- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03675009
Milwaukee Day Cares Indoor Air Quality Assessment and Educational Response Study
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Wisconsin
-
Milwaukee, Wisconsin, United States, 53226
- Medical College of Wisconsin
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- licensed child day care staff within Milwaukee County
- authorized consent to participate in study by day care organization
Exclusion Criteria:
- medical or adult day care centers
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Early Intervention
Educational curriculum will be delivered earlier in the timeframe after IAQ monitoring has initiated.
|
Green Cleaning educational programming to day care staff.
|
|
Other: Late Intervention
Educational curriculum will be delivered later in the timeframe after IAQ monitoring has initiated.
|
Green Cleaning educational programming to day care staff.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
baseline through 4 months
|
|
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
|
baseline through 4 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
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
|
before educational curriculum, up to 4 months following educational intervention
|
|
Assessment of Perceived Obstacles to Cleaning Behavior Change
Time Frame: immediately following educational intervention
|
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
|
immediately following educational intervention
|
|
Assessment of Percieved Quality of Educational Program
Time Frame: immediately following educational intervention
|
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)
|
immediately following educational intervention
|
|
Baseline Description of Day Care Indoor Air Quality tVOC
Time Frame: period of time before educational intervention (1-2 months)
|
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
|
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)
|
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
|
period of time before educational intervention (1-2 months)
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Anne Dressel, PhD, University of Wisconsin-Milwaukee School of Nursing
- Principal Investigator: Joshua Steinberg, MD, Medical College of Wisconsin
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 5520466
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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