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Motivational Interviewing + Air Cleaners for COPD (MOVE-COPD Trial)
N/A
Waitlist Available
Led By Nadia N Hansel, MD
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age ≥ 40 years
Physician diagnosis of COPD
Must not have
Chronic systemic corticosteroids
Other chronic lung disease including asthma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 3 month and 6 months post-randomization
Summary
This trial will test whether reducing indoor air pollution for smokers with COPD will improve their respiratory outcomes.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this trial involves non-medical interventions like air cleaners and counseling sessions, there are no direct side effects from medications or procedures. However, any changes in behavior or environment may indirectly affect participants' well-being.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 40 years old or older.
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My doctor has diagnosed me with COPD.
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My lung condition is moderate to very severe based on breathing tests.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am on long-term steroids for another condition.
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I have a chronic lung condition, such as asthma.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 3 month and 6 months post-randomization
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 3 month and 6 months post-randomization
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Dyspnea as assessed by the University of California San Diego Shortness of Breath Questionnaire (SDSOBQ)
Change in Quality of Life
Secondary study objectives
Change in COPD health status
Change in Dyspnea as assessed by modified medical research Council questionnaire(mMRC)
Change in aggregate Health Care Utilization (number of episodes reported due to COPD-related exacerbation)
+2 moreOther study objectives
Change in Markers of oxidative stress in urine (8-isoprostane)
Change in Systemic markers of inflammation in serum (C-reactive protein)
Change in Systemic markers of inflammation in serum (Interleukin-8)
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Active TreatmentActive Control2 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 ArmPlacebo Group1 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.
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Who is running the clinical trial?
National Institute of Environmental Health Sciences (NIEHS)NIH
290 Previous Clinical Trials
1,232,752 Total Patients Enrolled
Johns Hopkins UniversityLead Sponsor
2,321 Previous Clinical Trials
14,873,788 Total Patients Enrolled
Nadia N Hansel, MDPrincipal InvestigatorJohns Hopkins University
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You are currently a smoker and have a high level of carbon monoxide in your breath.I am on long-term steroids for another condition.I have a chronic lung condition, such as asthma.I am 40 years old or older.My doctor has diagnosed me with COPD.My lung condition is moderate to very severe based on breathing tests.You have smoked a pack of cigarettes every day for at least 10 years.
Research Study Groups:
This trial has the following groups:- Group 1: Control Arm
- Group 2: Active Treatment
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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