Motivational Interviewing and Air Cleaners for Smokers With COPD (MOVE COPD)
- Conditions
- COPD, Chronic Obstructive Pulmonary Disease
- Interventions
- Device: Active HEPA Air CleanerDevice: Sham Air CleanerBehavioral: Motivational interviewing
- Registration Number
- NCT03658538
- Lead Sponsor
- Johns Hopkins University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 144
- 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.
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Active Treatment Active HEPA Air Cleaner 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). Control Arm Sham Air Cleaner 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. Active Treatment Motivational interviewing 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).
- Primary Outcome Measures
Name Time Method Change in Quality of Life Baseline and 6 months St. George's Respiratory Questionnaire (SGRQ). The total score is from 0 to 100. Higher scores indicate more limitations
Change in Dyspnea as assessed by the University of California San Diego Shortness of Breath Questionnaire (SDSOBQ) Baseline and 6 months 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).
- Secondary Outcome Measures
Name Time Method Change in Dyspnea as assessed by modified medical research Council questionnaire(mMRC) Change from baseline and 6 months post-randomization 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 in COPD health status Baseline and 6 months 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.
Change in aggregate Health Care Utilization (number of episodes reported due to COPD-related exacerbation) Baseline, 3 month and 6 months post-randomization 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.
Lung Function as assessed by Forced Expiratory Volume in 1 second (FEV1%) Baseline and 6 months Pulmonary function testing will be assessed as FEV1% predicted, that is FEV1, adjusted for age, height, race and sex
The Clinical COPD Questionnaire (CCQ) Baseline and 6 months The CCQ will be administered to evaluate health status in patients with COPD. The CCQ is a 10-item questionnaire, health-related quality of life questionnaire (HRQoL) with good psychometric properties. The total score ranges from 0 to 6, where a higher scores indicates a worse health status.
Trial Locations
- Locations (1)
Johns Hopkins Bayview Campus
🇺🇸Baltimore, Maryland, United States