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

Primary Purpose

COPD, Chronic Obstructive Pulmonary Disease

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Active HEPA Air Cleaner
Motivational interviewing
Sham Air Cleaner
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for COPD, Chronic Obstructive Pulmonary Disease

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Johns Hopkins Bayview CampusRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Active Treatment

Control Arm

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

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.
Change in Quality of Life
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)
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

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 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.
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

Full Information

First Posted
August 30, 2018
Last Updated
June 14, 2023
Sponsor
Johns Hopkins University
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1. Study Identification

Unique Protocol Identification Number
NCT03658538
Brief Title
Motivational Interviewing and Air Cleaners for Smokers With COPD (MOVE COPD)
Acronym
MOVE-COPD
Official Title
Motivational Interviewing and Air Cleaners for Smokers With COPD (MOVE COPD)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 3, 2019 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD, Chronic Obstructive Pulmonary Disease

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active Treatment
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Control Arm
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Active HEPA Air Cleaner
Intervention Description
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
Behavioral
Intervention Name(s)
Motivational interviewing
Intervention Description
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
Device
Intervention Name(s)
Sham Air Cleaner
Intervention Description
The Control arm will receive sham air cleaners
Primary Outcome Measure Information:
Title
Change in COPD health status
Description
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.
Time Frame
Baseline and 6 months
Title
Change in Quality of Life
Description
St. George's Respiratory Questionnaire (SGRQ). The total score is from 0 to 100. Higher scores indicate more limitations
Time Frame
Baseline and 6 months
Title
Change in Dyspnea as assessed by the University of California San Diego Shortness of Breath Questionnaire (SDSOBQ)
Description
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).
Time Frame
Baseline and 6 months
Secondary Outcome Measure Information:
Title
Change in Dyspnea as assessed by modified medical research Council questionnaire(mMRC)
Description
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
Time Frame
Change from baseline and 6 months post-randomization
Title
Change in aggregate Health Care Utilization (number of episodes reported due to COPD-related exacerbation)
Description
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.
Time Frame
Baseline, 3 month and 6 months post-randomization
Title
Lung Function as assessed by Forced Expiratory Volume in 1 second (FEV1%)
Description
Pulmonary function testing will be assessed as FEV1% predicted, that is FEV1, adjusted for age, height, race and sex
Time Frame
Baseline and 6 months
Other Pre-specified Outcome Measures:
Title
Change in Systemic markers of inflammation in serum (Interleukin-1 beta)
Description
Interleukin-1 beta concentration in serum (units/mg)
Time Frame
Baseline and 6 months
Title
Change in Systemic markers of inflammation in serum (C-reactive protein)
Description
C-reactive protein concentration in serum will be expressed in: mg/l
Time Frame
Baseline and 6 months
Title
Change in Markers of oxidative stress in urine (8-isoprostane)
Description
8-isoprostane concentration in urine (pg/ml)
Time Frame
Baseline and 6 months
Title
Change in Markers of inflammation in induced sputum (neutrophils count differential)
Description
The induced sputum supernatant will be stored and frozen for comparison on cell count differential (neutrophils)
Time Frame
Baseline and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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: 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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wendy Lorizio, MD, MPH
Phone
4105502449
Email
wlorizi1@jhmi.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nadia N Hansel, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Bayview Campus
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maggie Maly
Phone
410-550-9527
Email
mmaly1@jhmi.edu
First Name & Middle Initial & Last Name & Degree
Nadia N Hansel, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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