NCT03675009

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 10, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 18, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2019

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 19, 2019

Completed
Last Updated

April 22, 2019

Status Verified

April 1, 2019

Enrollment Period

12 months

First QC Date

July 10, 2018

Last Update Submit

April 19, 2019

Conditions

Pollution; Exposure

Keywords

Child Day Care CentersIndoor Air QualityEducational Intervention

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (5)

  • Assessment of Cleaning Practices (including VOC generation) practice changes associated with the Educational Intervention

    before educational curriculum, up to 4 months following educational intervention

  • Assessment of Perceived Obstacles to Cleaning Behavior Change

    immediately following educational intervention

  • Assessment of Percieved Quality of Educational Program

    immediately following educational intervention

  • Baseline Description of Day Care Indoor Air Quality tVOC

    period of time before educational intervention (1-2 months)

  • Baseline Description of Day Care Indoor Air Quality PM2.5

    period of time before educational intervention (1-2 months)

Study Arms (2)

Early Intervention

OTHER

Educational curriculum will be delivered earlier in the timeframe after IAQ monitoring has initiated.

Other: Educational Programming

Late Intervention

OTHER

Educational curriculum will be delivered later in the timeframe after IAQ monitoring has initiated.

Other: Educational Programming

Interventions

Educational ProgrammingOTHER

Green Cleaning educational programming to day care staff.

Early InterventionLate Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • licensed child day care staff within Milwaukee County
  • authorized consent to participate in study by day care organization

You may not qualify if:

  • medical or adult day care centers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Study Officials

  • Anne Dressel, PhD

    University of Wisconsin-Milwaukee School of Nursing

    PRINCIPAL INVESTIGATOR

  • Joshua Steinberg, MD

    Medical College of Wisconsin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Masking Details
Participants and education providers will be unaware whether they are in an early or late delivery of education randomization group.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SEQUENTIAL
Model Details: stepped wedge
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 10, 2018

First Posted

September 18, 2018

Study Start

April 1, 2018

Primary Completion

March 31, 2019

Study Completion

April 19, 2019

Last Updated

April 22, 2019

Record last verified: 2019-04

Locations

US(1)