- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT03675009
Milwaukee Day Cares Indoor Air Quality Assessment and Educational Response Study
Přehled studie
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
-
Wisconsin
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Milwaukee, Wisconsin, Spojené státy, 53226
- Medical College of Wisconsin
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Výzkum zdravotnických služeb
- Přidělení: Randomizované
- Intervenční model: Sekvenční přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Jiný: Early Intervention
Educational curriculum will be delivered earlier in the timeframe after IAQ monitoring has initiated.
|
Green Cleaning educational programming to day care staff.
|
|
Jiný: Late Intervention
Educational curriculum will be delivered later in the timeframe after IAQ monitoring has initiated.
|
Green Cleaning educational programming to day care staff.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Alterations in total Volatile Organic Compounds (tVOC) temporally associated with the educational intervention
Časové okno: 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
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Assessment of Cleaning Practices (including VOC generation) practice changes associated with the Educational Intervention
Časové okno: 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
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before educational curriculum, up to 4 months following educational intervention
|
|
Assessment of Perceived Obstacles to Cleaning Behavior Change
Časové okno: immediately following educational intervention
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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
Časové okno: immediately following educational intervention
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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)
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immediately following educational intervention
|
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Baseline Description of Day Care Indoor Air Quality tVOC
Časové okno: period of time before educational intervention (1-2 months)
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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
Časové okno: 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)
|
Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Anne Dressel, PhD, University of Wisconsin-Milwaukee School of Nursing
- Vrchní vyšetřovatel: Joshua Steinberg, MD, Medical College of Wisconsin
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další identifikační čísla studie
- 5520466
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