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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03675009
Other study ID # 5520466
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 1, 2018
Est. completion date April 19, 2019

Study information

Verified date April 2019
Source Medical College of Wisconsin
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date April 19, 2019
Est. primary completion date March 31, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Educational Programming
Green Cleaning educational programming to day care staff.

Locations

Country Name City State
United States Medical College of Wisconsin Milwaukee Wisconsin

Sponsors (2)

Lead Sponsor Collaborator
Medical College of Wisconsin University of Wisconsin, Milwaukee

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 baseline through 4 months
Primary 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 baseline through 4 months
Secondary 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 before educational curriculum, up to 4 months following educational intervention
Secondary 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 immediately following educational intervention
Secondary 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) immediately following educational intervention
Secondary 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 period of time before educational intervention (1-2 months)
Secondary 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 period of time before educational intervention (1-2 months)
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