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Home Air Quality Impact for Adults With Asthma

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ClinicalTrials.gov Identifier: NCT05224076
Recruitment Status : Recruiting
First Posted : February 4, 2022
Last Update Posted : July 11, 2022
Sponsor:
Collaborator:
National Institute of Environmental Health Sciences (NIEHS)
Information provided by (Responsible Party):
University of Kansas Medical Center

Brief Summary:
The purposes of this study are to determine the practicality of using home indoor air quality monitoring and a smartphone app to identify home air quality changes and how these changes affect adults with asthma.

Condition or disease Intervention/treatment
Asthma Environmental Exposure Home Environment Related Disease Other: Home Air Quality

Detailed Description:
The aims of this feasibility study are: 1) determine the feasibility and usability of: (a) ecological momentary assessment (EMA) to assess self-report residential environmental exposures and asthma symptoms, (b) home monitoring of objective environmental exposures (total volatile organic compounds [VOCs], particulates [PM2.5]), and lung function (home spirometry); 2a) assess the frequency and degree of residential environmental exposures (e.g., disinfectants/cleaners, second-hand smoke) via (a) self-reported data, and (b) home monitoring objective measures, 2b) assess the level of asthma control as indicated by self-reported asthma symptoms and lung function; and 3) explore associations of self-reported and objective measures of residential environmental exposures with self-reported and objective measures of asthma control. Participants will receive an indoor air quality monitor and a home spirometer to measure VOCs, PM2.5, and forced expiratory volume percent predicted, respectively. EMA will be collected using a personal smartphone and EMA software platform. Participants' will be sent scheduled and random EMA notifications to assess asthma symptoms, environmental exposures, lung function, and mitigation strategies. After the 14-day data collection period, participants will respond to survey items related acceptability, appropriateness, and feasibility.

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Changing COVID-19 Landscape: A Feasibility Study to Capture Momentary Residential Environmental Exposures and Asthma Symptoms in Adults
Actual Study Start Date : March 30, 2022
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : October 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma


Intervention Details:
  • Other: Home Air Quality
    This study will assess the feasibility and usability of ecological momentary assessment (EMA) to capture the context of real time behaviors and environmental exposures that impact indoor environments. In addition, the study will assess the feasibility and usability of providing participants with a readily available indoor home air quality monitor to continuously capture total volatile organic compounds (VOCs) and particulates (PM2.5).


Primary Outcome Measures :
  1. Home environmental exposure to Volatile organic compounds [ Time Frame: Measured continuously for 14 days ]
    Degree of home exposures to volatile organic compounds as measured by the Awair home air quality monitor

  2. Home environmental exposure to particulate matter (PM) [ Time Frame: Measured continuously for 14 days ]
    Degree of home exposures to PM2.5 as measured by the Awair home air quality monitor

  3. Asthma control [ Time Frame: Assessed daily for 14 days ]
    Forced Expiratory Volume (FEV) Percent predicted as measured by ZEPHYRx home spirometer


Secondary Outcome Measures :
  1. Usability of study tools [ Time Frame: 14 days ]
    Adapted System Usability Scale, 30 items assessing usability of the ZEPHYRx home spirometer, Awair home air quality monitor, and the EMA - with response options of 1= Strongly agree to 5=Strongly Disagree

  2. Compliance with Ecological Momentary Assessment (EMA) prompts [ Time Frame: Compliance over 4-hour periods for 14 days ]
    Frequency of responses to daily scheduled, random, and air quality triggered EMA prompts



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adults with asthma living in the US
Criteria

Inclusion Criteria:

  • Adults who previously participated in the online Global Covid-19 and Asthma Study, indicated willingness to be contacted for future research, and reported high use of disinfectant/cleaning products since COVID-19 (≥5 per week).
  • Current Asthma Control Test (ACT) ≤19
  • Own a smartphone
  • Have a Wi-Fi/wireless internet connection in their home.

Exclusion Criteria:

  • Non-US residents
  • Non-English speaking

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05224076


Contacts
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Contact: Barbara J Polivka, PhD 19135881660 bpolivka@kumc.edu
Contact: Kamal Eldeirawi, PhD 3129967800 keldei1@uic.edu

Locations
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United States, Kansas
Barbara J Polivka Recruiting
Kansas City, Kansas, United States, 66160
Contact: Barbara J Polivka    913-588-1660    bpolivka@kumc.edu   
Sponsors and Collaborators
University of Kansas Medical Center
National Institute of Environmental Health Sciences (NIEHS)
Investigators
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Principal Investigator: Barbara Polivka, PhD Select
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT05224076    
Other Study ID Numbers: STUDY00145830
R21ES033118 ( U.S. NIH Grant/Contract )
First Posted: February 4, 2022    Key Record Dates
Last Update Posted: July 11, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: To maximize the utility of this research, and in the interests of allowing other researchers and the public to benefit from it, the investigators will make the entire protocol and deidentified dataset available to researchers.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Up to 24 months after the publication of the main study findings.
Access Criteria: Requests for IPD will be reviewed by the MPIs once a formal email request is submitted for research addressable aims/questions/hypotheses. Once the request has been approved by the MPIs and IRB approval is obtained, only deidentified data relevant to the research questions will be shared for secondary analyses deemed appropriate by the MPIs.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Kansas Medical Center:
volatile organic compounds
particulate matter
home air quality
asthma control
ecological momentary assessment
home air quality monitoring
smartphone technology
home spirometry
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases