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

COPD, Chronic Obstructive Pulmonary Disease Clinical Trial

— MOVE-COPD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03658538
• Other study ID #: IRB00185955
• Status: Recruiting
• Phase: N/A
• Start date: June 3, 2019
• Est. completion date: December 2024

Study information

• Verified date: June 2023
• Source: Johns Hopkins University
• Contact: Wendy Lorizio, MD, MPH
• Phone: 4105502449
• Email: wlorizi1[@]jhmi.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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: 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 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).

Related Conditions & MeSH terms

• COPD, Chronic Obstructive Pulmonary Disease
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Device:
• 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.

Behavioral:
• 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.

Device:
• Sham Air Cleaner
The Control arm will receive sham air cleaners

Locations

Country	Name	City	State
United States	Johns Hopkins Bayview Campus	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Systemic markers of inflammation in serum (Interleukin-1 beta)	Interleukin-1 beta concentration in serum (units/mg)	Baseline and 6 months
Other	Change in Systemic markers of inflammation in serum (C-reactive protein)	C-reactive protein concentration in serum will be expressed in: mg/l	Baseline and 6 months
Other	Change in Markers of oxidative stress in urine (8-isoprostane)	8-isoprostane concentration in urine (pg/ml)	Baseline and 6 months
Other	Change in Markers of inflammation in induced sputum (neutrophils count differential)	The induced sputum supernatant will be stored and frozen for comparison on cell count differential (neutrophils)	Baseline and 6 months
Primary	Change in COPD health status	COPD health status will be assessed with the COPD assessment test (CAT). The total score is from 0 to 40. Higher scores indicate worse COPD control.	Baseline and 6 months
Primary	Change in Quality of Life	St. George's Respiratory Questionnaire (SGRQ). The total score is from 0 to 100. Higher scores indicate more limitations	Baseline and 6 months
Primary	Change in Dyspnea as assessed by the University of California San Diego Shortness of Breath Questionnaire (SDSOBQ)	Dyspnea will be assessed using the University of California San Diego Shortness of Breath Questionnaire (SDSOBQ). The SDSOBQ scoring will range from 0 to 120 (with higher scores indicating greater difficulty breathing).	Baseline and 6 months
Secondary	Change in Dyspnea as assessed by modified medical research Council questionnaire(mMRC)	Dyspnea will be assessed using the modified medical research Council questionnaire(mMRC). The total score is from 0 (no dyspnea) to 2 (severe dyspnea).is from 0 to 40. Higher scores indicate worse COPD control	Change from baseline and 6 months post-randomization
Secondary	Change in aggregate Health Care Utilization (number of episodes reported due to COPD-related exacerbation)	We will administer a questionnaire to collect participant's self report of Health Care Utilization (HCU) episodes due to COPD-related exacerbation (including need for oral corticosteroids or antibiotics for worsening respiratory symptoms, emergency department (ED) visit or hospitalization). This questionnaire will be administered at baseline and during the 6 months of follow-up. Report of HCU due to COPD-related exacerbation will be collected at baseline, at 3 and at 6 month clinic visits. The aggregate HCU number could range from 0 (zero/none event reported) to 1 or more episodes reported during the last 3 months.	Baseline, 3 month and 6 months post-randomization
Secondary	Lung Function as assessed by Forced Expiratory Volume in 1 second (FEV1%)	Pulmonary function testing will be assessed as FEV1% predicted, that is FEV1, adjusted for age, height, race and sex	Baseline and 6 months