers of inflammation

6 months

3 visits (in-person) at baseline, 3 months, and 6 months

What Are the Treatments Tested in This Trial?

Interventions

• Active HEPA Air Cleaner
• Motivational interviewing
• Sham Air Cleaner

Trial Overview This study tests if using active HEPA air cleaners and motivational interviewing can improve respiratory health in smokers with COPD by reducing indoor air pollution. It's a randomized controlled trial where some participants will receive sham (fake) air cleaners as a comparison.

How Is the Trial Designed?

Group I: Active Treatment Active Control 2 Interventions

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 II: Control Arm Placebo Group 1 Intervention

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.

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

National Institute of Environmental Health Sciences (NIEHS)

Collaborator

Trials

294

Recruited

1,233,000+