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Residential Ventilation Systems and Filtration for Asthma Control in Adults

Primary Purpose

Asthma, Pollution; Exposure

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Residential mechanical ventilation system (Exhaust)
Residential mechanical ventilation system (CFIS) and air filtration upgrades
Residential mechanical ventilation system (ERV) and air filtration upgrades
Sponsored by
Illinois Institute of Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring Adult asthma, Home intervention, Mechanical ventilation, Air filtration, Indoor air pollution exposures

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Illinois Institute of Technology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Intervention (Exhaust-only ventilation)

Intervention (Central-fan-integrated-supply ventilation)

Intervention (Balanced energy recovery ventilation)

Arm Description

A study group with a continuous exhaust-only ventilation system

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

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

Outcomes

Primary Outcome Measures

Asthma Control
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

Health-Related Quality of Life
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.
Stress
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.
Asthma medications
Asthma medications via survey
Comorbidities
Comorbidities via survey

Full Information

First Posted
October 14, 2023
Last Updated
October 19, 2023
Sponsor
Illinois Institute of Technology
Collaborators
Elevate
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1. Study Identification

Unique Protocol Identification Number
NCT06098287
Brief Title
Residential Ventilation Systems and Filtration for Asthma Control in Adults
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
November 30, 2020 (Actual)
Study Completion Date
November 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Illinois Institute of Technology
Collaborators
Elevate

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma, Pollution; Exposure
Keywords
Adult asthma, Home intervention, Mechanical ventilation, Air filtration, Indoor air pollution exposures

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A quasi-randomized, within-subjects, parallel-group, pre-post intervention study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention (Exhaust-only ventilation)
Arm Type
Active Comparator
Arm Description
A study group with a continuous exhaust-only ventilation system
Arm Title
Intervention (Central-fan-integrated-supply ventilation)
Arm Type
Active Comparator
Arm Description
A study group with an intermittent central-fan-integrated-supply ventilation system and air filtration upgrades
Arm Title
Intervention (Balanced energy recovery ventilation)
Arm Type
Active Comparator
Arm Description
A study group with a continuous balanced energy recovery ventilation system and air filtration upgrades
Intervention Type
Device
Intervention Name(s)
Residential mechanical ventilation system (Exhaust)
Intervention Description
Exhaust-only ventilation system
Intervention Type
Device
Intervention Name(s)
Residential mechanical ventilation system (CFIS) and air filtration upgrades
Intervention Description
Central-fan-integrated-supply ventilation system and air filtration upgrades (MERV 10)
Intervention Type
Device
Intervention Name(s)
Residential mechanical ventilation system (ERV) and air filtration upgrades
Intervention Description
Balanced energy recovery ventilation system and air filtration upgrades (MERV 10)
Primary Outcome Measure Information:
Title
Asthma Control
Description
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")
Time Frame
Each month throughout the study completion, an average of 2 years (24 months)
Secondary Outcome Measure Information:
Title
Health-Related Quality of Life
Description
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.
Time Frame
Baseline (July 2017) and end-line (March 2020, end of study completion)
Title
Stress
Description
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.
Time Frame
Baseline (July 2017) and end-line (March 2020, end of study completion)
Title
Asthma medications
Description
Asthma medications via survey
Time Frame
Baseline (July 2017) and end-line (March 2020, end of study completion)
Title
Comorbidities
Description
Comorbidities via survey
Time Frame
Baseline (July 2017) and end-line (March 2020, end of study completion)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Illinois Institute of Technology
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60616
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Residential Ventilation Systems and Filtration for Asthma Control in Adults

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