Durham Healthy Breathing in Healthy Homes Project (DHBHH)
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|ClinicalTrials.gov Identifier: NCT04119271|
Recruitment Status : Not yet recruiting
First Posted : October 8, 2019
Last Update Posted : March 24, 2021
To determine if Home-based Environmental Interventions (HEI) that improve home air-quality problems can improve asthma outcomes. Participants will benefit through home-based environmental interventions that improve home air-quality problems and improve asthma outcomes. All participants will receive a Breath Easy at Home Kit, which could help with reducing environmental exposures. The primary objective is to assess the feasibility and acceptability of the HEI measured by the proportion of families completing intervention components and proportion of caregivers expressing satisfaction with intervention components. Secondary objective is to explore the efficacy of a HEI on reducing environmental exposures measured using personal wristband monitors.
Exploratory objective is improvements in asthma control following HEI measured using asthma control scores and lung function. The fourth objection is to explore correlations between demographics, body weight, housing characteristics (smokers, electronic cigarette use, number of pets, housing type) with measures of acceptability, satisfaction and improved exposure markers.
|Condition or disease||Intervention/treatment||Phase|
|Poor Asthma Control||Other: Breathe Easy at Home Kit Products||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Durham Healthy Breathing in Healthy Homes Project: A Duke-Reinvestment Partners Collaborative|
|Estimated Study Start Date :||July 2021|
|Estimated Primary Completion Date :||March 2, 2022|
|Estimated Study Completion Date :||March 2, 2022|
Breathe Easy at Home Kit Products
Families will be provided with a Breathe Easy at Home Kit. These kits will include:
a HEPA filtered upright vacuum cleaner, a HEPA-filtered Air Purifier, a Hypoallergenic latex free mattress cover, box spring cover, and two pillow covers, Healthier alternative to most household cleaners, Non- toxic glue type pest control devices for rodent control, and a combination of safe products to locate and kill roaches.
Other: Breathe Easy at Home Kit Products
HEPA filtered upright vacuum cleaner, HEPA-filtered Air Purifier, Hypoallergenic latex free mattress cover, box spring cover, and two pillow covers, Healthier alternative to most household cleaners, Non- toxic glue type pest control devices for rodent control and a combination of safe products to locate and kill roaches.
- Number of completed home visits as measured by completion logs [ Time Frame: 2 months ]
- Number of completion of the post-intervention phone visit as measured by call logs [ Time Frame: Four Months ]
- Number of caregiver reporting satisfaction with intervention as measured by survey responses [ Time Frame: Four Month ]
- Change in Environmental Wristband Markers [ Time Frame: 3 weeks and 7 weeks ]changes in targeted environmental wristband markers of exposure to organic contaminants in the home environment, including phthalates, organophosphate esters, several pesticides, and polyaromatic hydrocarbon (PAH) markers evaluated using personal silicone wristband monitors. Paired t-tests (or Wilcoxon signed rank tests for non-parametric data) will be used to assess post-intervention changes in targeted wristbands toxin levels.The relationship between changes in these outcomes and measures of intervention adherence will be analyzed using Pearson correlations and ANOVA trend testing as appropriate.
- Change in Indoor Air Quality measured by questionnaire [ Time Frame: 3 weeks and 7 weeks ]Sponsor developed questionnaire-15 to 20 questions asking about air quality.
- Change in Asthma Symptoms [ Time Frame: 1 week and 4 months ]Change in asthma symptom control measured by the asthma control questionnaire 6 (ACQ6) (ambulatory participants only).
- Change in Spirometry Values as measured by spirometric measures [ Time Frame: 1 week and 4 months ]Impulse Oscillometry (IOS) simply requires the child to breathe in and out through a mouthpiece for 20-30 seconds. During breathing, a loudspeaker delivers a quiet pulse-shaped pressure-flow signal to the respiratory system. Spirometric measures is the forced vital capacity (FVC),
- Change in Asthma Symptoms [ Time Frame: 1 week and 4 months ]Improvements in asthma control following HEI measured using asthma control scores and lung function. For patients enrolled in the ambulatory setting, change in FEV1, FEV1/FVC by spirometry will be calculated.
- Change in Spirometry Values as measured by spirometric measures [ Time Frame: 1 week and 4 months ]The Spirometer measure is theforced expiratory volume in 1 second (FEV1),
- Change in Spirometry Values as measured by spirometric measures [ Time Frame: 1 week and 4 months ]The Spirometeric Measure is the FEV1/FVC ratio
- Change in Spirometry Values as measured by spirometric measures [ Time Frame: 1 week and 4 months ]The Spirometric Measure is the forced expiratory flow average over 25-75% of FVC (FEF25-75).
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): NCT04119271
|Contact: Nedenia C Parker, BSfirstname.lastname@example.org|
|Principal Investigator:||Jason E Lang, MD, MPH||Duke University|