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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05224076
Other study ID # STUDY00145830
Secondary ID R21ES033118
Status Recruiting
Phase
First received
Last updated
Start date March 30, 2022
Est. completion date October 2023

Study information

Verified date July 2022
Source University of Kansas Medical Center
Contact Barbara J Polivka, PhD
Phone 19135881660
Email bpolivka@kumc.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date October 2023
Est. primary completion date March 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

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).

Locations

Country Name City State
United States Barbara J Polivka Kansas City Kansas

Sponsors (2)

Lead Sponsor Collaborator
University of Kansas Medical Center National Institute of Environmental Health Sciences (NIEHS)

Country where clinical trial is conducted

United States, 

References & Publications (5)

Eldeirawi K, Huntington-Moskos L, Nyenhuis SM, Polivka B. Increased disinfectant use among adults with asthma in the era of COVID-19. J Allergy Clin Immunol Pract. 2021 Mar;9(3):1378-1380.e2. doi: 10.1016/j.jaip.2020.12.038. Epub 2020 Dec 29. — View Citation

Gharpure R, Hunter CM, Schnall AH, Barrett CE, Kirby AE, Kunz J, Berling K, Mercante JW, Murphy JL, Garcia-Williams AG. Knowledge and Practices Regarding Safe Household Cleaning and Disinfection for COVID-19 Prevention - United States, May 2020. MMWR Morb Mortal Wkly Rep. 2020 Jun 12;69(23):705-709. doi: 10.15585/mmwr.mm6923e2. — View Citation

Le Moual N, Varraso R, Siroux V, Dumas O, Nadif R, Pin I, Zock JP, Kauffmann F; Epidemiological Study on the Genetics and Environment of Asthma. Domestic use of cleaning sprays and asthma activity in females. Eur Respir J. 2012 Dec;40(6):1381-9. doi: 10.1183/09031936.00197611. Epub 2012 Apr 10. — View Citation

Matulonga B, Rava M, Siroux V, Bernard A, Dumas O, Pin I, Zock JP, Nadif R, Leynaert B, Le Moual N. Women using bleach for home cleaning are at increased risk of non-allergic asthma. Respir Med. 2016 Aug;117:264-71. doi: 10.1016/j.rmed.2016.06.019. Epub 2016 Jun 25. — View Citation

Zock JP, Plana E, Jarvis D, Antó JM, Kromhout H, Kennedy SM, Künzli N, Villani S, Olivieri M, Torén K, Radon K, Sunyer J, Dahlman-Hoglund A, Norbäck D, Kogevinas M. The use of household cleaning sprays and adult asthma: an international longitudinal study. Am J Respir Crit Care Med. 2007 Oct 15;176(8):735-41. Epub 2007 Jun 21. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Home environmental exposure to Volatile organic compounds Degree of home exposures to volatile organic compounds as measured by the Awair home air quality monitor Measured continuously for 14 days
Primary Home environmental exposure to particulate matter (PM) Degree of home exposures to PM2.5 as measured by the Awair home air quality monitor Measured continuously for 14 days
Primary Asthma control Forced Expiratory Volume (FEV) Percent predicted as measured by ZEPHYRx home spirometer Assessed daily for 14 days
Secondary Usability of study tools 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 14 days
Secondary Compliance with Ecological Momentary Assessment (EMA) prompts Frequency of responses to daily scheduled, random, and air quality triggered EMA prompts Compliance over 4-hour periods for 14 days
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