Air Pollution, Risk Reduction BehaviorsNCT04563052
Measuring Knowledge and Behavior After an Educational Program on Air Pollution as a Health Risk Reduction Strategy
A study testing Educational Program on Air Pollution as a Health Risk Reduction Strategy in people with Air Pollution, Risk Reduction Behaviors, run by Villanova University at 1 site in United States.
Trial summary
Since air pollution contains harmful toxicants, it is important for potential exposure to indoor and outdoor air pollution to be considered as part of an overall health risk reduction strategy. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Air Pollution, Risk Reduction Behaviors
- What is being tested?
- Educational Program on Air Pollution as a Health Risk Reduction Strategy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jan 2020to 15 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Over the age of 18, speak and read English, have access to a computer or smart phone with Internet access.
Who cannot join
- Anyone not meeting Inclusion Criteria.
Trial locations and contacts
1 site in 1 country.
About this study
Since air pollution contains harmful toxicants, it is important for potential exposure to indoor and outdoor air pollution to be considered as part of an overall health risk reduction strategy. This is a behavioral intervention to assess the effectiveness on an air quality education program in reducing exposure to air pollution and negative health effects. Trial participants will complete a pre-test and home air quality assessment tool. Then, they will participate in an educational module on air quality learn about suggestions to take to avoid exposure and complete a spot test. One month after the educational intervention, the participants will be contacted and asked qualitative questions to assess study effectiveness.
Read the detailed description
Potential exposure to indoor and outdoor air pollution must be considered as part of an overall health risk reduction strategy. Toxicants identified in outdoor air pollution, fine particulate matter (PM2.5), and photochemical ozone cause a systemic inflammatory response to the heart and lungs after exposure. Inside the home, health issues from exposure to carbon monoxide (CO), PM2.5, nitrogen dioxide (NO2) and volatile organic compounds (VOC) are intensified when the home is sealed with the windows and doors closed. This exploratory study seeks to promote health by teaching participants about strategies to reduce risks related to indoor and outdoor effects of air pollution.
Data collection will consist of an electronic demographic data collection form, home air quality assessment, pre-test and post-test around an educational program and follow-up interview one month after the educational program. Avoidance of air pollution as a health risk reduction method is identified in the literature, however, there is limited research addressing the influence of education on avoidance of environmental toxins as a health risk reduction strategy. Therefore this study will provide a foundation for developing broader educational and behavioral initiatives to improve health outcomes. Due to the COVID-19 pandemic, all aspects of this study will be completed either on-line via the Internet or by telephone.
- Conditions
- Air Pollution, Risk Reduction Behaviors
- Being tested
- Educational Program on Air Pollution as a Health Risk Reduction Strategy
- Medical subject headings
- Risk Reduction Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational Program on Air Pollution as a Health Risk Reduction StrategyBehavioural
A power point presentation about the health impact of exposure to fine particulate matter (PM2.5) on health. Pm2.5 is found outdoors and indoors. Information will be reviewed about steps to take for the participants to locate the information using a smart phone and steps to take to decrease exposure to prevent illness such as heart disease or strokes.
| Study group | Role | What they receive |
|---|---|---|
| Education | Experimental | Air pollution educational module exposure. Receives: Behavioral: Educational Program on Air Pollution as a Health Risk Reduction Strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Understanding of Educational Intervention
Participants will be evaluated to determine if they understand the impact of air pollution on health, know how to interpret air quality index information, and how to reduce indoor air pollution.
Measured: At completion of intervention (one day)
Implementation of Learned Behaviors During Educational Intervention
Participants will be assessed for long term understanding of educational intervention and how they have altered their behavior.
Measured: One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2020
- Study start28 Jan 2020
- Primary completion15 Feb 2021
- Study completion15 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Air Pollution, Risk Reduction BehaviorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Villanova University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mary E Kloster, MSN, RN, Principal investigator, Villanova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04563052
- Sponsor's protocol ID
- IRB-FY-2020-133
- Status last verified
- Feb 2021
- First submitted
- 8 Sep 2020
- Last updated
- 17 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abelsohn A, Stieb DM. Health effects of outdoor air pollution: approach to counseling patients using the Air Quality Health Index. Can Fam Physician. 2011 Aug;57(8):881-7, e280-7.
PubMed 21841106Brook RD, Franklin B, Cascio W, Hong Y, Howard G, Lipsett M, Luepker R, Mittleman M, Samet J, Smith SC Jr, Tager I; Expert Panel on Population and Prevention Science of the American Heart Association. Air pollution and cardiovascular disease: a statement for healthcare professionals from the Expert Panel on Population and Prevention Science of the American Heart Association. Circulation. 2004 Jun 1;109(21):2655-71. doi: 10.1161/01.CIR.0000128587.30041.C8.
PubMed 15173049Cascio WE, Davis A, Stone SL. The Green Heart Initiative: using air quality information to reduce adverse health effects in patients with heart and vascular disease. J Cardiovasc Nurs. 2013 Sep-Oct;28(5):401-4. doi: 10.1097/JCN.0b013e318295d1ae. No abstract available.
PubMed 23938326Chen R, Zhao A, Chen H, Zhao Z, Cai J, Wang C, Yang C, Li H, Xu X, Ha S, Li T, Kan H. Cardiopulmonary benefits of reducing indoor particles of outdoor origin: a randomized, double-blind crossover trial of air purifiers. J Am Coll Cardiol. 2015 Jun 2;65(21):2279-87. doi: 10.1016/j.jacc.2015.03.553.
PubMed 26022815Di Q, Wang Y, Zanobetti A, Wang Y, Koutrakis P, Choirat C, Dominici F, Schwartz JD. Air Pollution and Mortality in the Medicare Population. N Engl J Med. 2017 Jun 29;376(26):2513-2522. doi: 10.1056/NEJMoa1702747.
PubMed 28657878Farmer SA, Nelin TD, Falvo MJ, Wold LE. Ambient and household air pollution: complex triggers of disease. Am J Physiol Heart Circ Physiol. 2014 Aug 15;307(4):H467-76. doi: 10.1152/ajpheart.00235.2014.
PubMed 24929855Laumbach R, Meng Q, Kipen H. What can individuals do to reduce personal health risks from air pollution? J Thorac Dis. 2015 Jan;7(1):96-107. doi: 10.3978/j.issn.2072-1439.2014.12.21.
PubMed 25694820Ruckerl R, Schneider A, Breitner S, Cyrys J, Peters A. Health effects of particulate air pollution: A review of epidemiological evidence. Inhal Toxicol. 2011 Aug;23(10):555-92. doi: 10.3109/08958378.2011.593587. No abstract available.
PubMed 21864219Seltenrich N. Take care in the kitchen: avoiding cooking-related pollutants. Environ Health Perspect. 2014 Jun;122(6):A154-9. doi: 10.1289/ehp.122-A154. No abstract available.
PubMed 24892412Zhang Z, Laden F, Forman JP, Hart JE. Long-Term Exposure to Particulate Matter and Self-Reported Hypertension: A Prospective Analysis in the Nurses' Health Study. Environ Health Perspect. 2016 Sep;124(9):1414-20. doi: 10.1289/EHP163. Epub 2016 May 13.
PubMed 27177127
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring Knowledge and Behavior After an Educational Program on Air Pollution as a Health Risk Reduction Strategy
- ClinicalTrials.gov ID
- NCT04563052
- Acronym / sponsor ID
- IRB-FY-2020-133
- Conditions
- Air Pollution, Risk Reduction Behaviors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Villanova UniversityUniversity, hospital or other
- Study start
- 28 Jan 2020 (actual)
- Primary completion
- 15 Feb 2021 (actual)
- Study completion
- 15 Feb 2021 (actual)
- First posted
- 24 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Since air pollution contains harmful toxicants, it is important for potential exposure to indoor and outdoor air pollution to be considered as part of an overall health risk reduction strategy. This is a behavioral intervention to assess the effectiveness on an air quality education program in reducing exposure to air pollution and negative health effects. Trial participants will complete a pre-test and home air quality assessment tool. Then, they will participate in an educational module on air quality learn about suggestions to take to avoid exposure and complete a spot test. One month after the educational intervention, the participants will be contacted and asked qualitative questions to assess study effectiveness.
Detailed description
Potential exposure to indoor and outdoor air pollution must be considered as part of an overall health risk reduction strategy. Toxicants identified in outdoor air pollution, fine particulate matter (PM2.5), and photochemical ozone cause a systemic inflammatory response to the heart and lungs after exposure. Inside the home, health issues from exposure to carbon monoxide (CO), PM2.5, nitrogen dioxide (NO2) and volatile organic compounds (VOC) are intensified when the home is sealed with the windows and doors closed. This exploratory study seeks to promote health by teaching participants about strategies to reduce risks related to indoor and outdoor effects of air pollution.
Data collection will consist of an electronic demographic data collection form, home air quality assessment, pre-test and post-test around an educational program and follow-up interview one month after the educational program. Avoidance of air pollution as a health risk reduction method is identified in the literature, however, there is limited research addressing the influence of education on avoidance of environmental toxins as a health risk reduction strategy. Therefore this study will provide a foundation for developing broader educational and behavioral initiatives to improve health outcomes. Due to the COVID-19 pandemic, all aspects of this study will be completed either on-line via the Internet or by telephone.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Education | Experimental | Behavioral: Educational Program on Air Pollution as a Health Risk Reduction StrategyAir pollution educational module exposure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Over the age of 18, speak and read English, have access to a computer or smart phone with Internet access.
Key exclusion criteria (1 listed)
- Anyone not meeting Inclusion Criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational Program on Air Pollution as a Health Risk Reduction StrategyA power point presentation about the health impact of exposure to fine particulate matter (PM2.5) on health. Pm2.5 is found outdoors and indoors. Information will be reviewed about steps to take for the participants to locate the information using a smart phone and steps to take to decrease exposure to prevent illness such as heart disease or strokes. | Behavioural | Education |
Primary outcome
Assessment of Understanding of Educational Intervention
Time frame: At completion of intervention (one day)
Participants will be evaluated to determine if they understand the impact of air pollution on health, know how to interpret air quality index information, and how to reduce indoor air pollution.
Implementation of Learned Behaviors During Educational Intervention
Time frame: One month
Participants will be assessed for long term understanding of educational intervention and how they have altered their behavior.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2021.
- Background: PubMed 21841106Abelsohn A, Stieb DM. Health effects of outdoor air pollution: approach to counseling patients using the Air Quality Health Index. Can Fam Physician. 2011 Aug;57(8):881-7, e280-7.
- Background: PubMed 15173049Brook RD, Franklin B, Cascio W, Hong Y, Howard G, Lipsett M, Luepker R, Mittleman M, Samet J, Smith SC Jr, Tager I; Expert Panel on Population and Prevention Science of the American Heart Association. Air pollution and cardiovascular disease: a statement for healthcare professionals from the Expert Panel on Population and Prevention Science of the American Heart Association. Circulation. 2004 Jun 1;109(21):2655-71. doi: 10.1161/01.CIR.0000128587.30041.C8.
- Background: PubMed 23938326Cascio WE, Davis A, Stone SL. The Green Heart Initiative: using air quality information to reduce adverse health effects in patients with heart and vascular disease. J Cardiovasc Nurs. 2013 Sep-Oct;28(5):401-4. doi: 10.1097/JCN.0b013e318295d1ae. No abstract available.
- Background: PubMed 26022815Chen R, Zhao A, Chen H, Zhao Z, Cai J, Wang C, Yang C, Li H, Xu X, Ha S, Li T, Kan H. Cardiopulmonary benefits of reducing indoor particles of outdoor origin: a randomized, double-blind crossover trial of air purifiers. J Am Coll Cardiol. 2015 Jun 2;65(21):2279-87. doi: 10.1016/j.jacc.2015.03.553.
- Background: PubMed 28657878Di Q, Wang Y, Zanobetti A, Wang Y, Koutrakis P, Choirat C, Dominici F, Schwartz JD. Air Pollution and Mortality in the Medicare Population. N Engl J Med. 2017 Jun 29;376(26):2513-2522. doi: 10.1056/NEJMoa1702747.
- Background: PubMed 24929855Farmer SA, Nelin TD, Falvo MJ, Wold LE. Ambient and household air pollution: complex triggers of disease. Am J Physiol Heart Circ Physiol. 2014 Aug 15;307(4):H467-76. doi: 10.1152/ajpheart.00235.2014.
- Background: PubMed 25694820Laumbach R, Meng Q, Kipen H. What can individuals do to reduce personal health risks from air pollution? J Thorac Dis. 2015 Jan;7(1):96-107. doi: 10.3978/j.issn.2072-1439.2014.12.21.
- Background: PubMed 21864219Ruckerl R, Schneider A, Breitner S, Cyrys J, Peters A. Health effects of particulate air pollution: A review of epidemiological evidence. Inhal Toxicol. 2011 Aug;23(10):555-92. doi: 10.3109/08958378.2011.593587. No abstract available.
- Background: PubMed 24892412Seltenrich N. Take care in the kitchen: avoiding cooking-related pollutants. Environ Health Perspect. 2014 Jun;122(6):A154-9. doi: 10.1289/ehp.122-A154. No abstract available.
- Background: PubMed 27177127Zhang Z, Laden F, Forman JP, Hart JE. Long-Term Exposure to Particulate Matter and Self-Reported Hypertension: A Prospective Analysis in the Nurses' Health Study. Environ Health Perspect. 2016 Sep;124(9):1414-20. doi: 10.1289/EHP163. Epub 2016 May 13.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary E Kloster, MSN, RN principal investigator
Villanova University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Program on Air Pollution as a Health Risk Reduction Strategy in people with Air Pollution, Risk Reduction Behaviors, run by Villanova University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of Understanding of Educational Intervention (time frame: At completion of intervention (one day)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04563052, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2021.