Residential Ventilation Systems and Filtration for Asthma Control in Adults

Sponsor
Illinois Institute of Technology (Other)
Overall Status
Completed
CT.gov ID
NCT06098287
Collaborator
Elevate (Other)
51
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Study Details

Study Description

Brief Summary

The goal of this study was to investigate the effectiveness of three common approaches to upgrading residential mechanical ventilation systems in existing homes for improving asthma-related health outcomes, reducing indoor pollutants of both indoor and outdoor origin, and maintaining adequate environmental conditions and ventilation rates in a cohort of adult asthmatics in existing homes in Chicago, IL.

Condition or Disease Intervention/Treatment Phase
  • Device: Residential mechanical ventilation system (Exhaust)
  • Device: Residential mechanical ventilation system (CFIS) and air filtration upgrades
  • Device: Residential mechanical ventilation system (ERV) and air filtration upgrades
N/A

Detailed Description

The Breathe Easy Study utilized a quasi-randomized, within-subjects, parallel-group, pre-post intervention study design with four weeklong periods of indoor air quality (IAQ) and indoor environmental data collection for approximately one year before the installation of mechanical ventilation systems, followed by four weeklong periods of IAQ and indoor environmental data collection for approximately one year after the installation of mechanical ventilation systems, conducted from July 2017 through March 2020 in Chicago, IL. With the nature of a healthy home intervention study by installing residential mechanical ventilation systems within the timeframe, each participant received interventions in the middle of the study period, including continuous exhaust-only systems; intermittent powered central-fan-integrated-supply (CFIS) systems; or continuous balanced systems with an energy recovery ventilator. Thus, each participant served as their own control and there was no formal control group that did not receive intervention nor did they receive a sham/placebo intervention. Primary health outcome, asthma control, was assessed by using the Asthma Control Test (ACT) every month, and quality of life, stress, and other asthma-related health outcomes were assessed via the baseline and end-line surveys.

Study Design

Study Type:
Interventional
Actual Enrollment :
51 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
A quasi-randomized, within-subjects, parallel-group, pre-post intervention studyA quasi-randomized, within-subjects, parallel-group, pre-post intervention study
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Cost-effective Approaches to Upgrading Residential Mechanical Ventilation Systems to Control Indoor Pollutants of Both Indoor and Outdoor Origin and Improve Asthma-related Health Outcomes
Actual Study Start Date :
Jan 1, 2017
Actual Primary Completion Date :
Nov 30, 2020
Actual Study Completion Date :
Nov 30, 2020

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Intervention (Exhaust-only ventilation)

A study group with a continuous exhaust-only ventilation system

Device: Residential mechanical ventilation system (Exhaust)
Exhaust-only ventilation system

Active Comparator: Intervention (Central-fan-integrated-supply ventilation)

A study group with an intermittent central-fan-integrated-supply ventilation system and air filtration upgrades

Device: Residential mechanical ventilation system (CFIS) and air filtration upgrades
Central-fan-integrated-supply ventilation system and air filtration upgrades (MERV 10)

Active Comparator: Intervention (Balanced energy recovery ventilation)

A study group with a continuous balanced energy recovery ventilation system and air filtration upgrades

Device: Residential mechanical ventilation system (ERV) and air filtration upgrades
Balanced energy recovery ventilation system and air filtration upgrades (MERV 10)

Outcome Measures

Primary Outcome Measures

  1. Asthma Control [Each month throughout the study completion, an average of 2 years (24 months)]

    Asthma Control Test (ACT) is a 5-item clinically validated survey, which is designed to measure the multi-dimensional nature of asthma control, including asthma symptoms, utilization of rescue medications, and the impact of asthma on daily functioning. The ACT score ranges from 5 ("poor control of asthma") to 25 ("complete control of asthma")

Secondary Outcome Measures

  1. Health-Related Quality of Life [Baseline (July 2017) and end-line (March 2020, end of study completion)]

    12-Item Short Form Survey (SF-12) measures eight concepts commonly represented in widely used surveys: general health, physical functioning, bodily pain, vitality (energy/fatigue), social functioning, role limitations due to physical and emotional problems, and mental health (psychological distress and psychological well-being). Both the SF-12 physical (PCS) and mental (MCS) component summary scales use norm-based scoring, 0-100, with higher scores indicating better physical and mental health functioning.

  2. Stress [Baseline (July 2017) and end-line (March 2020, end of study completion)]

    Perceived Stress Scale (PSS) is a 10-item psychological assessment to understand how unpredictable, uncontrollable, and overloaded participants find their lives. The PSS score ranges from 0 to 40 with higher scores indicating higher perceived stress, and scores ranging from 0 to 13, from 14 to 26, and from 27 to 40 are considered low, moderate, and high perceived stress, respectively.

  3. Asthma medications [Baseline (July 2017) and end-line (March 2020, end of study completion)]

    Asthma medications via survey

  4. Comorbidities [Baseline (July 2017) and end-line (March 2020, end of study completion)]

    Comorbidities via survey

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Age: 18 - 90+ years.

  • English speaking and writing.

  • Able to provide consent.

  • Chicago resident.

  • Households with at least one occupant with asthma

  • Non-smoking houses

  • Participant-owned houses

  • Participant's agreement to surveys and IAQ monitoring over 2 years

Exclusion Criteria:
  • Houses outside Chicago, IL USA

  • Houses with significant health and safety issues

Contacts and Locations

Locations

Site City State Country Postal Code
1 Illinois Institute of Technology Chicago Illinois United States 60616

Sponsors and Collaborators

  • Illinois Institute of Technology
  • Elevate

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Brent Stephens, Professor and Department Chair, Illinois Institute of Technology
ClinicalTrials.gov Identifier:
NCT06098287
Other Study ID Numbers:
  • IIT IRB2019-001
  • ILHHU0031-16
  • P-0136
First Posted:
Oct 24, 2023
Last Update Posted:
Oct 24, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Brent Stephens, Professor and Department Chair, Illinois Institute of Technology
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 24, 2023