Motivational Interviewing and Air Cleaners for Smokers With COPD (MOVE COPD)
Phase: NA
Conditions: COPD, Chronic Obstructive Pulmonary Disease
Sponsor: Johns Hopkins University

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Cover Page 
Record (NCT) Identifier Number: NCT03658538 
Johns Hopkins University  
Unique Protocol ID: IRB00185955 
Study Title: Motivational Interviewing and Air Cleaners for Smokers With COPD (MOVE COPD) 
Principal Investigator: Dr. Nadia Hansel  
Protocol Date: February 4, 2022 

 
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Study Title: Motivational Interviewing and Air Cleaners for Smokers With COPD (MOVE COPD) 
 
MOVE COPD Study Protocol 
 
 
Objectives  
 
Specific Aim #1: To determine whether a multi-component environmental intervention to improve 
home air quality (PM, SHS and NO2 reduction) will improve respiratory morbidity (i.e., symptoms, 
quality of life, lung function and reduce risk of exacerbations) in smokers with COPD. 
 
Specific Aim #2:  To determine whether a multi-component environmental intervention to improve 
home air quality (PM, SHS and NO2 reduction) will be associated with intermediate outcome 
measures known to be linked with long term outcomes in COPD, including airway (induced sputum) 
and systemic (serum and urine) markers of inflammation and oxidative stress, in smokers with COPD. 
 
Study Procedures 
1. Study design, including the sequence and timing of study procedures.  
We will recruit current smokers (n=150) with moderate to severe COPD and those still smoking after 
a one-month smoking cessation run-in period will be randomized (estimated 80% of original sample, 
goal n=120) to receive either 1) air cleaner (with HEPA filters for reduction of PM) and MI for SHS 
reduction or 2) sham air cleaners. All eligible participants will be offered smoking cessation 
counseling throughout the study period and will have air monitoring and outcomes assessed at 
randomization, and 3 and 6-months post intervention. All patients enrolled in this study will continue 
to have their usual care for COPD as determined by their primary care provider or their usual COPD 
caregiver.  No treatments will be discontinued.   
2. Screening Assessment Visit 
The initial clinic visit will take place at the Johns Hopkins Asthma and Allergy Center.  During the 
initial clinic visit participant eligibility will be established and informed consent obtained. The 
screening assessment visit is expected to take approximately 2 hours. 
The screening assessment visit will include the following: 
• 
Informed consent 
• 
Pre- and Post-BD spirometry  
• 
Eligibility assessment questionnaires 
• 
Clinical Examination to include anthropometry, vitals and skinfold assessment 
3. Home Air Quality Screening Assessment (IF APPLICABLE) 
In addition, we will have a home air quality screening assessment visit prior to enrollment in the home 
of participants who have a “home smoking ban” in order to ensure that we randomize homes that have 
elevated PM values that are more likely to benefit from the intervention of air cleaners to improve 
indoor air quality. To determine further eligibility, we will place an air pollution monitor in the home 
(room where the participant reports spending most of his/her time) up to 7 days to measure the air 
quality. Only participants residing in homes with PM2.5 values ≥ 10 µg /m3 (National Ambient Air 
Quality Standards (NAAQS) set by the EPA for annual ambient PM2.5 and slightly above WHO 
standards of 10 µg /m3 for annual indoor PM2.5) will be included. In the case, where we register MIE 
values borderlines 8-10, we will repeat the MIE assessment only if the participant agree. We will 
continue to not require home monitoring for homes where smoking is allowed indoors given that PM 
levels will likely to be elevated. 

 
 
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4.  Run-In Period (1 month) 
All enrolled will be given two Motivational Interviewing sessions for smoking cessation during the run-
in period. Participants will receive 1 in-person session and 1 phone call session. Nicotine replacement 
therapy (NRT) will be offered during this period to all participants following approval  by a study 
physician (a pulmonary attending or fellow). Referrals to community resources for additional support 
will also be provided.  
 
Individuals who quit smoking during the 1 month run-in (self-report 7 day abstinence) will not be 
randomized nor included in intent-to-treat analyses to maintain adequate power to determine whether 
pollutant reduction in those who actively smoke provides health benefit. However, if participant would 
like to continue receiving smoking cessation counseling and NRT they will be referred to the 
community resources provided during the Motivational Interviewing session. No additional clinic and 
home visits will be done. An active air cleaner will be offered to ensure there is no incentive to continue 
smoking and to optimize continued smoking abstinence.  
 
Individuals who continue to smoke (self-report) at the conclusion of the run-in period will be 
randomized. 
5. Home Visits: Exposure Assessment Methods 
Over the course of the enrollment period, we will assess each subject for 3 seven-day periods (at 
randomization, 3 months and 6 months post-intervention) to assure that each subject is examined in 
different seasons; and to evaluate the immediate as well as longer term effects of the interventions on 
air quality and COPD health. This approach is based on the measurement approach that we have 
previously demonstrated for PM reduction trials. Indoor air quality monitoring will be conducted over 
a 7-day period in the room where the participant is expected to spend the most time over the 
monitoring period.  
 
 
During each home visit:  
1) Monitors for air samples will be set up in the bedroom and in the room in which the participant 
spends most of his/her time. 
 
2) Detailed questionnaire about home characteristics will be administered  
 
3) A home inspection will be performed 
 
4) Participants will be instructed on how to complete a Time Activity Diary (TAD) and symptom 
 
diary which is to be done during the time of the air monitoring period,  
 
5) Outdoor air monitors will be placed in a convenient and secured location outside of each home 
 
6) Dust collection in the main living area and bedroom at home.  
 
  
 
The home visits will include the following: 
• 
Environmental monitoring equipment set up and dust collection.  
• 
Instructions on activity diary (TAD), symptom diary (BCSS) 
 
 
          
 
         Participant responsibilities: 
• Activity diary (TAD daily) 
• Breathlessness, Cough and Sputum Scale (BCSS daily) 
• Dust collection  
 
Household Inspection: At the time that monitoring is initiated, a trained home inspector will conduct 
a household inspection which will include the type, salient features and condition of the house 
including 1) type of home (detached, duplex, row house, apartment) and size of home; 2) type of 

 
 
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furnace (gas, oil, heat pump) as well as heating (radiator, forced air, electric space heater, other); 3) 
the presence of central or room air conditioning; dehumidifiers, or humidifiers, 4) evidence of 
cigarette smoke/smell of cigarettes/ashtrays. The home inspection will focus on the living/family 
room, the kitchen, basement, and the participant’s bedroom and identify potential sources of PM, SHS 
and NO2 as potential confounders to the effectiveness of home interventions. 
 
Collect Dust samples: Study team member will vacuum settled dust samples from the room in which 
air pollution monitors have been placed to study allergens at home.  
 
Time Activity Diary (TAD): Participants will be asked to keep a simple TAD during each week of 
sampling. TAD will collect information on participant location (indoor/outdoor/in vehicle, 
home/work/other), and indoor activities which are gas and particle generating such as cooking, heating, 
smoking, burning incense or candles. We will adapt TADs previously designed and used for our 
previous air pollution exposure assessments.  
Indoor Air Monitoring: Will be conducted for assessing: 
Airborne PM2.5 fine and PM2.5-10- coarse, conducting gravimetric analysis using time-integrated filter 
based sampler or using a commercially-available low cost PM sensor.  
Temperature and Humidity are also monitored.  
Ultrafine Particles (UFP) will be measured at high temporal resolution using a Partector (CH 
Technologies). This device measures lung deposited surface area, which is dominated by particles with 
diameter less than 100 nm. 
Airborne NO2 will be measured with passive samplers (Ogawa badges) using standard methods. 
Temperature and humidity will also be recorded to adjust NO2 analytical results.  All NO2 samples will 
include 10% blanks and duplicates and will be blank corrected. NO2 samples will be analyzed 
spectrophotometrically.   
Airborne nicotine will be monitored using passive sampling badges according to standard methods. 
Nicotine is collected by passive diffusion onto glass fiber filter treated with 4% sodium bisulfate 
solution.  The cassette is then sealed and transported back to the laboratory for extraction and analysis 
using GC-MS, Shimadzu GC-17A, QP 5000, (Shimadzu Corporation, Japan). 
 
Outdoor Air Monitoring: Will be conducted for PM2.5and NO2 with similar methods as described 
above for indoor monitoring. Monitors will be placed in a convenient and secured location outside of 
homes to measure air quality.  The monitoring machines will run day and night during each of the 3 
periods of seven days of monitoring. While they run, they make no more noise than a pump in a fish 
tank. We will give you the results of the air quality test after the study is completed 
 
± We will provide participants the results of the air quality test after the study is completed. 
*** If the participant is unable to attend their clinic visit, questionnaires and data collection may 
occur at home and/or by phone with the exception of six-minute walk and albuterol administration 
for spirometry. 
6. Clinical Visits: Outcomes Assessment 
Outcomes will be assessed at the end of each monitoring period (except exacerbations and health care 
utilization outcomes, which will be assessed by monthly telephone calls). The outpatient visits will take 
place in the pulmonary clinic at the Johns Hopkins Bayview Asthma and Allergy Center.  
 
 
 

 
 
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The clinical visit will include the following: 
• Assessment of general health status and questionnaire about sociodemographic variables (age, 
gender, race/ethnicity; family history of lung disease). 
• Assessment of a validated food questionnaire to analyze diet patterns.  
• Completion of respiratory and general health questionnaires: Quality of Life (QOL) will be 
determined using the St. George’s Respiratory Questionnaire (SGRQ), Modified Medical 
Research Council Dyspnea Scale (MMRC), University of California San Diego Shortness-of-
Breath Questionnaire (UCSD SOBQ), COPD Assessment Test (CAT), modified-American 
Thoracic Society and Division of Lung Diseases of the National Heart and Lung Institute 
Questionnaire (ATS-DLD-78 adult), Berlin Sleep questionnaire, Pittsburgh sleep quality 
index. Hospital anxiety and depression scale, perceived stress 10-items and hardship 
questionnaire.  
• Lifestyles questionnaires: electronic cigarette, marijuana and alcohol intake (FAST) 
• Adverse Childhood Experience (ACE)  
• Everyday Discrimination Scale (EDS) 
• Cognitive Impairment Tests ( MoCA-Test)  
• Social Cognitive measures: For each SCT construct, participants will be asked to rate how 
much confidence, importance, and motivation they had to implement a home smoking ban or 
quit smoking on a 10-point scale, where 1 is “not at all sure, not at all important, don’t want to 
do it at all”, 10 is “completely sure, extremely important, really want to do it every day”, and 5 
is “somewhere in between”. We will also administer our previously validated measure of SHS 
positive and negative expectancies and knowledge of SHSe harm, which has been shown to be 
associated with SHS air nicotine levels.  
• COVID-19 impact on health questionnaires (long version and short follow up): to assess 
exposure to COVID-19, experiences with testing, taking precautions with masking and 
isolating, and about impacts of the pandemic on well-being. 
• Nicotine dependence will be measured using the Fagerstrom Test for Nicotine Dependence 
which is a standard instrument for assessing intensity of physical addiction to nicotine.  
• Clinical Examination to include anthropometry, vitals and skinfold assessment 
• Breathing Tests: Spirometry will carry out to measure lung function. We will obtain at least 
three acceptable and reproducible spirometric maneuvers from a maximum of eight in 
accordance to the American Thoracic Society (ATS) and European Respiratory Society 
guidelines.  
• Salivary cotinine will be assessed during each clinic visit to assess smoking status. 
• Six Minute Walk Test will be assessed during each clinic visit to test participants exercise 
tolerance. Participant will be asked to walk for 6 minutes of a flat surface to see how far can 
go. If participants use oxygen when walking, they will use it for this test. As a safety 
precaution, the amount of oxygen in their blood will be measured using a pulse oximeter, 
which is a small device that attaches to the index finger. 
• Blood Draw: Fasting blood sample will be collected to measure systemic markers of 
inflammation and oxidation, and it will include a complete blood count with differential (CBC 
with diff) to assess effects of pollution and air cleaners on inflammatory profile.  
7. Telephone Calls 
01 call (during the 1 month run-in period) for Motivational Interviewing for smoking 
cessation: All participants will receive 1 call for smoking cessation prior to randomization. 
Additional counseling sessions will be scheduled for any participant or family member(s) interested 
in smoking cessation during this period.  

 
 
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04 calls (between randomization and the 3 month-follow-up) for Motivational Interviewing 
for home/car smoking ban (HCSB): The MI-component of the intervention will be adapted from 
the PRIDE phone-based MI intervention and delivered by a health coach. Each participant will 
receive 4 phone sessions between baseline and the 3 month visit focused on implementing a home 
smoking ban. All participants regardless of randomization group will receive the 4 phone call 
sessions (between baseline and the 3 month clinic visit) focused on smoking cessation counseling. 
Only participants randomized to the active group will receive the additional Motivational 
Interviewing for HCSB during the calls.  
04 Monthly calls (from randomization to 6 month-follow up) to assess Exacerbations and 
Health Care Utilization: Information on unscheduled doctor visits, emergency room visits, and 
days hospitalized, and intensive care unit admissions will be collected at each visit from all 
participants and by monthly telephone calls.  
03 Monthly Follow up calls (after final home visit) Individuals will also be contacted monthly 
for 3 months after the final home visit by study coordinators, in order to ascertain whether 
exacerbation events were experienced by participants. The Telephone Exacerbation questionnaire 
that will be administered, will take about 5 minutes.  
8. Study duration and number of study visits required of research participants.  
The study duration is 5 years and each subject will be enrolled for 9 months.  There will be one 
screening assessment visit and one home air quality assessment visit (if applicable) prior to 
enrollment, 1 month of run-in period (including two MI sessions) and 3 home monitoring visits 
preceding 3 follow-up clinical visits.  
9. Justification for inclusion of a placebo or non-treatment group. 
Randomization: At the conclusion of the run-in period, subjects enrolled will be randomly 
assigned to one of two treatment arms: 1) active air cleaners and MI for SHS reduction (n=60) and 
2) placement of sham air cleaners and continued smoking cessation counseling (n=60). 
Randomization will be stratified by season and will be performed by block to assure equal sized 
populations in each arm. This strategy also will ensure that each group is balanced with respect to 
season of randomization. 
10. Treatment Groups. 
1) Active Treatment arm: The active treatment arm will receive two active air cleaners with HEPA 
filters 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). 
Rationale:  Two air cleaners will be deployed in the home to be consistent with our previous trials 
that have successfully reduced PM and improved respiratory morbidity.  Air cleaners will have 
HEPA filters which remove PM. As portable air cleaners have not shown efficacy in reducing 
SHS exposure this intervention also targets a home smoking ban for both SHS and PM reduction, 
in order to provide greatest reduction in pollutant exposure and maximize ability to show that air 
quality improvement can improve health in smokers. 
 
Active air cleaner: Air cleaners containing HEPA and capable of removing PM filter will be placed 
in the bedroom and room where the participant reports spending the most time. Air cleaners are 

 
 
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suitably sized to provide clean air delivery rates for the rooms in which they will be placed. 
Participants will be instructed to run the air cleaners continually during the course of the study. 
Filtering elements will be maintained and changed based on manufacturer’s instructions by study 
staff. Data logging current meters will be used to determine the total time of air cleaner use. The 
meters, inserted inside the air cleaner to avoid tampering, sense the change in electric current 
associated with turning the air cleaners on /off and record the time/date for each on/off event. 
Families will be informed that air cleaner use is monitored. 
 
Motivational Interviewing for home/car smoking ban (HCSB): The MI-component of the 
intervention will be adapted from the PRIDE phone-based MI intervention and delivered by a health 
coach. Each participant will receive 4 phone sessions between baseline and the 3 month visit focused 
on implementing a home smoking ban and additional counseling sessions will be scheduled for any 
participant or family member(s) interested in smoking cessation. Participants will be paid $25 for 
completing all four sessions to ensure completion. These incentives are provided regardless of 
behavior change and are included in this efficacy study to evaluate whether a full dose of 
intervention results in meaningful changes in behavior.   
2) Control Arm: the Control arm will receive sham air cleaners and continued counseling for smoking 
cessation. A control arm is needed to ensure that reduced pollutant levels and health effects are not 
due to temporal trends and ‘placebo effects’ of being enrolled in an intervention trial. 
 Sham Air Cleaner.  Homes in the control group will receive sham air cleaners that have the internal 
HEPA filters removed, but which will run normally, including similar noise, airflow and overall 
appearance compared to active air cleaners, thus blinding participants to filter status. We will use 
tamper-proof fasteners to replace conventional screws to prevent tampering with the air cleaner or 
opening by participants to learn if filters are in place. In our previous studies, compliance with active 
and sham air cleaners have been similar suggesting adequate blinding to the sham. At the end of the 
study, all participants will receive active air cleaners. 
Smoking Cessation counseling and Nicotine Replacement Therapy (NRT): Smoking Cessation 
counseling will be offered to all eligible participants throughout the study. Study will offer NRT to all 
participants during the Run-In period. If participants would like to continue NRT after the Run-In period 
they will be referred to the community resources provided during the Motivational Interviewing session. 
Participants in the control group will receive 4 sessions of education smoking cessation counseling as 
an attention control condition. Cognitive based therapy will be provided to participants and will focus 
on anticipating triggers for relapse and developing coping strategies to deal with withdrawal. Problem 
solving and skills training will be integrated to support cessation. Participants will be paid $25 for 
completing all four sessions to ensure completion. These incentives are provided regardless of behavior 
change and are included in this efficacy study to evaluate whether a full dose of intervention results in 
meaningful changes in behavior.  
11.  Definition of treatment failure or participant removal criteria.  
 
Participants may be removed from the study early if they are not living in their home during the           
      study time (including admission to the hospital).  In these cases, monitoring of the home     
        
      environment would not reflect exposure.  
12. Description of what happens to participants receiving therapy when study ends or if a participant’s 
participation in the study ends prematurely.  

 
 
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At the end of the study, participants in the control group will also receive active air cleaners. 
13. Inclusion/Exclusion Criteria 
Inclusion Criteria:  
1) Age ≥ 40 years,  
2) Physician diagnosis of COPD,  
3) GOLD Stage II-IV disease with (post-bronchodilator) FEV1/FVC < 70% and FEV1 (% predicted)   
< 80%. IF FEV1/FVC <70% and FEV1 (% predicted) ≥ 80%, additional requirement will apply/will 
be asked: CAT score ≥ 10 OR exacerbation history during the last 12 months. Also, IF available for 
screening purposes: participant can provide a previous PFT report within the last 6 months. 
4) Tobacco exposure ≥ 10 pack-years, and  
5) Current smoker with an eCO ≥ 7 ppm to confirm smoking status (Deveci Erhan S., et al, 2004). We 
will employ a combination of self-report and a biochemical marker to identify former-smokers.  
Exhaled CO (eCO) and salivary cotinine will be used as a marker of smoking status, as they are easy 
to perform, provides immediate data and is non-invasive (If no eCO performed due to COVID-19 
pandemic safety reasons, we will rely on self-report smoking status and self-report 7-day abstinence 
questionnaire answers).  
6) No home smoking ban. IF smoking is not allowed indoor (inside participant’s home) then a “home 
air quality assessment visit” will be done. MIE PM ≥ 10 mcg/m3 at home air quality assessment visit 
will apply for enrollment (see also 4.a.2). In the case, where we register MIE values borderlines (8-
10), we will repeat the MIE assessment if the participant agree.  
 
Exclusion criteria for all participants will include:  
1) Chronic systemic corticosteroids, equivalent to > 10 mg of daily prednisone continuously for ≥ 3 
months in the past 12 months,  
2) Other chronic lung disease, except those with history of asthma if it felt by the investigator not to 
be a primary diagnosis.   
3) Living in location other than home (e.g., long term care facility) and  
4) Home owner or home occupant planning to move or change residence within the study period. 
5) Air Cleaners drop off (home visits temporary criteria due to COVID-19): if participant is unable to 
bring air cleaners inside the home and setting them up or if no one else living in the home can help, 
the baseline visit will be rescheduled or cancel to a later time.