Pollution; ExposureNCT03675009
Milwaukee Day Cares Indoor Air Quality Assessment and Educational Response Study
A study testing Educational Programming in people with Pollution; Exposure, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
This CTSI pilot study will assess for benefit of a community health worker or nursing student taught green cleaning curriculum (developed by the local asthma coalition) provided to Milwaukee County day care staff. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pollution; Exposure
- What is being tested?
- Educational Programming
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2018to 19 Apr 2019
- 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
- licensed child day care staff within Milwaukee County
- authorized consent to participate in study by day care organization
Who cannot join
- medical or adult day care centers
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
About this study
This CTSI pilot study will assess for benefit of a community health worker or nursing student taught green cleaning curriculum (developed by the local asthma coalition) provided to Milwaukee County day care staff. Consumer grade indoor air quality monitors will be deployed before and after the educational intervention to objectively monitor changes as a result of the intervention. Surveys regarding changes in cleaning practices by day care staff will also be obtained to assess changes resulting from the intervention.
Read the detailed description
A research and community service partnership of the Medical College of Wisconsin, the Univ. of Wisconsin-Milwaukee School of Nursing and the non-profit asthma coalition Fight Asthma Milwaukee Allies (FAM) was developed to describe and improve health relevant air quality conditions within urban Milwaukee daycare environments. Daycare air quality and the ability of education to improve air quality, both within Milwaukee and elsewhere, has not been extensively studied nor addressed in Wisconsin state law to date.
This project aims to understand the levels of indoor organic pollution and fine particles in the air, as well as temperature and humidity with using inexpensive, consumer-grade, internet cloud enabled continuous indoor air quality (IAQ) monitors. These air quality variables are scientifically established important risk factors for both the development and exacerbation of asthma.
This project aims to train UWM Nursing students, FAM Allies volunteers and MCW staff to teach an established educational programing curriculum developed by FAM Allies to daycare staff. Daycare programs may be motivated to participate in study as the curriculum is approved continuing education credits for daycare staff members.
The FAM Allies curriculum will address understanding of the importance of asthma and IAQ with irritant reduction measures, and safer cleaning and pest-control techniques. Additionally, the program will review the importance of IAQ upon the lungs and review knowledge about asthma.
The proposal is a 4-month intervention in which the IAQ monitor will be placed in daycares to obtain baseline measurements. Half of the facilities will receive education at the second month allowing the team to assess before and after education air quality readings. The rest of the facilities will receive the same education at the third month. After 4 months, the devices will be removed from the facilities and results in aggregate will be shared with the daycare.
- Conditions
- Pollution; Exposure
- Being tested
- Educational Programming
- Keywords
- Child Day Care Centers, Indoor Air Quality, Educational Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational ProgrammingOther
Green Cleaning educational programming to day care staff.
| Study group | Role | What they receive |
|---|---|---|
| Early Intervention | Other | Educational curriculum will be delivered earlier in the timeframe after IAQ monitoring has initiated. Receives: Other: Educational Programming |
| Late Intervention | Other | Educational curriculum will be delivered later in the timeframe after IAQ monitoring has initiated. Receives: Other: Educational Programming |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alterations in total Volatile Organic Compounds (tVOC) temporally associated with the educational intervention
Assessment of tVOC levels (ppb) before and after educational intervention, reduction an intended effect of the curriculum
Measured: baseline through 4 months
Alterations in particulate matter (PM2.5) temporally associated with the educational intervention
Assessment of particulate matter 2.5um levels (PM2.5, ug/m3) before and after educational intervention; reduction an intended effect of the curriculum
Measured: baseline through 4 months
Secondary outcomes (5)
Assessment of Cleaning Practices (including VOC generation) practice changes associated with the Educational Intervention
Quantitative before/after surveys of Day Care cleaning behavior practices before the educational intervention and up to 4 months following, via survey inventories (practice frequencies assessed with 5 tiers survey, range: everyday to never); completed by a single designated Day Care administrator
Measured: before educational curriculum, up to 4 months following educational intervention
Assessment of Perceived Obstacles to Cleaning Behavior Change
Survey-based assessment of beliefs about Obstacles to Cleaning Behavior Change (ranked survey with 8 domains, scale 1-8 of importance); all child care staff participating in educational intervention
Measured: immediately following educational intervention
Assessment of Percieved Quality of Educational Program
Survey-based assessment of beliefs about Quality of Educational Program (survey with ranked scale poor/neutral/good, 5 domains), pre-specified subgroup analysis based upon teacher type (nursing student, Americorp worker, professional asthma educator)
Measured: immediately following educational intervention
Baseline Description of Day Care Indoor Air Quality tVOC
Assessment of tVOC (ppb) averages and range before educational interventions; observed values before curriculum to establish baseline values in community, to assess if elevated values are associated with specific cleaning behaviors discouraged in the educational curriculum
Measured: period of time before educational intervention (1-2 months)
Baseline Description of Day Care Indoor Air Quality PM2.5
Assessment of PM2.5 (ug/m3) averages and range before educational interventions; observed values before curriculum to establish baseline values in community, to assess if elevated values are associated with specific cleaning behaviors discouraged in the educational curriculum
Measured: period of time before educational intervention (1-2 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2018
- Study start1 Apr 2018
- Primary completion31 Mar 2019
- Study completion19 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pollution; ExposureStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- stepped wedge
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Collaborators
- University of Wisconsin, Milwaukee
- Responsible party
- Principal investigator, Joshua Steinberg, Medical College of Wisconsin
- Investigators
- Anne Dressel, PhD, Principal investigator, University of Wisconsin-Milwaukee School of NursingJoshua Steinberg, MD, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03675009
- Sponsor's protocol ID
- 5520466
- Status last verified
- Apr 2019
- First submitted
- 10 Jul 2018
- Last updated
- 22 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Milwaukee Day Cares Indoor Air Quality Assessment and Educational Response Study
- ClinicalTrials.gov ID
- NCT03675009
- Acronym / sponsor ID
- 5520466
- Conditions
- Pollution; Exposure
- Keywords
- Child Day Care Centers, Indoor Air Quality, Educational Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Collaborators
- University of Wisconsin, Milwaukee
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 31 Mar 2019 (actual)
- Study completion
- 19 Apr 2019 (actual)
- First posted
- 18 Sep 2018 (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.
This CTSI pilot study will assess for benefit of a community health worker or nursing student taught green cleaning curriculum (developed by the local asthma coalition) provided to Milwaukee County day care staff. Consumer grade indoor air quality monitors will be deployed before and after the educational intervention to objectively monitor changes as a result of the intervention. Surveys regarding changes in cleaning practices by day care staff will also be obtained to assess changes resulting from the intervention.
Detailed description
A research and community service partnership of the Medical College of Wisconsin, the Univ. of Wisconsin-Milwaukee School of Nursing and the non-profit asthma coalition Fight Asthma Milwaukee Allies (FAM) was developed to describe and improve health relevant air quality conditions within urban Milwaukee daycare environments. Daycare air quality and the ability of education to improve air quality, both within Milwaukee and elsewhere, has not been extensively studied nor addressed in Wisconsin state law to date.
This project aims to understand the levels of indoor organic pollution and fine particles in the air, as well as temperature and humidity with using inexpensive, consumer-grade, internet cloud enabled continuous indoor air quality (IAQ) monitors. These air quality variables are scientifically established important risk factors for both the development and exacerbation of asthma.
This project aims to train UWM Nursing students, FAM Allies volunteers and MCW staff to teach an established educational programing curriculum developed by FAM Allies to daycare staff. Daycare programs may be motivated to participate in study as the curriculum is approved continuing education credits for daycare staff members.
The FAM Allies curriculum will address understanding of the importance of asthma and IAQ with irritant reduction measures, and safer cleaning and pest-control techniques. Additionally, the program will review the importance of IAQ upon the lungs and review knowledge about asthma.
The proposal is a 4-month intervention in which the IAQ monitor will be placed in daycares to obtain baseline measurements. Half of the facilities will receive education at the second month allowing the team to assess before and after education air quality readings. The rest of the facilities will receive the same education at the third month. After 4 months, the devices will be removed from the facilities and results in aggregate will be shared with the daycare.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- stepped wedge
| Arm | Type | Receives |
|---|---|---|
| Early Intervention | Other | Other: Educational ProgrammingEducational curriculum will be delivered earlier in the timeframe after IAQ monitoring has initiated. |
| Late Intervention | Other | Other: Educational ProgrammingEducational curriculum will be delivered later in the timeframe after IAQ monitoring has initiated. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- licensed child day care staff within Milwaukee County
- authorized consent to participate in study by day care organization
Key exclusion criteria (1 listed)
- medical or adult day care centers
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 ProgrammingGreen Cleaning educational programming to day care staff. | Other | Early Intervention, Late Intervention |
Primary outcome
Alterations in total Volatile Organic Compounds (tVOC) temporally associated with the educational intervention
Time frame: baseline through 4 months
Assessment of tVOC levels (ppb) before and after educational intervention, reduction an intended effect of the curriculum
Alterations in particulate matter (PM2.5) temporally associated with the educational intervention
Time frame: baseline through 4 months
Assessment of particulate matter 2.5um levels (PM2.5, ug/m3) before and after educational intervention; reduction an intended effect of the curriculum
5 secondary outcomes
Assessment of Cleaning Practices (including VOC generation) practice changes associated with the Educational Intervention
Time frame: before educational curriculum, up to 4 months following educational intervention
Assessment of Perceived Obstacles to Cleaning Behavior Change
Time frame: immediately following educational intervention
Assessment of Percieved Quality of Educational Program
Time frame: immediately following educational intervention
Baseline Description of Day Care Indoor Air Quality tVOC
Time frame: period of time before educational intervention (1-2 months)
Baseline Description of Day Care Indoor Air Quality PM2.5
Time frame: period of time before educational intervention (1-2 months)
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 22 Apr 2019.
- Individual participant dataSharing planned: Undecided
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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.
Anne Dressel, PhD principal investigator
University of Wisconsin-Milwaukee School of Nursing
Joshua Steinberg, MD principal investigator
Medical College of Wisconsin
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 Programming in people with Pollution; Exposure, run by Medical College of Wisconsin 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 2 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 22 Apr 2019. 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?
Alterations in total Volatile Organic Compounds (tVOC) temporally associated with the educational intervention (time frame: baseline through 4 months). 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?
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 22 Apr 2019.